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.

First Received: April 24, 2006 Last Updated: December 7, 2007 History of Changes

Sponsor:	Wyeth
Information provided by:	Wyeth
ClinicalTrials.gov Identifier:	NCT00318500

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 II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
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:

MedlinePlus related topics: Endometriosis Female Sexual Dysfunction Pelvic Pain

U.S. FDA Resources

Further study details as provided by Wyeth:

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

Investigators

Study Director:	Medical Monitor	Wyeth
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

Study ID Numbers:	3142A2-203
Study First Received:	April 24, 2006
Last Updated:	December 7, 2007
ClinicalTrials.gov Identifier:	NCT00318500 History of Changes
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:

Endometriosis
Dysmenorrhea
Pelvic pain
Dyspareunia

Additional relevant MeSH terms:

Sexual Dysfunctions, Psychological
Endometriosis
Pain
Genital Diseases, Male
Sexual and Gender Disorders
Dyspareunia
Genital Diseases, Female

Signs and Symptoms
Pelvic Pain
Pathologic Processes
Sexual Dysfunction, Physiological
Dysmenorrhea
Menstruation Disturbances
Mental Disorders

ClinicalTrials.gov processed this record on February 08, 2010