Conditions: Uterine Fibroids
Keywords: Uterine fibroids
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 4
Healthy volunteers: no

Brief summary:
An open label, extension study for subjects completing the ZPU-003 Ext 1 study.

Detailed description:
This is an open label, extension study for subjects completing the ZPU-003 Ext 1 study and an off-drug interval (menses), prior to the start of the first 16-week dosing cycle. Subjects will receive a 50 mg Proellex® daily dose. Total study participation for ZPU-003 Ext 2 (Extension 2) may be up to three 4 month drug cycles separated by off drug intervals.

Arms:
arm 1: 25 mg Proellex daily

Interventions: intervention 1: 25 mg Proellex
Intervention descriptions: intervention 1: one 25 mg capsules

Protocol document: