Spots Global Cancer Trial Database for Study of Proellex in Pre-menopausal Women With Symptomatic Uterine Fibroids
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Trial Identification
Brief Title: Study of Proellex in Pre-menopausal Women With Symptomatic Uterine Fibroids
Official Title: A Phase II, Multicenter, Randomized, Placebo-controlled, Double-blinded Study of the Selective Progesterone Receptor Modulator Proellex (CDB-4124) in Pre-menopausal Women With Symptomatic Leiomyomata
Study ID: NCT00882258
Conditions
Study Description
Brief Summary: Two (2) dose levels of Proellex or placebo will be administered once-daily for up to 91 days. Following screening and a pre-treatment endometrial biopsy, subjects will be followed monthly for the three month treatment phase.
Detailed Description: Two (2) dose levels of Proellex or placebo will be administered once-daily for up to 91 days. Following screening and a pre-treatment endometrial biopsy, subjects will be followed monthly for the three month treatment phase. At the three-month treatment visit, subjects will be entered into an open-label extension treatment protocol, if deemed eligible. At four months after their first treatment visit, subjects not electing to enter the open-label study will be assessed at a final follow-up visit.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
Alabama Clinical Therapeutics, LLC, Birmingham, Alabama, United States
Women's Health Research, Phoenix, Arizona, United States
Arizona Wellness Centre for Women, Phoenix, Arizona, United States
Visions Clinical Research Tuscon, Tuscon, Arizona, United States
Medical Centre for Clinical Research, San Diego, California, United States
Women's Health Care, Inc., San Diego, California, United States
Downtown Women's Health Care, Denver, Colorado, United States
Visions Clinical Research, Boynton Beach, Florida, United States
Miami Research Associates, Women's Health Studies, Miami, Florida, United States
Insignia Clinical Research (Tampa Bay Women's Center), Tampa, Florida, United States
Caring for Women, Las Vegas, Nevada, United States
Affiliated Clinical Research, Inc., Las Vegas, Nevada, United States
SC Clinical Research Center, Columbia, South Carolina, United States
Advances in Health Inc., Houston, Texas, United States
Obstetrical & Gynecolgical Associates, PA (OGA), Houston, Texas, United States
Women's Clinical Research Centre, Seattle, Washington, United States
Contact Details
Name: Andre VanAs, PhD, MD
Affiliation: Repros Therapeutics Inc.
Role: STUDY_DIRECTOR
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