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| ID | Type | Description | Link |
|---|---|---|---|
| 2004-001829-22 |
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This study is to evaluate the effects of continuously combined 17b-estradiol/dydrogesterone in comparison with tibolone on the breast metabolic markers, in particular the total insulin-like growth factor-1 (IGF-1), in postmenopausal women.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 17ß-Estradiol/Dydrogesterone | Drug | 1/5 mg/day for 12 cycles of 28 days |
| |
| Measure | Description | Time Frame |
|---|---|---|
| IGF1 values after 12 cycles of 28 days | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| after 12 cycles of 28 days: other breast metabolic markers [IGFBP 1 and 3, SHBG, free estradiol, fasting insulin], breast tenderness and breast density, cardiovascular metabolic markers, menopausal symptoms and bleeding pattern | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Global Clinical Director Solvay | Solvay Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site 8 | Ancona | Italy | ||||
| Site 15 |
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| Tibolone |
| Drug |
2,5 mg/day for 12 cycles of 28 days |
|
| Cagliari |
| Italy |
| Site 4 | Catania | Italy |
| Site 9 | Florence | Italy |
| Site 10 | Milan | Italy |
| Site 11 | Milan | Italy |
| Sit 14 | Modena | Italy |
| Site 6 | Roma | Italy |
| Site 1 | Torino | Italy |
| Site 2 | Torino | Italy |
| Site 7 | Udine | Italy |
| ID | Term |
|---|---|
| D004394 | Dydrogesterone |
| C027385 | tibolone |
| ID | Term |
|---|---|
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
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