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| ID | Type | Description | Link |
|---|---|---|---|
| 305545 |
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The purpose of this study is to evaluate the effects on the quality of life and BMI of new contraceptives.
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 |
|---|---|---|---|---|
| Yasmin (30 µg EE, 3 mg Drospirenone, BAY86-5131) | Drug | Yasmin, SH T 470 FA; 30 µg ethinylestradiol and 3 mg drospirenone, oral administration over 6 treatment cycles, one tablet per day for 21 days followed by a 7 day pill-free interval. |
| Measure | Description | Time Frame |
|---|---|---|
| Change of Psychological General Well Being Questionnaire score | pretreatment cycle to cycle 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in body composition (evaluated by Multifrequency Bioelectrical Impedance Analysis) | pretreatment to cycle 6 | |
| Subject satisfaction with treatment at final visit | at final visit | |
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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 |
|---|---|
| C534342 | drospirenone and ethinyl estradiol combination |
| C035144 | drospirenone |
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| Subject evaluation of changes in greasy skin and greasy hair |
| baseline to cycle 6 |