NuvaRing, 3 pcs., 15 mcg+120 mcg/24 h, vaginal rings

Dear readers, I am very pleased with your active interest! You ask questions that I haven’t asked myself, allow me to look at the problem from a different angle, contribute to the realization of several of my highest needs according to Abraham Maslow, stimulate interest in mastering new and clarifying known information, and give impetus to growth and development! Thank you! Let's continue to grow and develop together. They say correctly, one mind is good, but... the more, the better!

I was very pleased by the request to share knowledge about the well-known vaginal hormonal ring. At first, the request surprised me very much, since the ring is very similar in its mechanism of action, indications and contraindications to combined oral contraceptives (COCs) (therefore, the corresponding analogy will be given very often in the text). And then I got carried away with searching for differences: as it turned out, in addition to the route of administration, there were several more. Dear reader, who asked the question, the birth of this article is entirely your merit!

In order to save your time, at the end I have given the quintessence of what was written. So, if you don’t have time for lyrics and explanations, you are welcome to scroll down the main text. And, dear readers, I ask for feedback on the summary at the end, will this format of my future publications be pleasant to read?

Also, during the course of the main text, I decided to ask you questions, and I will be very glad to see your answers!

Question 1: Do you use hormonal contraception? If the answer is yes, then what is her option? And are you satisfied?

Hormone ring on the agenda

This publication, despite my generally positive opinion about the drug, is in no way an advertisement. I’ll honestly tell you about the positive and negative sides of this option for protecting against unwanted pregnancy.

The vaginal hormonally active ring refers to combined hormonal contraceptives, with an alternative option for the supply of hormones to COCs. The drug is a flexible ring with a diameter of 54 mm, consisting of a hypoallergenic material (ethynyl vinyl acetate) used for the manufacture of implants.

The contraceptive, like COCs, contains two active components: estrogenic (ethinyl estradiol) and gestagenic (etonogestrel).

The drug has no analogues in our country. More than one and a half million women around the world use this particular contraceptive option, and the world experience of use spans 18 years.

Risk group for the development of uterine and vaginal prolapse

Women who have aggravating factors that contribute to the development of POP are at risk.

Risk factors

• Childbirth with a large fetus, traumatic birth, rapid labor, multiple pregnancies, multiparous women;
• Hard physical work, sports;
• Sedentary lifestyle and work (doctors, teachers, office workers, etc.);
• Connective tissue dysplasia;
• Obesity;
• Chronic constipation and cough (chronic bronchitis, smoking);
• Age over 45 years - hypoestrogenism and associated dystrophic changes in the tissues of the pelvic floor and lower parts of the genitourinary system.

READ SUMMARY

Consultation and treatment of women with pelvic organ prolapse in our clinic is carried out by a regional representative of the Pelvioperinatology Center (St. Petersburg):

Why are they looking for an alternative to birth control pills?

The search for alternative options for the use of combined contraception is due to the fact that not every woman is satisfied with daily oral administration of the drug.

1. Not everyone is so disciplined that they have never missed a pill, at least among my patients - only a few are able to take the drug at the same time.
2. Moreover, the passage of the drug through the stomach and primarily through the hepatic circulation, whatever one may say, is an additional burden on the above organs.
3. And the most justified reason for searching for a non-tablet method of introducing the drug into the body: the search for the minimum effective dose of active ingredients. I know of only one oral drug that is equivalent in dose to the vaginal ring of ethinyl estradiol. The lower the hormonal load and systemic exposure, the safer the drug profile.

Indications

The introduction of a gynecological pessary is indicated for the following reasons:

• prolapse and prolapse of the uterine body;
• urinary incontinence;
• presence of contraindications for surgical treatment;
• the threat of spontaneous abortion, which is provoked by isthmic-cervical insufficiency;
• in case of categorical refusal of the patient from the operation;
• for preliminary treatment of gynecological diseases before surgery.

Mechanism of action of the vaginal ring

1. The basis is the suppression of ovulation by maintaining a constant concentration of sex steroids in the peripheral blood and reducing the production of gonadotropic hormones (without their participation, ovulation becomes impossible).
2. The second mechanism is the thickening of the mucus located in the cervical canal of the cervix, which makes it difficult for sperm to move into the uterine cavity and fallopian tubes.
3. In addition, changes occur in the endometrium (the mucous membrane of the uterus), leading to the impossibility of implantation (introduction) of the fertilized egg and the development of pregnancy.
4. The motor activity of the fallopian tubes also changes, which slows down the movement of sperm.

Other conservative treatments for pelvic organ prolapse

When a diagnosis of pelvic organ prolapse is made, it is recommended to carry out protective measures aimed at reducing increased intra-abdominal pressure.

Preventive actions

• Lifestyle changes and weight loss;
• Reducing the intensity of physical activity (limiting heavy lifting);
• Change of occupation - transfer to light work;
• Prevention of constipation and respiratory diseases accompanied by a chronic increase in abdominal pressure.

Exercises to strengthen the pelvic floor muscles

In the initial stages of prolapse of the vaginal walls, it is possible to perform exercises to strengthen the pelvic floor muscles (Kegel exercises). These exercises are effective only in the early stages of the disease when the muscles of the pelvic floor and the tendon center of the perineum are preserved. If the pelvic floor muscles are incompetent, these exercises will only do harm - they will lead to the progression of pelvic organ prolapse.

Physiotherapy

There are various methods of influencing physical factors (laser, magnetic field) on the vaginal walls and underlying tissues. This method can lead to a reduction in the degree of prolapse by improving tissue nutrition - increasing the tone of the pelvic floor. The use of physical factors is effective in the early stages of the disease, when there are still no complaints and the diagnosis is made only upon examination in a chair.

Physiotherapy is widely used as a recovery stage after surgical treatment and in the prevention of the development of prolapse in the postpartum period.

Volume-forming methods based on hyaluronic acid

The method is used to treat urinary incontinence in the early stages of the disease. It consists of creating additional support for the urethra during stress urinary incontinence through tissue tension by creating additional volume. The effect is temporary, from 6 to 8 months. for hyaluronic acid fillers, up to a year or more for lipofilling.

Injections and fillers of hyaluronic acid are used to treat degenerative processes in the tissues of the perineum and pelvic floor; the effect is very pronounced but also temporary.

All of these methods are prescribed when a diagnosis has been established, after a preliminary examination, because they have contraindications. The most pronounced effect can be achieved by combining these techniques, taking into account contraindications to each of them. It is not possible to do this on your own! We recommend that all women at risk undergo a specialized consultation with a gynecologist at the Androgynecological Clinic to identify pelvic organ prolapse

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What is the reason for the creation of a vaginal hormonal ring?

The choice of the vaginal route of drug administration is determined by the anatomical and functional features of the vagina.

The vagina is anatomically a hollow connective tissue-muscular tube, truncated in the upper third, 10-12 cm long, covered with a folded mucous membrane, which provides good extensibility of the walls and significant capacity of the organ. Just imagine, physiologically it is created to carry out one of the most important functions of a woman - reproduction! During vaginal delivery, the vagina stretches to the size of the head of a full-term fetus: diameter 9.5 cm, circumference 32 cm! Do you think a woman will feel a ring with a diameter of 54 mm?

It is also known that the temperature and tactile sensitivity of the vagina in the upper two-thirds is reduced, and the upper third of the vagina is located horizontally. This indicates that the ring will not fall out and will not be felt by the woman (although anything can happen in life!).

The ring is also held in place by the muscles of the urogenital and pelvic diaphragms and the physiologically closed vaginal walls. The vaginal mucosa is well supplied with blood, which creates favorable conditions for the absorption of active substances into the systemic circulation.

How to install a vaginal ring?

The ring is elastic and for insertion into the vagina it is enough to squeeze it in the anteroposterior direction between the thumb and forefinger and insert it vaginally like a regular tampon.

Next, use your index finger to push the ring into the upper third of the vagina or to a comfortable position.

Next, the contraceptive will independently take the required position in the vagina, more often around the cervix, this fact was confirmed by the manufacturer based on the results of MRI studies of the subjects.

Details of the position of the ring will not affect the contraceptive effect, as long as it remains in the vagina.

