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
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 |
The safety of Proellex 25 and 50 mg administered once daily for three treatment cycles (four months each) will be evaluated.
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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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 |
Lead Sponsor | Collaborator |
---|---|
Repros Therapeutics Inc. |
United States,
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 |
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