Overview

This trial is active, not recruiting.

Condition uterine fibroids
Treatments telapristone acetate, placebo
Phase phase 2
Sponsor Repros Therapeutics Inc.
Start date December 2014
End date December 2016
Trial size 45 participants
Trial identifier NCT02301897, ZPU-203

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Placebo Comparator)
sugar pill manufactured to mimic Proellex capsule
placebo sugar pill
(Experimental)
telapristone acetate Proellex
Evaluate the safety and efficacy of 6 and 12 mg Proellex in the treatment of Premenopausal Women with confirmed symptomatic uterine fibroids
(Experimental)
telapristone acetate Proellex
Evaluate the safety and efficacy of 6 and 12 mg Proellex in the treatment of Premenopausal Women with confirmed symptomatic uterine fibroids

Primary Outcomes

Measure
Amenorrhea
time frame: 18 weeks of treatment

Eligibility Criteria

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.

Additional 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
Trial information was received from ClinicalTrials.gov and was last updated in January 2016.
Information provided to ClinicalTrials.gov by Repros Therapeutics Inc..