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| ID | Type | Description | Link |
|---|---|---|---|
| 2005-004688-45 | EudraCT Number | ||
| 310122 | Other Identifier | Company internal |
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The aim of this study is to evaluate the impact of SH T00658ID (EV/DNG tablet) on hemostatic parameters in comparison to a reference oral contraceptive (OC) (SH D01155E) in a crossover design.
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 |
| |
| Arm 2 | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EV/DNG (Qlaira, BAY86-5027, SH T00658ID) | Drug | per cycle (28 days): Days 1-2: 3.0 mg EV; Days 3-7: 2.0 mg EV + 2.0 mg DNG; Days 824: 2.0 mg EV + 3.0 mg DNG; Days 25-26: 1.0 mg EV; Days 27-28: Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Intraindividual absolute changes from Baseline in the Parameters of thrombin and fibrin turnover | Baseline, Cycle 3 of each treatment period |
| Measure | Description | Time Frame |
|---|---|---|
| Intraindividual absolute changes from Baseline in Pro- and anti-coagulatory parameters and the parameter of thrombin and fibrin turnover (activation marker): Prothrombin (Factor II). | Baseline, Cycle 3 of each treatment period | |
| Adverse events | 2 treatment periods (3 cycles each), 2 cycles whash out-period and 14 days follow-up period |
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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 |
|---|---|---|---|---|---|---|
| Dinox B.V. | Groningen | 9713GZ | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21679006 | Result | Klipping C, Duijkers I, Parke S, Mellinger U, Serrani M, Junge W. Hemostatic effects of a novel estradiol-based oral contraceptive: an open-label, randomized, crossover study of estradiol valerate/dienogest versus ethinylestradiol/levonorgestrel. Drugs R D. 2011;11(2):159-70. doi: 10.2165/11591200-000000000-00000. |
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| SH D01155E | Drug | per cycle: Days 1-21: 0.03 mg EE + 0.15 mg LNG; Days 22-28: Placebo |
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