Status: Currently recruiting patients in U.S.
Purpose:
The primary objective is to evaluate the pharmacokinetics (PK) of 25mg and 50mg Proellex® administered once daily (QD) over a 4-month period.
Eligibility:
Females, ages 18 years to 45 years
Inclusion Criteria:
- Female, between the ages of 18 and 48 years with Body Mass Index (BMI) between 18 and 39, inclusive;
- Surgical interventions for uterine fibroids (e.g. hysterectomy or myomectomy or uterine arterial embolization) must not be planned or anticipated during the study;
- Subject must have the following uterine fibroid-associated symptom: history of excessive menstrual bleeding;
- Regular or steady menstrual cycle lasting from 24 to 36 days;
- Willing to comply with all study procedures, including the endometrial biopsies and PK blood draws for all visits, including Follow-up Visits;
- Subject must agree to use a medically acceptable and effective non-hormonal double barrier birth control method throughout the study and for 30 days following the end of the study or discontinuation of study drug.
Exclusion Criteria:
- Documented endometriosis or active pelvic inflammatory disease (PID);
- History of alcohol and/or drug abuse;
- Any history or diagnosis of gynecological cancer or cervical dysplasia
- Use of prohibited concomitant medications:
- Depo-Provera use must cease ten months prior to first dose of study drug, or
- Use of GnRH agonists use (e.g. Lupron® Depot) must cease four (4) months prior to first dose study drug and Lupton® Depot 8 months prior to the first visit
- Known active infection with HIV, Hepatitis A, B or C, Gonorrhea, or Chlamydia;
Study Drug:
Proellex® 25mg, Proellex® 50mg, Lupron® Depot 3.75 mg
Study Design:
Prevention, Randomized, Single Blind (Subject), Active Control, Parallel Assignment, Pharmacokinetics Study
Primary Outcome Measures:
The PK characteristics of 25 mg and 50 mg Proellex.
Secondary Outcome Measures:
Transformed UFS-QOL severity score, uterine fibroid size as measured by MRI, relapse of symptoms as recorded on subject diary cards, and persistence of effect as measured by UFS-QOL.
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Study Director:
Andre van As, MD, PhD
Repros Therapeutics Inc.
If you meet the study criteria and are interested in participating in the study, please contact:
Study Manager:
Colleen Trosclair
Pharm-Olam International
713-559-7900
Current Clinical Site Locations:
Sarasota, FL
Houston, TX
Mexico, D.F. C.P. 03100 Mexico
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