Clinical Trial: Pharmacokinetics, Safety and Efficacy Study of Proellex in Pre-menopausal Women With Symptomatic Uterine Fibroids
Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional
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 o
Brief Summary: PK of 25 mg and 50 mg Proellex® administered once daily (QD) over a 4-month period.
Detailed Summary: 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.
Sponsor: Repros Therapeutics Inc.
Current Primary Outcome: The Primary Outcome Measure is the PK Characteristics of 25 mg and 50 mg Proellex. [ Time Frame: 4 months ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
Original Secondary Outcome: Transformed UFS-QoL severity score, uterine fibroid size as measured by MRI, relapse of symptoms as recorded on subject diary cards, and persistence of effect as measured by UFS-QoL. [ Time Frame: 4 months ]
Information By: Repros Therapeutics Inc.
Dates:
Date Received: May 22, 2008
Date Started: May 2008
Date Completion:
Last Updated: August 5, 2014
Last Verified: August 2014