Spots Global Cancer Trial Database for Multicenter Study Evaluating the Safety of Proellex® in Premenopausal Women With Uterine Fibroids
The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.
Trial Identification
Brief Title: Multicenter Study Evaluating the Safety of Proellex® in Premenopausal Women With Uterine Fibroids
Official Title: A Phase III, Open-Label, Parallel, Randomized, Multicenter Study Evaluating the Safety of 25 And 50 mg Proellex® (CDB-4124) in the Treatment of Premenopausal Women With Symptomatic Uterine Fibroids
Study ID: NCT00737282
Conditions
Study Description
Brief Summary: The safety of Proellex 25 and 50 mg administered once daily for three treatment cycles (four months each) will be evaluated.
Detailed Description: Subjects will be randomized to either Proellex dose, 25 mg or 50 mg, in a 1:1 ratio. Subjects will receive drug for a four (4) month cycle of therapy three (3) times, each treatment cycle being separated by an off-drug interval until menstruation occurs. During the treatment periods, all subjects will be assessed monthly. Subjects will undergo an additional follow-up for 3 months following their last treatment visit.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
Lynn Institute of the Ozarks, Little Rock, Arkansas, United States
AWC Clinical Trials LLC, Little Rock, Arkansas, United States
Impact Clinical Trials, Beverly Hills, California, United States
Genesis Center for Clinical Research, San Diego, California, United States
Physician Care Clinical Research, LLC, Sarasota, Florida, United States
Atlanta Women's Research Inst, Atlanta, Georgia, United States
Medical Network for Education and Research, Decatur, Georgia, United States
Soapstone Center for Clinical Research, Decatur, Georgia, United States
York Clinical Consulting, Marrero, Louisiana, United States
NECCR Falls River LLC, Fall River, Massachusetts, United States
ClinSite, LLC, Ann Arbor, Michigan, United States
Female Pelvic Medicine, Grand Rapids, Michigan, United States
Alegent Research, Omaha, Nebraska, United States
Hawthorne Medical Research, Inc., Winston-Salem, North Carolina, United States
Lyndhurst Gynecologic Associates, Winston-Salem, North Carolina, United States
Clinical Trials of America, Eugene, Oregon, United States
Thomas Jefferson University - Jefferson Center for Women's Medical Specialties, Philadelphia, Pennsylvania, United States
University Medical Group, Dept of OB/GYN, Greenville, South Carolina, United States
Greenville Pharmaceutical Research, Greenville, South Carolina, United States
Memphis Women's Healthcare, Memphis, Tennessee, United States
Women's Care Center, PLC Research Memphis Associates, Memphis, Tennessee, United States
Meharry Medical College, Nashville, Tennessee, United States
Women Partners in Health, Austin, Texas, United States
Willowbend Health & Wellness Associates, Plano, Texas, United States
Medical Associates Inc., Menomonee Falls, Wisconsin, United States
Contact Details
Name: Andre vanAs, MD, PhD
Affiliation: Repros Therapeutics Inc.
Role: STUDY_DIRECTOR
Take Control of Your Skin and Body Changes Today.
Try out Spots for free, set up only takes 2 mins.
Join others from around the world:
