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 Fibro

• Status: Completed
• Trial end date: 2017-06-02
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Repros Therapeutics Inc.

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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