NCT00958334

Extension Study of Proellex in Women Who Have Previously Completed Study ZPU 003

A Multicenter, Open-Label, Safety And Efficacy, Two Year Extension Study of the Selective Progesterone Receptor Modulator Proellex® (CDB-4124) in Pre-Menopausal Women With Symptomatic Leiomyomata Who Have Previously Completed Study ZPU 003

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 65 (actual)
• Sponsor: Repros Therapeutics Inc. · Industry
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

ZPU-003 EXT is a 2-year extension study of ZPU-003 (NCT00882258) to determine the continued safety and efficacy of Proellex in women who have previously completed the double-blind portion of the study.

Detailed description

ZPU-003 EXT is a 2-year extension study of ZPU-003 (NCT00882258). The purpose of the study is to determine the continued safety and efficacy of Proellex in women who have previously completed the double-blind portion of the study. The desired primary efficacy outcome will be a changes in vaginal bleeding from baseline to 14 months and 17 months on study drug. The total duration of the study is up to 24 months including transition times, off drug intervals, and follow-up visits). It is expected that over a 16 week on drug interval menses will subside and return after a 4-8 week off drug interval (ODI).

Conditions

• Uterine Fibroids

Interventions

Type	Name	Description
DRUG	Proellex®	25 mg daily (two 12.5 mg capsules)

Timeline

• Start date: 2006-09-07
• Primary completion: 2008-10-15
• Completion: 2008-10-15
• First posted: 2009-08-13
• Last updated: 2019-06-18
• Results posted: 2011-01-07

Locations

11 sites across 1 country: United States