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| ID | Type | Description | Link |
|---|---|---|---|
| 308381 |
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Study to demonstrate that the therapeutic efficacy of Angeliq® is better than placebo in Korean postmenopausal women with hot flushes and other climacteric symptoms. Safety and tolerability of Angeliq.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 2 | Placebo Comparator |
| |
| Arm 1 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Angeliq (Drospirenone/17ß-estradiol, BAY86-4891) | Drug | Treatments will be administered daily, orally during the whole treatment period of 16 weeks without a treatment-free interval. |
| Measure | Description | Time Frame |
|---|---|---|
| Hot flush (frequency and severity) | Daily in pre-treatment and treatment period |
| Measure | Description | Time Frame |
|---|---|---|
| Menopausal symptoms | Baseline and after 4 weeks, 8, 12 and 16 weeks of treatment | |
| Urogenital symptoms | Baseline and after 4 weeks, 8, 12 and 16 weeks of treatment | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul | 110-744 | South Korea | ||||
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| ID | Term |
|---|---|
| C488382 | estradiol-drospirenone combination |
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| Placebo | Drug | Placebo treatments will be administered daily, orally during the whole treatment period of 16 weeks without a treatment-free interval. |
|
| Assessment of bleeding |
| daily in pre-treatment and treatment period |
| Seoul |
| 135-710 |
| South Korea |
| Seoul | 138-736 | South Korea |
| Seoul | South Korea |