Spots Global Cancer Trial Database for Pharmacokinetics, Safety and Efficacy Study of Proellex in Pre-menopausal Women With Symptomatic Uterine Fibroids
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Trial Identification
Brief Title: Pharmacokinetics, Safety and Efficacy Study of Proellex in Pre-menopausal Women With Symptomatic Uterine Fibroids
Official Title: 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
Study ID: NCT00683917
Conditions
Study Description
Brief Summary: PK of 25 mg and 50 mg Proellex® administered once daily (QD) over a 4-month period.
Detailed Description: The primary objective is to evaluate the pharmacokinetics (PK) of 25 mg and 50 mg Proellex® administered once daily (QD) over a 4-month period.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
Physician Care Clinical Research, Sarasota, Florida, United States
Advances in Health, Inc., Houston, Texas, United States
West Houston Clinical Research Services, Houston, Texas, United States
Centro de Estudios Cientificos y Clinicos Pharma, S.A. de C.V. (CECYC-Pharma), Mexico City, Federal District, Mexico
Contact Details
Name: Andre vanAs, MD, PhD
Affiliation: Repros Therapeutics Inc.
Role: STUDY_DIRECTOR
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