Mammary glands and combined oral contraception: a combination of esthetrol and drospirenone (сlinical trial results)
AbstractThe aim of the study was to assess the condition of the mammary glands and the quality of life of women using a combined oral contraceptive (COC) based on esthetrol and drospirenone (E4/DRSP).
Material and methods. The study included 330 patients with verified benign mammary dysplasia (BMD) (average age 24.12±1.73 years), who, depending on the presence/absence of mastalgia, were stratified into two study groups: the first included 155 women with mastalgia, and in the second – 175 without it. For the purpose of contraception in the “24+4” mode, the patients of the study cohort took a drug containing esthetrol (15 mg) and drospirenone (3 mg) daily, according to the current instructions (LP-No. 000350-RG-RU). The control group (n=50) included patients of the same age (24.30±1.96 years) without BMD and mastalgia, also using E4/DRSP-based COCs for contraception in the traditional mode.
At the first and subsequent visits (after 3 and 12 months), the results of a sonographic examination of the mammary glands, pain intensity on the VAS scale (in patients with BMD and mastalgia) and quality of life indicators on the SF-12 scale were assessed. In all women, after 3 and 12 months, adherence to the prescribed COC was determined using the Morisky–Green scale.
Study design: an open, independent, prospective observational study was conducted.
Results. In patients with verified BMD using COCs based on E4/DRSP for contraception, there was a statistically significant decrease in the severity of mastalgia: from 6.28±1.24 to 3.19±1.01 and 1.16±0.60 points according to VAS scale (p<0.05), reduction in the thickness of the glandular layer (p<0.001), reduction in the severity and prevalence of areas of adenomatosis (p<0.001), ductectasia (p<0.001), reduction in the size of areas with cystic transformation (p<0.001 ) and single cysts up to 5 mm in size (p<0.001), as well as a decrease in the severity of linear and periductal fibrosis (p<0.001), the density of Cooper’s ligaments, Durette’s ridges and interlobular septa according to sonography (p<0.001). There was a statistically significant improvement in qualityof life indicators on the SF-12 scale: from 34.16±4.84 to 17.75±4.06 points in patients of group I and from 29.62±4.90 to 15.79±3,39 in patients of study group II (p<0.001). All patients in the study cohort had consistently high compliance rates according to the Morisky–Green scale throughout the study with a significant improvement by the 12th month of using the drug (4.58±1.10 and 5.49±0.50, respectively, p<0.001, in the control group – similar dynamics, p=0.709).
Conclusion. The study established the positive effect of COCs based on E4/DRSP on the condition of the mammary glands and the quality of life of women suffering from BMD with or without mastalgia. Patients in need of contraception with verified BMD can use COCs based on E4/DRSP not only for contraception and improve the quality of life, but also to improve the structural and functional characteristics of the mammary glands.
Keywords: esthetrol; benign mammary dysplasia; mastalgia; combined oral contraceptive
Funding. The study had no sponsor support.
Conflict of interest. The authors declare no conflict of interest.
For citation: Orazov M.R., Radzinskiy V.E., Kanevtsov V.V., Khamoshina M.B., Kiseleva M.V., Dolgov E.D. Mammary glands and combined oral contraception: a combination of esthetrol and drospirenone. Clinical trial results. Akusherstvo i ginekologiya: novosti, mneniya, obuchenie [Obstetrics and Gynecology: News, Opinions, Training]. 2024; 12 (3): 109–17. DOI: https://doi.org/10.33029/2303-9698-2024-12-3-109-117 (in Russian)
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