Typically, patients do not have any difficulties with inserting and removing the ring. But it happens that the first time the master class is conducted at an appointment by a gynecologist, then women successfully use the method on their own.

Rules for using vaginal pessaries

Vaginal rings can be left in the vagina for up to 5-6 days; cubic and mushroom-shaped pessaries cannot be worn for more than 24 hours; they are removed daily before bed! If a woman does not need the ring while sleeping, it is also removed. After removal, the pessary should be washed under warm running water and soap and dried. It should be stored in a plastic container or bag.

The pessary is inserted in the morning in a standing position with a raised leg or squatting, this is described in detail in the video above. To facilitate insertion, you can use a hygienic gel.

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How effective is the hormonal ring?

The content of hormones in each ring is designed to guarantee stable maintenance of the required concentrations of active substances in the systemic circulation for the implementation of a contraceptive effect.

The maximum is reached during the first week of use, decreasing slightly by the end of the third week.

15 mcg of ethinyl estradiol and 120 mcg of etonogestrel are released daily, which is less than most COCs.

Moreover, the effectiveness of this method of contraception is comparable to that when using COCs.

The ring must remain in the vagina for three weeks, after which it must be removed, which is not difficult at all.

Next, you need to take a seven-day break, and then reintroduce a new contraceptive.

If you need to delay the onset of a menstrual-like reaction, you, as when using COCs, can do this by inserting a new ring immediately after removing the contraceptive. Naturally, the duration of its presence in the vagina should also be three weeks.

Nuvaring

Vaginal ring for contraception. Used intravaginally. Contains ethinyl estradiol (estrogen) and etonogestrel (gestagen). The contraceptive effect is achieved by suppressing ovulation. In addition to the main effect, Nuvaring has a positive effect on the menstrual cycle, makes it regular, reduces the intensity of bleeding and pain. It also reduces iron deficiency in the body and reduces the risk of endometrial and ovarian cancer.

Reception scheme

Nuvaring is inserted into the vagina and remains there for three weeks. The insertion and removal of the ring occurs on the same day of the week. After removing the ring, you need to take a week's break, during which withdrawal bleeding occurs - it usually begins after 2-3 days and may not stop by the time a new ring needs to be inserted. The new ring is inserted on the same day of the week on which the first ring was inserted. Thus, the menstrual cycle is exactly four weeks.

To insert the ring into the vagina, a woman should choose a comfortable position. This can be done, for example, standing, raising one leg, squatting, or lying down. Nuvaring should be lightly squeezed with your fingers and inserted into the vagina. There are no rules or regulations for the location of the ring - the main thing is that the woman is comfortable. The contraceptive effect will be present in any case. After insertion, the ring must remain in the vagina continuously for 3 weeks.

It is convenient to remove the ring by picking it up with your index finger, or pressing it between the index and middle fingers. If the ring was accidentally removed ahead of schedule (for example, when removing a tampon), it should be rinsed with warm water and placed in the vagina as quickly as possible.

Side effects when using Nuvaring may be as follows:

• headache, migraine, dizziness;
• depression, emotional instability, irritability, anxiety, feeling tired;
• nausea, abdominal pain, diarrhea, vomiting;
• decreased libido;
• soreness, tension and enlargement of the mammary glands;
• change in body weight;
• vaginal discharge, cervicitis;
• fear of sexual intercourse, discomfort during sexual intercourse;
• urinary tract infections (including cystitis).

Contraindications are:

• thrombosis and thromboembolism;
• migraine with focal neurological symptoms;
• diabetic angiopathy;
• pancreatitis in combination with a high degree of hypertriglyceridemia (LDL concentration more than 500 mg/dL);
• severe liver diseases, liver tumors;
• hormone-dependent malignant tumors (established or suspected);
• vaginal bleeding of unknown etiology.

Nuvaring cannot be used during pregnancy and breastfeeding.

Nuvaring may be recommended for use with extreme caution and close monitoring in the following cases:

• diabetes mellitus;
• obesity;
• high blood pressure;
• atrial fibrillation, heart defects;
• dyslipoproteinemia;
• liver or gallbladder diseases;
• Crohn's disease or ulcerative colitis;
• sickle cell anemia;
• systemic lupus erythematosus;
• hemolytic uremic syndrome;
• epilepsy;
• fibrocystic mastopathy;
• uterine fibroids;
• congenital hyperbilirubinemia (Gilbert, Dubin-Johnson and Rotor syndrome);
• chloasma.

For women over 35 who smoke, Nuvaring is not the drug of choice.

In cases of prolonged immobilization and major surgical interventions, Nuvaring is not recommended.

Start of reception

If hormonal contraceptives were not used in the previous menstrual cycle, Nuvaring is administered from the first to the fifth day of menstruation. Within a week from the date of insertion of the ring, it is recommended to additionally use barrier methods of protection.

If hormonal oral contraceptives were used in the previous period, Nuvaring is administered on the day on which the first tablet from the new package of the drug could have been taken. If you are taking a biphasic drug, Nuvaring is administered the day after the last placebo tablet.

If you used progestin oral contraceptives (mini-pills) in the previous period, then switching to Nuvaring can be done on any day.

If an implant was used in the previous period, then Nuvaring should be administered the next day after removal of the implant.

If an injection method of contraception was used in the previous period, then Nuvaring is administered on the day when the next injection could have been given.

If a progestin intrauterine device was used in the previous period, then Nuvaring should be administered the next day after removal of the IUD.

In all cases of previous progestin contraception (mini-pill, implant, injection, IUD), it is recommended to additionally protect yourself with barrier methods during the first week of using Nuvaring.

After an abortion performed in the first trimester of pregnancy, Nuvaring can be administered immediately. No additional precautions are required.

After childbirth or abortion performed in the second trimester of pregnancy, you should wait three weeks and administer Nuvaring in the fourth week. If use Additional contraception is not required. However, if you did not start using Nuvaring in the fourth week, you can do it later, while simultaneously using barrier methods of contraception during the first week. If there was sexual intercourse during the postpartum period, pregnancy must be excluded before inserting the ring.

What to do if the regimen for using Nuvaring is forced to be violated?

The contraceptive effect guaranteed by the manufacturer can only be ensured if the drug is used according to the regimen. If the regime is not followed, this effect may be reduced. In such situations, you should adhere to the following recommendations:

If there is a forced break in using the ring for less than three hours, the contraceptive effect is not reduced. The ring needs to be inserted as soon as possible. No other measures are required.

If the break was more than three hours, then you need to place a new ring in the vagina as soon as possible. Additionally, you should use a barrier method of contraception for a week. If there was sexual intercourse during the “no ring” period, pregnancy may occur. If the ring was outside the vagina for more than three hours during the third week of its use, then the pattern of using Nuvaring changes. You need to place the ring in the vagina as soon as possible and remove it seven days after the ring is reinserted (that is, to shift the withdrawal bleeding). After seven days, the ring should be removed and follow the usual pattern: a week's break, then insertion of a new ring.

Please note: if the ring is removed from the vagina for a period of more than three hours during the first week of using the ring, pregnancy may occur.

In cases where the regimen of using the ring was not followed and there is no withdrawal bleeding, it is necessary to do a pregnancy test\.

Important points

Women who use Nuvaring are recommended to visit a gynecologist at least once a year.

If you are prescribed drug therapy, be sure to tell your doctor that you are using Nuvaring. In combination with a number of drugs, it can reduce its contraceptive effect. These are primarily phenytoin, phenobarbital, primidone, carbamazepine, rifampicin, oxcarbazepine, topiramate, felbamate, ritonavir, griseofulvin, preparations with St. John's wort extract, penicillins and tetracyclines. While taking these medications, it is advisable to use barrier methods of protection.

When a vaginal ring causes discomfort

There are situations when a woman feels the ring and its use causes discomfort, which is a reason to refuse the drug.

This happens infrequently, mainly among those who, for the same reasons, do not use tampons. As a doctor, I don’t feel much love for this personal hygiene product due to the fact that discharge from the uterine cavity accumulates in the vagina, which physiologically should leave the body (and in nature nothing is created “just like that”, everything is carefully thought out).

But in the conditions of our life, the occasional use of tampons is a necessity, which is justified in situations where you need to be “on top”.

So, how you feel when using tampons can serve as a predictor of acceptability for the vaginal option of combined contraception.

