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

Stopped early · Phase 3

Conditions studied: Uterine Fibroids

In brief

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

Key facts

Study ID

NCT00737282

Run by

Repros Therapeutics Inc.

People needed

175

Starts

2008-10-01

Expected to finish

2009-08-01

Last updated by the study team

2014-08-21

Who can join

Age: 18 and older, up to 48. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

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

Full record on ClinicalTrials.gov

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