check_circleStudy Completed
Contraception
Bayer Identifier:
90927
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Metabolism study to investigate the impact of a sequential oral contraceptive
Trial purpose
The purpose of this study is to confirm the safety of SH T00658ID with regard to plasma lipids, hemostatic variables, and carbohydrate metabolism. In addition, the pharmacokinetic parameter following the long term administration of SH T00658ID will be assessed.
Key Participants Requirements
Sex
FemaleAge
18 - 50 YearsTrial summary
Enrollment Goal
58Trial Dates
March 2005 - March 2006Phase
Phase 2Could I Receive a placebo
NoProducts
Natazia/Qlaira (EV/DNG, BAY86-5027)Accepts Healthy Volunteer
YesWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Bayer Schering Pharma AG - Clin. Pharm. Berlin | Berlin, 13342, Germany |
Primary Outcome
- Impact on metabolic parameters (e.g. hemostatic parameters) after 6 month treatmentdate_rangeTime Frame:Baseline, Cycle 7enhanced_encryptionNoneSafety Issue:
Secondary Outcome
- Measurement of PK parametersdate_rangeTime Frame:Cycle 4, Cycle 7enhanced_encryptionNoneSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
PreventionAllocation
RandomizedBlinding
Open LabelAssignment
Parallel AssignmentTrial Arms
2