What are vaginal pessaries and rings

Vaginal pessaries are devices that are placed in the vagina and prevent prolapse of the uterus and vaginal walls. We wrote in detail about prolapse and prolapse of the vaginal walls and uterine prolapse here.

It should be understood that this method does not lead to a cure, it is a kind of “crutch” that helps a woman alleviate the symptoms of the disease and improve the quality of life. The method is simple, understandable and has been used successfully for a long time. Currently, thanks to modern technologies and hypoallergenic (inert) materials, various forms of pessaries have been created for different forms of pelvic organ prolapse (POP) in women (Figure 1). They are also successfully used for stress urinary incontinence (stress).

Figure 1. Various forms of vaginal pessaries

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Can a vaginal ring fall out?

Often ring users, especially in the first months of use, worry about the location of their contraceptive: has it fallen out?

Frankly speaking, this is rare, but it does happen. The manufacturer in the instructions for the drug recommends regularly checking the location of the ring. Checks are especially relevant after sexual intercourse or going to the toilet, as well as if a tampon was suddenly used (although this is unlikely, the drug extremely rarely gives a side effect in the form of spotting) or, perhaps, douching was performed (do not do this, Please!).

None of my patients had such an incident. But, if it does happen, the main task is to return it to its place as soon as possible by rinsing it with cold or warm (but not hot!) water.

There is no need to sterilize the ring. The vagina is not sterile.

NuvaRing®

If any of the following conditions/diseases or risk factors are present, a thorough assessment of the benefit-risk ratio of using the drug NuvaRing® should be carried out and discussed with the woman before starting to use the drug. In case of exacerbation of diseases, deterioration of the condition or the appearance of the first symptoms of conditions/diseases or risk factors, the woman should immediately consult a doctor to decide whether to discontinue or the possibility of further use of the drug.

Risk of developing VTE and ATE

The use of any combined hormonal contraceptives (CHCs) is associated with an increased risk of developing venous and arterial thrombosis and thromboembolism (such as DVT and PE, myocardial infarction, cerebrovascular disorders). These diseases are rare. The use of drugs containing levonorgestrel, norgestimate or norethisterone as a progestogen component has the lowest risk of developing VTE.

The use of other medications, such as NuvaRing®, can double the risk of developing this complication. An increased risk is present after initial use of CHCs or resumption of use after a break of 4 weeks or more. The choice in favor of a CHC with a higher risk of developing VTE can only be made after consultation with the woman to ensure that she fully understands the risk of VTE associated with the use of NuvaRing®; the effect of the drug on her existing risk factors and that the risk of developing VTE is greatest in the first year of using the drug.

VTE can be life-threatening or lead to death (in 1-2% of cases).

Thrombosis of other blood vessels, for example, hepatic, mesenteric, renal, cerebral veins and arteries or retinal vessels, has occurred extremely rarely with the use of CGCs.

Symptoms of deep vein thrombosis (DVT):

unilateral swelling of the lower limb or along the vein, pain or discomfort only in an upright position or when walking, local increase in temperature, redness or discoloration of the skin in the affected lower limb.

Symptoms of pulmonary embolism (PE)

: difficulty or rapid breathing; sudden cough, including with hemoptysis; sharp pain in the chest, which may intensify with deep inspiration; sense of anxiety; severe dizziness; fast or irregular heartbeat. Some of these symptoms (eg, shortness of breath, cough) are nonspecific and may be misinterpreted as signs of other more common and less severe conditions (eg, respiratory tract infection).

ATE can lead to stroke, vascular occlusion, or myocardial infarction.

Symptoms of a stroke:

sudden weakness or loss of sensation in the face, limbs, especially on one side of the body, sudden confusion, severe or prolonged headache for no apparent reason, unilateral or bilateral loss of vision; problems with speech and understanding; sudden disturbance in gait, dizziness, loss of balance or coordination; sudden loss of consciousness or fainting with or without a seizure.

Other signs of vascular occlusion

: sudden pain, swelling and slight cyanosis of the extremities, “acute” abdomen.

Symptoms of myocardial infarction:

pain, discomfort, pressure, heaviness, a feeling of compression or fullness in the chest or behind the sternum, radiating to the back, jaw, upper limb, epigastric region; cold sweat, nausea, vomiting or dizziness, severe weakness, anxiety or shortness of breath; fast or irregular heartbeat.

ATE can be life-threatening and lead to death.

In women with a combination of several risk factors or high severity of one of them, the possibility of their mutual reinforcement should be considered. In such cases, the degree of increase in risk may be higher than with a simple summation of factors. In this case, the use of NovaRing® is contraindicated.

The risk of developing thrombosis (venous and/or arterial) and thromboembolism or cerebrovascular disorders increases:

- with age;

- in women who smoke (with an increase in the number of cigarettes or an increase in age, the risk increases, especially over the age of 35);

- if there is a family history (for example, venous or arterial thromboembolism in close relatives or parents under the age of 50 years). In the case of a hereditary or acquired predisposition, the woman should be examined by an appropriate specialist to decide on the possibility of using CHC;

— for obesity (UTI more than 30 kg/m2);

- with dislipoproteinemia;

- for arterial hypertension;

- for migraine;

- for diseases of the heart valves;

- with atrial fibrillation;

- in case of prolonged immobilization, major surgery, any operation on the lower extremities or major trauma. In these cases, the use of CHCs should be discontinued (in the case of planned surgery, at least four weeks before it) and not resumed for two weeks after the end of immobilization. Temporary immobilization (eg, air travel lasting more than 4 hours) may also be a risk factor for the development of VTE, especially in the presence of other risk factors.

The possible role of varicose veins and superficial thrombophlebitis in the development of VTE remains controversial.

The increased risk of thromboembolism in the postpartum period should be taken into account.

Peripheral circulatory disorders may also occur in diabetes mellitus, systemic lupus erythematosus, hemolytic uremic syndrome, chronic inflammatory bowel disease (Crohn's disease or ulcerative colitis) and sickle cell anemia.

An increase in the frequency or severity of migraine (which may also precede cerebrovascular events) during the use of CHCs is grounds for immediate discontinuation of these drugs.

Biochemical indicators indicating a hereditary or acquired predisposition to the development of venous or arterial thrombosis include: resistance to activated protein C, hyperhomocysteinemia, antithrombin III deficiency, protein C deficiency, protein S deficiency, antiphospholipid antibodies (anticardiolipin antibodies, lupus anticoagulant).

The risk of thrombosis and thromboembolism during pregnancy and the postpartum period is higher than when taking low-dose CHCs (containing less than 0.05 mg ethinyl estradiol).

If VTE or ATE is suspected or confirmed, use of the drug should be stopped immediately. In this case, it is necessary to use effective contraception, since anticoagulants (coumarins) have a teratogenic effect.

Risk of developing tumors

The most important risk factor for developing cervical cancer is infection with the human papillomavirus (HPV). Epidemiological studies have shown that long-term use of COCs leads to an additional increase in this risk, but it is unclear how much of this is due to other factors, such as increased frequency of cervical screening and sexual behavior, including the number of sexual partners and less frequent use of barrier contraceptives. and their cause-and-effect relationship. Epidemiological data regarding the incidence of cervical cancer in women using the drug NuvaRing®

There are no data from epidemiological studies regarding the risk of developing cervical cancer in women using the drug NuvaRing®.

A meta-analysis of the results of 54 epidemiological studies found a small increase (1.24) in the relative risk of developing breast cancer in women taking COCs. The risk gradually decreases over 10 years after stopping the drugs. Breast cancer rarely develops in women under 40 years of age, so the additional incidence of breast cancer in women who take or have taken COCs is small compared to the overall risk of developing breast cancer. Women who use COCs are diagnosed with earlier clinical stages of breast cancer than women who have never used COCs. The observed increased risk may be due to earlier diagnosis of breast cancer in women taking COCs, the biological effects of COCs, or a combination of both.

In rare cases, cases of development of benign, and even more rarely, malignant liver tumors have been observed in women taking COCs. In some cases, these tumors led to the development of life-threatening bleeding into the abdominal cavity. The doctor should consider the possibility of a liver tumor in the differential diagnosis of diseases in a woman taking NuvaRing® if symptoms include acute pain in the upper abdomen, liver enlargement, or signs of intra-abdominal bleeding.

