Status:
COMPLETED
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
Lead Sponsor:
Repros Therapeutics Inc.
Conditions:
Uterine Fibroids
Eligibility:
FEMALE
18-47 years
Phase:
PHASE2
Brief 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 I...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 16 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 2 2017
Estimated Enrollment :
43 Patients enrolled
Trial Details
Trial ID
NCT02301897
Start Date
March 16 2015
End Date
June 2 2017
Last Update
June 19 2019
Active Locations (16)
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1
Alabama Clinical Therapeutics, LLC
Birmingham, Alabama, United States, 35235
2
Phoenix, Arizona, United States, 85015
3
MomDoc Women's Health Research
Scottsdale, Arizona, United States, 85251
4
KO Clinical Research, LLC
Fort Lauderdale, Florida, United States, 33316