check_circleStudy Completed
pregnancy, unplanned
Bayer Identifier:
91477
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
Impact of SH T00658ID as compared to a monophasic contraceptive containing ethinylestradiol and levonorgestrel (SH D01155E) on hemostatic parameters
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.
Key Participants Requirements
Sex
FemaleAge
18 YearsTrial summary
Enrollment Goal
29Trial Dates
April 2006 - May 2007Phase
Phase 2Could I Receive a placebo
NoProducts
Natazia/Qlaira (EV/DNG, BAY86-5027)Accepts Healthy Volunteer
YesWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Dinox B.V. | Groningen, 9713GZ, Netherlands |
Primary Outcome
- Intraindividual absolute changes from Baseline in the Parameters of thrombin and fibrin turnoverdate_rangeTime Frame:Baseline, Cycle 3 of each treatment periodenhanced_encryptionNoSafety Issue:
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).date_rangeTime Frame:Baseline, Cycle 3 of each treatment periodenhanced_encryptionNoSafety Issue:
- Adverse eventsdate_rangeTime Frame:2 treatment periods (3 cycles each), 2 cycles whash out-period and 14 days follow-up periodenhanced_encryptionYesSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
PreventionAllocation
RandomizedBlinding
Open LabelAssignment
Crossover AssignmentTrial Arms
2