Effectiveness and safety of dydrogesterone in regularization of menstrual cycle: a post-marketing study

Abstract

Oral administration of dydrogesterone during second half of menstrual cycle has been shown to reduce menstrual irregularities. This prospective, observational study aimed to determine continued effectiveness of dydrogesterone (prescribed between 1 and 6 cycles or longer) in menstrual cycle regularization in Indian women aged ≥18 years with irregular menstrual cycle for at least 3 months. Those achieving regular cycles (21 to 35 days, inclusive) during treatment were followed up for 6 months after cessation of dydrogesterone treatment. Of the 910 women completing dydrogesterone treatment, 880 (96.7%) achieved cycle regularization (p<0.0001 for 90% success rate) at end of treatment (EOT). Of the 788 subjects available for follow up at 6 months, 747 (94.8%) reported cycle regularity (p<0.0001 for 90% success rate). At EOT, the mean cycle duration reduced by 16.14 (±24.04) days and mean amount of menstrual bleeding decreased by 0.45 (±1.20) pads/day. While five subjects reported worst pain at baseline, none experienced it at EOT. One serious adverse event (appendicitis) and three non-serious adverse events were reported. Dydrogesterone regularizes and improves the duration of the menstrual cycle, reduces the amount of bleeding, relieves menstrual pain and prevents relapse of irregular cycles at six months after discontinuation of treatment.

Chinese abstract

在月经周期的后半程服用孕激素已被证实可有效减少月经失调。这项前瞻性观察研究的目的是确定至少服用3个周期地屈孕酮对于18岁以上月经失调的印度女性月经周期调节的持续效果（1至6个周期或更长时间）。那些在治疗期间获得正常月经周期（21至35天）的女性在停用地屈孕酮后继续被随访6个月。在910例完成地屈孕酮治疗的患者中, 880例（96.7%）在治疗结束时（end of treatment, EOT）获得规律的月经周期（p < 0.0001, 90%成功率）。在788例参与停药后6个月随访的患者中, 747例（94.8%）的月经周期规律（p < 0.0001, 90%成功率）。截至EOT, 平均月经周期减少了16.14（±24.04）天, 平均月经血量减少了0.45（±1.20）片/天。有5位受试者在基线期报道严重痛经, 但在EOT时并未发生。一例严重不良事件（阑尾炎）与3例非严重不良事件报道。地屈孕酮可调节、改善月经周期, 减少月经血量, 缓解痛经, 且在用药结束后的6个月内可预防月经失调的复发。

• Cycle regularization
• dydrogesterone
• menstrual bleeding
• menstrual pain
• observational study

Acknowledgements

The authors wish to thank all the participating physicians, site management organization, data management and the medical writing agency for their efforts.

Declaration of interest

The financial support for this study was provided by Abbott India Limited, Mumbai, India.

Dr. Nilesh Trivedi declares that he has no conflict of interest. Dr. Naveen Chauhan and Mr. Vishal Vaidya declare that they are an employee of Abbott India Limited and have participated in the planning and writing of the manuscript. They have seen, reviewed and approved the final version of manuscript.