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.