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25 mg Proellex

Andre van As, MD, PhD

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.

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

An Open-Label Extension Study Evaluating Safety and Efficacy of Proellex® In Women With Leiomyomata Who Have Previously Completed ZPU 003 Ext

Repros Therapeutics Inc.

<=18 years

Between 18 and 65 years

>=65 years

Age, Categorical

Female

Male

Sex: Female, Male

United States

Region of Enrollment

The study was prematurely terminated for safety reasons (Proellex studies were put on clinical hold due to liver toxicity). Sponsor was unable to pay vendor, and was therefore not provided with any study data.

Jennifer Wike

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.

Overall Study

Menopause

All Drugs and Chemicals

Progesterone

12.5 mg Proellex administered orally daily

12.5 mg Proellex

Placebo

Andre VanAs, PhD, MD

Two (2) dose levels of Proellex or placebo will be administered once-daily for up to 91 days. Following screening and a pre-treatment endometrial biopsy, subjects will be followed monthly for the three month treatment phase.

Two (2) dose levels of Proellex or placebo will be administered once-daily for up to 91 days. Following screening and a pre-treatment endometrial biopsy, subjects will be followed monthly for the three month treatment phase. At the three-month treatment visit, subjects will be entered into an open-label extension treatment protocol, if deemed eligible. At four months after their first treatment visit, subjects not electing to enter the open-label study will be assessed at a final follow-up visit.

Study of Proellex in Pre-menopausal Women With Symptomatic Uterine Fibroids

A Phase II, Multicenter, Randomized, Placebo-controlled, Double-blinded Study of the Selective Progesterone Receptor Modulator Proellex (CDB-4124) in Pre-menopausal Women With Symptomatic Leiomyomata

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
An Extension Study Evaluating Safety and Efficacy of Proellex® In Women Who Have Previously Completed ZPU 003 Ext	NCT00958893	Uterine Fibroid...	25 mg Proellex	18 Years - 50 Years	Repros Therapeutics Inc.
Study of Proellex in Pre-menopausal Women With Symptomatic Uterine Fibroids	NCT00882258	Uterine Fibroid...	12.5 mg Proelle... 25 mg Proellex Placebo	18 Years - 50 Years	Repros Therapeutics Inc.
Study of Proellex in Pre-menopausal Women With Symptomatic Uterine Fibroids	NCT00882258	Uterine Fibroid...	12.5 mg Proelle... 25 mg Proellex Placebo	18 Years - 50 Years	Repros Therapeutics Inc.

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