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

This study has been terminated.

( Repros decided to stop the study because of safety and the FDA decided to put the study on hold because of safety. )

First Received: May 22, 2008 Last Updated: August 11, 2009 History of Changes

Sponsor:	Repros Therapeutics Inc.
Information provided by:	Repros Therapeutics Inc.
ClinicalTrials.gov Identifier:	NCT00683917

Purpose

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.

Condition	Intervention	Phase
Uterine Fibroids	Drug: Proellex 25 mg Drug: Proellex 50 mg Drug: Lupron Depot	Phase II

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

Resource links provided by NLM:

MedlinePlus related topics: Menopause

Drug Information available for: Leuprolide Leuprolide acetate

Further study details as provided by Repros Therapeutics Inc.:

Primary Outcome Measures:

The primary outcome measure is the PK characteristics of 25 mg and 50 mg Proellex. [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]

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. [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	30
Study Start Date:	May 2008
Estimated Study Completion Date:	March 2010
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental Proellex 25 mg	Drug: Proellex 25 mg Proellex 25 mg, 1 capsule daily for 4 months
B: Experimental Proellex 50 mg	Drug: Proellex 50 mg Proellex 50 mg, 2 capsules daily for 4 months
C: Active Comparator Lupron Depot	Drug: Lupron Depot Lupron 3.75 mg monthly intramuscular injections for 4 months

Eligibility

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00683917

Locations

United States, Florida
Physician Care Clinical Research
Sarasota, Florida, United States, 34239
United States, Texas
West Houston Clinical Research Services
Houston, Texas, United States, 77055
Advances in Health, Inc.
Houston, Texas, United States, 77030
Mexico, Federal District
Centro de Estudios Cientificos y Clinicos Pharma, S.A. de C.V. (CECYC-Pharma)
Mexico City, Federal District, Mexico, 03100

Sponsors and Collaborators

Repros Therapeutics Inc.

Investigators

Study Director:

Andre vanAs, MD, PhD

Repros Therapeutics Inc.

More Information

No publications provided

Responsible Party:	Repros Therapeutics, Inc. ( Andre vanAs, MD, PhD )
Study ID Numbers:	ZPU-202
Study First Received:	May 22, 2008
Last Updated:	August 11, 2009
ClinicalTrials.gov Identifier:	NCT00683917 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Repros Therapeutics Inc.:

Uterine fibroids
Fibroids

Additional relevant MeSH terms:

Neoplasms, Connective and Soft Tissue
Neoplasms, Muscle Tissue
Neoplasms
Myofibroma

Neoplasms by Histologic Type
Connective Tissue Diseases
Neoplasms, Connective Tissue
Leiomyoma

ClinicalTrials.gov processed this record on November 30, 2009