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NCT00958334 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study of Uterine Fibroids, sponsored by Repros Therapeutics.

Completed
Registry status
Phase 2
Development phase
65
Enrollment target
11
Study locations

NCT00958334 is a Phase 2 study of Uterine Fibroids that has completed, run by Repros Therapeutics. The registered enrollment target is 65 participants, below the 238-participant average among 10 other Uterine Fibroids trials with a reported enrollment target (73% lower). The trial reports 11 study locations across 8 states.

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The verdict

NCT00958334, a Phase 2 study of Uterine Fibroids, has completed, sponsored by Repros Therapeutics.

COMPLETED
Registry status
Phase 2
Development phase
65 participants
Enrollment target
11
Study locations

Study 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.

Conditions Studied

Interventions

  • DRUG Proellex®

Study Locations (11)

Arizona

  • Women's Health Research - Phoenix
  • Arizona Wellness Centre for Women - Phoenix

California

  • Medical Centre for Clinical Research - San Diego
  • Women's Health Care, Inc. - San Diego

Texas

  • Advances in Health Inc. - Houston
  • Obstetrical & Gynecolgical Associates, PA (OGA) - Houston

Colorado

  • Downtown Women's Health Care - Denver

Florida

  • Insignia Clinical Research (Tampa Bay Women's Center) - Tampa

Nevada

  • Affiliated Clinical Research, Inc. - Las Vegas

South Carolina

  • SC Clinical Research Center - Columbia

Washington

  • Women's Clinical Research Centre - Seattle

Trial Details

FieldValue
Enrollment Target 65 participants
Start Date 2006-09-07
Est. Completion 2008-10-15
Phase Phase 2

Sponsor

Repros Therapeutics

50 total trials

What the Registry Record Tells You About NCT00958334

The ClinicalTrials.gov registry entry for NCT00958334 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 65 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 238-participant average among 10 other Uterine Fibroids trials with a reported enrollment target (73% lower). The listed sponsor is Repros Therapeutics, which has 50 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Uterine Fibroids appearing as the primary indexed condition, and to 1 intervention - of which Proellex® is the first listed.

NCT00958334 reports 11 study locations spanning 8 distinct geographic areas - top geographies include Arizona, California, Texas.

Frequently Asked Questions

What is clinical trial NCT00958334 about?

NCT00958334 is a clinical study titled "Extension Study of Proellex in Women Who Have Previously Completed Study ZPU 003". 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.

What is the current status of trial NCT00958334?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 65 participants. The study started on 2006-09-07. Estimated completion is 2008-10-15.

What conditions does trial NCT00958334 study?

This clinical trial studies the following conditions: Uterine Fibroids.

What interventions are being tested in trial NCT00958334?

The interventions under investigation include: Proellex® (DRUG).

Who is sponsoring clinical trial NCT00958334?

This trial is sponsored by Repros Therapeutics, which has 50 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00958334 being conducted?

This trial has 11 study locations across Arizona, California, Colorado, Florida, Nevada. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.