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

Completed · Phase 2 · Has a placebo group

Conditions studied: Uterine Fibroids

In brief

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.

Key facts

Study ID

NCT02301897

Run by

Repros Therapeutics Inc.

People needed

43

Starts

2015-03-16

Expected to finish

2017-06-02

Last updated by the study team

2019-06-19

Who can join

Age: 18 and older, up to 47. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Is a pre-menopausal female, between 18 and 47 years
• 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

You may not qualify if…

• Participant 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
• Participants with abnormally high liver enzymes or liver disease

Where it is running

• Alabama Clinical Therapeutics, LLC — Birmingham, Alabama, United States
• Study site — 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

Full record on ClinicalTrials.gov

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