Conditions: Uterine Fibroids
Keywords: Uterine Fibroids
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 77
Healthy volunteers: no

Brief summary:
Premenopausal women with symptomatic uterine fibroids will be randomized to either Proellex 25mg or 50mg or placebo for one treatment cycle (four months). Safety and effectiveness between 50 mg versus placebo, and between 25mg and placebo will be analyzed.

Detailed description:
Subjects with documented uterine fibroids, screening UFS-QOL severity score of at least 40, and meeting other eligibility criteria will be enrolled in the study. Following screening and a pre-treatment endometrial biopsy, subjects will be assessed monthly for the four (4) month double-blinded treatment phase. The study duration is approximately six months, comprised of a one-month screening period, 4 month treatment period and one month follow-up period. Subjects' blood will be drawn in a fasting state to obtain the pre-dose trough (PK) levels of study drug at each study drug dosing/dispensation visit to determine the potential for drug accumulation.

Arms:
arm 1: 25 mg oral daily dose of Proellex arm 2: 50 mg oral daily dose of Proellex arm 3: oral daily dose of placebo

Interventions: intervention 1: Proellex intervention 2: Proellex intervention 3: Placebo
Intervention descriptions: intervention 1: One 25 mg capsule of Proellex® and one placebo capsule orally daily for up to four months intervention 2: Two 25 mg mg capsules of Proellex® orally daily for up to four months intervention 3: Two placebo capsules orally daily for up to four months

Protocol document: