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Multi-Center, Double-Blind, Double-Dummy, Randomized, Parallel-Group Study to Evaluate Cycle Control, Bleeding Pattern, Blood Pressure, Lipid and Carbohydrate Metabolism of the Transdermal Contraceptive Patch (Material no. 80876395 / 2.1 mg Gestodene and 0.55 mg Ethinylestradiol) Versus an Oral Comparator Containing 20 microg Ethinylestradiol and 100 microg Levonorgestrel in a 21-Day Regimen for 7 Cycles in 400 Women.

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Trial Profile

Multi-Center, Double-Blind, Double-Dummy, Randomized, Parallel-Group Study to Evaluate Cycle Control, Bleeding Pattern, Blood Pressure, Lipid and Carbohydrate Metabolism of the Transdermal Contraceptive Patch (Material no. 80876395 / 2.1 mg Gestodene and 0.55 mg Ethinylestradiol) Versus an Oral Comparator Containing 20 microg Ethinylestradiol and 100 microg Levonorgestrel in a 21-Day Regimen for 7 Cycles in 400 Women.

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 14 Mar 2014

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At a glance

  • Drugs Ethinylestradiol/gestodene (Primary) ; Ethinylestradiol/levonorgestrel
  • Indications Pregnancy
  • Focus Pharmacodynamics; Registrational
  • Sponsors Bayer

    • Most Recent Events

    • 28 Jan 2011 Actual end date (Sep 2010) added as reported by ClinicalTrials.gov.
    • 28 Jan 2011 Status changed from active, no longer recruiting to completed as reported by ClinicalTrials.gov.
    • 25 Jun 2010 Actual patient number changed from 254 to 307 as reported by ClinicalTrials.gov.
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