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Sponsored by: |
Novartis |
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Information provided by: | Novartis |
ClinicalTrials.gov Identifier: | NCT00240942 |
Endometriosis is a condition in which abnormal growth of tissue histologically resembling the lining of the uterus (endometrium) is present outside of the uterus. This study will investigate the effect of a daily dose of letrozole compared to GnRH is safe and in addition effective in reducing measurable endometriosis lesions and in reducing pain in patients with active endometriosis which were pretreated with GnRH analogs for 2 months.
Condition | Intervention | Phase |
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Severe and Recurrent Endometriosis |
Drug: Letrozole |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety Study |
Official Title: | Letrozole in the Treatment of Severe and Recurrent Endometriosis |
Estimated Enrollment: | 40 |
Study Start Date: | October 2002 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Exclusion Criteria
Additional protocol-defined inclusion / exclusion criteria may apply
Study ID Numbers: | CFEM345ADE04 |
Study First Received: | October 14, 2005 |
Last Updated: | July 5, 2007 |
ClinicalTrials.gov Identifier: | NCT00240942 History of Changes |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Endometriosis GnRH analog Aromataseinhibitor Letrozole |
Genital Diseases, Female Letrozole Endometriosis Aromatase Inhibitors Recurrence |
Genital Diseases, Female Disease Attributes Pathologic Processes Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Therapeutic Uses |
Enzyme Inhibitors Letrozole Endometriosis Aromatase Inhibitors Pharmacologic Actions Recurrence |