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

December 7, 2007 updated by: Wyeth is now a wholly owned subsidiary of Pfizer

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

150

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Randwick, New South Wales, Australia, 2031
      • Sydney, New South Wales, Australia, 200
    • Victoria
      • Richmond, Victoria, Australia, 3121
    • Western Australia
      • Nedlands, Western Australia, Australia, 6009
  • Belgium
    • Leuven
      • Herestraat, Leuven, Belgium, 3000
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 4L7
    • British Columbia
      • Vancouver, British Columbia, Canada, V6Z 1Y6
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3A 1R9
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 2N1
    • Ontario
      • London, Ontario, Canada, N6A 4V2
      • Toronto, Ontario, Canada, M5B 1W8
    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada, S7K 1N4
  • Hong Kong
      • Hong Kong, Hong Kong
  • South Africa
    • Capetown
      • Cape Town, Capetown, South Africa, 7925
    • Eastern Cape
      • Port Elizabeth, Eastern Cape, South Africa, 6001
    • Jgb Gauteng
      • Roodepoort, Jgb Gauteng, South Africa, 1724
    • KwaZulu Natal
      • Durban, KwaZulu Natal, South Africa, 4320
  • United Kingdom
    • Nottinghamshire
      • Nottingham, Nottinghamshire, United Kingdom, NG7 2UH
    • Scotland
      • Glasgow, Scotland, United Kingdom, G51 4TF
    • South Yorshire
      • Sheffield, South Yorshire, United Kingdom, S10 2SF
    • Wiltshire
      • Swindon, Wiltshire, United Kingdom, SN3 6BD
  • United States
    • Alabama
      • Montgomery, Alabama, United States, 36116
    • Arizona
      • Chandler, Arizona, United States, 85225
      • Phoenix, Arizona, United States, 85032
      • Phoenix, Arizona, United States, 85035
      • Tucson, Arizona, United States, 85712
    • California
      • San Francisco, California, United States, 94115
      • Vista, California, United States, 92083
    • Colorado
      • Denver, Colorado, United States, 80206
      • Denver, Colorado, United States, 80202
    • Connecticut
      • New Britain, Connecticut, United States, 06050
    • Florida
      • Clearwater, Florida, United States, 33759
      • New Port Richey, Florida, United States, 34652
      • Plantation, Florida, United States, 33324
      • Venice, Florida, United States, 34285
      • West Palm Beach, Florida, United States, 33409
      • West Palm Beach, Florida, United States, 33401
    • Georgia
      • Marietta, Georgia, United States, 30066
    • Idaho
      • Idaho Falls, Idaho, United States, 83404
    • Illinois
      • Oak Brook, Illinois, United States, 60523
    • Indiana
      • Evansville, Indiana, United States, 47714
    • Nevada
      • Reno, Nevada, United States, 89502
    • New Jersey
      • Lawrenceville, New Jersey, United States, 08648
    • North Carolina
      • Durham, North Carolina, United States, 27710
      • New Bern, North Carolina, United States, 28562
      • Raleigh, North Carolina, United States, 27612
      • Winston-Salem, North Carolina, United States, 27103
    • Ohio
      • Cleveland, Ohio, United States, 44122
      • Miamisburg, Ohio, United States, 45342
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73112
    • Oregon
      • Portland, Oregon, United States, 97210
    • Pennsylvania
      • Abington, Pennsylvania, United States, 19001
      • Lansdale, Pennsylvania, United States, 19446
      • Philadelphia, Pennsylvania, United States, 19107
      • Philadelphia, Pennsylvania, United States, 19114
      • Pittsburgh, Pennsylvania, United States, 15243
    • South Carolina
      • Columbia, South Carolina, United States, 29201
      • Greenville, South Carolina, United States, 29607
    • Tennessee
      • Bristol, Tennessee, United States, 37620
      • Chattanooga, Tennessee, United States, 37403
      • Memphis, Tennessee, United States, 38119
    • Texas
      • Corpus Christi, Texas, United States, 78414
      • San Antonio, Texas, United States, 78229
    • Utah
      • West Valley City, Utah, United States, 84120
    • Virginia
      • Norfolk, Virginia, United States, 23507
      • Richmond, Virginia, United States, 23294
      • Richmond, Virginia, United States, 23233
      • Virginia Beach, Virginia, United States, 23456
    • Washington
      • Renton, Washington, United States, 98055
    • Wisconsin
      • Madison, Wisconsin, United States, 53792

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

Outcome Measure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Investigators

  • Principal Investigator: Trial Manager, For South Africa, ZAFinfo@wyeth.com
  • Principal Investigator: Trial Manager, For United Kingdom, ukmedinfo@wyeth.com
  • Principal Investigator: Trial Manager, For Canada, clintrialparticipation@wyeth.com
  • Principal Investigator: Trial Manager, For Australia and Hong Kong, medinfo@wyeth.com

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2006

Study Completion (Actual)

December 1, 2006

Study Registration Dates

First Submitted

April 24, 2006

First Submitted That Met QC Criteria

April 25, 2006

First Posted (Estimate)

April 26, 2006

Study Record Updates

Last Update Posted (Estimate)

December 10, 2007

Last Update Submitted That Met QC Criteria

December 7, 2007

Last Verified

December 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3142A2-203

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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