Hypersensitivity reactions

Hypersensitivity reactions, such as angioedema and anaphylaxis, have been observed during use of the drug NovaRing®. If you suspect angioedema and/or anaphylaxis, you should stop using the drug NuvaRing® and carry out appropriate treatment.

Hepatitis C

In clinical trials of the drug combination for the treatment of hepatitis C virus ombitasvir/paritaprevir/ritonavir with or without dasabuvir, increases in ALT levels greater than 5 times the upper limit of normal were observed significantly more often in women using drugs containing ethinyl estradiol, such as COOK. The use of NovaRing® should be discontinued before starting therapy with the combination of ombitasvir/paritaprevir/ritonavir with or without dasabuvir (see section “Contraindications” and “Interaction with other drugs”). The use of NuvaRing® can be resumed approximately 2 weeks after completion of treatment with the combination of these drugs.

Other states

- In women with hypertriglyceridemia (or a family history of this condition), the risk of developing pancreatitis may increase while using CHCs.

- Although slight increases in blood pressure (BP) have been described in many women using COCs, clinically significant increases in BP have been reported rarely. However, if a persistent clinically significant increase in blood pressure develops while using the drug NuvaRing®, the use of the drug should be stopped and treatment of arterial hypertension should be started. If normal blood pressure values ​​are achieved with the help of antihypertensive therapy, use of the drug NuvaRing® can be continued.

- The following conditions have been reported to develop or worsen during pregnancy and when taking CHCs, but their relationship with the use of CHCs has not been proven: cholestatic jaundice and/or pruritus associated with cholestasis; formation of gallstones; porphyria; systemic lupus erythematosus; hemolytic-uremic syndrome; chorea; herpes during pregnancy; hearing loss associated with otosclerosis. Cases of Crohn's disease and ulcerative colitis have also been described with the use of CHCs.

— In women with hereditary forms of angioedema, exogenous estrogens may cause or worsen symptoms of angioedema.

— Acute or chronic liver diseases may require discontinuation of the drug NuvaRing® until liver function tests return to normal.

— Recurrence of cholestatic jaundice and/or itching caused by cholestasis, which first developed during pregnancy or previous use of sex hormones, requires discontinuation of the drug NuvaRing®.

- Although estrogens and progestogens can affect insulin resistance and glucose tolerance, in patients with diabetes mellitus using low-dose CHCs, as a rule, no dose adjustment of hypoglycemic drugs is required. However, patients with diabetes mellitus should be carefully monitored while using NuvaRing®.

- Chloasma can sometimes develop, especially in women with a history of chloasma during pregnancy. Women with a tendency to chloasma should avoid prolonged exposure to the sun and ultraviolet irradiation while using NuvaRing®.

— Conditions of a woman in which she will not be able to insert the ring correctly or in which the ring may fall out: cervical prolapse, bladder hernia and/or rectal hernia, severe chronic constipation.

— In very rare cases, women have unintentionally inserted the NuvaRing® vaginal ring into the urethra and possibly into the bladder. When symptoms of cystitis appear, it is necessary to consider the possibility of incorrect insertion of the ring.

— Cases of vaginitis have been described during the use of the drug NuvaRing®. There are no clinical data regarding the effect of vaginitis therapy on the effectiveness of the use of the drug NovaRing®, as well as the effect of the use of the drug NovaRing® on the effectiveness of therapy for vaginitis.

— Very rare cases of a ring sticking to the vaginal mucosa have been described, requiring its removal by a medical professional. In some cases where tissue had grown around the ring, removal was accomplished by cutting the ring without cutting the vaginal tissue.

Medical examination/consultation

Before prescribing the drug NuvaRing® or resuming its use, you should carefully review the woman’s medical history (including family history) and conduct a gynecological examination to exclude pregnancy. It is necessary to measure blood pressure, conduct an examination of the mammary glands, pelvic organs, including a cytological examination of cervical smears and some laboratory tests, to exclude contraindications and reduce the risk of possible side effects of the drug. The frequency and nature of medical examinations depend on the individual characteristics of each patient. but medical examinations are carried out at least once every 6 months. A woman should read the instructions for use and follow all recommendations. The woman should be informed that NuvaRing® does not protect against HIV infection (AIDS) and other sexually transmitted diseases.

Reduced efficiency

The effectiveness of the drug NovaRing® may decrease if the regimen is not followed (see the subsection “Deviations from the recommended regimen” of the section “Dosage and Administration”) or concomitant therapy is carried out that reduces the concentration of etonogestrel in the blood plasma (see section “Interaction with other drugs” ).

Changes in the nature of menstruation

During use of the drug NovaRing®, acyclic bleeding may occur (“spotting” spotting or sudden bleeding). If such bleeding is observed after regular cycles with the correct use of the drug NuvaRing®, you should contact your gynecologist to conduct the necessary diagnostic studies, including to exclude organic pathology or pregnancy. A diagnostic curettage may be required.

Some women do not bleed after the ring is removed. If the drug NuvaRing® was used according to the instructions, it is unlikely that the woman is pregnant. If the recommendations of the instructions are not followed and there is no bleeding after removing the ring, as well as if there is no bleeding for two cycles in a row, pregnancy must be excluded.

Effects of ethinyl estradiol and etonogestrel on a sexual partner

The possible pharmacological effects and extent of exposure of ethinyl estradiol and etonogestrel to male sexual partners (due to absorption through penile tissue) have not been studied.

Ring damage

In rare cases, when using the drug NuvaRing®, ring rupture was observed. The core of the drug NuvaRing® is solid, so its contents remain intact, and the release of hormones does not change significantly. Vaginal injury associated with ring rupture has been reported. If the ring ruptures, it usually falls out of the vagina (see the recommendations in the subsection “What to do if the ring has been temporarily removed from the vagina” in the “Dosage and Administration” section). If the ring ruptures, a new ring must be inserted.

Ring falling out

Sometimes the NuvaRing® vaginal ring may fall out of the vagina, for example, if it is inserted incorrectly, when a tampon is removed, during sexual intercourse, or due to severe or chronic constipation. In this regard, it is advisable for a woman to regularly check the presence of the NuvaRing® vaginal ring in the vagina (for example, before and after sexual intercourse). If the NuvaRing® vaginal ring falls out of the vagina, you must follow the recommendations of the subsection “What to do if the ring has been temporarily removed from the vagina” in the “Method of administration and dosage” section.

Does a vaginal hormonal active ring cause bacterial vaginosis?

There is an opinion that the use of vaginal contraception contributes to the development of bacterial vaginosis, which has not been confirmed in studies.

In 63% of cases, women using a hormonal ring note increased moisture in the mucous membrane and increased secretion (more vaginal discharge). This fact can be explained both by the local effect of hormonal influences and by the presence of a foreign body in the vagina. For reference, 43% of women who use COCs also report increased vaginal moisture. In their practice, obstetrician-gynecologists often use pessaries, which is also associated with an increase in vaginal secretion.

Analysis of the discharge showed the absence of inflammatory and dysbiotic changes.

On the contrary, vaginal ring users, compared to patients using COCs, had a 2.7 times higher number of lactobacilli producing hydrogen peroxide, a natural protective factor that suppresses the growth of conditional pathogens and protects against absolute ones.

In addition, one of the mechanisms of action of the vaginal ring is the thickening of cervical mucus, which also provides infection protection.

NuvaRing, 3 pcs., 15 mcg+120 mcg/24 h, vaginal rings

If any of the diseases, conditions or risk factors listed below are present, the benefits of using the drug NuvaRing® and the possible risks for each individual woman should be assessed before she starts using the drug NuvaRing®. In case of exacerbation of diseases, deterioration of the condition, or the occurrence of any of the conditions listed below for the first time, a woman should consult a doctor to decide on the possibility of further use of the drug NuvaRing®.

Circulatory disorders

The use of hormonal contraceptives may be associated with the development of venous thrombosis (deep vein thrombosis and pulmonary embolism) and arterial thrombosis, as well as associated complications, sometimes fatal.

