Study to Evaluate Menses Induction in Women Administered Proellex
- Registration Number
- NCT00881608
- Lead Sponsor
- Repros Therapeutics Inc.
- Brief Summary
The purpose of this study is to determine the oral dose level at which the investigative drug, Proellex, is able induce menstruation.
- Detailed Description
The purpose of this study is to determine the oral dose level at which the investigative drug, Proellex, is able to suppress endogenous progesterone in women. It is believed that giving Proellex in the early/mid-luteal phase of the cycle will suppress the effects of endogenous progesterone triggering the end of the cycle and inducing menstruation as happens naturally
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Female
- Target Recruitment
- 11
Inclusion Criteria
- Clinical laboratory tests within normal ranges
- A normal menstrual period of 26-30 days
- Desiring not to become pregnant
- Agreeing to use a double barrier method of birth control for the duration of the trial
Exclusion Criteria
- Post-menopausal status
- Aamenorrhea or dysfunctional uterine bleeding
- Subjects demonstrating any clinically significant medical condition rendering the subjects infertile or marginally fertile
- Subjects with a Body Mass Index (BMI) below 18 or over 39
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Placebo Placebo Initiation-Placebo Cycle-Five (5) placebo capsules will be dispensed to subjects to self-administer for five days starting on cycle day 18. 6 mg Proellex Proellex Second Cycle (6 mg)-Subjects, who have not experienced menses, will have their dose of Proellex escalated, and be dispensed ten (10) 3 mg capsules of Proellex to self-administer 2, 3 mg capsules each day for five days starting on cycle day 18. 12 mg Proellex Proellex Third Cycle (12 mg)-Subjects, who have not experienced menses, will have their dose of Proellex escalated, and be dispensed twenty (20) 3 mg capsules of Proellex to self-administer 4, 3 mg capsules for five days starting on cycle day 18. 3 mg Proellex Proellex First Cycle (3 mg)- Five (5) 3 mg capsules of Proellex will be dispensed to subjects to self-administer for five days starting on cycle day 18. 25 mg Proellex Proellex Fourth Cycle (25 mg)-Subjects, who have not experienced menses, will be dispensed five (5) 25 mg capsules of Proellex to self-administer for five days starting on cycle day 18.
- Primary Outcome Measures
Name Time Method Day of Initial Vaginal Bleeding Event Following Treatment With Proellex. An early vaginal bleeding event lasting at least two days and occurring on or before day 24 will be deemed to have achieved an induced menses
- Secondary Outcome Measures
Name Time Method Duration of Vaginal Bleeding Following Treatment With Proellex. At least 2 days
Trial Locations
- Locations (1)
Advances in Health Inc.
🇺🇸Houston, Texas, United States