Evaluating the Safety and Efficacy of Proellex® (CDB-4124) in Premenopausal Women With Symptomatic Uterine Fibroids
Public ClinicalTrials.gov record NCT00735553. 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.
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, Three-arm, Parallel Design, Placebo-controlled, Randomized, Double-blind, Multicenter Study Evaluating the Safety and Efficacy of Proellex® (CDB-4124) in the Treatment of Premenopausal Women With Symptomatic Uterine Fibroids
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Premenopausal women with symptomatic uterine fibroids will be randomized to either Proellex 25mg or 50mg or placebo for one treatment cycle (four months). Safety and effectiveness between 50 mg versus placebo, and between 25mg and placebo will be analyzed.
Study identification
- NCT ID
- NCT00735553
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 77 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 48 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
- Aug 2008 (Type not available)
- Primary completion
- Aug 2009 (Actual)
- Completion
- Aug 2009 (Actual)
- Last update posted
- Aug 21, 2014
2008 – 2009
United States locations
- U.S. sites
- 15
- U.S. states
- 7
- U.S. cities
- 13
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Alabama Clinical Therapeutics | Birmingham | Alabama | 35235 | — |
| Women's Health Research | Phoenix | Arizona | 85015 | — |
| Genova Clinical Research, Inc. | Tucson | Arizona | 85741 | — |
| Women's Health Care at Frost Steet | San Diego | California | 92123 | — |
| Downtown Women's Health Care | Denver | Colorado | 80218 | — |
| Visions Clinical Research | Boynton Beach | Florida | 33472 | — |
| OB-GYN Associates of Mid-Florida, P.A. | Leesburg | Florida | 34748 | — |
| Miami Research Associates | Miami | Florida | 33143 | — |
| Insignia Clinical Research | Tampa | Florida | 33613 | — |
| SC Clinical Research Center | Columbia | South Carolina | 29201 | — |
| Advanced Research Associates | Corpus Christi | Texas | 78414 | — |
| Advances in Health Inc. | Houston | Texas | 77030 | — |
| The Woman's Hospital of Texas, Clinical Research Center | Houston | Texas | 77054 | — |
| Institute for Women's Health | San Antonio | Texas | 78229 | — |
| Seven Oaks Women's Ctr. | San Antonio | Texas | 78229 | — |
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 NCT00735553, 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 Aug 21, 2014 · Synced Oct 19, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00735553 live on ClinicalTrials.gov.