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) a

• Status: Completed
• Trial end date: 2007-09-01
• Target enrollment: 0
• Participant gender: Female

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 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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Bayer
• Treatments: Calcium, Dietary; Drospirenone; Ethinyl Estradiol; Tetrahydrofolates

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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