The use of any COC increases the risk of developing VTE compared to the risk of VTE in patients not using COCs. The greatest risk of developing VTE is observed in the 1st year of COC use. Data from a large prospective cohort study of the safety of various COCs suggest that the greatest increase in risk compared with the risk in women not using COCs is observed in the first 6 months after starting COC use or resuming their use after a break (4 weeks or more). In non-pregnant women not using oral contraceptives, the risk of developing VTE is 1 to 5 per 10,000 woman-years (WY). In women using oral contraceptives, the risk of developing VTE ranges from 3 to 9 cases per 10,000 women. However, the risk increases to a lesser extent than during pregnancy, when it is 5–20 cases per 10,000 YL (pregnancy data are based on the actual duration of pregnancy in studies; when converted to a pregnancy duration of 9 months, the risk ranges from 7 to 27 cases per 10,000 ZhL). In postpartum women, the risk of developing VTE ranges from 40 to 65 cases per 10,000 women. VTE is fatal in 1–2% of cases.

According to research results, the increased risk of developing VTE in women using NuvaRing® is similar to that in women using COCs (adjusted risk ratio, see Table 2 below). A large prospective observational study, TASC (Transatlantic Active Study of the Safety of the Drug NuvaRing® for Cardiovascular Stress), assessed the risk of developing VTE in women who started using the drug NuvaRing® or COCs, switched to NovaRing® or COCs from other contraceptives, or resumed using the drug NuvaRing® ® or COC, in a population of typical users. Women were followed up for 24–48 months. The results showed a similar level of risk of developing VTE in women using the drug NuvaRing® (8.3 cases per 10,000 YL) and women using COCs (9.2 cases per 10,000 YL). For women using COCs other than those containing desogestrel, gestodene and drospirenone, the incidence of VTE was 8.5 cases per 10,000 women.

A retrospective cohort study initiated by the FDA (US Food and Drug Administration) showed that the incidence of VTE in women who started using the drug NuvaRing® was 11.4 cases per 10,000 YL, while in women of those who started using COCs containing levonorgestrel, the incidence of VTE is 9.2 cases per 10,000 young people.

table 2

Assessment of the risk (risk ratio) of developing VTE in women using the drug NuvaRing®, compared with the risk of developing VTE in women using COCs

1Incl. low-dose COCs containing the following progestins: chlormadinone acetate, cyproterone acetate, desogestrel, dienogest, drospirenone, ethynodiol diacetate, gestodene, levonorgestrel, norethindrone, norgestimate or norgestrel.

2Taking into account age, body mass index, duration of use, history of VTE.

3 Incl. low-dose COCs containing the following progestins: norgestimate, norethindrone or levonorgestrel.

4Taking into account age, place and year of inclusion in the study.

There are extremely rare cases of thrombosis of other blood vessels (for example, arteries and veins of the liver, mesenteric vessels, kidneys, brain and retina) when using COCs. It is unknown whether these cases are related to the use of COCs. Possible symptoms of venous or arterial thrombosis may be unilateral swelling and/or pain in the lower extremity, local increase in temperature in the lower extremity, hyperemia or discoloration of the skin on the lower extremity; sudden severe chest pain, possibly radiating to the left arm; attack of shortness of breath, cough; any unusual, severe, prolonged headaches; sudden partial or complete loss of vision; double vision; slurred speech or aphasia; dizziness; collapse, accompanied or not accompanied by a focal epileptic seizure; sudden weakness or severe numbness on one side of the body or any part of the body; movement disorders; acute stomach

Risk factors for the development of venous thrombosis and embolism:

- age;

- presence of diseases in the family history (venous thrombosis and embolism in brothers/sisters at any age or in parents at a young age). If a hereditary predisposition is suspected, before starting any hormonal contraceptives, the woman should be referred to a specialist for consultation;

- prolonged immobilization, major surgical interventions, any surgical interventions on the lower extremities or serious trauma. In such situations, it is recommended to stop using the drug (in the case of a planned operation, at least 4 weeks in advance) with subsequent resumption of use no earlier than 2 weeks after complete restoration of motor activity;

— obesity (body mass index more than 30 kg/m2);

- possibly thrombophlebitis of the superficial veins and varicose veins.

There is no consensus on the possible role of these conditions in the etiology of venous thrombosis.

Risk factors for the development of complications of arterial thromboembolism:

- age;

- smoking (with heavy smoking and with age, the risk increases even more significantly, especially in women over 35 years of age);

- dislipoproteinemia;

— obesity (body mass index more than 30 kg/m2);

- increased blood pressure;

- migraine;

- heart valve disease;

- atrial fibrillation;

- presence of diseases in the family history (arterial thrombosis in brothers/sisters at any age or parents at a relatively early age).

If a hereditary predisposition is suspected, the woman should be referred to a specialist for consultation before starting any hormonal contraceptives. Biochemical factors that may indicate hereditary or acquired predisposition to venous or arterial thrombosis include activated protein C resistance, hyperhomocysteinemia, antithrombin III deficiency, protein C deficiency, protein S deficiency, antiphospholipid antibodies (anticardiolipin antibodies, lupus anticoagulant).

Other conditions that can lead to unwanted circulatory problems include diabetes mellitus, systemic lupus erythematosus, hemolytic uremic syndrome and chronic inflammatory bowel disease (such as Crohn's disease or ulcerative colitis), as well as sickle cell anemia. It is necessary to take into account the increased risk of thromboembolism in the postpartum period.

An increase in the frequency or severity of migraine (which may be a prodromal symptom of cerebrovascular accidents) while using hormonal contraceptives may be a reason to immediately discontinue use of hormonal contraceptives.

Women using CHCs should be advised to consult a doctor if possible symptoms of thrombosis occur. If thrombosis is suspected or confirmed, CHC use should be discontinued. In this case, it is necessary to use effective contraception, since anticoagulants (coumarins) have a teratogenic effect.

Risk of developing tumors

The most important risk factor for developing cervical cancer is infection with the human papillomavirus. Epidemiological studies have shown that long-term use of COCs leads to an additional increase in this risk, but it remains unclear to what extent this is due to other factors, such as more frequent cervical smears and differences in sexual behavior, including. use of barrier contraceptives. It remains unclear how this effect is related to the use of the drug NuvaRing®.

A meta-analysis of 54 epidemiological studies found a small increase (1.24) in the relative risk of breast cancer in women taking COCs. The risk gradually decreases over 10 years after stopping the drugs. Breast cancer rarely develops in women under 40 years of age, so the additional incidence of breast cancer in women who take or have taken COCs is small compared to the overall risk of developing breast cancer. Breast cancer diagnosed in women who use COCs is clinically less severe than cancer diagnosed in women who have never used COCs. The increased risk of breast cancer may be due to both earlier detection of breast cancer in women taking COCs, the biological effects of COCs, or a combination of both.

In rare cases, women taking COCs have developed benign, and even more rarely, malignant liver tumors. In some cases, these tumors led to the development of life-threatening bleeding into the abdominal cavity. The doctor should consider the possibility of a liver tumor in the differential diagnosis of diseases in a woman taking NuvaRing® if symptoms include acute pain in the upper abdomen, liver enlargement, or signs of intra-abdominal bleeding.

Other states

Women with hypertriglyceridemia or a corresponding family history have an increased risk of developing pancreatitis when taking hormonal contraceptives.

Many women taking hormonal contraceptives experience a slight increase in blood pressure, but clinically significant increases in blood pressure are rare. A direct connection between the use of hormonal contraceptives and the development of arterial hypertension has not been established.

If a constant increase in blood pressure is observed when using the drug NuvaRing®, you should contact your doctor to decide whether it is necessary to remove the vaginal ring and prescribe antihypertensive therapy. With adequate blood pressure control using antihypertensive drugs, it is possible to resume use of the drug NuvaRing®.

During pregnancy and during the use of COCs, the development or worsening of the following conditions was noted (although their relationship with the use of contraceptives has not been definitively established): jaundice and/or itching caused by cholestasis, formation of gallstones, porphyria, systemic lupus erythematosus, hemolytic uremic syndrome, Sydenham's chorea (minor chorea), herpes of pregnancy, hearing loss due to otosclerosis, (hereditary) angioedema.

Acute or chronic liver dysfunction may serve as a basis for discontinuation of the drug NuvaRing® until normalization of liver function indicators. Recurrence of cholestatic jaundice, previously observed during pregnancy or during the use of sex hormones, requires discontinuation of the drug NuvaRing®.

