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

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

This study is ongoing, but not recruiting participants.

Study NCT00556075. Last updated on October 31, 2008. Information provided by Repros Therapeutics Inc.

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields

Brief Title ^†

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

Official Title ^†

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 ^†

Interventional

Study Design ^†

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

Primary Outcome Measure ^†

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 ]

Secondary Outcome Measure ^†

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 ]

Condition ^†

Endometriosis

Intervention ^†

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

MEDLINE PMIDs

Links

Recruitment Information Fields

Recruitment Status ^†

Active, not recruiting

Enrollment ^†

Start Date ^†

November 2007

Completion Date

February 2009

Eligibility Criteria ^†

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 ^††

Location Countries ^†

United States

Administrative Information Fields

NCT ID ^†

NCT00556075

Organization ID

ZPE-201

Secondary IDs ^††

Study Sponsor ^†

Repros Therapeutics Inc.

Collaborators ^††

Investigators ^†

Study Director:

Andre vanAs, MD, PhD

Repros Therapeutics Inc.

Information Provided By

Repros Therapeutics Inc.

Verification Date

October 2008

First Received Date ^†

November 7, 2007

Last Updated Date

October 31, 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.