NCT00874302

Safety and Efficacy of 25 and 50 mg Doses of Proellex® in Treating the Recurrence of Uterine Fibroid Symptoms

A Phase III, Open Label, Randomized, Multicenter Study Evaluating the Safety and Efficacy of 25 mg and 50 mg Doses of Proellex to Assess Recurrence of Symptoms in the Treatment of Symptomatic Uterine Fibroids

• Status: Withdrawn
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Repros Therapeutics Inc. · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Subjects with symptomatic uterine fibroids will be enrolled and will receive daily oral study medication for 4 months. This will be followed by a 6 month off-drug interval until there is a return of significant symptomatology. If they experience symptoms of a certain severity, the subject will enter a second 4 month treatment cycle and then a follow-up period.

Detailed description

Subjects with documented symptomatic uterine fibroids will be enrolled in the study. Following screening, subjects will receive daily oral study medication and will be assessed monthly for a 4 month treatment cycle. This first cycle will be followed by an off-drug interval until there is a return of significant symptomatology. Subjects will be followed for up to six (6) months post-treatment. If their lack of symptoms does not qualify them for a second cycle of treatment, they will be discharged from the study. If they experience symptoms of a certain severity, the subject will enter a second 4 month treatment cycle and then a follow-up period.

Conditions

• Uterine Fibroids

Interventions

Type	Name	Description
DRUG	Proellex	One 25mg capsule taken orally once every day.
DRUG	Proellex	Two 25mg capsules Proellex (50mg) taken orally once every day

Timeline

• First posted: 2009-04-02
• Last updated: 2014-06-27

Locations

20 sites across 2 countries: United States, Brazil