Evaluating the Safety and Efficacy of Proellex® in Premenopausal Women With Symptomatic Uterine Fibroids

• Status: Terminated
• Trial end date: 2009-08-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Repros Therapeutics Inc.

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.

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.