title: Dydrogesterone treatment for menstrual-cycle regularization in routine clinical practice: a multicenter observational study.
abstract: Dydrogesterone is an oral retroprogesterone widely used to treat progesterone deficiencies, including irregular menstrual cycles (MCs). This prospective, non-interventional, single-arm, post-marketing, observational study evaluated the effects of dydrogesterone on MC regularization. Women aged 18-40 years who had been prescribed dydrogesterone to treat irregular MCs due to progesterone deficiency were enrolled across 64 centers in Russia, Ukraine, Kazakhstan and Uzbekistan. Study objectives included: patients reporting ≥1 regular MC during treatment; the number of regular MCs after the end of treatment over a 6-month follow-up (FU) period. In total, 996 women were enrolled. Of those who completed treatment, 946/955 patients (99.1%) achieved ≥1 regular MC. During FU, 680/860 patients (79.1%) maintained ≥6 regular MCs. Patient grading of menstrual pain and anxiety decreased significantly during treatment (p ≤ 0.0001 versus baseline); this persisted during FU. Dydrogesterone was associated with high or very high patient satisfaction (856/955; 89.6%); the clinical response was considered good or excellent in 819/955 patients (85.8%). In total, 16/986 patients (1.6%) reported an adverse event (AE); two had serious AEs (SAEs) (unrelated to treatment) and three discontinued treatment due to non-SAEs. Dydrogesterone therapy was effective in achieving MC regularization and reducing menstrual pain and anxiety, during both treatment and 6-month FU.
authors.affiliation: a Medical Academy of Postgraduate Education , Moscow , Russia .
authors.forename: Natalia
authors.initials: N
authors.lastname: Podzolkova
authors.affiliation: b Institute of Pediatrics, Obstetrics and Gynecology of NAMS , Kiev , Ukraine .
authors.forename: Tetiana
authors.initials: T
authors.lastname: Tatarchuk
authors.affiliation: c Medical University of Astana , Astana , Kazakhstan .
authors.forename: Aikerm
authors.initials: A
authors.lastname: Doshchanova
authors.affiliation: d Tashkent Institute of Postgraduate Medical Education , Tashkent , Uzbekistan , and.
authors.forename: Gulsara
authors.initials: G
authors.lastname: Eshimbetova
authors.affiliation: e Abbott GmbH & Co. KG , Ludwigshafen , Germany.
authors.forename: Claire
authors.initials: C
authors.lastname: Pexman-Fieth
mesh_terms: D000328:Adult; D004394:Dydrogesterone / Q000494:pharmacology / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D008597:Menstrual Cycle / Q000187:drug effects; D008599:Menstruation Disturbances / Q000188:drug therapy*; D011372:Progestins / Q000494:pharmacology / Q000627:therapeutic use*; D011446:Prospective Studies; D055815:Young Adult
chemical_list: D011372:Progestins; D004394:Dydrogesterone
keywords: Abnormal uterine bleeding; dydrogesterone; menstrual-cycle regularization; quality of life