Advantages and disadvantages of the contraceptive patch

Benefits of the contraceptive patch

• Easy to use.
• Can only be used by a woman, it is not needed by a partner.
• Highly effective when used correctly, with almost 100% protection.
• It needs to be applied only once a week and not in conjunction with sexual intercourse, which improves the patient's ability to adhere to the schedule.
• The presence of the patch can be checked visually.
• Does not separate when exposed to water or sweat.
• May improve menorrhagia and dysmenorrhea due to hormonal reasons (not due to organic conditions).
• Improves skin condition - acne goes away if its cause is hormonal imbalance.
• Strengthens bone strength due to the content of the hormone estrogen, which is involved in important metabolic processes.
• Reduces the risk of benign breast diseases, endometrial and ovarian cancer, which often develop when hormone levels in the body are disturbed.

Menorrhagia

Improved skin condition

Breast diseases

Today, hormonal contraception is one of the most reliable methods of preventing unwanted pregnancy. It has a beneficial effect on a woman’s health and provides a therapeutic effect for various menstrual dysfunction, hyperplastic processes in the endometrium, endometriosis, etc.

However, although hormonal contraceptives have been constantly improved over the past decades, they are still not without a number of disadvantages. Combined oral contraceptives (COCs) must be taken daily, preferably at the same time, while the level of steroid hormones in a woman’s blood changes significantly throughout the day, which can contribute to the occurrence of a number of adverse reactions. Because COCs are metabolized in the gastrointestinal tract and undergo first-pass effects in the liver, their effectiveness may be reduced by vomiting or other digestive disorders, or when taken concomitantly with other drugs.

A study of 943 women taking oral contraceptives found that nearly half (47%) missed one or more pills, and 22% missed two or more pills during a cycle. This may explain the high failure rate of hormonal contraception (3–8%) during the first year of use [4]. All this served as the basis for the development of alternative methods in order to expand the possibilities of individual choice of the most acceptable method of contraception for a woman.

One of these methods proposed recently is the EBRA transdermal contraceptive system. The system is a thin beige patch, the contact area of ​​which with the skin is 20 cm2. Each patch contains 600 mcg ethinyl estradiol (EE) and 6 mg norelgestromin (NG). In terms of dosages of hormones entering the blood, the EBRA system corresponds to microdose oral contraceptives. NG, which is a biologically active metabolite of norgestimate, is a highly selective gestagen of the latest generation, which, like norgestimate, effectively suppresses ovulation and increases the viscosity of cervical mucus [1].

During one menstrual cycle, 3 patches are used, each of which is applied for 7 days. The patch must be replaced on the same day of the week. Then you should take a 7-day break, during which a menstrual-like reaction occurs.

The mechanism of the contraceptive action of the EBRA system is due to the suppression of ovulation and an increase in the viscosity of cervical mucus. EVRA has been found to suppress ovulation as effectively as combined oral contraceptives.

In a randomized study of the pharmacokinetics of NG and EE released by the EBRA transdermal contraceptive system, it was shown that the amount of steroids released from the patch is proportional to its size: with a patch area of ​​20 cm2, 150 μg of NG and 20 μg of EE enter the systemic circulation in 24 hours . It is important to emphasize that the patch maintains the concentration of NG and EE at this level for 10 days, which provides effective contraception, even if the patch is changed 2 days later than the recommended period.

The effectiveness of the transdermal system does not depend on the site of application of the patch (abdomen, buttocks, upper arm or torso), with the exception of the mammary glands; it is practically not affected by increased ambient temperature, air humidity, physical activity, or immersion in cold water [1].

The results of clinical studies conducted from 2000 to 2004 confirmed not only the high contraceptive effectiveness and acceptability of the EBRA system for women, but also good cycle control during contraception, the absence of a negative effect on blood pressure (BP), body weight and hemostasis.

