check_circleStudy Completed
Contraception, Ovulation Inhibition
Bayer Identifier:
13468
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
Bioequivalence study: 3 mg Estradiol Valerate (EV) with and without levomefolate calcium
Trial purpose
Investigation of the bioequivalence (BE) of Estradiol Valerate (EV) after administration of one film-coated tablet containing 3 mg Estradiol Valerate and 0.451 mg Levomefolate calcium as compared to one film-coated tablet containing 3 mg Estradiol Valerate
Investigation of the bioequivalence of levomefolate calcium after administration of one film-coated tablet containing 3 mg Estradiol Valerate and 0.451 mg Levomefolate calcium as compared to one film-coated tablet containing 0.451 mg levomefolate calcium
Investigation of the bioequivalence of levomefolate calcium after administration of one film-coated tablet containing 3 mg Estradiol Valerate and 0.451 mg Levomefolate calcium as compared to one film-coated tablet containing 0.451 mg levomefolate calcium
Key Participants Requirements
Sex
FemaleAge
45 - 75 YearsTrial summary
Enrollment Goal
42Trial Dates
December 2009 - March 2010Phase
Phase 1Could I Receive a placebo
NoProducts
EV/DNG/Folate (BAY98-7079)Accepts Healthy Volunteer
YesWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Nuvisan GmbH | Neu-Ulm, 89231, Germany |
Primary Outcome
- Uncorrected Cmax and AUC(0-tlast) and baseline corrected Cmax and AUC (if possible) for E1, E2, E1S, and L-5- methyl-THFdate_rangeTime Frame:2 monthsenhanced_encryptionnoSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
RandomizedBlinding
Open LabelAssignment
Crossover AssignmentTrial Arms
3