Although estrogens and progestogens may influence peripheral insulin resistance and tissue glucose tolerance, there is no evidence to support the need to change hypoglycemic therapy during the use of hormonal contraceptives. However, women with diabetes should be under constant medical supervision when using NuvaRing®, especially in the first months of contraception.

There is evidence of a worsening of Crohn's disease and ulcerative colitis with the use of hormonal contraceptives.

In rare cases, pigmentation of the facial skin (chloasma) may occur, especially if it occurred earlier during pregnancy. Women predisposed to the development of chloasma should avoid exposure to sunlight and UV radiation while using NovaRing®.

The following conditions may prevent the ring from being inserted correctly or may cause it to fall out: cervical prolapse, bladder and/or rectal hernia, severe chronic constipation.

In very rare cases, women have unintentionally inserted the NuvaRing® vaginal ring into the urethra and possibly into the bladder. When symptoms of cystitis appear, it is necessary to consider the possibility of incorrect insertion of the ring.

Cases of vaginitis have been described during use of the drug NuvaRing®. There is no evidence that treatment of vaginitis affects the effectiveness of the use of the drug NuvaRing®, as well as evidence of the effect of the use of the drug NovaRing® on the effectiveness of treatment of vaginitis.

Very rare cases of difficult ring removal have been described that required removal by a medical professional.

Medical examination/consultation

Before prescribing the drug NuvaRing® or resuming its use, you should carefully review the woman’s medical history (including family history) and conduct a gynecological examination to exclude pregnancy. It is necessary to measure blood pressure, conduct an examination of the mammary glands, pelvic organs, including a cytological examination of cervical smears and some laboratory tests, to exclude contraindications and reduce the risk of possible side effects of the drug. The frequency and nature of medical examinations depend on the individual characteristics of each patient, but medical examinations are carried out at least once every 6 months. A woman should read the instructions and follow all recommendations. The woman should be informed that NuvaRing® does not protect against HIV infection (AIDS) and other sexually transmitted diseases.

Reduced efficiency

The effectiveness of NovaRing® may decrease if the regimen is not followed or if concomitant therapy is carried out.

Changes in the nature of menstruation

During use of the drug NovaRing®, acyclic bleeding (spotting or sudden bleeding) may occur. If such bleeding is observed after regular cycles with the correct use of the drug NuvaRing®, you should contact your gynecologist to conduct the necessary diagnostic studies, incl. to exclude organic pathology or pregnancy. A diagnostic curettage may be required. Some women do not bleed after the ring is removed. If the drug NuvaRing® was used according to the instructions, it is unlikely that the woman is pregnant. If the recommendations of the instructions are not followed and there is no bleeding after removing the ring, as well as if there is no bleeding for two cycles in a row, pregnancy must be excluded.

Effects of ethinyl estradiol and etonogestrel on a sexual partner

The possible pharmacological effects and extent of exposure of ethinyl estradiol and etonogestrel to male sexual partners (due to absorption through penile tissue) have not been studied.

Ring damage

In rare cases, when using the drug NuvaRing®, ring rupture was observed.

The core of the drug NuvaRing® is solid, so its contents remain intact, and the release of hormones does not change significantly. If the ring ruptures, it usually falls out of the vagina (see the recommendations in the subsection What to do if the ring has been temporarily removed from the vagina

in the section “Method of administration and dosage”). If the ring ruptures, a new ring must be inserted.

Ring falling out

Sometimes the NuvaRing® vaginal ring may fall out of the vagina, for example, if it is inserted incorrectly, a tampon is removed, during sexual intercourse, or due to severe or chronic constipation. In this regard, it is advisable for a woman to regularly check the presence of the NuvaRing® vaginal ring in the vagina. If the NuvaRing® vaginal ring falls out of the vagina, you must follow the recommendations of the subsection What to do if the ring has been temporarily removed from the vagina

in the section "Method of administration and dosage".

Impact on the ability to drive vehicles and operate machinery.

Based on information about the pharmacodynamic properties of the drug NovaRing®, it can be expected that it does not affect the ability to drive vehicles and operate machinery.

Change in libido when using a vaginal ring

In terms of libido, most women who use the ring note an increase in sexual desire and increased sexual satisfaction.

It is interesting to note that the presence of such an extraordinary thing as a ring in the vagina stimulates sexual interest on the part of not only the woman, but also the opposite sex. A number of couples surveyed draw an analogy between a ring and a sex toy, which cannot but affect the fantasies that precede sexual intercourse.

However, there is also the exact opposite point of view. One thing I can say for sure is that no one remains indifferent, and interest, whatever it may be, is interest.

Does a vaginal ring bother men?

It would be more correct to ask the stronger half of humanity about the sensations that a man experiences when using this method.

Publications about the drug describe increased sensations or no changes.

The instructions for the drug describe cases of local reactions in the partner, including irritation, abrasions, and discomfort.

Similar situations occur in life, although most patients and their partners are satisfied with the method.

In addition, the manufacturer writes in the instructions about the possibility of removing the contraceptive “with impunity” (in terms of reducing the contraceptive effect) for a period of up to three hours. Therefore, sexual intercourse may well occur without a ring, if suddenly it interferes.

Pleasant effects for women

1. The improvement in the woman’s sensations can be explained by a number of factors: confidence in protection from unwanted pregnancy, lack of thinking about whether she forgot to take the pill, good hydration of the vaginal mucosa, and awareness that the man’s sensations should supposedly be brighter. Again, everything is individual. Rarely, but patients complain, on the contrary, of vaginal dryness, lack of lubrication during sexual intercourse and lack of desire.
2. A pleasant effect of a vaginal contraceptive is better control of the menstrual cycle compared to COCs. That is, a menstrual-like reaction occurs during a seven-day break and lasts from 2 to 4–5 days, which is not always possible to achieve when using microdosed COCs. The frequency of such undesirable effects as “breakthrough bleeding” (a situation when, when using a contraceptive, a menstrual-like reaction occurred regularly, and then acyclic heavy or moderate bleeding suddenly appeared) and acyclic spotting when using a vaginal ring is significantly lower.
3. Despite the existence of isolated publications about the high risk of thrombosis when using combined vaginal contraception, the vast majority of reports, common sense and the regulatory framework allow us to make an unambiguous conclusion that the risk of thrombosis is comparable, or rather lower, than when using COCs, since the dose of ethinyl estradiol here is minimal.

Local effects of the vaginal contraceptive ring (literature review)

Over the past decades, the list of hormonal contraceptives has increased significantly, and the doctor faces an important task - to help a woman choose the method that best suits her needs and lifestyle. It must be taken into account that when making a decision, a woman perceives the convenience of using a contraceptive method as no less important than its effectiveness, tolerability, health benefits and risks. Women's preferences and needs regarding hormonal contraceptives were recently studied based on a global online survey that included more than 5,000 women aged 18–44 from 9 countries, including Russia (more than 70% were current contraceptive users) . The survey showed that 73% of respondents wanted more information about alternative contraceptive methods to oral contraception, and 76% expressed particular interest in monthly methods [1].

The NuvaRing vaginal ring is a contraceptive method that uses the vaginal route of hormone administration, and the only method that provides protection against unwanted pregnancy for a whole month. This flexible ring, made of hypoallergenic ethylene vinyl acetate material, releases 15 mcg ethinyl estradiol (EE) and 120 mcg etonogestrel daily through a membrane system. The trigger for the ring to start working is a change in the concentration gradient when inserted into the vagina. The ring, which is easily inserted and removed by the woman herself, should be in the vagina for 3 weeks, after which it is removed, allowing withdrawal bleeding, and after 1 week. a new ring is introduced [2]. The advantages of the vaginal method of drug delivery are well established: the elimination of gastrointestinal absorption and the first-pass effect through the liver makes it possible to use low doses of hormones in a vaginal contraceptive and maintain a constant concentration of the drug in the blood. These advantages are coupled with the convenience of a long-term dosing regimen compared to the oral route [3].

