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

Repros Therapeutics

Status and phase: Terminated; Phase 2

Conditions: Uterine Fibroids

Treatments: Drug: 25 mg Proellex

Study type: Interventional

Funder types: Industry

Identifiers

NCT00958893

ZPU-003 Extension 2

Details and patient eligibility

About

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

Full 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.

Enrollment: 4 patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Four subjects at one site whom have completed ZPU 003 Ext 1 study

Exclusion criteria

• All other subjects

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

4 participants in 1 patient group

25 mg Proellex

Experimental group

Description:

25 mg Proellex daily

Treatment:

Drug: 25 mg Proellex