MLE4901 vs. Placebo for the Treatment of PCOS

PHASE2TerminatedINTERVENTIONAL
Enrollment

55

Participants

Timeline

Start Date

July 31, 2016

Primary Completion Date

September 30, 2017

Study Completion Date

September 30, 2017

Conditions
Polycystic Ovary Syndrome (PCOS)
Interventions
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

Trial Locations (31)

14221

Upstate Clinical Research Associates, Williamsville

17033

The Pennsylvania State University (Penn State) Milton S. Hershey Medical Center, Hershey

19010

Main Line Fertility and Reproductive Medicine, Bryn Mawr

19104

University of Pennsylvania Perelman Center for Advanced Medicine - Penn Fertility Care, Philadelphia

22911

Charlottesville Medical Research Center, LLC, Charlottesville

23502

Tidewater Clinical Research, Inc., Norfolk

27518

PMG Research of Cary, Cary

29572

Magnolia OB/GYN Research Center, Myrtle Beach

30342

Atlanta Women's Research Institute, Atlanta

32207

University of Florida (UF), Jacksonville

32720

Avail Clinical Research, LLC, DeLand

32806

Compass Research, LLC, Orlando

33012

Health Care Family Rehab & Research Center, Hialeah

33161

Segal Institute for Clinical Research, North Miami

33175

Palmetto Professional Research, Miami

33613

Stedman Clinical Trials, LLC, Tampa

43213

Aventiv Research, Inc., Columbus

44122

Rapid Medical Research, Inc., Cleveland

44124

University Hospitals Cleveland Medical Center, Mayfield Heights

44883

Clinical Research of Tiffin, Tiffin

59102

Montana Health Research Institute, Inc., Billings

61820

Womens Health Practice, Champaign

66218

GTC Enterprises LLC, Shawnee Mission

72401

NEA Baptist Clinic, Jonesboro

78749

Texas Diabetes and Endocrinology, P.A. - South Austin, Austin

83642

Advanced Clinical Research, Boise

84107

Wasatch Clinical Research, Salt Lake City

84124

Highland Clinical Research, Salt Lake City

85018

Hope Research Institute, LLC, Phoenix

92056

Excell Research, Oceanside

06460

Clinical Research Consulting, LLC, Milford

Sponsors
All Listed Sponsors
collaborator

Medpace, Inc.

INDUSTRY

collaborator

Covance

INDUSTRY

lead

Millendo Therapeutics US, Inc.

INDUSTRY