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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ERB-041 | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Wyeth is now a wholly owned subsidiary of Pfizer | Study Director |
| 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 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Montgomery | Alabama | 36116 | United States | |||
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| Chandler |
| Arizona |
| 85225 |
| United States |
| Phoenix | Arizona | 85032 | United States |
| Phoenix | Arizona | 85035 | United States |
| Tucson | Arizona | 85712 | United States |
| San Francisco | California | 94115 | United States |
| Vista | California | 92083 | United States |
| Denver | Colorado | 80202 | United States |
| Denver | Colorado | 80206 | United States |
| New Britain | Connecticut | 06050 | United States |
| Clearwater | Florida | 33759 | United States |
| New Port Richey | Florida | 34652 | United States |
| Plantation | Florida | 33324 | United States |
| Venice | Florida | 34285 | United States |
| West Palm Beach | Florida | 33401 | United States |
| West Palm Beach | Florida | 33409 | United States |
| Marietta | Georgia | 30066 | United States |
| Idaho Falls | Idaho | 83404 | United States |
| Oak Brook | Illinois | 60523 | United States |
| Evansville | Indiana | 47714 | United States |
| Reno | Nevada | 89502 | United States |
| Lawrenceville | New Jersey | 08648 | United States |
| Durham | North Carolina | 27710 | United States |
| New Bern | North Carolina | 28562 | United States |
| Raleigh | North Carolina | 27612 | United States |
| Winston-Salem | North Carolina | 27103 | United States |
| Cleveland | Ohio | 44122 | United States |
| Miamisburg | Ohio | 45342 | United States |
| Oklahoma City | Oklahoma | 73112 | United States |
| Portland | Oregon | 97210 | United States |
| Abington | Pennsylvania | 19001 | United States |
| Lansdale | Pennsylvania | 19446 | United States |
| Philadelphia | Pennsylvania | 19107 | United States |
| Philadelphia | Pennsylvania | 19114 | United States |
| Pittsburgh | Pennsylvania | 15243 | United States |
| Columbia | South Carolina | 29201 | United States |
| Greenville | South Carolina | 29607 | United States |
| Bristol | Tennessee | 37620 | United States |
| Chattanooga | Tennessee | 37403 | United States |
| Memphis | Tennessee | 38119 | United States |
| Corpus Christi | Texas | 78414 | United States |
| San Antonio | Texas | 78229 | United States |
| West Valley City | Utah | 84120 | United States |
| Norfolk | Virginia | 23507 | United States |
| Richmond | Virginia | 23233 | United States |
| Richmond | Virginia | 23294 | United States |
| Virginia Beach | Virginia | 23456 | United States |
| Renton | Washington | 98055 | United States |
| Madison | Wisconsin | 53792 | United States |
| Randwick | New South Wales | 2031 | Australia |
| Sydney | New South Wales | 200 | Australia |
| Richmond | Victoria | 3121 | Australia |
| Nedlands | Western Australia | 6009 | Australia |
| Herestraat | Leuven | 3000 | Belgium |
| Calgary | Alberta | T2N 4L7 | Canada |
| Vancouver | British Columbia | V6Z 1Y6 | Canada |
| Winnipeg | Manitoba | R3A 1R9 | Canada |
| Halifax | Nova Scotia | B3H 2N1 | Canada |
| London | Ontario | N6A 4V2 | Canada |
| Toronto | Ontario | M5B 1W8 | Canada |
| Saskatoon | Saskatchewan | S7K 1N4 | Canada |
| Hong Kong | Hong Kong |
| Cape Town | Capetown | 7925 | South Africa |
| Port Elizabeth | Eastern Cape | 6001 | South Africa |
| Roodepoort | Jgb Gauteng | 1724 | South Africa |
| Durban | KwaZulu-Natal | 4320 | South Africa |
| Nottingham | Nottinghamshire | NG7 2UH | United Kingdom |
| Glasgow | Scotland | G51 4TF | United Kingdom |
| Sheffield | South Yorshire | S10 2SF | United Kingdom |
| Swindon | Wiltshire | SN3 6BD | United Kingdom |
| ID | Term |
|---|---|
| D004412 | Dysmenorrhea |
| D004414 | Dyspareunia |
| D004715 | Endometriosis |
| D017699 | Pelvic Pain |
| ID | Term |
|---|---|
| D008599 | Menstruation Disturbances |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D005832 | Genital Diseases, Male |
| D012735 | Sexual Dysfunction, Physiological |
| D052801 | Male Urogenital Diseases |
| D020018 | Sexual Dysfunctions, Psychological |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C478102 | ERB 041 |
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