Study Evaluating ERB-041 in Endometriosis in Reproductive-Age Women

April 30, 2015 updated by: Wyeth is now a wholly owned subsidiary of Pfizer

A Double-Blind, Randomized, Placebo-Controlled, Dose-Ranging Study of the Effect of ERB-041 in the Reduction of Symptoms Associated With Endometriosis in Reproductive-Age Women

The purpose of this investigational study is to determine if a study medication is safe and effective in reducing the symptoms associated with endometriosis; if the study medication reduces the need for pain medication for endometriosis symptoms; and if the study medication improves a participant's ability to carry out daily activities. Qualified participants will receive no cost treatment, which may include study-related examinations, diagnostic procedures including a Pap smear, laboratory testing, and a mammogram (aged 40-45). Qualified participants will also receive study medication at no cost. As a participant, the study volunteer may also experience the satisfaction of knowing she is helping the advancement of women's health care.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

200

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

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85015
      • Tucson, Arizona, United States, 85710
    • California
      • Carmichael, California, United States, 95608
      • La Jolla, California, United States, 92093
      • Redding, California, United States, 96001
      • San Diego, California, United States, 92123
    • Colorado
      • Lakewood, Colorado, United States, 80228
    • Florida
      • Aventura, Florida, United States, 33180
      • Boynton, Florida, United States, 33437
      • Celebration, Florida, United States, 34747
      • Clearwater, Florida, United States, 33758
      • Miami, Florida, United States, 33136
      • Miami, Florida, United States, 33143
      • New Port Richey, Florida, United States, 34652
      • Ocala, Florida, United States, 34471
      • Palm Harbor, Florida, United States, 34684
    • Georgia
      • Alpharetta, Georgia, United States, 30005
      • Atlanta, Georgia, United States, 30342
    • Illinois
      • Arlington Heights, Illinois, United States, 60005
      • Champaign, Illinois, United States, 61820
      • Chicago, Illinois, United States, 60637
      • Chicago, Illinois, United States, 60611
      • Oak Brook, Illinois, United States, 60523
    • Indiana
      • South Bend, Indiana, United States, 46601
    • Louisiana
      • Shreveport, Louisiana, United States, 71103
    • Maryland
      • Lanham, Maryland, United States, 20706
      • Laurel, Maryland, United States, 20707
    • Michigan
      • Detroit, Michigan, United States, 48201
    • Minnesota
      • Chaska, Minnesota, United States, 55318
    • Missouri
      • Chesterfield, Missouri, United States, 63017
    • Nevada
      • Las Vegas, Nevada, United States, 89104
    • New Jersey
      • Berlin, New Jersey, United States, 08009
    • North Carolina
      • Charlotte, North Carolina, United States, 28209
    • North Dakota
      • Fargo, North Dakota, United States, 58104
    • Ohio
      • Cincinnati, Ohio, United States, 45267
      • Cleveland, Ohio, United States, 44195
    • Oregon
      • Eugene, Oregon, United States, 97401
    • South Carolina
      • Greenville, South Carolina, United States, 29605
      • Greer, South Carolina, United States, 29651
    • Texas
      • Dallas, Texas, United States, 75390-9032
      • Fort Worth, Texas, United States, 76104
      • Webster, Texas, United States, 77598
    • Utah
      • Sandy, Utah, United States, 84070
    • Virginia
      • Norfolk, Virginia, United States, 23507-1627
      • Richmond, Virginia, United States, 23298
    • Wisconsin
      • Madison, Wisconsin, United States, 53792-6188

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 5 years
  • Not pregnant and not lactating
  • Willing to use non-hormonal contraception, history of regular menstrual cycles

Exclusion Criteria:

  • Hysterectomy, surgical treatment for endometriosis within 3 months
  • Certain medications for the treatment of endometriosis
  • Previous history of a malignancy
  • Abnormalities on physical or gyn exams and abnormal lab tests

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: Single Group Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
To assess the effects and to compare the safety profile of an investigational
medication on the relief of endometriosis-related symptoms.

Secondary Outcome Measures

Outcome Measure
Clinical and subject assessment of symptoms related to endometriosis and the
use of analgesia to relieve symptoms.

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

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

January 1, 2005

Study Completion (Actual)

December 1, 2006

Study Registration Dates

First Submitted

May 9, 2005

First Submitted That Met QC Criteria

May 9, 2005

First Posted (Estimate)

May 10, 2005

Study Record Updates

Last Update Posted (Estimate)

May 1, 2015

Last Update Submitted That Met QC Criteria

April 30, 2015

Last Verified

December 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3142A2-200

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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