Conditions: Amenorrhea
Keywords: Menstruation
Allocation: NON_RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 11
Healthy volunteers: yes

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

Arms:
arm 1: Initiation-Placebo Cycle-Five (5) placebo capsules will be dispensed to subjects to self-administer for five days starting on cycle day 18. arm 2: 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. arm 3: 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. arm 4: 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. arm 5: 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.

Interventions: intervention 1: Placebo intervention 2: Proellex
Intervention descriptions: intervention 1: Placebo, 1 capsule daily for five days intervention 2: Proellex, one 3, 6, 12 or 25 mg capsule daily for five days

Protocol document: