Overview

This trial is active, not recruiting.

Condition uterine fibroids
Treatments placebo comparator, proellex 6 mg, proellex 12 mg
Phase phase 2
Sponsor Repros Therapeutics Inc.
Start date December 2014
End date December 2016
Trial size 45 participants
Trial identifier NCT02323646, ZPV-201

Summary

The primary objective of this study is to determine the safety and efficacy of two vaginal 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)
placebo comparator Placebo
Safety and efficacy comparison of 6 mg and 12 mg for 2, 18 week courses of treatment for uterine fibroids
(Experimental)
6 mg Proellex® (Telapristone Acetate) vaginal suppository
proellex 6 mg Telapristone Acetate
Safety and efficacy comparison of 6 mg and 12 mg for 2, 18 week courses of treatment for uterine fibroids
(Experimental)
12 mg Proellex® (Telapristone Acetate) vaginal suppository
proellex 12 mg Telapristone Acetate
Safety and efficacy comparison of 6 mg and 12 mg for 2, 18 week courses of treatment for uterine fibroids

Primary Outcomes

Measure
Percentage of subjects who become amenorrheic after one course of treatment
time frame: 6 months

Eligibility Criteria

Female participants from 18 years up to 47 years old.

Inclusion Criteria: - Otherwise healthy adult females between 18 and 47 years - Subject has a history of at least 3 regular menstrual cycles in which menorrhagia is due to uterine fibroids. - Subject must have uterine fibroids. - Agreement not to attempt to become pregnant during the trial - Agreement to use only sanitary pads provided throughout the course of the study, tampon use is prohibited - Ability to complete a daily subject diary and study procedures in compliance with the protocol - Has a negative pregnancy test at the Screening and Baseline visits, and subsequent study visits - A Body Mass Index (BMI) between 18 and 45 inclusive - Confirmed > 80 mL of menstrual blood loss caused by uterine fibroids Exclusion Criteria: - Subject is a post-menopausal woman, defined as either; six (6) months or more (immediately prior to screening visit) without a menstrual period, or prior hysterectomy and/or oophorectomy. - 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 - Subject has a history of PCOS - Concurrent use of any testosterone, progestin, androgen, estrogen, anabolic steroids, DHEA or hormonal products for at least 2 weeks prior to screening and during the study - Use of oral contraceptives in the preceding 30 days. Use of Depo-Provera® in the preceding 10 months. - Use of GnRHas (e.g. Lupron Depot) within 3 months of the first dose of study drug (Lupron Depot must have a wash-out period of 3 months) - Has an IUD in place - Known or suspected carcinoma of the breast or reproductive organs - Recent history (within past 6 months) of alcoholism or drug abuse - Clinically significant abnormal findings on screening examination and laboratory assessments or any condition which in the opinion of the investigator would interfere with the participant's ability to comply with the study instructions or endanger the participant if she took part in the study

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 Vaginally 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..