A Multi-center, Active Controlled, Pharmacokinetic, Safety and Efficacy Study of Proellex in Pre-Menopausal Women With Symptomatic Uterine Fibroids to Assess Persistence of Response
Interventional
Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention
The primary outcome measure is the PK characteristics of 25 mg and 50 mg Proellex.
4 months
Yes
Andre vanAs, MD, PhD
Study Director
Repros Therapeutics Inc.
United States: Food and Drug Administration
ZPU-202
NCT00683917
May 2008
August 2009
Name | Location |
---|---|
Physician Care Clinical Research | Sarasota, Florida 34239 |
West Houston Clinical Research Services | Houston, Texas 77055 |
Advances in Health, Inc. | Houston, Texas 77030 |