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Sponsored by: |
Meditrina Pharmaceuticals |
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Information provided by: | Meditrina Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00467493 |
Aromatase inhibitors have been approved for use in postmenopausal women to treat and prevent breast cancer. They act by blocking the action of the enzyme, aromatase, that is necessary for the production of estradiol. This class of drugs, aromatase inhibitors, are very effective in reducing estradiol levels in postmenopausal women and in treating estrogen receptor positive breast cancers. This study is examining the effect of a specific inhibitor, anastrozole, on endometrial thickness in premenopausal women. The endometrium is sensitive to estradiol and also has local aromatase which, if inhibited, may result in reduced endometrial thickness. The main hypothesis is that anastrozole can be administered at any time during the menstrual cycle and reduce endometrial thickness compared to placebo.
Condition | Intervention | Phase |
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Menstruation Disorders |
Drug: Anastrozole |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Partial Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Anastrozole, an Aromatase Inhibitor, on Endometrial Thickness in Healthy Premenopausal Women When Dosed at Various Times During the Menstrual Cycle (Protocol M-001) |
Ages Eligible for Study: | 25 Years to 45 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
United States, Michigan | |
Jasper Research Clinic | Recruiting |
Kalamazoo, Michigan, United States, 49007 | |
Contact: Luann Leverette, LPN 800-458-6072 LuannLeverette@jasperclinic.biz | |
Principal Investigator: Thomas Blok, MD | |
University Women's Care | Recruiting |
Southfield, Michigan, United States, 48034 | |
Contact: Karen Collins 313-745-7885 kcollins@med.wayne.edu | |
Principal Investigator: Michael P Diamond, MD |
Study ID Numbers: | M-001 |
Study First Received: | April 27, 2007 |
Last Updated: | April 27, 2007 |
ClinicalTrials.gov Identifier: | NCT00467493 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Anastrozole Antineoplastic Agents, Hormonal Menstruation Disturbances Healthy Aromatase Inhibitors |
Anastrozole Pathologic Processes Molecular Mechanisms of Pharmacological Action Antineoplastic Agents, Hormonal Menstruation Disturbances |
Antineoplastic Agents Therapeutic Uses Enzyme Inhibitors Aromatase Inhibitors Pharmacologic Actions |