NCT02865915

MLE4901 vs. Placebo for the Treatment of PCOS

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 55 (actual)
• Sponsor: Millendo Therapeutics US, Inc. · Industry
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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

Conditions

• Polycystic Ovary Syndrome (PCOS)

Interventions

Type	Name	Description
DRUG	MLE4901	For 80% of subjects randomized to MLE4901 (n=24/30), the dose is 40 mg twice daily. Six subjects (20%) randomized to higher MLE4901 dose cohorts that were promptly discontinued.
DRUG	Placebo	Placebo to match active drug

Timeline

• Start date: 2016-07-01
• Primary completion: 2017-09-01
• Completion: 2017-09-01
• First posted: 2016-08-15
• Last updated: 2021-02-01
• Results posted: 2020-06-16

Locations

31 sites across 1 country: United States

Regulatory

• FDA-regulated drug study