NCT01631903

Extension of Study ZPV-200

A Phase 2, Multi-Center, Five-Arm, Parallel Design, Randomized, Single-Blind Study to Evaluate the Safety, Pharmacokinetics and Efficacy of Proellex® (Telapristone Acetate) Administered Vaginally in the Treatment of Premenopausal Women With Uterine Fibroids Confirmed by Ultrasound

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: Repros Therapeutics Inc. · Industry
• Sex: Female
• Age: 18 Years – 47 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine the safety, pharmacokinetics and efficacy of four doses of vaginally administered Proellex in premenopausal women with uterine fibroids confirmed by ultrasound.

Conditions

• Uterine Fibroids

Interventions

Type	Name	Description
DRUG	telepristone acetate 12 mg	12 mg, vaginal capsule, once daily for 4 months
DRUG	telepristone acetate 3 mg	3 mg, vaginal capsule, once daily for 3 months
DRUG	telepristone acetate 6 mg	6 mg, vaginal capsule, once daily for 3 months
DRUG	telepristone acetate 12 mg	12 mg, vaginal capsule, once daily, for 3 months
DRUG	telepristone acetate 24 mg	24 mg, vaginal capsule, once daily for 4 months

Timeline

• Start date: 2012-09-01
• Primary completion: 2014-04-01
• Completion: 2014-04-01
• First posted: 2012-06-29
• Last updated: 2014-04-16

Locations

2 sites across 1 country: United States