During clinical studies, the EBRA patch was used by more than 3,300 women, while the total number of menstrual cycles in which the drug was used exceeded 22 thousand. According to summarized data from 3 studies, in women weighing up to 90 kg, the rate of ineffectiveness of the EBRA system ranged from 0.4 up to 0.6%, which indicates a very high contraceptive effectiveness of the method [6].

The adhesive properties of the transdermal patch were studied in 3 clinical studies involving 3319 women who used it for 13 months. The frequency of premature patch replacement in the overall group was 4.7%, including due to complete rejection - 1.8%, partial - 2.9%. In 1.7% of cases, the patch was changed due to peeling due to exposure to elevated ambient temperatures, and in 2.6% due to peeling due to high humidity. Only one of the 87 patches completely came off when exposed to intense physical activity. Thus, good adhesive properties of contraceptive transdermal patches were noted in all studies. Increased ambient temperature, humidity and physical activity did not have a significant effect on the adhesive properties of EVRA.

Results from a clinical trial conducted in North America involving 1,785 women and 76 sites showed that a woman's age did not affect the acceptability of transdermal patches. All women used them correctly. The acceptability of the EBPA system was superior to oral contraceptives, the frequency of correct use of which varied significantly by age [2].

It is known that the use of COCs is associated with a number of adverse reactions (headache, nausea, mastalgia and mastodynia). As it turned out, transdermal administration of steroids can reduce the severity of these estrogen-dependent side effects compared to oral drugs. Although the adverse reactions that developed with the use of EVRA were typical for hormonal contraception, in most cases they were mild or moderate, transient in nature and did not limit the possibility of subsequent use of the drug [5].

Data on side effects obtained during 3 clinical studies showed that when using the EVPA patch, nausea was observed in 16.8% of women, headaches in 21.1%, breast engorgement in 22%, local (skin) reactions – in 17.4%. In total, according to the results of the studies, only 6% of women refused further use of EVRA due to side effects.

A common reason for refusing oral contraceptives is a woman's fears about possible weight gain. An open-label study conducted in 71 centers and including 1672 healthy sexually active women examined the effect of EVPA on body weight over 1 year of contraception. There was an almost complete absence of weight gain when using this method of contraception: the average weight gain was only 400 g [5].

According to survey results, 90% of women who took part in multicenter studies of the EBRA transdermal contraceptive system rated it as “very comfortable” compared to the previously used method; 86% of women were “highly satisfied” with the use of the contraceptive patch [6].

The Scientific Center for Obstetrics, Gynecology and Perinatology of the Russian Academy of Medical Sciences is also conducting research to study the effectiveness and acceptability of the EBRA transdermal system in women of reproductive age. Analysis of preliminary results of observation of 20 women who use the EBRA system confirms the high contraceptive effectiveness of this method. Not a single patient who used this system became pregnant during 6 months of observation.

Characterizing the tolerability of the transdermal system, it should be noted that during its use, the following adverse reactions were noted in 8 patients: mastodynia - in 2, headache - in 2, intermenstrual bleeding during the first month of using the contraceptive - in 1, allergic reactions in the form skin rash – in 2, weight gain (+3 kg) during the first month of using the drug – in 1.

Analysis of individual blood pressure indicators before the start of the use of the EVRA system and against the background of its applications indicated that its use had virtually no effect on blood pressure. The blood pressure level fluctuated within the normative values ​​– from 110/60 to 120/70 mm Hg. Art. No increase in blood pressure was observed in any patient.

Dynamic monitoring of the condition of the cervix by cytological examination also did not reveal any pathological changes.

The results of the preliminary study allow us to conclude that the EBRA transdermal system is highly contraceptive in women of reproductive age. Adverse reactions observed in a small number of patients were transient in nature and did not require additional treatment.

Thus, according to research data, the EBRA contraceptive patch has the following main advantages:

• ease of use;
• release of minimal doses of hormones;
• lack of first pass effect through the liver and gastrointestinal tract;
• rapid restoration of fertility after withdrawal;
• Possibility of use in women of different ages;
• possibility of independent use (without the participation of medical personnel);
• a small number of adverse reactions.

