An Extension Study Evaluating Safety and Efficacy of Proellex® In Women Who Have Previously Completed ZPU 003 Ext

Phase 2TerminatedNCT00958893

Repros Therapeutics Inc.4 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Uterine Fibroids

Interventions

25 mg ProellexDRUG

one 25 mg capsules

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 50 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Four subjects at one site whom have completed ZPU 003 Ext 1 study Exclusion Criteria: * All other subjects

Locations (1)

Advances in Health, Inc.

Houston, Texas, United States

Outcomes

Primary Outcomes

To Further Evaluate Adverse Events of a 25 mg Dose of Proellex® Administered to Women Once Daily for Three 4 Month Cycles Separated by Off-drug Intervals.

Time frame: three 4 month cycles separated by off-drug intervals

Data from ClinicalTrials.gov

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