Official Title: “A Multi-Center, Active Controlled, Pharmacokinetic, Safety and Efficacy Study of Proellex in Pre-Menopausal Women With Symptomatic Uterine Fibroids to Assess Persistence of Response”

The primary objective is to evaluate the pharmacokinetics (PK) of 25 mg and 50 mg Proellex® administered once daily (QD) over a 4-month period.

Study Type: Interventional

Study Design: Prevention, Randomized, Single Blind (Subject), Active Control, Parallel Assignment, Pharmacokinetics Study

Study Primary Completion Date: December 2008

Intervention(s) in this Clinical Trial

• Drug: Proellex 25 mg
  • Proellex 25 mg, 1 capsule daily for 4 months
• Drug: Proellex 50 mg
  • Proellex 50 mg, 2 capsules daily for 4 months
• Drug: Lupron Depot
  • Lupron 3.75 mg monthly intramuscular injections for 4 months

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: A
  • Proellex 25 mg
• Experimental: B
  • Proellex 50 mg
• Active Comparator: C
  • Lupron Depot

Primary Measures

• The primary outcome measure is the PK characteristics of 25 mg and 50 mg Proellex.
  • Time Frame: 4 months
    Safety Issue?: Yes

Secondary 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.
  • Time Frame: 4 months
    Safety Issue?: Yes

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

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 45 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Repros Therapeutics Inc.

Overall Clinical Trial Officials and Contacts

Andre vanAs, MD, PhD Study Director Repros Therapeutics Inc.  

Overall Contact: Pankaj Patel, PhD 713-559-5961 pankaj.patel@pharm-olam.com

Information obtained from ClinicalTrials.gov on August 29, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00683917

Study ID Number: ZPU-202

ClinicalTrials.gov Identifier: NCT00683917

Health Authority: United States: Food and Drug Administration