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

Tracking Information

First Received Date ^ICMJE

May 22, 2008

Last Updated Date

August 11, 2009

Start Date ^ICMJE

May 2008

Estimated Primary Completion Date

December 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00683917 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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.

Detailed Description

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

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

Condition ^ICMJE

Uterine Fibroids

Intervention ^ICMJE

Drug: Proellex 25 mg
Drug: Proellex 50 mg
Drug: Lupron Depot

Study Arms / Comparison Groups

Experimental: Proellex 25 mg
Experimental: Proellex 50 mg
Active Comparator: Lupron Depot

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Estimated Enrollment ^ICMJE

Estimated Completion Date

March 2010

Estimated Primary Completion Date

December 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Female

Ages

18 Years to 45 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Mexico

Administrative Information

NCT ID ^ICMJE

NCT00683917

Responsible Party

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

Study ID Numbers ^ICMJE

ZPU-202

Study Sponsor ^ICMJE

Repros Therapeutics Inc.

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Andre vanAs, MD, PhD

Repros Therapeutics Inc.

Information Provided By

Repros Therapeutics Inc.

Verification Date

August 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP