check_circleStudy Completed
Contraception
Bayer Identifier:
91509
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
Assessment of the pharmacodynamic effect on plasma folate and red blood cell folate and comparison of the folate metabolites during the 24 weeks of treatment (Yasmin + Metafolin versus Yasmin + folic acid) followed by a 20 week elimination phase of folate
Trial purpose
The purpose of this study is to examine and compare the uptake of levomefolate calcium (Metafolin, a registered vitamin supplement) and folic acid in the body during 24 weeks of treatment with a following folate elimination phase of 20 weeks in healthy volunteers seeking contraception. Yasmin (oral contraceptive containing drospirenone and ethinylestradiol) was co-administered over the entire period of 44 weeks.
Key Participants Requirements
Sex
FemaleAge
18 - 40 YearsTrial summary
Enrollment Goal
172Trial Dates
December 2006 - January 2008Phase
Phase 1Could I Receive a placebo
NoProducts
EE/DRSP/L-5-MTHF (BAY86-5131)Accepts Healthy Volunteer
YesWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Nuvisan GmbH | Neu-Ulm, 89231, Germany |
Primary Outcome
- Area under the curve (AUC) from time 0 to 24 weeks [AUC(0-24weeks)] for plasma folate and RBC (Red Blood Cell) folate (baseline uncorrected)date_rangeTime Frame:up to 24 weeks of treatmentenhanced_encryptionNoSafety Issue:
- Area under the curve from time 0 to 24 weeks [AUC(0-24weeks)] for plasma folate and RBC (Red Blood Cell) folate (baseline corrected)date_rangeTime Frame:up to 24 weeks of treatmentenhanced_encryptionNoSafety Issue:
- Proportion of participants with RBC folate below 906 nmol/L in the Yasmin + Metafolin group in the folate elimination phase (week 24 to 44)date_rangeTime Frame:from week 24 to week 44enhanced_encryptionNoSafety Issue:
Secondary Outcome
- Folate metabolite pattern in plasma at baselinedate_rangeTime Frame:pre-treatmentenhanced_encryptionNoSafety Issue:
- Folate metabolite pattern in plasma at cycle 3date_rangeTime Frame:week 12enhanced_encryptionNoSafety Issue:
- Folate metabolite pattern in plasma at cycle 6date_rangeTime Frame:week 24enhanced_encryptionNoSafety Issue:
- Homocysteine concentrations in plasma at baseline and at the end of treatment (week 24) with Metafolindate_rangeTime Frame:baseline and week 24enhanced_encryptionNoSafety Issue:
- Homocysteine concentrations in plasma at baseline and at the end of treatment (week 24) with folic aciddate_rangeTime Frame:baseline, and up to 24 weeks of treatmentenhanced_encryptionNoSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
RandomizedBlinding
Double BlindAssignment
Parallel AssignmentTrial Arms
2