Open-label, Randomized, Three-fold Crossover Study to Investigate the Bioequivalence of Two Different Tablet Formulations Containing 0.02 mg Ethinylestradiol (EE) and 3 mg Drospirenone (DRSP) Without [SH T00186D] and With [SH T04532B] 0.451 mg L-mefolinate (Metafolin), and to Investigate the Bioequivalence of Two Different Tablet Formulations Containing 0.451 mg L-mefolinate (Metafolin) Without [SH T04532C] and With 0.02 mg EE/ 3 mg DRSP [SH T04532B] in 42 Healthy Young Women.
Phase of Trial: Phase I
Latest Information Update: 06 Aug 2012
At a glance
- Drugs Drospirenone/ethinylestradiol; Ethinylestradiol/drospirenone/levomefolic acid; Levomefolic acid
- Indications Pregnancy
- Focus Pharmacokinetics
- Sponsors Bayer
- 28 Jul 2011 Additional lead trial centre identified as reported by ClinicalTrials.gov.
- 13 Dec 2010 New trial record