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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Anastrozole - A | Experimental | Treatment for 26 consecutive days |
|
| Anastrozole -B | Experimental | Treatment for 7 consecutive days early in menstrual cycle |
|
| Anastrozoe - C | Experimental | Treatment for 7 consecutive days mid follicular phase |
|
| Anastrozole - D | Experimental | Treatment for 7 consecutive days - mid cycle |
|
| Anastrozole - E | Experimental | Treatment for 7 consecutive days - luteal |
|
| Anastrozole - F | Placebo Comparator | Treatment with placebo for 26 consecutive days |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anastrozole | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Endometrial thickness as measured by transvaginal ultrasound, safety | Over one menstrual cycle |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jasper Research Clinic | Kalamazoo | Michigan | 49007 | United States | ||
| University Women's Care |
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| ID | Term |
|---|---|
| D008599 | Menstruation Disturbances |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000077384 | Anastrozole |
| ID | Term |
|---|---|
| D009570 | Nitriles |
| D009930 | Organic Chemicals |
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 |
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| Southfield |
| Michigan |
| 48034 |
| United States |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |