Investigation of bioequivalence of ethinylestradiol (EE) and drospirenone (DRSP) in two different tablet formulations: Yasmin and Yasmin + levomefolate calcium (Metafolin) & L-5-MTHF in two different tablet formulations: levomefolate calcium (Metafolin) and Yasmin + levomefolate calcium (Metafolin)
The purpose of this study is to examine and compare the uptake of Yasmin (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 Yasmin in the body, in healthy volunteers not using hormonal contraception.
- 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
- 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
Hamburg, Germany, 22525
E-mail: [email protected]
Phone: Not Available
Open-label, randomized, three-fold crossover study to investigate the bioequivalence of two different tablet formulations containing 0.03 mg ethinylestradiol (EE) and 3 mg drospirenone (DRSP) without [SH T470FA] and with [SH T04532A] 0.451 mg Metafolin®, and to investigate the bioequivalence of two different tablet formulations containing 0.451 mg Metafolin® without [SH T04532C] and with 0.03 mg EE/ 3 mg DRSP [SH T04532A] in 42 healthy young women