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

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

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.

Study Overview

• Status: Completed
• Conditions: Uterine Fibroids
• Intervention / Treatment: Drug: Proellex®

Detailed 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).

• Study Type: Interventional
• Enrollment (Actual): 65
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85015
      • Women's Health Research
    • Phoenix, Arizona, United States, 85032
      • Arizona Wellness Centre for Women
  • California
    • San Diego, California, United States, 92123
      • Women's Health Care, Inc.
    • San Diego, California, United States, 92108
      • Medical Centre for Clinical Research
  • Colorado
    • Denver, Colorado, United States, 80218
      • Downtown Women's Health Care
  • Florida
    • Tampa, Florida, United States, 33607
      • Insignia Clinical Research (Tampa Bay Women's Center)
  • Nevada
    • Las Vegas, Nevada, United States, 89128
      • Affiliated Clinical Research, Inc.
  • South Carolina
    • Columbia, South Carolina, United States, 29201
      • SC Clinical Research Center
  • Texas
    • Houston, Texas, United States, 77030
      • Advances in Health Inc.
    • Houston, Texas, United States, 77054
      • Obstetrical & Gynecolgical Associates, PA (OGA)
  • Washington
    • Seattle, Washington, United States, 98105
      • Women's Clinical Research Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Proellex 25 mg; Two Proellex® 12.5 mg capsules once daily	Drug: Proellex®; 25 mg daily (two 12.5 mg capsules); Other Names: CDB-4124; telapristone acetate
Experimental: Proellex 12.5 mg; One Proellex® 12.5 mg capsules once daily	Drug: Proellex®; 25 mg daily (two 12.5 mg capsules); Other Names: CDB-4124; telapristone acetate
Placebo Comparator: Placebo; Capsule once a day	Drug: Proellex®; 25 mg daily (two 12.5 mg capsules); Other Names: CDB-4124; telapristone acetate

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Repros Therapeutics Inc.

Study record dates

Study Major Dates

• Study Start (Actual): September 7, 2006
• Primary Completion (Actual): October 15, 2008
• Study Completion (Actual): October 15, 2008

Study Registration Dates

• First Submitted: August 11, 2009
• First Submitted That Met QC Criteria: August 12, 2009
• First Posted (Estimate): August 13, 2009

Study Record Updates

• Last Update Posted (Actual): June 18, 2019
• Last Update Submitted That Met QC Criteria: May 29, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Keywords: Uterine fibroids
• Additional Relevant MeSH Terms: Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Connective Tissue Diseases; Neoplasms, Connective Tissue; Neoplasms, Muscle Tissue; Leiomyoma; Myofibroma
• Other Study ID Numbers: ZPU-003 Ext