Evaluating the Safety and Efficacy of Proellex® in Premenopausal Women With Symptomatic Uterine Fibroids

Uterine Fibroids Clinical Trial

Official title:

A Phase III, Three-Arm, Parallel Design, Placebo-Controlled, Randomized, Double-Blind, Multicenter Study Evaluating the Safety and Efficacy of Proellex® (CDB-4124) in the Treatment of Premenopausal Women With Symptomatic Uterine Fibroids

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00853567
• Other study ID #: ZPU-304
• Status: Terminated
• Phase: Phase 3
• First received: February 27, 2009
• Last updated: August 5, 2014
• Start date: February 2009
• Est. completion date: August 2009

Study information

• Verified date: August 2014
• Source: Repros Therapeutics Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

Premenopausal women with symptomatic uterine fibroids will be randomized to either Proellex 25mg or 50mg or placebo for one treatment cycle (four months). Safety and effectiveness between 50 mg versus placebo, and between 25mg and placebo will be analyzed.

Description:

Subjects with documented uterine fibroids, screening UFS-QOL severity score of at least 40, and meeting other eligibility criteria will be enrolled in the study. Following screening and a pre-treatment endometrial biopsy, subjects will be assessed monthly for the four (4) month double-blinded treatment phase. The study duration is approximately six months, comprised of a one-month screening period, 4 month treatment period and one month follow-up period. Subjects' blood will be drawn in a fasting state to obtain the pre-dose trough (PK) levels of study drug at each study drug dosing/dispensation visit to determine the potential for drug accumulation.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 71
• Est. completion date: August 2009
• Est. primary completion date: August 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 48 Years

Eligibility

Inclusion Criteria:

• Speak, read and understand English or Spanish;

• Not have undergone hysterectomy, uterine arterial embolization or endometrial ablation therapy (previous myomectomy is acceptable) for any cause and no surgical interventions for uterine fibroids (e.g. hysterectomy, myomectomy, uterine arterial embolization) are planned or anticipated during the study;

• One uterine fibroid must be identifiable and measurable by transvaginal ultrasound;

• Menstrual cycle lasting from 24 to 36 days;

• History of excessive menstrual bleeding;

• Negative urine pregnancy test at screening.

Exclusion Criteria:

• Six months or more (immediately prior to Screening Visit) without a menstrual period;

• Prior hysterectomy;

• Prior bilateral oophorectomy;

• Pregnant or lactating females or women who are attempting or expecting to become pregnant at any time during the study;

• Documented endometriosis, active pelvic inflammatory disease (PID), platelet dysfunction, or Von Willebrand's Disease;

• Any history or diagnosis of gynecological cancer or cervical dysplasia of any grade including atypical squamous cells of undetermined significance (ASCUS) associated with Human Papilloma Virus (HPV);

• Subject with diagnosed or suspected carcinoma of the breast, reproductive organs or any other organ system;

• Subject with known active infection with HIV, Hepatitis A, B or C, Gonorrhea, or Chlamydia or previous history of auto-immune disease or positive serum antinuclear antibodies.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Leiomyoma
• Uterine Fibroids

Intervention

Drug:
• Proellex
25 mg oral daily dose vs. 50 mg oral daily dose vs. placebo

Other:
• placebo
Placebo

Locations

Country	Name	City	State
United States	Advanced Clinical Research Institute	Anaheim	California
United States	Central Brooklyn Medical Group (eCast)	Brooklyn	New York
United States	Chattanooga Medical Research, LLC	Chattanooga	Tennessee
United States	Rapid Medical Research, Inc. (Elite)	Cleveland	Ohio
United States	Phoenix Women's Center (eCast0	College Park	Georgia
United States	Clinical Trials Select (eCast)	Decatur	Georgia
United States	Dekalb Gynecology Associates/Legacy Obstetrics & Gynecology (eCast)	Decatur	Georgia
United States	Medical Network for Education and Research	Decatur	Georgia
United States	HWC Women's Research Center	Englewood	Ohio
United States	Center for Women's Medicine	Houston	Texas
United States	Impact Clinical Trials	Los Angeles	California
United States	Impact Clinical Trials	Los Angeles	California
United States	National Institute of Clinical Research	Los Angeles	California
United States	Bluegrass Clinical Research, Inc.	Louisville	Kentucky
United States	Segal Institute for Clinical Research	Miami	Florida
United States	Smith & Hackney (eCast)	Morrow	Georgia
United States	Comprehensive Clinical Trials, LLC	West Palm Beach	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Repros Therapeutics Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To Determine the Efficacy of 50 mg Proellex® Versus Placebo in the Treatment of Subjects With Symptomatic Uterine Fibroids From Baseline to Month 4 as Determined by Scoring Changes in the Pictorial Blood Loss Assessment Chart (PBAC)		4 months	No