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

Phase 2

Terminated

• Conditions: Uterine Fibroids
• Interventions: Drug: Proellex 25 mg; Drug: Proellex 50 mg; Drug: Lupron Depot

• Registration Number: NCT00683917
• Lead Sponsor: Repros Therapeutics Inc.

Brief Summary

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

Detailed Description

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 Timeline

• Study Start: 2008-05
• Study First Submitted: 2008-05-22
• Study First Submitted QC: 2008-05-23
• Study First Posted: 2008-05-26
• Primary Completion: 2009-08
• Study Completion: 2009-08
• Results First Submitted: 2014-06-25
• Status Verified: 2014-08
• Results First Submitted QC: 2014-08-05
• Last Update Submitted: 2014-08-05
• Results First Posted: 2014-08-21
• Last Update Posted: 2014-08-21

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Proellex 25 mg	Proellex 25 mg	Proellex 25 mg
Proellex 50 mg	Proellex 50 mg	Proellex 50 mg
Lupron	Lupron Depot	Lupron Depot

Primary Outcome Measures

Name	Time	Method
The Primary Outcome Measure is the PK Characteristics of 25 mg and 50 mg Proellex.	4 months

Trial Locations

Locations (4)

Physician Care Clinical Research; 🇺🇸 Sarasota, Florida, United States

Centro de Estudios Cientificos y Clinicos Pharma, S.A. de C.V. (CECYC-Pharma); 🇲🇽 Mexico City, Federal District, Mexico

West Houston Clinical Research Services; 🇺🇸 Houston, Texas, United States

Advances in Health, Inc.; 🇺🇸 Houston, Texas, United States