Literature data and the results of preliminary studies at the Scientific Center for Obstetrics, Gynecology and Perinatology of the Russian Academy of Medical Sciences indicate that the new contraceptive agent that has become available to doctors - the EBRA transdermal system, from many points of view, increases the acceptability of contraception for a number of categories of women.

Flaws

The patch is not an ideal contraceptive due to some disadvantages listed below:

• The birth control patch does not protect against sexually transmitted infections (STIs), including HIV.
• It must be selected and prescribed by a gynecologist, since different patches contain completely different dosages and types of hormones. The use of an inappropriate composition can, on the contrary, provoke the growth of hormone-dependent tumors, cause weight gain and other complications.
• The patches contain higher levels of estrogen than other hormonal contraceptives.
• Interacts with some medications. The effectiveness of the patch decreases if a woman is also taking rifampin (an anti-tuberculosis antibiotic), corticosteroids, anticonvulsants, or herbal supplements containing St. John's wort. They increase the activity of liver enzymes that metabolize hormones and therefore may result in a shorter duration of hormone activity than expected.
• The return to pregnancy after stopping use of the patch may be delayed for up to two months.
• Some women experience skin irritation.
• The partner sees that the woman is protecting herself from unwanted pregnancy. If a man wants children, this will inevitably lead to conflict.

Transdermal contraceptive system EVRA

Every year, 500,000 women around the world die from complications associated with unplanned pregnancy, more than 45 million abortions are performed, there is an increase in the number of gynecological diseases, and the number of sexually transmitted infections (STIs) is increasing, which determines the need for a consistent policy aimed at preserving reproductive health women. One of the main directions of this policy is the prevention of unwanted pregnancy through the use of highly effective modern methods of contraception.

Modern contraceptives have certain requirements: high efficiency (low Pearl index), acceptability, ease of use, the ability to regulate the menstrual cycle and the presence of non-contraceptive - medicinal properties.

In this regard, the search and development of new methods of contraception continues, which will undoubtedly help preserve the reproductive health of women.

In recent years, a whole arsenal of low-dose and micro-dose oral contraceptives with new highly selective progestogens has been synthesized, which has made it possible to virtually eliminate complications and significantly reduce the risk of adverse reactions. However, this did not eliminate a number of disadvantages inherent in all oral drugs: the need for daily administration, which requires high behavioral motivation, fluctuations in hormone levels throughout the day, metabolism in the gastrointestinal tract, the effect of primary passage through the liver, etc. This was a prerequisite for the creation of non-oral , prolonged methods of hormonal contraception, which would be devoid of the listed disadvantages, which certainly expands the possibilities of contraception and increases its acceptability in relation to differentiated, individual choice in each specific case.

It should be noted that many researchers in the field of family planning believe that in the 21st century the most popular methods of contraception will be hormonal releasing systems (subcutaneous, intrauterine, vaginal, cutaneous, etc.).

The advantages of hormonal releasing systems are:

• long-term non-daily contraception;
• the release of hormones along a biological gradient and, therefore, the absence of fluctuations in hormone levels throughout the day;
• no need for daily self-monitoring of use;
• non-oral route of administration;
• lack of first pass effect through the gastrointestinal tract and liver;
• rapid restoration of fertility after withdrawal.

Releasing systems have the same medicinal properties as other types of hormonal contraception: they regulate the menstrual cycle, are used to treat the symptoms of premenstrual syndrome, dysmenorrhea, endometriosis, to prevent endometrial hyperplastic processes, etc. According to WHO (2002), hormonal contraceptives reduce the risk of developing ovarian cancer by 80%, endometrial cancer by 50%, chorionic carcinoma by 100%, colorectal cancer by 50%.

One of the latest developments in the field of contraceptives is the creation of a transdermal contraceptive system in the form of an EVRA skin patch.

