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

NCT00958334 | Completed Phase 2 Results DMC

• 1 other identifier: ZPU-003 Ext
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 11

Brief Summary

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.

Conditions

Uterine Fibroids

Keywords

Uterine fibroids

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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)

  Baseline, 14 months, 17 months

Study Arms (3)

Proellex 25 mg

EXPERIMENTAL

Two Proellex® 12.5 mg capsules once daily

Drug: Proellex®

Proellex 12.5 mg

EXPERIMENTAL

One Proellex® 12.5 mg capsules once daily

Drug: Proellex®

Placebo

PLACEBO COMPARATOR

Capsule once a day

Drug: Proellex®

Interventions

Proellex® DRUG

25 mg daily (two 12.5 mg capsules)

Also known as: CDB-4124, telapristone acetate

Placebo; Proellex 12.5 mg; Proellex 25 mg

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may not qualify if:

• Low or high grade cervical dysplasia, as determined by Papanicolaou (PAP) smear.
• Pregnant or breastfeeding.

Sponsors & Collaborators

• Repros Therapeutics Inc.: lead

Study Sites (11)

Women's Health Research

Phoenix, Arizona, 85015, United States

Location

Arizona Wellness Centre for Women

Phoenix, Arizona, 85032, United States

Location

Medical Centre for Clinical Research

San Diego, California, 92108, United States

Location

Women's Health Care, Inc.

San Diego, California, 92123, United States

Location

Downtown Women's Health Care

Denver, Colorado, 80218, United States

Location

Insignia Clinical Research (Tampa Bay Women's Center)

Tampa, Florida, 33607, United States

Location

Affiliated Clinical Research, Inc.

Las Vegas, Nevada, 89128, United States

Location

SC Clinical Research Center

Columbia, South Carolina, 29201, United States

Location

Advances in Health Inc.

Houston, Texas, 77030, United States

Location

Obstetrical & Gynecolgical Associates, PA (OGA)

Houston, Texas, 77054, United States

Location

Women's Clinical Research Centre

Seattle, Washington, 98105, United States

Location

MeSH Terms

Conditions

Leiomyoma

Interventions

telapristone acetate

Condition Hierarchy (Ancestors)

Neoplasms, Muscle Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Results Point of Contact

• Title: Therapeutic Area Head
• Organization: Allergan

IR-CTRegistration@allergan.com

714-246-4500

Study Officials

• Anna Chan

  Allergan

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2009
• First Posted: August 13, 2009
• Study Start: September 7, 2006
• Primary Completion: October 15, 2008
• Study Completion: October 15, 2008
• Last Updated: June 18, 2019
• Results First Posted: January 7, 2011

Record last verified: 2019-05

Locations

US (11)