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Withdrawn Phase 3 Interventional

Safety and Efficacy of 25 and 50 mg Doses of Proellex® in Treating the Recurrence of Uterine Fibroid Symptoms

ClinicalTrials.gov ID: NCT00874302

Public ClinicalTrials.gov record NCT00874302. 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, 4:58 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 Phase III, Open Label, Randomized, Multicenter Study Evaluating the Safety and Efficacy of 25 mg and 50 mg Doses of Proellex to Assess Recurrence of Symptoms in the Treatment of Symptomatic Uterine Fibroids

Brief summary

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

Subjects with symptomatic uterine fibroids will be enrolled and will receive daily oral study medication for 4 months. This will be followed by a 6 month off-drug interval until there is a return of significant symptomatology. If they experience symptoms of a certain severity, the subject will enter a second 4 month treatment cycle and then a follow-up period.

Study identification

NCT ID
NCT00874302
Recruitment status
Withdrawn
Study type
Interventional
Phase
Phase 3
Lead sponsor
Repros Therapeutics Inc.
Industry
Enrollment
Not listed

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
18 Years and older
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
Not listed
Primary completion
Not listed
Completion
Not listed
Last update posted
Jun 27, 2014

United States locations

U.S. sites
13
U.S. states
10
U.S. cities
12
Facility City State ZIP Site status
Genesis Center for Clinical Research San Diego California 92103 —
Physician Care Clinical Research, LLC Sarasota Florida 34239 —
Atlanta Women's Research Inst. Atlanta Georgia 30342 —
Soapstone Center for Clinical Research Decatur Georgia 30034 —
York Clinical Consulting Marrero Louisiana 70072 —
Female Pelvic Medicine Grand Rapids Michigan 49503 —
Hawthorne Medical Research, Inc. Winston-Salem North Carolina 27103 —
Lyndhurst Gynecologic Associates Winston-Salem North Carolina 27103 —
Clinical Trials of America Eugene Oregon 97408 —
Thomas Jefferson University - Jefferson Center for Women's Medical Specialties Philadelphia Pennsylvania 19107-5127 —
Women's Care Center, PLC Research Memphis Associates Memphis Tennessee 38119 —
Meharry Medical College Nashville Tennessee 37208 —
Willowbend Health & Wellness Associates Plano Texas 75093 —

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

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 7 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00874302, 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 27, 2014 · Synced Oct 21, 2026

Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.

Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT00874302 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →