Conditions: Uterine Fibroids
Keywords: Uterine fibroids
Allocation: NON_RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 65
Healthy volunteers: no

Brief summary:
ZPU-003 EXT is a 2-year extension study of ZPU-003 (NCT00882258) to determine the continued safety and efficacy of Proellex in women who have previously completed the double-blind portion of the study.

Detailed description:
ZPU-003 EXT is a 2-year extension study of ZPU-003 (NCT00882258). The purpose of the study is to determine the continued safety and efficacy of Proellex in women who have previously completed the double-blind portion of the study. The desired primary efficacy outcome will be a changes in vaginal bleeding from baseline to 14 months and 17 months on study drug. The total duration of the study is up to 24 months including transition times, off drug intervals, and follow-up visits). It is expected that over a 16 week on drug interval menses will subside and return after a 4-8 week off drug interval (ODI).

Arms:
arm 1: Two Proellex® 12.5 mg capsules once daily arm 2: One Proellex® 12.5 mg capsules once daily arm 3: Capsule once a day

Interventions: intervention 1: Proellex®
Intervention descriptions: intervention 1: 25 mg daily (two 12.5 mg capsules)

Protocol document: