Safety of 25 and 50 mg Proellex® in the Treatment of Women With Symptomatic Uterine Fibroids
- Registration Number
- NCT01069120
- Lead Sponsor
- Repros Therapeutics Inc.
- Brief Summary
Safety and efficacy study of 25 and 50 mg doses of Proellex
- Detailed Description
The study is intended to provide more abundant safety and efficacy data of both the 25 and 50 mg doses of Proellex than ZPU-301, ZPU-302, ZPU-303 and ZPU-304 alone.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Female
- Target Recruitment
- 27
Inclusion Criteria
- At least 1 uterine fibroid must be identifiable and measurable by Transvaginal Ultrasound (TVU)
- Subject has a menstrual cycle lasting from 20 to 40 days.
- Subject must have satisfactorily completed all study visits from the previous study in which she participated: ZPU-301, ZPU-302, ZPU-303, or ZPU-304
Exclusion Criteria
- Subjects who have not participated in 1 of the previous Repros studies: ZPU-301, ZPU-302, ZPU-303, or ZPU-304.
- Subjects who met treatment stopping rules as per the DILI Guidance requirements while participating in ZPU-301, ZPU-302, ZPU-303, or ZPU-304
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 25 mg Proellex® Proellex 1, 25 mg capsule 50 mg Proellex® Proellex 2, 25 mg capsules
- Primary Outcome Measures
Name Time Method To Assess the Incidence of Adverse Events (AE) and Serious Adverse Events (SAEs) During two 4 month treatment periods
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (4)
Advances in Health Inc
🇺🇸Houston, Texas, United States
The Women's Hospital of Texas, Clinical Research Center
🇺🇸Houston, Texas, United States
Visions Clinical Research
🇺🇸Boynton Beach, Florida, United States
Insignia Clinical Research (Tampa Bay Women's Center)
🇺🇸Tampa, Florida, United States