Clinical Trial: MLE4901 vs. Placebo for the Treatment of PCOS

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: A Double-blind, Randomized, Parallel-group, Placebo-controlled Study of MLE4901 for the Treatment of Polycystic Ovary Syndrome (PCOS)

Brief Summary: This is a Phase 2b double-blind, randomized, parallel-group, placebo-controlled study of MLE4901 versus placebo in women with PCOS.

Detailed Summary: Following a Screening/Wash-out Period of up to 12 weeks, an 8-week Lead-in Period (starting with a progestin challenge) will be used to better characterize the study population. A Treatment Period of 28 weeks' duration will follow the Lead-in Period. Then, an 8-week Follow-up Period (i.e., no study drug) will be used to assess the durability of effects of MLE4901. The study duration will be approximately 48 weeks (11 months) per subject
Sponsor: Millendo Therapeutics, Inc.

Current Primary Outcome: Menstrual Cycle Duration [ Time Frame: 28 Week double blind treatment period ]

Assessment of the number of days between menstrual cycles from baseline to end of 28 week double blind treatment period


Original Primary Outcome: Same as current

Current Secondary Outcome: Number of Menstrual Periods [ Time Frame: 28 Week double blind treatment period ]

Number of menstrual periods from baseline to the end of the 28 week double blind treatment period


Original Secondary Outcome: Same as current

Information By: Millendo Therapeutics, Inc.

Dates:
Date Received: August 10, 2016
Date Started: July 2016
Date Completion: November 2018
Last Updated: May 16, 2017
Last Verified: April 2017