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.

Trial Profile

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.

Completed
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
  • Most Recent Events

    • 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
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