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

This study has been completed.
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00318500
First received: April 24, 2006
Last updated: December 7, 2007
Last verified: December 2007
History of Changes
  Purpose

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.


Condition Intervention Phase
Dysmenorrhea
Dyspareunia
Endometriosis
Pelvic Pain
 Drug: ERB-041
 Phase 2

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

Resource links provided by NLM:

U.S. FDA Resources

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

Primary Outcome Measures:
  • 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:
  • 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

Estimated Enrollment: 150
Study Start Date: May 2006
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 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00318500

  Show 70 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
Principal Investigator: Trial Manager For United Kingdom, ukmedinfo@wyeth.com
Principal Investigator: Trial Manager For Australia and Hong Kong, medinfo@wyeth.com
Principal Investigator: Trial Manager For South Africa, ZAFinfo@wyeth.com
Principal Investigator: Trial Manager For Belgium, trials-BEL@wyeth.com
Principal Investigator: Trial Manager For Canada, clintrialparticipation@wyeth.com
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00318500     History of Changes
Other Study ID Numbers: 3142A2-203
Study First Received: April 24, 2006
Last Updated: December 7, 2007
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
Canada: Health Canada
European Union: European Medicines Agency
Hong Kong: Department of Health
South Africa: Medicines Control Council
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United States: Food and Drug Administration

Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:
Endometriosis
Dysmenorrhea
Pelvic pain
Dyspareunia

Additional relevant MeSH terms:
Dysmenorrhea
Dyspareunia
Endometriosis
Pelvic Pain
Menstruation Disturbances
Pathologic Processes
Pain
 Signs and Symptoms
Sexual Dysfunction, Physiological
Genital Diseases, Male
Genital Diseases, Female
Sexual Dysfunctions, Psychological
Sexual and Gender Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 19, 2013