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

Phase 3

Terminated

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.

Recruitment & 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.

Arm && Interventions

Group	Intervention	Description
Proellex 50 mg	Proellex 50 mg	Proellex 50 mg once daily
25 mg Proellex	Proellex 25 mg	Proellex 25 mg once daily

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method

Locations (25): 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
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Lynn Institute of the Ozarks
🇺🇸Little Rock, Arkansas, United States