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Pharmacokinetics, Safety and Efficacy Study of Proellex in Pre-menopausal Women With Symptomatic Uterine Fibroids

Uterine Fibroids Clinical Trial

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

Clinical Trial Summary

PK of 25 mg and 50 mg Proellex® administered once daily (QD) over a 4-month period.

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00683917
Study type Interventional
Source Repros Therapeutics Inc.
Contact
Status Terminated
Phase Phase 2
Start date May 2008
Completion date August 2009
View Details
See also
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