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

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

Official Title
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A Multicenter, Open-Label, Safety And Efficacy, Two Year Extension Study of the Selective Progesterone Receptor Modulator Proellex® (CDB-4124) in Pre-Menopausal Women With Symptomatic Leiomyomata Who Have Previously Completed Study ZPU 003

Conditions
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Uterine Fibroids

Intervention / Treatment
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* Drug: Proellex®


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Proellex 25 mg<br>Two Proellex® 12.5 mg capsules once daily | Drug: Proellex®<br>* 25 mg daily (two 12.5 mg capsules)<br>* Other names: telapristone acetate;|
| Experimental: Proellex 12.5 mg<br>One Proellex® 12.5 mg capsules once daily | Drug: Proellex®<br>* 25 mg daily (two 12.5 mg capsules)<br>* Other names: telapristone acetate;|
| Placebo Comparator: Placebo<br>Capsule once a day | Drug: Proellex®<br>* 25 mg daily (two 12.5 mg capsules)<br>* Other names: telapristone acetate;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Change in Menorrhagia From the Baseline of ZPU-003 to the End of Each Off Drug Interval(ODI) Within the ZPU-003 Extension Study and the Baseline of ZPU-003 to the End of ZPU-003 Ext. | An ODI is defined as a time period of less than 3 months during which a return to menses occurs. All statistical endpoints will use the baseline of ZPU-003 Ext for 14-month data and baseline of ZPU-003 for 17-month data. | Baseline to 17 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline of ZPU-003 Ext to 14 Months and 17 Months in Subject's Menstrual Pictogram Scores (mL) (Subjects Evaluable for Menorrhagia Only) | Patient assessed all menstrual products used for bleeding during the month-long time period between study visits. For the total menstrual pictogram score, a lower score indicated less menstrual bleeding, a higher score indicated more menstrual bleeding. Over the course of a menstrual cycle, each pad was scored on an ordinal scale from 1 to 5, each tampon scored either 1, 1.5, 3 or 8, and clots were scored 1, 3 or 5, based on apparent size. Pictogram scored assessments were converted to approximate mL of blood. | Baseline, 14 months, 17 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Uterine fibroids