Clinical trial NCT00737282: Multicenter Study Evaluating the Safety of Proellex® in Premenopausal Women With Uterine Fibroids
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Uterine Fibroids
Keywords: Uterine Fibroids
Lead sponsor: Repros Therapeutics Inc.
Sponsor class: INDUSTRY
First posted: 2008-08-18
Enrollment: 175
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 48
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: To Assess the Safety of Proellex Administered Once Daily for Three Treatment Cycles (4 Months Each Cycle)
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Lynn Institute of the Ozarks
state: Arkansas
city: Little Rock
country: United States
facility: AWC Clinical Trials LLC
state: Arkansas
city: Beverly Hills
country: United States
facility: Impact Clinical Trials
state: California
city: San Diego
country: United States
facility: Genesis Center for Clinical Research
state: California
city: Sarasota
country: United States
facility: Physician Care Clinical Research, LLC
state: Florida
city: Atlanta
country: United States
facility: Atlanta Women's Research Inst
state: Georgia
city: Decatur
country: United States
facility: Medical Network for Education and Research
state: Georgia
city: Decatur
country: United States
facility: Soapstone Center for Clinical Research
state: Georgia
city: Marrero
country: United States
facility: York Clinical Consulting
state: Louisiana
city: Fall River
country: United States
facility: NECCR Falls River LLC
state: Massachusetts
city: Ann Arbor
country: United States
facility: ClinSite, LLC
state: Michigan
city: Grand Rapids
country: United States
facility: Female Pelvic Medicine
state: Michigan
city: Omaha
country: United States
facility: Alegent Research
state: Nebraska
city: Winston-Salem
country: United States
facility: Hawthorne Medical Research, Inc.
state: North Carolina
city: Winston-Salem
country: United States
facility: Lyndhurst Gynecologic Associates
state: North Carolina
city: Eugene
country: United States
facility: Clinical Trials of America
state: Oregon
city: Philadelphia
country: United States
facility: Thomas Jefferson University - Jefferson Center for Women's Medical Specialties
state: Pennsylvania
city: Greenville
country: United States
facility: University Medical Group, Dept of OB/GYN
state: South Carolina
city: Greenville
country: United States
facility: Greenville Pharmaceutical Research
state: South Carolina
city: Memphis
country: United States
facility: Memphis Women's Healthcare
state: Tennessee
city: Memphis
country: United States
facility: Women's Care Center, PLC Research Memphis Associates
state: Tennessee
city: Nashville
country: United States
facility: Meharry Medical College
state: Tennessee
city: Austin
country: United States
facility: Women Partners in Health
state: Texas
city: Plano
country: United States
facility: Willowbend Health & Wellness Associates
state: Texas
city: Menomonee Falls
country: United States
facility: Medical Associates Inc.
state: Wisconsin
Study officials:
affiliation: Repros Therapeutics Inc.
name: Andre vanAs, MD, PhD
role: STUDY_DIRECTOR
References: