NCT00737282

Multicenter Study Evaluating the Safety of Proellex® in Premenopausal Women With Uterine Fibroids

A Phase III, Open-Label, Parallel, Randomized, Multicenter Study Evaluating the Safety of 25 And 50 mg Proellex® (CDB-4124) in the Treatment of Premenopausal Women With Symptomatic Uterine Fibroids

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 175 (actual)
• Sponsor: Repros Therapeutics Inc. · Industry
• Sex: Female
• Age: 18 Years – 48 Years
• Healthy volunteers: Not accepted

Summary

The safety of Proellex 25 and 50 mg administered once daily for three treatment cycles (four months each) will be evaluated.

Detailed description

Subjects will be randomized to either Proellex dose, 25 mg or 50 mg, in a 1:1 ratio. Subjects will receive drug for a four (4) month cycle of therapy three (3) times, each treatment cycle being separated by an off-drug interval until menstruation occurs. During the treatment periods, all subjects will be assessed monthly. Subjects will undergo an additional follow-up for 3 months following their last treatment visit.

Conditions

• Uterine Fibroids

Interventions

Type	Name	Description
DRUG	Proellex 25 mg	One capsule Proellex 25 mg administered as daily oral doses for four (4) consecutive months during each treatment cycle
DRUG	Proellex 50 mg	Two capsules Proellex 25 mg administered as daily oral doses for four (4) consecutive months during each treatment cycle

Timeline

• Start date: 2008-10-01
• Primary completion: 2009-08-01
• Completion: 2009-08-01
• First posted: 2008-08-18
• Last updated: 2014-08-21
• Results posted: 2014-08-21

Locations

25 sites across 1 country: United States