Status:
COMPLETED
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)
Lead Sponsor:
Bayer
Conditions:
Contraception
Eligibility:
FEMALE
18-38 years
Phase:
PHASE1
Brief Summary
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 vitam...
Eligibility Criteria
Inclusion
- Healthy female volunteer
- Age: 18 - 38 years inclusive
- Body mass index (BMI)1: ≥ 19 and \< 28 kg/m²
- Regular cyclic menstrual periods at screening OR when using combined oral contraceptives during the recruitment period reporting of natural cyclic menstrual periods prior to their use
- Willingness to use non-hormonal methods of contraception during the complete trial OR previous tubal ligation
Exclusion
- incompletely cured pre-existing diseases for which it can be assumed that the absorption, distribution, metabolism, excretion and effect of the study drugs will not be normal
- known or suspected sex-steroid influenced malignancies
- endometrial hyperplasia; genital bleeding of unknown origin; uterus myomatosus
- known or suspected tumors of the liver and pituitary
- presence or history of severe hepatic disease as long as liver function values have not returned to normal
- severe renal insufficiency or acute renal failure
- thrombophlebitis, venous / arterial thromboembolic diseases; presence or history of prodromi of a thrombosis
- other conditions that increase susceptibility to thromboembolic diseases
- known neuropsychiatric diseases, especially known or suspected epilepsy, and/ or deficient status of folate or vitamin B12
- use of any other medication within 2 cycles before first study drug administration which could affect the study aim
- use of potassium sparing drugs; use of folic acid containing supplements or medicines or use of any medication within 2 cycles before first study drug administration known to interfere with folate metabolism
- inadequate folate and/or Vitamin B12 status, clinically relevant deviations in red cell folate concentrations
Key Trial Info
Start Date :
October 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2007
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT01253187
Start Date
October 1 2006
End Date
September 1 2007
Last Update
August 7 2013
Active Locations (1)
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1
Dinox B.V.
Groningen, Netherlands, 9713GZ