The EVRA transdermal contraceptive system is a thin patch whose contact area with the skin is 20 cm2. Each patch contains 600 mcg ethinyl estradiol (EE) and 6 mg norelgestromin (NG). Within 24 hours, the system releases 150 mcg of NG and 20 mcg of EE into the blood, which provides a contraceptive effect. In terms of daily hormone release, EVRA corresponds to microdose oral contraceptives. Serum concentrations of norelgestromin and ethinyl estradiol, which are released from the transdermal patch, remain within appropriate limits for 7 days of use, regardless of its location (abdomen, buttocks, arm, torso). Norelgestromin is a highly selective gestagen of the latest generation and is a biologically active metabolite of norgestimate. It has been proven that norelgestromin has high gestagenic activity, effectively suppresses ovulation, and increases the viscosity of cervical mucus (Abrams LS et al., 2002).

The transdermal contraceptive system provides a constant and uniform delivery of hormones throughout the week. During the same month, three contraceptive patches are used. Each patch is used for one week (7 days) and then replaced with another on the same day of the next week. In the future, you should take a 7-day break, during which a menstrual-like reaction occurs.

The patch adheres well to the skin and remains effective during swimming, various water procedures, physical exercise, and also in conditions of high humidity (swimming, sauna, etc.).

The structure of the skin patch is represented by four layers:

• containing active ingredients: EE and norelgestromin;
• a protective layer that forms the outer surface of the patch and protects the ingredients from damage;
• a permeable membrane that controls the release of EE and norelgestromin through the skin;
• the adhesive inner surface that holds the patch to the skin.

When the patch is applied to the skin, the active ingredients begin to diffuse directly through the skin into the bloodstream at a rate controlled by the membrane. This is an important factor that helps to avoid or reduce a number of adverse effects that occur with other methods of contraception. The cutaneous system provides a sustained, long-lasting release of active substances and serves as a viable alternative for women who find it difficult to remember to take pills every day.

The great advantage of the patch is that gastrointestinal diseases (vomiting, diarrhea) do not interfere with the administration of the drug and do not affect its effectiveness.

The mechanism of the contraceptive action of EVRA is due to the suppression of ovulation and an increase in the viscosity of cervical mucus. EVRA has been found to suppress ovulation as effectively as combined oral contraceptives.

A number of recent studies demonstrate the high acceptability of the EBPA transdermal system.

In particular, the results of clinical studies conducted from 2000 to 2004. confirmed not only the high contraceptive effectiveness and acceptability of EVRA, but also good cycle control during contraception, the absence of a negative effect on blood pressure, body weight, and hemostasis.

The good pharmacokinetic properties of the transdermal patch make it possible to maintain effective hormone levels in various conditions of a woman’s life. The failure rate of the method ranges from 0.4 to 0.6%, which is a very low rate (Zieman M. et al., 2002).

The adhesive properties of the transdermal patch were studied in three clinical studies: 3319 women used it for 13 months. The rate of premature patch replacement was 4.7%: due to complete rejection - 1.8%, partial - 2.9%. 1.7% of the patches had to be replaced due to peeling due to exposure to elevated ambient temperatures and 2.6% due to increased humidity. Only one of 87 patches completely came off when exposed to intense physical activity. Thus, studies have revealed good adhesive properties of contraceptive transdermal patches.

Clinical studies conducted in the United States (1785 women in 76 centers) showed that the age of the woman did not affect the acceptability of transdermal patches. All patients who used the patches used them correctly. According to some researchers, the acceptability of transdermal patches compared to OCs is significantly higher, because the frequency of correct use of OCs depended on a number of factors, in particular the age of the patient (Archer DF et al., 2002).

Side effects typical of hormonal contraception when using EVPA in most cases were mild to moderate, were transient in nature and did not limit the possibility of using the patch in the future (Smallwood G et al., 2001). Only 6% of women refused further use of EVRA due to adverse reactions.

When the patch comes off, it is recommended to re-stick it; if unsuccessful, use a new patch. It is important to know that when the patch is completely peeled off, full protection against pregnancy is maintained for 48 hours without the use of any contraceptive methods. If the skin is irritated, it is recommended to remove the patch and stick a new one to another place. Women with a body weight of 90 kg or more should be recommended other methods of contraception, because the presence of a large fat layer prevents the diffusion of components and contributes to the rejection of the patch.

