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.
Phase of Trial: Phase I
Latest Information Update: 06 Aug 2013
At a glance
- Drugs Ethinylestradiol/drospirenone/levomefolic acid (Primary) ; Drospirenone/ethinylestradiol; Levomefolic acid
- Indications Pregnancy
- Focus Pharmacokinetics
- Sponsors Bayer
- 06 Aug 2012 Actual end date changed from Jun 2007 to Jul 2007 as reported by ClinicalTrials.gov.
- 28 Jul 2011 Additional lead trial centre identified as reported by ClinicalTrials.gov.
- 13 Dec 2010 New trial record