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
NCT ID: NCT02301897
Last Updated: 2019-06-19
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
43 participants
INTERVENTIONAL
2015-03-16
2017-06-02
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Placebo
Following the baseline assessment no treatment period, matching placebo, orally, once daily for 18 weeks (Treatment Course 1) and repeated for an additional 18 weeks (Treatment Course 2) following the off drug interval (ODI).
Placebo
Matching placebo, orally, once daily for 18 weeks (Course 1) and repeated for an additional 18 weeks (Course 2) following the ODI.
Telapristone Acetate 6 mg
Following the baseline assessment no treatment period, telapristone acetate 6 milligrams (mg), orally, once daily for 18 weeks (Treatment Course 1) and repeated for an additional 18 weeks (Treatment Course 2) following the ODI.
Telapristone Acetate
Telapristone acetate, orally, once daily for 18 weeks (Course 1) and repeated for an additional 18 weeks (Course 2) following the ODI.
Telapristone Acetate 12 mg
Following the baseline assessment no treatment period, telapristone acetate 12 mg, orally, once daily for 18 weeks (Treatment Course 1) and repeated for an additional 18 weeks (Treatment Course 2) following the ODI.
Telapristone Acetate
Telapristone acetate, orally, once daily for 18 weeks (Course 1) and repeated for an additional 18 weeks (Course 2) following the ODI.
Interventions
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Telapristone Acetate
Telapristone acetate, orally, once daily for 18 weeks (Course 1) and repeated for an additional 18 weeks (Course 2) following the ODI.
Placebo
Matching placebo, orally, once daily for 18 weeks (Course 1) and repeated for an additional 18 weeks (Course 2) following the ODI.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Participant has a history of at least 3 regular menstrual cycles in which menorrhagia (heavy bleeding) is due to uterine fibroids
* Confirmed uterine fibroid(s) at screening
* Visit 1 historical pictorial blood loss assessment chart of \>120 milliliters (mL) of blood loss, to ensure participants have a menstrual blood loss of at least 80 mL by Alkaline Hematin Assay (during the baseline assessment period).
* A Body Mass Index (BMI) between 18 and 45 inclusive
Exclusion Criteria
* Received an investigational drug in the 30 days prior to the screening for this study
* Has an intrauterine device in place
* Observation or history of abnormal endometrial biopsy including the presence of endometrial intraepithelial neoplasia
* Participants with abnormally high liver enzymes or liver disease
18 Years
47 Years
FEMALE
No
Sponsors
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Repros Therapeutics Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Anna Chan
Role: STUDY_DIRECTOR
Allergan
Locations
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Alabama Clinical Therapeutics, LLC
Birmingham, Alabama, United States
Phoenix, Arizona, United States
MomDoc Women's Health Research
Scottsdale, Arizona, United States
KO Clinical Research, LLC
Fort Lauderdale, Florida, United States
South Florida Clinical Research Institute
Margate, Florida, United States
Atlanta Women's Research Institute, Inc.
Atlanta, Georgia, United States
Augusta University
Augusta, Georgia, United States
WR-Mount Vernon Clinical Research, LLC
Sandy Springs, Georgia, United States
Southern Clinical Research Associates, LLC
Metairie, Louisiana, United States
Palmetto Clinical Research
Summerville, South Carolina, United States
The Jackson Clinic, PA
Jackson, Tennessee, United States
Volunteer Research Group
Knoxville, Tennessee, United States
DCT-HCWC, LLC dba Discovery Clinical Trials
Dallas, Texas, United States
Advances in Health
Houston, Texas, United States
The Women's Hospital of Texas Clinical Research Center
Houston, Texas, United States
Clinical Research Partners, LLC
Richmond, Virginia, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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ZPU-203
Identifier Type: -
Identifier Source: org_study_id
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