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

This study has been completed.
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00110487
First received: May 9, 2005
Last updated: December 7, 2007
Last verified: December 2007
History of Changes
  Purpose

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.


Condition Intervention Phase
Endometriosis
 Drug: ERB-041
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Endometriosis
U.S. FDA Resources

Further study details as provided by Wyeth is now a wholly owned subsidiary of Pfizer:

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.

Estimated 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
Accepts Healthy Volunteers:   No
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

  Show 46 Study Locations
Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00110487     History of Changes
Other Study ID Numbers: 3142A2-200
Study First Received: May 9, 2005
Last Updated: December 7, 2007
Health Authority: United States: Food and Drug Administration

Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:
Endometriosis

Additional relevant MeSH terms:
Endometriosis
Genital Diseases, Female

ClinicalTrials.gov processed this record on May 16, 2013