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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
29
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
per cycle: Days 1-21: 0.03 mg EE + 0.15 mg LNG; Days 22-28: Placebo
Dinox B.V.
Groningen, Netherlands
Intraindividual absolute changes from Baseline in the Parameters of thrombin and fibrin turnover
Time frame: Baseline, Cycle 3 of each treatment period
Intraindividual absolute changes from Baseline in Pro- and anti-coagulatory parameters and the parameter of thrombin and fibrin turnover (activation marker): Prothrombin (Factor II).
Time frame: Baseline, Cycle 3 of each treatment period
Adverse events
Time frame: 2 treatment periods (3 cycles each), 2 cycles whash out-period and 14 days follow-up period
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