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Study Evaluating the Safety and Efficacy of ERB-041 on Reduction of Symptoms Associated With Endometriosis in Reproductive-Aged Women

Primary Purpose

Dysmenorrhea, Dyspareunia, Endometriosis

Status

Completed

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

ERB-041

About this trial

This is an interventional treatment trial for Dysmenorrhea focused on measuring Endometriosis, Dysmenorrhea, Pelvic pain, Dyspareunia

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: Surgical diagnosis of endometriosis within the last 10 years Sexually active, nonpregnant, nonlactating women (18-45 years) with regular menstrual cycles who are willing to use non-hormonal contraception Exclusion Criteria: Conditions requiring the use of chronic pain therapy Prophylactic use of analgesics to avoid endometriosis-related pain

Sites / Locations

Outcomes

Primary Outcome Measures

severity scores for dysmenorrhea, pelvic pain and deep dyspareunia from baseline through 12 weeks of treatment using the B & B scale administered by the investigator

Secondary Outcome Measures

change in severity scores for pelvic tenderness and pelvic induration during 12 weeks of treatment

change in rescue medication use

change in health related quality of life questionnaires

Full Information

NCT ID

NCT00318500

First Posted

April 24, 2006

Last Updated

December 7, 2007

Sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT00318500

Brief Title

Study Evaluating the Safety and Efficacy of ERB-041 on Reduction of Symptoms Associated With Endometriosis in Reproductive-Aged Women

Official Title

A Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Safety and Efficacy of 75 mg and 150 mg Doses of ERB-041 on the Reduction of Symptoms Associated With Endometriosis During Treatment and Post Treatment in Reproductive-Aged Women

Study Type

Interventional

2. Study Status

Record Verification Date

December 2007

Overall Recruitment Status

Completed

Study Start Date

May 2006 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

December 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

4. Oversight

5. Study Description

Brief Summary

The purpose of the study is to evaluate the efficacy and safety of two doses of ERB-041 (75 mg and 150 mg) relative to placebo on the relief of endometriosis-related symptoms (dysmenorrhea, pelvic pain, and deep dyspareunia) in reproductive aged women.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Dysmenorrhea, Dyspareunia, Endometriosis, Pelvic Pain

Keywords

Endometriosis, Dysmenorrhea, Pelvic pain, Dyspareunia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

Double

Allocation

Randomized

Enrollment

150 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

ERB-041

Primary Outcome Measure Information:

Title

severity scores for dysmenorrhea, pelvic pain and deep dyspareunia from baseline through 12 weeks of treatment using the B & B scale administered by the investigator

Secondary Outcome Measure Information:

Title

change in severity scores for pelvic tenderness and pelvic induration during 12 weeks of treatment

Title

change in rescue medication use

Title

change in health related quality of life questionnaires

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials: