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Spots Global Cancer Trial Database for 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

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Trial Identification

Brief Title: 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

Official Title: A Phase 2, 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

Study ID: NCT02301897

Study Description

Brief Summary: The primary objective of this study is to determine the safety and efficacy of two oral doses of Proellex administered for up to 2 courses of treatment (18 weeks each), each separated by an Off-Drug Interval (ODI), to premenopausal women with symptomatic uterine fibroids.

Detailed Description:

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT

Sex: FEMALE

Healthy Volunteers: No

Locations

Alabama Clinical Therapeutics, LLC, Birmingham, Alabama, United States

, Phoenix, Arizona, United States

MomDoc Women's Health Research, Scottsdale, Arizona, United States

KO Clinical Research, LLC, Fort Lauderdale, Florida, United States

South Florida Clinical Research Institute, Margate, Florida, United States

Atlanta Women's Research Institute, Inc., Atlanta, Georgia, United States

Augusta University, Augusta, Georgia, United States

WR-Mount Vernon Clinical Research, LLC, Sandy Springs, Georgia, United States

Southern Clinical Research Associates, LLC, Metairie, Louisiana, United States

Palmetto Clinical Research, Summerville, South Carolina, United States

The Jackson Clinic, PA, Jackson, Tennessee, United States

Volunteer Research Group, Knoxville, Tennessee, United States

DCT-HCWC, LLC dba Discovery Clinical Trials, Dallas, Texas, United States

Advances in Health, Houston, Texas, United States

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

Clinical Research Partners, LLC, Richmond, Virginia, United States

Contact Details

Name: Anna Chan

Affiliation: Allergan

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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