Randomized controlled and non-comparative studies have shown that the vaginal ring has high contraceptive efficacy and a favorable tolerability profile similar to those of combined oral contraceptives (COCs), but higher rates of acceptability and better cycle control compared with COCs [2, 4–6]. . The constant release of hormones possible with the vaginal route avoids fluctuations in hormone levels, which most likely explains the good cycle control of ring users despite the very low daily circulating dose of EE [7]. The proportion of estrogen-related adverse events among ring users was low: headache was reported by 5.8%, nausea by 3.2%, and breast engorgement by 2.6% of women. Local adverse events associated with the ring included vaginitis (5.6%), leukorrhea (4.8%), foreign body sensation, problems with coitus and expulsion (4.4%), vaginal discomfort (2.4%) . Due to problems caused by the ring, 2.5% of women refused to use it, while only 0.8% refused to use it due to irregular bleeding [8].

Both comparative and non-comparative studies, as well as studies based on routine clinical practice, have shown high levels of acceptability and compliance associated with the vaginal ring [9–11]. Thus, in two studies conducted in North America and Europe, of 1950 women who completed a questionnaire specifically designed to assess the acceptability of the vaginal ring, 96% were satisfied with the ring and 97% intended to recommend this method to others [12]. Initially, 66% of women perceived COCs as the best method of contraception, and after 3 cycles of using the ring, vaginal contraception was perceived best by 81% of respondents. At the end of the study, the ease of use of the ring was noted by 97% of participants, and the vast majority of women and their sexual partners found the ring sexually comfortable: 85% of women and 71% of their partners never or rarely felt the ring during intercourse and 94% of partners did not mind using the ring woman [12].

Similar evidence regarding the acceptability and ease of use of the ring comes from studies based on routine clinical practice in various European countries [13–16]. The high acceptability of vaginal contraception is also evidenced by data from an American study, in which the level of calls to the doctor during the first 3 months. use of hormonal contraceptive methods among users of the vaginal ring was lower (11/72) than among users of oral contraceptives (30/96) and transdermal patch (11/72) [17].

In summary, vaginal contraception offers many advantages, including high effectiveness, good tolerability, ease of use, monthly dosing schedule, and minimal impact on other aspects of women's health [6, 18]. More than 10 years have passed since the NuvaRing vaginal contraceptive ring appeared on the world market, and, nevertheless, in comparison with established knowledge about COCs, vaginal contraception can still be considered a new method and cause some concern or questions among potential users. To facilitate an informed decision, contraceptive counseling should provide the woman not only with information about the benefits of the vaginal route of hormone administration, but also with basic knowledge of the anatomy and physiology of the vagina, and clarify the possible local effects of the contraceptive ring.

Issues related to ring placement

The NuvaRing vaginal ring is designed taking into account the anatomy of the female body. The shape and elastic properties of the ring allow a woman to squeeze it between her fingers and insert it into the vagina as easily as she inserts a tampon. The musculature of the urogenital and pelvic diaphragms, as well as the vaginal wall, help hold the ring in place, while the large surface area of ​​the squamous epithelium and intense blood supply make the vagina an ideal site for steroid absorption [3, 5]. Only the lower quarter of the vagina is highly sensitive due to the rich supply of peripheral nerves; the upper three quarters of the vagina are innervated by the autonomic nervous system and are insensitive to painful stimuli. Therefore, tampons or a ring, located in the upper third of the vagina, do not bring a woman a feeling of discomfort [3]. Tampon use can be considered an indicator of acceptability of a vaginal contraceptive ring [19], but the ring should certainly be offered to all women, regardless of experience with tampons.

After insertion, the ring takes an optimal position, adapting to the individual contours of the woman’s body. To determine the anatomical position of the ring, two women, parous and nulliparous, underwent a series of magnetic resonance studies: before insertion of the ring, immediately after insertion, and after the woman moved. The image showed that when the woman begins to move, the ring does not fall out, but moves upward and is installed, usually surrounding the cervix. The ring is compressed laterally and takes on an oval shape, especially in nulliparous women. There is no pressure on the urethra [20].

And yet, a small number of women still have certain genital problems associated with the location of the ring. In an efficacy study, ring-related events (foreign body sensation, problems during coitus, expulsion) were reported by 4% of women [4, 8]. Two randomized trials compared the ring with the COC and the patch. In the first, 9% of women reported the ring slipping at least once a week. [21], in another, 20% experienced ring slippage at least once in 3 weeks. [22]. Since ring expulsion can occur spontaneously, the woman should be informed about the need to monitor the situation after coitus, defecation, and tampon removal. Research has also shown that some women (13–16%) prefer to remove the ring during intercourse [13, 14, 22]. It has been proven that contraceptive effectiveness is maintained if the ring is returned to its place within a 3-hour interval [23].

In order to feel comfortable using a ring, women need knowledge about the anatomy and physiology of the vagina, which in fact they may have limited knowledge of. Italian researchers R. Nappi et al. analyzed data from an online survey of 9441 women aged 18–44 from 13 countries [24]. Most survey respondents felt that vaginal health does not receive the attention it deserves (66%), there are too many misconceptions in society (65%), and social taboos around the vagina contribute to women's lack of education on the issue (78%). While 79% of women rely on their doctor's advice when choosing a contraceptive method, less than 50% felt comfortable discussing vaginal issues, and 25% were definitely uncomfortable. According to the authors, a more open and informative approach when discussing this part of the body with a woman is extremely important, especially when it comes to vaginal contraception [24].

Vaginal ring and vaginal biocenosis

Another very important issue to discuss in contraceptive counseling is the comprehensive system of natural protection of the vagina, since many women misunderstand its importance, incorrectly believing that vaginal hygiene products make the main contribution to genital health [24]. The vaginal environment of a healthy woman is a unique balanced ecosystem (biocenosis), which is the natural protection of the vagina from pathogenic flora. The key elements of normal biocenosis are the vaginal epithelium and lactobacilli. Continuous sloughing of the squamous epithelium prevents bacterial invasion of the basement membrane, while lactobacilli regulate the growth of potential pathogens by competing with them for nutrients, and also provide protective properties to the vaginal environment through the production of lactic acid, hydrogen peroxide and other antimicrobial substances [25].

Vaginal epithelium, local flora, cervical mucus and other secretions are all barriers to infection, and counseling should include explaining to the woman that vaginal discharge is natural unless it is associated with other irritating vaginal symptoms. Each woman has her own microflora and her own amount of vaginal discharge, since the quantitative and qualitative composition of vaginal microorganisms is influenced by various factors, such as hormonal levels, characteristics of the toilet of the genital organs, the degree of sexual activity, as well as the method of contraception [26–28].

The most common genital complaint presented by women due to a vaginal ring is increased vaginal secretion, the so-called vaginal wetness. It has previously been suggested that increased discharge with the contraceptive ring is due to inflammation, and one study showed a slight increase in white blood cell count in smears compared with oral contraceptives (OCs), although the bacterial flora was not affected [29]. Evidence that the ring contributes to the development of bacterial vaginosis (BV) has not been obtained in any study, and in some women it has even been shown to normalize the microflora [30]. In a more recent randomized trial, the complaint of increased vaginal discharge, although reported twice as often with the ring compared with the transdermal patch (17% vs. 8%, respectively), was not associated with BV. The Nugent index, used to assess vaginal flora, showed that after 3 cycles, BV was not more common among ring users than among patch users [22].

A detailed assessment of genital symptoms and laboratory parameters associated with the use of a vaginal ring and COCs containing levonorgestrel/20 mcg EE was given in a randomized trial by S. Veres et al. [21]. After 3 cycles of these hormonal methods, women using the ring were slightly more likely to report a slight or moderate increase in vaginal secretion in their diary compared to OC users (63% vs. 43%). However, no features were identified during the examination, including laboratory examination, except for the initial ectopia of the cervix, which predisposes to the appearance of this symptom, and the detection of leukorrhea during examination. No differences were found between contraceptive methods in the amount of discharge, even when determining its weight, as well as when assessing vaginal pH, Nugent index and the number of leukocytes in the smear. Despite reports of yeast adhesion to the surface of the ring in vitro [32], candidal vaginitis was not more common in ring users. Moreover, in this study, an interesting and important discovery was made by comparing the results of laboratory tests. In women who used the ring, the number of lactobacilli colonies producing hydrogen peroxide (H2O2) was 2.7 times higher than in the COC group (95% CI 1.49–4.78; p<0.001). It is known that the production of H2O2 by lactobacilli represents a nonspecific protective mechanism of the normal vaginal ecosystem [33]. An increase in the concentration of these lactobacilli can prevent viral and bacterial infections, and a decrease is associated with BV [33, 34]. Minor differences in symptoms did not lead to discontinuation of this method, and at the end of the study, most women wished to continue using the ring. In addition, the degree of satisfaction with the method, determined on a point scale, was higher for the ring than for the OC. The authors concluded that although some women experienced an increase in vaginal secretions when using the contraceptive ring, the method was generally well tolerated and had a positive effect on vaginal health [21].