90% of women participating in multicenter studies rated the EBPA transdermal contraceptive system as “very convenient” compared to the previously used method,” 86% were “highly satisfied” (Zieman M. et al., 2002) .

The Scientific Center for Obstetrics, Gynecology and Perinatology of Rosmedtekhnologii was a participant in the Multicenter European Study to study the effectiveness and acceptability of the transdermal cutaneous system EBRA in women of reproductive age. Analysis of the results of observation of 325 women who used the EBRA transdermal system revealed its high contraceptive effectiveness (Pearl index - 0.76). None of the patients became pregnant. 1,700 cycles of skin patch use were analyzed. The frequency of adverse reactions was low: 6% of patients had mastodynia, 2% had headache, 2% had intermenstrual bleeding, 2% had allergic reactions in the form of skin rash, 1% had weight gain (+3 kg ). Adverse reactions were short-term in nature and did not require treatment or discontinuation of the method.

Thus, the results of our studies indicate high contraceptive effectiveness and acceptability of the transdermal system in women of reproductive age.

Summarizing the literature data, we can say that the most important things for women when using the EVRA skin patch are:

• low incidence of adverse reactions;
• reducing the likelihood of omissions or errors in taking the drug;
• ease of use.

Absolute contraindications to the use of cutaneous contraception are the same as for hormonal contraception in general: venous thrombosis in the active stage, malignant diseases, ovarian tumors, severe liver diseases, vaginal bleeding of unknown etiology, pregnancy or suspected pregnancy, hypersensitivity to the components included in composition of the patch.

Women using the EVPA skin patch, according to WHO recommendations, should visit a gynecologist annually, or if she experiences any complaints or side effects.

Recommended methods of monitoring for contraception using EVRA: annual gynecological examination (colposcopy, PAP-test), clinical examination of the mammary glands, regular measurement of blood pressure, body weight, blood tests. The expansion of the range of examination is determined by the doctor in relation to a specific patient.

It should be noted that the use of patches does not protect against sexually transmitted infections, therefore, if there is an increased risk of infection, it is necessary to additionally use barrier methods of contraception, preferably condoms.

Thus, the contraceptive releasing system is a qualitatively new method of contraception, combining high contraceptive effectiveness, duration and ease of use, acceptability, medicinal properties, i.e. This is a method that corresponds to the lifestyle of a modern woman and opens up new ways and new opportunities for individual, differentiated contraception.

Possible side effects when using the pregnancy patch

Minor side effects may occur during the first few months.

A woman may experience:

• headache;
• high blood pressure;
• nausea;
• soreness of the mammary glands;
• depressive mood changes;
• intermenstrual bleeding;
• soreness of the mammary glands;
• vaginal itching or discharge.

Nausea

Headache

Breast tenderness

Contraindications

Women with the following conditions should not use the patch due to the possibility of thromboembolism:

• severe obesity;
• smoking, currently or within the past year;
• age over 35 years;
• family or personal history of thromboembolic complications, especially if the relative was under 45 years of age at the time;
• immobilization after surgery, injury or other conditions;
• severe degree of varicose veins;
• hepatitis or benign liver tumors;
• gallbladder disease;
• diabetes with complications or duration of more than 20 years;
• migraines on a regular basis.

The patch is also not suitable for women who are exclusively breastfeeding and are less than six months postpartum.

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Abortion and contraception clinic in St. Petersburg - department of the medical gynecological association "Diana"

Make an appointment, tests or ultrasound via the contact form or by calling +8 (812) 62-962-77. We work seven days a week from 09:00 to 21:00.

We are located in the Krasnogvardeisky district, next to the Novocherkasskaya, Ploshchad Alexander Nevsky and Ladozhskaya metro stations.

The cost of a medical abortion in our clinic is 3,300 rubles. The price includes all pills, an examination by a gynecologist and an ultrasound to determine the timing of pregnancy.