Conditions: Uterine Fibroids
Keywords: Uterine Fibroids
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 175
Healthy volunteers: no

Brief summary:
The safety of Proellex 25 and 50 mg administered once daily for three treatment cycles (four months each) will be evaluated.

Detailed description:
Subjects will be randomized to either Proellex dose, 25 mg or 50 mg, in a 1:1 ratio. Subjects will receive drug for a four (4) month cycle of therapy three (3) times, each treatment cycle being separated by an off-drug interval until menstruation occurs. During the treatment periods, all subjects will be assessed monthly. Subjects will undergo an additional follow-up for 3 months following their last treatment visit.

Arms:
arm 1: Proellex 25 mg once daily arm 2: Proellex 50 mg once daily

Interventions: intervention 1: Proellex 25 mg intervention 2: Proellex 50 mg
Intervention descriptions: intervention 1: One capsule Proellex 25 mg administered as daily oral doses for four (4) consecutive months during each treatment cycle intervention 2: Two capsules Proellex 25 mg administered as daily oral doses for four (4) consecutive months during each treatment cycle

Protocol document: