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