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
This trial is active, not recruiting.
|Treatments||telapristone acetate, placebo|
|Sponsor||Repros Therapeutics Inc.|
|Start date||December 2014|
|End date||December 2016|
|Trial size||45 participants|
|Trial identifier||NCT02301897, ZPU-203|
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.
|United States||No locations recruiting|
|Other Countries||No locations recruiting|
|Birmingham, AL 35235||not available||no longer recruiting|
|Phoenix, AZ 85015||not available||no longer recruiting|
|Fort Lauderdale, FL 33316||not available||no longer recruiting|
|Margate, FL 33063||not available||no longer recruiting|
|Atlanta, GA 30342||not available||no longer recruiting|
|Augusta, GA 30912||not available||no longer recruiting|
|Metairie, LA 70001||not available||no longer recruiting|
|Summerville, SC 29485||not available||no longer recruiting|
|Jackson, TN 38305||not available||no longer recruiting|
|Knoxville, TN 37920||not available||no longer recruiting|
|Dallas, TX 75231||not available||no longer recruiting|
|Houston, TX 77030||not available||no longer recruiting|
|Houston, TX 77054||not available||no longer recruiting|
|Richmond, VA 23235||not available||no longer recruiting|
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
|Masking||double blind (subject, caregiver, investigator, outcomes assessor)|
time frame: 18 weeks of treatment
Female participants from 18 years up to 47 years old.
Inclusion Criteria: - Is a pre-menopausal female, 18-47 - Subject 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 mL of blood loss, to ensure subjects 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: - Subject is pregnant or lactating or is attempting or expecting to become pregnant during the entire study period - 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 - Subjects with abnormally high liver enzymes or liver disease.
|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|
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