check_circleStudy Completed
Contraception
Bayer Identifier:
91460
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
Investigation of bioequivalence of ethinylestradiol (EE) and drospirenone (DRSP) in two different tablet formulations: YAZ and YAZ + levomefolate calcium (Metafolin) & L-5-MTHF in two different tablet formulations: levomefolate calcium (Metafolin) and YAZ + levomefolate calcium (Metafolin)
Trial purpose
The purpose of this study is examine and compare the uptake of YAZ (oral contraceptive containing drospirenone and ethinylestradiol) with or without levomefolate calcium (Metafolin, a registered vitamin supplement) in the body and to examine and compare the uptake of levomefolate calcium with or without YAZ in the body, in healthy volunteers not using hormonal contraception
Key Participants Requirements
Sex
FemaleAge
18 - 38 YearsTrial summary
Enrollment Goal
44Trial Dates
October 2006 - September 2007Phase
Phase 1Could I Receive a placebo
NoProducts
EE/DRSP/L-5-MTHF (BAY86-5131)Accepts Healthy Volunteer
YesWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Dinox B.V. | Groningen, 9713GZ, Netherlands |
Primary Outcome
- Mean maximum concentration (Cmax) of EE incl. bioequivalence (BE) evaluationdate_rangeTime Frame:up to 96 hours after administrationenhanced_encryptionNoSafety Issue:
- Mean Area Under the concentration-time Curve from administration to the last measurement [AUC(0-tlast)] of EE incl. bioequivalence (BE) evaluationdate_rangeTime Frame:up to 96 hours after administrationenhanced_encryptionNoSafety Issue:
- Mean maximum concentration (Cmax) of DRSP incl. bioequivalence (BE) evaluationdate_rangeTime Frame:up to 168 hours after administrationenhanced_encryptionNoSafety Issue:
- Mean Area Under the concentration-time Curve from administration to the last measurement [AUC(0-tlast)] of DRSP incl. bioequivalence (BE) evaluationdate_rangeTime Frame:up to 168 hours after administrationenhanced_encryptionNoSafety Issue:
- Mean maximum concentration (Cmax) of L-5-methyl-THF (baseline corrected) incl. bioequivalence (BE) evaluationdate_rangeTime Frame:up to 12 hours after administrationenhanced_encryptionNoSafety Issue:
- Mean Area Under the concentration-time Curve from administration to the last measurement [AUC(0-tlast)] of L-5-methyl-THF (baseline corrected) incl. bioequivalence (BE) evaluationdate_rangeTime Frame:up to 12 hours after administrationenhanced_encryptionNoSafety Issue:
- Mean maximum concentration (Cmax) of L-5-methyl-THF (baseline uncorrected) incl. bioequivalence (BE) evaluationdate_rangeTime Frame:up to 12 hours after administrationenhanced_encryptionNoSafety Issue:
- Mean Area Under the concentration-time Curve from administration to the last measurement [AUC(0-tlast)] of L-5-methyl-THF (baseline uncorrected) incl. bioequivalence (BE) evaluationdate_rangeTime Frame:up to 12 hours after administrationenhanced_encryptionNoSafety Issue:
Secondary Outcome
- Time to reach maximum concentration (tmax) of EEdate_rangeTime Frame:up to 96 hours after administrationenhanced_encryptionNoSafety Issue:
- Mean Area Under the concentration-time Curve from administration up to 72h AUC(0-72h) of DRSPdate_rangeTime Frame:up to 72 hours after administrationenhanced_encryptionNoSafety Issue:
- Time to reach maximum concentration (tmax) of DRSPdate_rangeTime Frame:up to 168 hours after administrationenhanced_encryptionNoSafety Issue:
- Time to reach maximum concentration (tmax) of L-5-methyl-THFdate_rangeTime Frame:up to 12 hours after administrationenhanced_encryptionNoSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
RandomizedBlinding
Open LabelAssignment
Crossover AssignmentTrial Arms
3