Terminated PHASE3 INTERVENTIONAL 3-arm NCT00702702

Safety and Efficacy of Proellex in Pre-menopausal Anemic Women With Symptomatic Uterine Fibroids

A Multi-Center, Placebo Controlled, Safety and Efficacy Study of the Selective Progesterone Receptor Modulator Proellex® (CDB-4124) in Anemic, Pre-Menopausal Women With Symptomatic Uterine Fibroids Requiring Hysterectomy

Sponsor: Repros Therapeutics Inc.

Conditions Anemia Uterine Fibroids

Interventions Placebo Proellex 25 mg Proellex 50 mg

Updated 8 times since 2017 Last updated: Aug 5, 2014 Started: Jun 30, 2008 Primary completion: Aug 31, 2009 Completion: Aug 31, 2009

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Terminated

Repros stopped study for safety and FDA put study on hold because of safety.

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This PHASE3 trial investigates Anemia and Uterine Fibroids and is currently terminated or withdrawn. Repros Therapeutics Inc. leads this study, which shows 8 recorded versions since 2008 — indicating limited longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.

Status Flow

Change History

8 versions recorded

Sep 2025 — Present [monthly]

Terminated PHASE3
Sep 2024 — Sep 2025 [monthly]

Terminated PHASE3
Jul 2024 — Sep 2024 [monthly]

Terminated PHASE3
Dec 2021 — Jul 2024 [monthly]

Terminated PHASE3
Jan 2021 — Dec 2021 [monthly]

Terminated PHASE3

▶ Show 3 earlier versions

Jun 2018 — Jan 2021 [monthly]

Terminated PHASE3
Feb 2017 — Jun 2018 [monthly]

Terminated PHASE3
Jan 2017 — Feb 2017 [monthly]

Terminated PHASE3

First recorded

Jun 2008

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

Repros Therapeutics Inc.

Data source: Repros Therapeutics Inc.

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

Anaheim, United States , Birmingham, United States , Boynton Beach, United States , Brooklyn, United States , Chattanooga, United States , Cleveland, United States , College Park, United States , Columbia, United States , Corpus Christi, United States , Decatur, United States and 14 more locations