NCT02301897 - A Multi-Center, Parallel Design, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of 6 and 12 mg Proellex® (Telapristone Acetate) Administered Orally in the Treatment of Premenopausal Women With Confirmed Symptomatic Uterine Fibroids | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

March 16, 2015

Primary Completion Date

June 2, 2017

Study Completion Date

June 2, 2017

Conditions

Uterine Fibroids

Interventions

DRUG

Telapristone Acetate

Telapristone acetate, orally, once daily for 18 weeks (Course 1) and repeated for an additional 18 weeks (Course 2) following the ODI.

DRUG

Placebo

Matching placebo, orally, once daily for 18 weeks (Course 1) and repeated for an additional 18 weeks (Course 2) following the ODI.

Trial Locations (16)

23235

Clinical Research Partners, LLC, Richmond

29485

Palmetto Clinical Research, Summerville

30328

WR-Mount Vernon Clinical Research, LLC, Sandy Springs

30342

Atlanta Women's Research Institute, Inc., Atlanta

30912

Augusta University, Augusta

33063

South Florida Clinical Research Institute, Margate

33316

KO Clinical Research, LLC, Fort Lauderdale

35235

Alabama Clinical Therapeutics, LLC, Birmingham

37920

Volunteer Research Group, Knoxville

38305

The Jackson Clinic, PA, Jackson

70001

Southern Clinical Research Associates, LLC, Metairie

75231

DCT-HCWC, LLC dba Discovery Clinical Trials, Dallas

77030

Advances in Health, Houston

77054

The Women's Hospital of Texas Clinical Research Center, Houston

85015

Phoenix

85251

MomDoc Women's Health Research, Scottsdale

All Listed Sponsors

lead

Repros Therapeutics Inc.

INDUSTRY