A Multi-Center, Parallel Design, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of 6 and 12 mg Proellex® (Telapristone Acetate) Administered Orally in the Treatment of Premenopausal Women With Confirmed Symptomatic Uterine Fibroids
Public ClinicalTrials.gov record NCT02301897. 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 2, Multi-Center, Parallel Design, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of 6 and 12 mg Proellex® (Telapristone Acetate) Administered Orally in the Treatment of Premenopausal Women With Confirmed Symptomatic Uterine Fibroids
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The primary objective of this study is to determine the safety and efficacy of two oral doses of Proellex administered for up to 2 courses of treatment (18 weeks each), each separated by an Off-Drug Interval (ODI), to premenopausal women with symptomatic uterine fibroids.
Study identification
- NCT ID
- NCT02301897
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 43 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 47 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
- Mar 16, 2015 (Actual)
- Primary completion
- Jun 2, 2017 (Actual)
- Completion
- Jun 2, 2017 (Actual)
- Last update posted
- Jun 19, 2019
2015 – 2017
United States locations
- U.S. sites
- 16
- U.S. states
- 9
- U.S. cities
- 15
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Alabama Clinical Therapeutics, LLC | Birmingham | Alabama | 35235 | — |
| Not listed | Phoenix | Arizona | 85015 | — |
| MomDoc Women's Health Research | Scottsdale | Arizona | 85251 | — |
| KO Clinical Research, LLC | Fort Lauderdale | Florida | 33316 | — |
| South Florida Clinical Research Institute | Margate | Florida | 33063 | — |
| Atlanta Women's Research Institute, Inc. | Atlanta | Georgia | 30342 | — |
| Augusta University | Augusta | Georgia | 30912 | — |
| WR-Mount Vernon Clinical Research, LLC | Sandy Springs | Georgia | 30328 | — |
| Southern Clinical Research Associates, LLC | Metairie | Louisiana | 70001 | — |
| Palmetto Clinical Research | Summerville | South Carolina | 29485 | — |
| The Jackson Clinic, PA | Jackson | Tennessee | 38305 | — |
| Volunteer Research Group | Knoxville | Tennessee | 37920 | — |
| DCT-HCWC, LLC dba Discovery Clinical Trials | Dallas | Texas | 75231 | — |
| Advances in Health | Houston | Texas | 77030 | — |
| The Women's Hospital of Texas Clinical Research Center | Houston | Texas | 77054 | — |
| Clinical Research Partners, LLC | Richmond | Virginia | 23235 | — |
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 NCT02301897, 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 19, 2019 · Synced Oct 20, 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 NCT02301897 live on ClinicalTrials.gov.