Extension Study of Proellex in Women Who Have Previously Completed Study ZPU 003

Repros Therapeutics

Status and phase: Completed; Phase 2

Conditions: Uterine Fibroids

Treatments: Drug: Proellex®

Study type: Interventional

Funder types: Industry

Identifiers

NCT00958334

ZPU-003 Ext

Details and patient eligibility

About

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.

Full 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).

Enrollment: 65 patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Completed the ZPU 003 study and met the inclusion/exclusion criteria of that study.

Exclusion criteria

• Low or high grade cervical dysplasia, as determined by Papanicolaou (PAP) smear.
• Pregnant or breastfeeding.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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65 participants in 3 patient groups, including a placebo group

Proellex 25 mg

Experimental group

Description:

Two Proellex® 12.5 mg capsules once daily

Treatment:

Drug: Proellex®

Proellex 12.5 mg

Experimental group

Description:

One Proellex® 12.5 mg capsules once daily

Treatment:

Drug: Proellex®

Placebo

Placebo Comparator group

Description:

Capsule once a day

Treatment:

Drug: Proellex®