Evaluating the Safety and Efficacy of Proellex® (CDB-4124) 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: NCT00735553
• Other study ID #: ZPU-303
• Status: Terminated
• Phase: Phase 3
• First received: August 13, 2008
• Last updated: August 5, 2014
• Start date: August 2008
• 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: 77
• 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
One 25 mg capsule of Proellex® and one placebo capsule orally daily for up to four months
• Proellex
Two 25 mg mg capsules of Proellex® orally daily for up to four months
• Placebo
Two placebo capsules orally daily for up to four months

Locations

Country	Name	City	State
United States	Alabama Clinical Therapeutics	Birmingham	Alabama
United States	Visions Clinical Research	Boynton Beach	Florida
United States	SC Clinical Research Center	Columbia	South Carolina
United States	Advanced Research Associates	Corpus Christi	Texas
United States	Downtown Women's Health Care	Denver	Colorado
United States	Advances in Health Inc.	Houston	Texas
United States	The Woman's Hospital of Texas, Clinical Research Center	Houston	Texas
United States	OB-GYN Associates of Mid-Florida, P.A.	Leesburg	Florida
United States	Miami Research Associates	Miami	Florida
United States	Women's Health Research	Phoenix	Arizona
United States	Institute for Women's Health	San Antonio	Texas
United States	Seven Oaks Women's Ctr.	San Antonio	Texas
United States	Women's Health Care at Frost Steet	San Diego	California
United States	Insignia Clinical Research	Tampa	Florida
United States	Genova Clinical Research, Inc.	Tucson	Arizona

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