The beneficial effect of the combined contraceptive vaginal ring on the number and composition of lactobacilli is also evidenced by the results of a recent prospective study in which 60 women used vaginal contraception or COCs of their choice. After 3 and 6 months. In women who used the vaginal ring, there was a significant increase in the number of lactobacilli compared with those who resorted to COCs, while in the latter the content of group B streptococci increased [35]. The NuvaRing contraceptive ring was also actively studied in Russian studies, most of which not only did not reveal a negative effect of the NuvaRing ring on the vaginal microflora, but also demonstrated its preventive and therapeutic effect on the vaginal biocenosis [36–39].

Although the mechanisms of changes in the vaginal environment observed in ring users are not yet known, they are likely a response to local increases in estrogen concentrations. The increase in vaginal secretion often reported by female ring users is not believed to be a pathological sign, but rather reflects an increase in the lactobacilli population and is protective in preventing vaginal imbalance/infection [21].

The effect of the vaginal ring on the cervical epithelium

Since the hormonal contraceptive ring is located in the upper third of the vagina in close proximity to the vaginal part of the cervix, the question often arises about its effect on the cervical epithelium. The condition of the cervicovaginal epithelium during the use of the NuvaRing contraceptive ring was studied in an open multicenter study involving 1200 healthy women observed for a year [4], and then as part of a large open international study involving 2322 women who also used the ring for 13 cycles [8]. Analysis of cervical smears obtained during a screening examination before inclusion in the study, after 6 months. and upon completion of the study, it was concluded that NuvaRing does not increase the risk of cervical pathology. The absence of a negative effect of the ring on the condition of the cervix, including in patients with benign diseases, is evidenced by the results of short-term Russian studies. Moreover, according to colposcopic examination, after 6 months. the use of a vaginal ring has shown positive dynamics in the epithelization of ectopia and a beneficial effect on endometrioid heterotopia [38, 40].

According to WHO medical eligibility criteria for contraceptive methods, the vaginal ring can be used in women with cervical ectropion and cervical intraepithelial neoplasia [41].

The effect of the vaginal contraceptive ring on sexual function

It is known that contraceptive choice can influence a woman's sexual well-being, which largely determines long-term adherence to a method [42, 43]. Most of the available data demonstrate the beneficial effects of the vaginal ring on various parameters of sexual function. Thus, in the randomized study “NovaRing vs. COCs” involving 51 healthy women who had regular sexual partners, half of the women used a vaginal ring for 6 cycles, the other half used a COC containing desogestrel and 20 mcg of EE. The control group consisted of 25 women who did not use hormonal contraception [44]. The sexual activity of women and their partners was assessed using a special questionnaire. Compared with controls, women in both groups reported significant improvements in sexual function at 3 and 6 months. Both COC and ring users experienced significantly decreased anxiety, increased frequency of sexual intercourse, and increased frequency and intensity of orgasm (p<0.001). However, rates of sexual interest and complicity were significantly higher among ring users versus COC users (p<0.05), and only the ring was associated with an increase in the vividness of sexual fantasies in both partners, compared with both the control group and users. COC (p<0.001). As the researchers suggest, these data indicate that both oral and vaginal contraception improve the sex lives of women and their partners to some extent, but the vaginal ring has a further beneficial effect on the physiological aspects of sexual function [44].

In another randomized comparative study using NuvaRing and COCs containing levonorgestrel/EE 20 mcg or gestodene/EE 15 mcg, after 12 cycles, increases in sexual desire were more common among ring users compared with users of both COC options (76, 27, 30% respectively; p<0.05), as well as an increase in sexual satisfaction (78, 48 and 23%, respectively; p<0.05). As expected, a beneficial effect of the ring on vaginal lubrication was observed. After 3 cycles of hormonal contraception, vaginal dryness was reported by 30% of women in the Gestodene/EE 15 mcg group, 13% in the levonorgestrel/EE 20 mcg group, and only 2% in the vaginal ring group [45]. Finally, a recent American study involved 500 women who had previously taken COCs and were then randomly switched to a vaginal ring or patch. After 3 months For both ring and patch users, changes in sexual function were not clinically significant [46].

Overall, acceptability of the ring among women and their partners is as high as that of COCs and is associated with similar improvements in sexual function [6].

Conclusion

The NuvaRing vaginal ring is a contraceptive method that provides many benefits, including those most needed and desired by women: along with effectiveness and a good safety profile, a monthly dosing regimen, constant levels of serum hormones and good cycle control, it is characterized by an additional positive effect on the vaginal biocenosis and sexual function . These local positive effects of vaginal contraception may contribute to the high acceptability of the method and improved reproductive health for women.

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How does the drug affect weight?

Like most modern COCs. The drug has no weight loss effects. But it will not increase if you monitor your eating behavior.

In theory, the gestagen of the drug has a residual androgenic effect, which means it can influence carbohydrate and lipid metabolism, but no significant changes were found in clinical studies.

When surveyed, information about the patient’s side effects, as with the use of any COCs (even those that promote weight loss), indicated that it was the drug that was to blame for the increase in the hated numerical value.

Dear girls and women! Remember that as the time interval increases relative to the four digits indicated in the passport, the weight also increases. Unfortunately, this is physiology. There are happy owners of magical heredity who are, rather, the exception to the rule. And the rest have to work on themselves and limit themselves in the pleasure of eating delicious food. However, we have already discussed this issue in the article “Wrong reasons for refusing hormonal contraception.”

Should I use a vaginal ring?

In my opinion, as a doctor, the method is worthy, but it is not suitable for patients with certain gynecological diseases.

The presence of only one combination of estrogen and gestagen components does not allow this option to be flexible enough and, if when using COCs it is possible to change the active ingredients, being in fact within the framework of one method, then here - alas and ah!

It has only one indication: contraception! And since healthy girls are at the appointment “with fire during the day...”, I personally don’t have to prescribe it very often. And yet, the non-contraceptive effect, although not specified in the instructions, is present thanks to the etonogestrel included in the composition: good cycle control.

Reasons for decreased effectiveness of the vaginal ring

The effectiveness of the vaginal ring may be reduced if the following medications are used simultaneously:

• anticonvulsants (phenytoin, barbiturates, carbamazepine, primidone, topiramate, oxcarbazepine, lamotrigine);
• antifungal (griseofulvin);
• drugs used to treat HIV infection (ritonavir);
• products containing St. John's wort;
• some antibacterial drugs (ampicillin, rifampicin, tetracycline antibiotics).

At the same time, if there is a need to take antibacterial drugs, the manufacturer of the vaginal contraceptive has provided two antibiotics that can be taken together with the drug safely and without fear: amoxicillin and doxycycline (the latter is from the tetracycline group). Their intake affects the metabolism of steroids to a small extent, which has been proven in clinical studies.

Is it expensive to use a hormone ring?

An important aspect of the patient’s adherence to a particular method of contraception is the cost of the issue. Of course, they don’t skimp on health, but not everyone has such an opportunity. Therefore, before prescribing this or that drug, I try to bring the economic component to the patient.

The cost of one ring at the time of writing ranges from 1060.10 to 1699.00 rubles. If, usually, by buying a COC for three months at once, you can save a lot of money, but here, unfortunately, this principle does not work: the minimum cost of three rings is 3,108.60 rubles.

For comparison, COCs with a similar composition can be purchased for 350 rubles and more. But there are also drugs similar in price to the ring, with a different composition of active ingredients.

In any case, there are a lot of options in the COC group, including a large number of generics (drugs with identical composition, but produced by another manufacturer), which allows you to choose a contraceptive for every taste and budget, in the case, of course, there are no contraindications.