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.

Chinese abstract

地屈孕酮是一种口服逆转孕酮，被广泛应用于治疗孕酮缺乏，包括不规则月经周期(MCs)。该项前瞻性、非干预性、无对照的、上市后的观察性研究评估地屈孕酮调整月经周期的疗效。18-40岁服用地屈孕酮以治疗因孕酮缺乏导致不规则月经周期的妇女被纳入该研究，包括俄罗斯、乌克兰、哈萨克斯坦和乌兹别克斯坦的64个中心。研究目的包括：在治疗期间患者≥1次规律月经周期；在治疗结束后6个月的随访(FU)中规律月经周期的患者数量。共有996名妇女纳入该研究。完成治疗的患者中，946/955(99.1%)的患者有≥1次规律月经周期。随访过程中，680/860(79.1%)的患者有≥6次规律月经周期。患者的痛经和焦虑分级在治疗期间显著减少(p≤0.0001与基线对照)，并在随访过程中维持。地屈孕酮获得了高的或极高的病人满意度(856/955; 89.6%)；临床效应优秀或卓越(819/955; 85.8%)。共有16/986(1.6%)的患者报告不良反应(AE)；2例严重不良反应(SAEs)(与治疗无关)，3例因非严重不良反应停止治疗。在治疗期间和6个月的随访中，地屈孕酮有效调整月经周期，减少痛经和焦虑。

• Abnormal uterine bleeding
• dydrogesterone
• menstrual-cycle regularization
• quality of life

Acknowledgements

The authors would like to thank Dr John Timney of Alpharmaxim Healthcare Communications for medical writing support.

Declaration of interest

Claire Pexman-Fieth is an employee of Abbott and owns shares of Abbott. All other authors report no conflicts of interest.