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


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  • endometriosis
  • erb-041
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    • Purpose

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      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.


      status: completed
      conditions: Endometriosis
      interventions: ERB-041
      phase: Phase 2
      study type: Interventional
      study design: Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety/Efficacy Study
      official title: 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

    • Further study details (as provided by Wyeth)

      primary outcome measures:

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

      secondary outcome measures:

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

      enrollment: 200

      study start date: January 2005

      study completion date: December 2006


    • Eligibility

      ages eligible for study: 18 Years to 45 Years
      genders eligible for study: Female

      Criteria

      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

    • Contacts and locations

      Please refer to this study by its ClinicalTrials.gov identifier: NCT00110487

      Locations

      United States , Arizona

      facility: Phoenix, Arizona, United States, 85015

      United States , Arizona

      facility: Tucson, Arizona, United States, 85710

      United States , California

      facility: La Jolla, California, United States, 92093

      United States , California

      facility: San Diego, California, United States, 92123

      United States , California

      facility: Redding, California, United States, 96001

      United States , California

      facility: Carmichael, California, United States, 95608

      United States , Colorado

      facility: Lakewood, Colorado, United States, 80228

      United States , Florida

      facility: Boynton, Florida, United States, 33437

      United States , Florida

      facility: Miami, Florida, United States, 33136

      United States , Florida

      facility: Miami, Florida, United States, 33143

      United States , Florida

      facility: Aventura, Florida, United States, 33180

      United States , Florida

      facility: Celebration, Florida, United States, 34747

      United States , Florida

      facility: Ocala, Florida, United States, 34471

      United States , Florida

      facility: New Port Richey, Florida, United States, 34652

      United States , Florida

      facility: Palm Harbor, Florida, United States, 34684

      United States , Florida

      facility: Clearwater, Florida, United States, 33758

      United States , Georgia

      facility: Atlanta, Georgia, United States, 30342

      United States , Georgia

      facility: Alpharetta, Georgia, United States, 30005

      United States , Illinois

      facility: Oak Brook, Illinois, United States, 60523

      United States , Illinois

      facility: Arlington Heights, Illinois, United States, 60005

      United States , Illinois

      facility: Chicago, Illinois, United States, 60611

      United States , Illinois

      facility: Chicago, Illinois, United States, 60637

      United States , Illinois

      facility: Champaign, Illinois, United States, 61820

      United States , Indiana

      facility: South Bend, Indiana, United States, 46601

      United States , Louisiana

      facility: Shreveport, Louisiana, United States, 71103

      United States , Maryland

      facility: Lanham, Maryland, United States, 20706

      United States , Maryland

      facility: Laurel, Maryland, United States, 20707

      United States , Michigan

      facility: Detroit, Michigan, United States, 48201

      United States , Minnesota

      facility: Chaska, Minnesota, United States, 55318

      United States , Missouri

      facility: Chesterfield, Missouri, United States, 63017

      United States , Nevada

      facility: Las Vegas, Nevada, United States, 89104

      United States , New Jersey

      facility: Berlin, New Jersey, United States, 08009

      United States , North Carolina

      facility: Charlotte, North Carolina, United States, 28209

      United States , North Dakota

      facility: Fargo, North Dakota, United States, 58104

      United States , Ohio

      facility: Cleveland, Ohio, United States, 44195

      United States , Ohio

      facility: Cincinnati, Ohio, United States, 45267

      United States , Oregon

      facility: Eugene, Oregon, United States, 97401

      United States , South Carolina

      facility: Greer, South Carolina, United States, 29651

      United States , South Carolina

      facility: Greenville, South Carolina, United States, 29605

      United States , Texas

      facility: Dallas, Texas, United States, 75390-9032

      United States , Texas

      facility: Fort Worth, Texas, United States, 76104

      United States , Texas

      facility: Webster, Texas, United States, 77598

      United States , Utah

      facility: Sandy, Utah, United States, 84070

      United States , Virginia

      facility: Norfolk, Virginia, United States, 23507-1627

      United States , Virginia

      facility: Richmond, Virginia, United States, 23298

      United States , Wisconsin

      facility: Madison, Wisconsin, United States, 53792-6188

    • Sponsors and collaborators

      Wyeth

      investigators: Medical Monitor, Study Director, Wyeth

    • More information

      first received: May 9, 2005
      last updated: December 7, 2007
      ClinicalTrials.gov Identifier: NCT00110487
      health authority: United States: Food and Drug Administration

    Information obtained from ClinicalTrials.gov on September 25, 2009   Link to the current ClinicalTrials.gov record.

    © 2009 NextBio