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

Sponsored by:	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

MedlinePlus related topics: Endometriosis Female Sexual Dysfunction Pelvic Pain

U.S. FDA Resources

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

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

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

Study placed in the following topic categories:

Sexual Dysfunctions, Psychological
Genital Diseases, Female
Signs and Symptoms
Sexual Dysfunction, Physiological
Pelvic Pain
Menstruation Disturbances

Dysmenorrhea
Mental Disorders
Endometriosis
Pain
Genital Diseases, Male
Dyspareunia

Additional relevant MeSH terms:

Pathologic Processes
Sexual and Gender Disorders

ClinicalTrials.gov processed this record on January 16, 2009