Dydrogesterone treatment for menstrual-cycle regularization in routine clinical practice a multicenter observational study
Keywords:abnormal uterine bleeding, dydrogesterone, menstrual-cycle regularization, quality of life
Dydrogesterone is an oral retroprogesterone widely used to treat progesterone deficiencies, including irregular menstrual cycles. This prospective, non-interventional, single-arm, post-marketing, observational study evaluated the effects of dydrogesterone on menstrual cycle regularization. Women aged 18-40 years who had been prescribed dydrogesterone to treat irregular menstrual cycles due to progesterone deficiency were enrolled across 64 centers in Russia, Ukraine, Kazakhstan and Uzbekistan.
Study objectives included: patients reporting ≥ 1 regular menstrual cycle during treatment; the number of regular menstrual cycles after the end of treatment over a 6-month follow-up period. In total, 996 women were enrolled. Of those who completed treatment, 946 (99.1%) of 955 patients achieved ≥ 1 regular menstrual cycle. During follow-up period, 680 (79.1%) of 860 patients maintained ≥ 6 regular menstrual cycles.Patient grading of menstrual pain and anxiety decreased significantly during treatment (p ≤ 0.0001 versus baseline); this persisted during follow-up period.
Dydrogesterone was associated with high or very high patient satisfaction – 856 (89.6%) of 955 women; the clinical response was considered good or excellent in 819 (85.8%) of 955 patients. This is comparable with the results of previous studies and confirms once again that the efficacy of treatment of abnormal uterine bleedings with dydrogesterone is highly appreciated by patients and physicians in routine clinical practice.
In total, 16 (1.6%) of 986 patients reported an adverse event; two had serious adverse events (unrelated to treatment) and three discontinued treatment due to non-serious adverse events.
Dydrogesterone therapy was effective in achieving menstrual cycle regularization and reducing menstrual pain and anxiety, during both treatment and 6-month follow-up period.
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Copyright (c) 2016 Н. М. Подзолкова, Т. Ф Татарчук, А. М. Дощанова, Г. З. Ешимбетова, К. Пексман-Фейс
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