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Background. An unfavorable bleeding pattern is a common reason for refusing to continue hormonal contraception. Aim. To evaluate the characteristics of uterine bleeding when using a new combined oral contraceptive (COC) containing estetrol and drospirenone (Esteretta®). Materials and methods. A multicenter observational study included 1402 females aged 18–49 who received Esteretta® for 6 cycles. The frequency, duration, and severity of withdrawal bleeding, as well as the frequency of unpredictable bleeding, were assessed. Results. The rate of regular withdrawal bleeding was 100%. The proportion of women with heavy menstruation/withdrawal bleeding decreased from 29.6 to 10.07% (p0.0001). The duration of regular withdrawal bleeding was significantly reduced (p=0.008). The incidence of unpredictable bleeding during COC use decreased from 4.57 to 3.29% (p=0.05). Satisfactory cycle control was observed in 87.43% of women. 2.5% of participants refused to continue using COCs. Conclusion. Esteretta® provides a high rate of regular withdrawal bleeding and a low rate of unpredictable bleeding. Given the optimal safety profile, this drug may be the first choice for contraception in sexually active women who are not planning a pregnancy.

The concept of the demographic policy of the Russian Federation is to increase the birth rate, preserve citizens' health, and increase life expectancy. One of the priority areas is the reproductive health of women. The pleiotropic effect of the components of combined hormonal drugs is successfully used in clinical practice by obstetricians-gynecologists not only for contraception but also for conditions requiring prophylaxis and drug therapy. Estrogens have a protective effect on the reproductive and extragenital organs; however, evidence of the effect of estrogen-containing drugs on breast tissue and hemostasis remains debatable. We analyzed the data published in the international databases PubMed, Google Scholar, and MEDLINE (search depth – 5 years). Estetrol (E4) is a native fetal estrogen produced by the fetal liver during pregnancy. The key difference from other estrogens is its highly selective and differentiated effect on various tissues and its unique antiproliferative properties. The review presents the results of studies on estrogenic and antiestrogenic effects of E4 and the combination of E4 with progestogen (Esteretta drug product approved in Russia), with particular attention paid to the oncoprotective effect of E4. Research data suggest that E4 may have different effects on breast epithelial cells and breast cancer cells compared to other estrogens. Clinical data indicate that E4 has a more selective pharmacological profile compared to other estrogens, which is reflected in a low estrogenic effect on the liver, including the production of sex hormone binding globulin, hemostasis parameters, and lipid profile.

Aim. To evaluate the effect of a combined oral contraceptive (COC) containing estetrol and drospirenone on the sexual function of women using it. Materials and methods. A total of 251 women aged 21–35 years (mean age, 25.30±2.82 years) referred for contraceptive fitting were included in the study (ICD-10: Z30.0 General contraceptive advice and counseling, Z30.4 Contraceptive drug monitoring). Women in the study cohort used the original formulation containing 15 mg estetrol and 3 mg drospirenone in a 24+4 regimen for contraceptive purposes, according to the current instructions. All female participants (n=251) were assessed for sexual function at baseline, 6 and 12 months using FSFI (The Female Sexual Function Index), FSDS-R (The Female Sexual Distress Scale-Revised) and SQoL-F (The Sexual Quality of Life-Female) scales. Study design. An open, independent, prospective observational study. Results. Women taking COC containing estetrol 15 mg and drospirenone 3 mg maintained a baseline high level of sexual satisfaction (p0.05) throughout the study, as assessed by FSFI, SQoL-F and FSDS-R scales. Conclusion. The results obtained indicate that there is no negative effect of COC containing 15 mg estetrol and 3 mg drospirenonone on the sexual function of women. High contraceptive efficacy of the drug was confirmed.

Breast diseases (BD) are among the most urgent issues of modern reproductive medicine. This organ is an integral part of the female reproductive system and undergoes cyclic changes during the menstrual cycle. The modern "nosological trio" of BD is mastodynia, benign dysplasia, and breast cancer. These diseases have an extremely high prevalence, and breast cancer, in turn, ranks 1st in the structure of mortality from malignant neoplasms of the female reproductive system. All these aspects warrant the research of the key pathogenetic mechanisms of these conditions. However, one of the most relevant topics in modern gynecology is the counseling on the selection of contraceptive methods in these patients. Therefore, it is necessary to address the safety of hormonal contraceptive methods and to analyze innovations in hormonal contraceptives, which may have several protective and risk-reducing properties for BD.

