Trial Condition(s):
pregnancy, unplanned
Impact of SH T00658ID as compared to a monophasic contraceptive containing ethinylestradiol and levonorgestrel (SH D01155E) on hemostatic parameters
Bayer Identifier:
91477
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
Trial Purpose
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.
Inclusion Criteria
- Healthy female volunteers
Exclusion Criteria
- Pregnancy or lactation - Any condition that might interfere with the outcome as all contraindications for OC use.
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Dinox B.V. Groningen, Netherlands, 9713GZ | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
A single-centre, open-label, crossover, controlled, randomized study to investigate the impact of SH T00658ID as compared to a monophasic contraceptive containing ethinylestradiol and levonorgestrel (SH D01155E) on hemostatic parameters in 30 healthy female volunteers over 3 treatment cycles
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Prevention
Allocation:
Randomized
Blinding:
Open Label
Assignment:
Crossover Assignment
Trial Arms:
2
Primary Outcome
- Intraindividual absolute changes from Baseline in the Parameters of thrombin and fibrin turnoverTimeframe: Baseline, Cycle 3 of each treatment period
Secondary Outcome
- Intraindividual absolute changes from Baseline in Pro- and anti-coagulatory parameters and the parameter of thrombin and fibrin turnover (activation marker): Prothrombin (Factor II).Timeframe: Baseline, Cycle 3 of each treatment period
- Adverse eventsTimeframe: 2 treatment periods (3 cycles each), 2 cycles whash out-period and 14 days follow-up period
Additional Information
Copyright © Bayer
Powered by
