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| ID | Type | Description | Link |
|---|---|---|---|
| B2481004 |
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This is a Phase IV prospective, randomized, open label, comparative, multicenter study in generally healthy postmenopausal women receiving Totelle (17B Estradiol/TMG CC (1mg)) and Livial (Tibolone).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | 17B Estradiol (1mg) / (0.125 mg) Trimegestone (TMG) Continuous combined, 1 Daily, 1 year duration |
|
| 2 | Active Comparator | Tibolone 2.5 mg 1 daily, 1 year duration |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 17B Estradiol (1mg) / (0.125 mg) TMG Continuous combined (Totelle) | Drug | 17B Estradiol (1mg) / (0.125 mg) TMG Continuous combined, 1 Daily, 1 year duration |
|
| Measure | Description | Time Frame |
|---|---|---|
| Decreased of Vasomotor Symptoms [from baseline to six and twelve months] | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Body Weight (from baseline to six and twelve months) | 1 year | |
| Quality of Life (from baseline to six and twelve months) | 1 year | |
| Treatment Adherence (from baseline to six and twelve months) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Monterrey | Nuevo León | 01090 | Mexico |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| ID | Term |
|---|---|
| C027385 | tibolone |
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| Tibolone (Livial) | Drug | Tibolone 2.5 mg 1 daily, 1 year duration |
|
|
| 1 year |
| Breast Tenderness (from baseline to six and twelve months) | 1 year |