Study to Evaluate Menses Induction in Women Administered Proellex
Amenorrhea
About this trial
This is an interventional treatment trial for Amenorrhea focused on measuring Menstruation
Eligibility Criteria
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
Sites / Locations
- Advances in Health Inc.
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Placebo Comparator
Experimental
Experimental
Experimental
Experimental
Placebo
3 mg Proellex
6 mg Proellex
12 mg Proellex
25 mg Proellex
Initiation-Placebo Cycle-Five (5) placebo capsules will be dispensed to subjects to self-administer for five days starting on cycle day 18.
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.
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.
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.
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.