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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
150

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Wyeth is now a wholly owned subsidiary of Pfizer

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2006

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2006

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 24, 2006

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 25, 2006

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 26, 2006

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 10, 2007

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 7, 2007

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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