drugset / Trial / NCT02103764

Efficacy of Cyclic DSG Compared With Cyclic MPA for the Treatment of Anovulatory DUB

NCT02103764 ↗

Phase 3 Unknown 160 enrolled Mahidol University
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The objectives of the present study is to determine the effectiveness of cyclic desogestrel (DSG) compared with cyclic medroxyprogesterone acetate for the treatment of anovulatory dysfunctional uterine bleeding (DUB) in the following aspects: 1. Endometrial histopathology changes 2. Menstrual cycle control.

Timeline

Start
2013-08
Primary completion
2018-07
Completion
2018-12

Outcome

Met primary endpoint

paper endometrial response rate of 78.0% vs. 70.4%, 95% CI of difference - 9.1-24.4%, non-inferiority limit of - 10% PMID 35102226 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Desogestrel Small molecule 150 ug Oral
Comparator medroxyprogesterone acetate Other / unclassified 10 mg Oral

Indications