Multicenter Study Evaluating the Safety of Proellex® in Premenopausal Women With Uterine Fibroids

Uterine Fibroids Clinical Trial

Official title:

A Phase III, Open-Label, Parallel, Randomized, Multicenter Study Evaluating the Safety of 25 And 50 mg Proellex® (CDB-4124) in the Treatment of Premenopausal Women With Symptomatic Uterine Fibroids

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00737282
• Other study ID #: ZPU-305
• Status: Terminated
• Phase: Phase 3
• First received: August 14, 2008
• Last updated: August 5, 2014
• Start date: October 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

The safety of Proellex 25 and 50 mg administered once daily for three treatment cycles (four months each) will be evaluated.

Description:

Subjects will be randomized to either Proellex dose, 25 mg or 50 mg, in a 1:1 ratio. Subjects will receive drug for a four (4) month cycle of therapy three (3) times, each treatment cycle being separated by an off-drug interval until menstruation occurs. During the treatment periods, all subjects will be assessed monthly. Subjects will undergo an additional follow-up for 3 months following their last treatment visit.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 175
• 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.

Additional inclusion criteria may apply.

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.

Additional exclusion criteria may apply.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Leiomyoma
• Uterine Fibroids

Intervention

Drug:
• Proellex 25 mg
One capsule Proellex 25 mg administered as daily oral doses for four (4) consecutive months during each treatment cycle
• Proellex 50 mg
Two capsules Proellex 25 mg administered as daily oral doses for four (4) consecutive months during each treatment cycle

Locations

Country	Name	City	State
United States	ClinSite, LLC	Ann Arbor	Michigan
United States	Atlanta Women's Research Inst	Atlanta	Georgia
United States	Women Partners in Health	Austin	Texas
United States	Impact Clinical Trials	Beverly Hills	California
United States	Medical Network for Education and Research	Decatur	Georgia
United States	Soapstone Center for Clinical Research	Decatur	Georgia
United States	Clinical Trials of America	Eugene	Oregon
United States	NECCR Falls River LLC	Fall River	Massachusetts
United States	Female Pelvic Medicine	Grand Rapids	Michigan
United States	Greenville Pharmaceutical Research	Greenville	South Carolina
United States	University Medical Group, Dept of OB/GYN	Greenville	South Carolina
United States	AWC Clinical Trials LLC	Little Rock	Arkansas
United States	Lynn Institute of the Ozarks	Little Rock	Arkansas
United States	York Clinical Consulting	Marrero	Louisiana
United States	Memphis Women's Healthcare	Memphis	Tennessee
United States	Women's Care Center, PLC Research Memphis Associates	Memphis	Tennessee
United States	Medical Associates Inc.	Menomonee Falls	Wisconsin
United States	Meharry Medical College	Nashville	Tennessee
United States	Alegent Research	Omaha	Nebraska
United States	Thomas Jefferson University - Jefferson Center for Women's Medical Specialties	Philadelphia	Pennsylvania
United States	Willowbend Health & Wellness Associates	Plano	Texas
United States	Genesis Center for Clinical Research	San Diego	California
United States	Physician Care Clinical Research, LLC	Sarasota	Florida
United States	Hawthorne Medical Research, Inc.	Winston-Salem	North Carolina
United States	Lyndhurst Gynecologic Associates	Winston-Salem	North Carolina

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 Assess the Safety of Proellex Administered Once Daily for Three Treatment Cycles (4 Months Each Cycle)		12 months	Yes