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| ID | Type | Description | Link |
|---|---|---|---|
| 307286 |
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The objective of this study was to investigate the impact of the oral contraceptive YASMIN (containing: drospirenone 3 mg/ethinyl estradiol 30 mcg) in comparison with the oral contraceptive MICROGYNON (containing: levonorgestrel 150 mcg/ethinyl estradiol 30mcg) on factors of blood coagulation and fibrinolysis in female subjects
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental |
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| Arm 2 | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Yasmin (DRSP 3mg/EE 0.03 mg) | Drug | The study medication was packaged in 21-tablet blister packs. Each subject kit contained 7 blister packs plus 1 reserve blister pack.Subjects randomly assigned to the treatment group received 21 consecutive days of hormonally active tablets (3mg DRSP/0.03 mgEE). In each treatment cycle 21 tablets (1 tablet daily) have to be taken in sequence, followed by a pill-free interval of 7 days. The treatment period was 7 cycles (28 days per cycle). |
| Measure | Description | Time Frame |
|---|---|---|
| Pro-coagulatory parameters: Factor VIII (activity), Fibrinogen | At baseline and after wash out (period 2); after 7 cycles of treatment in each of the two study periods | |
| Anti-coagulatory parameters: Protein C (activity), Antithrombin III(activity), APC resistance (factor V mutation) | At baseline and after wash out (period 2); after 7 cycles of treatment in each of the two study periods |
| Measure | Description | Time Frame |
|---|---|---|
| Rosing test: APC sensitivity ratio | At baseline and after wash out (period 2); after 7 cycles of treatment in each of the two study periods | |
| Pro-coagulatory parameters: Factor VIII (activity), Activation markers: D-dimer, Prothrombin fragment 1+2 | At baseline and after wash out (period 2); after 7 cycles of treatment in each of the two study periods |
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Inclusion Criteria:
Exclusion Criteria:
Standard contraindications for use of combined oral contraceptives (class label). Including:
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Berlin | State of Berlin | 10115 | Germany |
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| ID | Term |
|---|---|
| D013927 | Thrombosis |
| ID | Term |
|---|---|
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C534342 | drospirenone and ethinyl estradiol combination |
| C035144 | drospirenone |
| C072593 | ethinyl estradiol, levonorgestrel drug combination |
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| Microgynon (LNG 0.15 mg/EE 0.03 mg) | Drug | The study medication was packaged in 21-tablet blister packs. Each subject kit contained 7 blister packs plus 1 reserve blister pack.Subjects randomly assigned to the treatment group received 21 consecutive days of hormonally active tablets (LNG 0.15 mg/EE 0.03 mg). In each treatment cycle 21 tablets (1 tablet daily) have to be taken in sequence, followed by a pill-free interval of 7 days. The treatment period was 7 cycles (28 days per cycle). |
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