Safety and Efficacy Study to Evaluate Proellex in the Treatment of Premenopausal Women With Symptomatic Endometriosis - Tabular View

Tracking Information

First Received Date ^ICMJE

November 7, 2007

Last Updated Date

August 11, 2009

Start Date ^ICMJE

November 2007

Primary Completion Date

May 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Difference between the 50 mg Proellex group and placebo group in the Month 4 subject diary composite pain score [ Time Frame: 4 months ] [ Designated as safety issue: No ]
Difference between the 25 mg and 50 mg Proellex groups and placebo group in the Month 4 subject diary composite pain score [ Time Frame: 4 months ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Difference between the 50 mg Proellex group and placebo group in the Month 4 subject diary composite pain score [ Time Frame: 4 months ]
Difference between the 25 mg and 50 mg Proellex groups and placebo group in the Month 4 subject diary composite pain score [ Time Frame: 4 months ]

Change History

Complete list of historical versions of study NCT00556075 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Difference between each treatment group in the subject diary composite pain score at the monthly visits [ Time Frame: monthly ] [ Designated as safety issue: No ]
Time to pain-free assessments using the composite pain score as determined by data recorded in the subject diaries [ Time Frame: days ] [ Designated as safety issue: No ]
Duration of pain-free assessments using the composite pain score as determined by data recorded in the subject diaries [ Time Frame: days ] [ Designated as safety issue: No ]
The number of days with pain as determined by data recorded in the subject diaries, analyzed between treatment groups at the monthly visits [ Time Frame: days ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Difference between each treatment group in the subject diary composite pain score at the monthly visits [ Time Frame: monthly ]
Time to pain-free assessments using the composite pain score as determined by data recorded in the subject diaries [ Time Frame: days ]
Duration of pain-free assessments using the composite pain score as determined by data recorded in the subject diaries [ Time Frame: days ]
The number of days with pain as determined by data recorded in the subject diaries, analyzed between treatment groups at the monthly visits [ Time Frame: days ]

Descriptive Information

Brief Title ^ICMJE

Safety and Efficacy Study to Evaluate Proellex in the Treatment of Premenopausal Women With Symptomatic Endometriosis

Official Title ^ICMJE

A Phase II, Three-Arm, Parallel Design, Dose-Ranging Placebo-Controlled, Randomized, Double-Blind, Multicenter Study Evaluating the Safety and Efficacy of Proellex in the Treatment of Premenopausal Women With Symptomatic Endometriosis

Brief Summary

The purpose of this study is to determine whether Proellex is safe and effective for the treatment of symptomatic endometriosis.

Detailed Description

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Endometriosis

Intervention ^ICMJE

Drug: Proellex 25 mg
Drug: Placebo
Drug: Proellex 50 mg

Study Arms / Comparison Groups

Placebo Comparator: Placebo
Experimental: Proellex 25 mg
Experimental: Proellex 50 mg

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

Completed

Estimated Enrollment ^ICMJE

Completion Date

July 2009

Primary Completion Date

May 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Premenopausal women aged 18-48 inclusive
Endometriosis documented by laparoscopic or surgical assessment within the past ten (10) years
Clinical symptoms of endometriosis for at least the past three (3) months
Endometriosis symptoms
Must be sexually active unless sexually inactive for endometriosis-related dyspareunia
Must have a regular or steady menstrual cycle lasting from 24 to 36 days and a detectable ovulation during the baseline period using an ovulation monitoring kit (for timing of endometrial biopsy)
Other inclusion criteria may apply

Exclusion Criteria:

Six (6) months or more without a menstrual period, or
Prior hysterectomy or
Prior bilateral oophorectomy
Diagnosis of osteopenia
Present history or condition that causes non-endometriosis-related dyspareunia
Presence of excessive bleeding or menorrhagia
Abnormal screening endometrial biopsy
Other exclusion criteria may apply

Gender

Female

Ages

18 Years to 48 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00556075

Responsible Party

Repros Therapeutics Inc., Andre vanAs, MD, PhD

Study ID Numbers ^ICMJE

ZPE-201

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