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Sponsored by: |
Wyeth |
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Information provided by: | Wyeth |
ClinicalTrials.gov Identifier: | NCT00318500 |
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 |
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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 |
Estimated Enrollment: | 150 |
Study Start Date: | May 2006 |
Study Completion Date: | December 2006 |
Ages Eligible for Study: | 18 Years to 45 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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 |
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 |
Endometriosis Dysmenorrhea Pelvic pain Dyspareunia |
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 |
Pathologic Processes Sexual and Gender Disorders |