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Completed Phase 2 Interventional Results available

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

ClinicalTrials.gov ID: NCT00958334

Public ClinicalTrials.gov record NCT00958334. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 21, 2026, 12:47 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT00958334
Recruitment status
Completed
Study type
Interventional
Phase
Phase 2
Lead sponsor
Repros Therapeutics Inc.
Industry
Enrollment
65 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
18 Years to 50 Years
Sex
Female
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Sep 7, 2006 (Actual)
Primary completion
Oct 15, 2008 (Actual)
Completion
Oct 15, 2008 (Actual)
Last update posted
Jun 18, 2019

2006 – 2008

United States locations

U.S. sites
11
U.S. states
8
U.S. cities
8
Facility City State ZIP Site status
Women's Health Research Phoenix Arizona 85015 —
Arizona Wellness Centre for Women Phoenix Arizona 85032 —
Medical Centre for Clinical Research San Diego California 92108 —
Women's Health Care, Inc. San Diego California 92123 —
Downtown Women's Health Care Denver Colorado 80218 —
Insignia Clinical Research (Tampa Bay Women's Center) Tampa Florida 33607 —
Affiliated Clinical Research, Inc. Las Vegas Nevada 89128 —
SC Clinical Research Center Columbia South Carolina 29201 —
Advances in Health Inc. Houston Texas 77030 —
Obstetrical & Gynecolgical Associates, PA (OGA) Houston Texas 77054 —
Women's Clinical Research Centre Seattle Washington 98105 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00958334, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jun 18, 2019 · Synced Oct 21, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT00958334 live on ClinicalTrials.gov.

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