Hormonal-induced changes in the breast occur due to both endogenous and exogenous sex hormones. For two decades, the safety of hormonal contraceptives (HC) in terms of their effect on breast tissue has been discussed in the literature. The pleiotropic effect of the components in the combined HC, on the one hand, prevents unwanted pregnancy; on the other hand, they help to maintain good health of women of childbearing age due to a wide range of non-contraceptive effects (eliminating hyperandrogenism manifestations, reducing the pain severity during menstruation and the menstrual blood loss, the risk of recurrence of functional ovarian cysts, oncoprotective effect due to reducing the risk of ovarian, endometrial, colorectal, pancreatic, and lung cancer). However, according to epidemiological studies, in addition to the beneficial effects, there are risks that require further study, including the controversial impact of HC on the oncogenesis and progression of breast cancer. In addition, some young women with breast cancer experience induced menopause after antitumor treatment. However, amenorrhea is not a marker for complete disabling of ovarian function, and pregnancy is associated with a risk of disease recurrence or progression. Therefore, in each case, it is necessary to determine the need for an effective and safe method of contraception.

One of the most effective contraception methods is combined hormonal contraceptives. According to the current prescribing information, in addition to their primary effect, they have several concomitant positive effects on the female body non-contraceptive effects. These include a well-predictable and controlled "menstrual cycle" (menstrual-like reaction), anti-androgenic effect, anti-anemic effect due to reduced menstrual blood loss, reducing the severity of dysmenorrhea and premenstrual syndrome, reducing the risk of pelvic inflammatory diseases, ectopic pregnancy, and some benign and malignant tumors of the reproductive system. Combined oral contraceptives (COCs) also have effects on the central nervous system, hypothalamic-pituitary structures that regulate sex hormones, and the psycho-emotional health of women. For a long time, the main estrogen component of COCs remained ethinylestradiol. Although not well-studied, its mechanisms of action on the nervous system are similar, regardless of the progestogen component. However, the effect was not entirely positive: taking contraceptives containing ethinylestradiol can lead to increased emotional lability, anxiety, and depressive disorders. It drives researchers to search for new estrogen without these adverse properties. Such is the long-known but overlooked esthetrol. Numerous studies indicate a pronounced neuroprotective effect of esthetrol, which can increase patients' satisfaction with hormonal contraceptives and their compliance. It also opens up great opportunities for the use of this drug beyond gynecological practice.

Combined oral contraceptives (COCs) containing synthetic analogs of sex steroids are considered the most effective and popular method of contraception worldwide. The low rate of hormonal contraceptive use is often because of the fear of side effects due to existing myths. Complex questions that most often arise among doctors and patients when choosing COCs include the risk of thrombosis and cancer, the effect on fertility after the use of COCs, the use of COCs in patients with COVID-19, etc. COCs are highly effective, well-studied, and pose minimal risks that are well understood, described in the labels, and can be avoided with proper use.

The use of hormonal contraception is widespread worldwide. Over the years of use, it has been possible to study its contraceptive effectiveness and its effect on carbohydrate metabolism, blood coagulation, lipid profile, liver function tests, and other systems and organs. However, the effect on sexual function has not been sufficiently studied. For a long time, ethinylestradiol remained the main estrogen in combined oral contraceptives; however, the desire to improve safety led to the development of a new drug containing natural, highly selective estrogen estetrol and the well-known progestogen drospirenone. Therefore, it is relevant to study the effect of the new combined oral contraceptive on sexual function.

The problem of mastalgia is widespread: up to 70% of women report regular or episodic pain in the mammary gland. The role of benign breast disease in the occurrence of these complaints was noted only in 10–30% of cases, while in most women mastalgia is a manifestation of premenstrual syndrome caused by excessive water retention in the body. As a therapy for such patients, the optimal solution would be to prescribe a new combined oral contraceptive containing 15 mg of estetrol and 3 mg of drospirenone. The uniqueness of this combination in this situation lies in the pronounced antimineralocorticoid effect of drospirenone, supported by a high safety profile of estetrol, including a reduced risk of developing breast cancer compared to other combined oral contraceptive.

Estetrol (E4) is a steroid hormone found in the urine of pregnant women in 1965. E4 is produced only during pregnancy and enters the maternal bloodstream through the placenta. Its concentration in maternal human plasma increases during pregnancy, reaching a maximum by the end of pregnancy (1 ng/mL). The pharmacological properties of E4 make it a promising agent for hormonal therapy and contraception. To date, phase II and III studies have shown promising results with the combination of 15 mg of E4 and 3 mg of drospirenone: this combined oral contraceptive has shown a good effect with a neutral metabolic effect. However, evidence is scarce about the effect of the new combination on the breast and bone tissue. Further studies are needed to consolidate the available data and to investigate possible side effects of prolonged use of E4-containing combined oral contraceptives compared to known ethinylestradiol and estradiol-containing combinations.