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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
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:
Minimum Age: 18 Years
Eligible Ages: ADULT
Sex: FEMALE
Healthy Volunteers: No
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
Name: Anna Chan
Affiliation: Allergan
Role: STUDY_DIRECTOR