Impact of SH T00658ID as Compared to a Monophasic Contraceptive Containing Ethinylestradiol and Levonorgestrel (SH D01155E) on Hemostatic Parameters
Phase 2
Completed
- Conditions
- Pregnancy, Unplanned
- Interventions
- Drug: EV/DNG (Qlaira, BAY86-5027, SH T00658ID)Drug: SH D01155E
- Registration Number
- NCT00318799
- Lead Sponsor
- Bayer
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 29
Inclusion Criteria
- Healthy female volunteers
Exclusion Criteria
- Pregnancy or lactation
- Any condition that might interfere with the outcome as all contraindications for OC use.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Arm 1 EV/DNG (Qlaira, BAY86-5027, SH T00658ID) - Arm 2 SH D01155E -
- Primary Outcome Measures
Name Time Method Intraindividual absolute changes from Baseline in the Parameters of thrombin and fibrin turnover Baseline, Cycle 3 of each treatment period
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Dinox B.V.
🇳🇱Groningen, Netherlands