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A Safety & Efficacy Study of BGS649 in Women With Refractory Endometriosis - NCT01116440-36617(Clinical Trial 623137)



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City:  Mobile
State:  
AL
Zip Code: 36617
Conditions: Pelvic Pain Associated With Refractory Endometriosis
Purpose: The purpose of this study is to determine efficacy, safety, tolerability and pharmacokinetics of multiple doses of BGS649 with concurrent daily administration of combined oral contraception in patients with refractory endometriosis
Study summary:
Criteria: Inclusion Criteria: - Must have surgical dianosis of endometriosis est. w/in 5 years before screening. Subjects must have self reported moderate to severe pelvic pain at screening to be confirmed during the run-in-phase - Subjects with moderate to ssever pelvic pain who responded inadequately to at least 2 months of prior therapy with GnRH agonists and at least one other hormonal therapy that have not had a surgical intervention for endometriosis after they were recorded to have inadequately responded to GnRH agonists and at least one other homonal therapy. Exclusion Criteria: - Subjects who have undergone hysteectomy or bilateral oophorectomy. - Surgical treatment of endometriosis within 6 months before screening. - Subjects who are pregnant or who were pregnant within 3 months of visit one. - Subjects who are nursing or lactating - Subjects who are tobacco smokers. Other protocol-defined inclusion/exclusion criteria may apply
Study is available at: University of South Alabama Medical Center
Mobile, AL 36617
United States

Primary Contact:
Novartis Pharmaceuticals
Phone: 862 778 8300
If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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Data Source: ClinicalTrials.gov
Date Processed: March 23, 2011
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