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| ID | Type | Description | Link |
|---|---|---|---|
| 309367 |
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To evaluate the safety, tolerability, and efficacy of Angeliq in Thai post menopausal women with hot flushes and other climacteric symptoms.
The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany.
Bayer Schering Pharma AG, Germany is the sponsor of the trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Estradiol/DRSP (Angeliq, BAY86-4891) | Drug | 1 tablet of 2 mg drospirenone and 1 mg estradiol, orally administered once daily, over three 28-day treatment cycles |
|
| Measure | Description | Time Frame |
|---|---|---|
| The relative change in the frequency of hot flushes | At baseline, week 4, 8, 12 |
| Measure | Description | Time Frame |
|---|---|---|
| The change in intensity of hot flushes | At baseline, week 4, 8, 12 | |
| The relative change in frequency of hot flushes | At baseline, week 4, 8 | |
| The change in intensity of hot flushes |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
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| ID | Term |
|---|---|
| C488382 | estradiol-drospirenone combination |
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| At baseline, week 4, 8 |
| The proportions of subjects with urogenital symptoms | At baseline, week 4, 8, 12 |
| Bleeding pattern | At baseline, week 4, 8, 12 |
| Adverse events collection | Collection of AE throughout the study period |