Pharmacokinetics, Safety and Efficacy Study of Proellex in Pre-menopausal Women With Symptomatic Uterine Fibroids

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

Summary

PK of 25 mg and 50 mg Proellex® administered once daily (QD) over a 4-month period.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Repros Therapeutics Inc.
• Treatments: Leuprolide

Criteria

Inclusion Criteria:

• Female subjects between the ages of 18 and 45 years with body mass index (BMI) between 18 and 35 mg/kg2 inclusive

• Surgical interventions for uterine fibroids (e.g., hysterectomy, 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

• History of alcohol and/or drug abuse

• Any history or diagnosis of gynecological cancer or cervical dysplasia

• Use of an IUD

• Use of prohibited concomitant medications:

• Use of Depo-Provera must cease 10 months prior to first dose of study drug

• Use of GnRH agonists (e.g., Lupron®) must cease 4 months prior to first dose of 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