A Multicenter, Open-label, 3-arm, Active-controlled, Parallel-group, 1-year Study to Investigate the Efficacy and Safety of a Flexible Regimen of the Combined Oral Contraceptive, With and Without 0.451 mg Levomefolate Calcium (BAY98-7071 and BAY86-5300, Respectively) Versus the Standard 24 + 4 Regimen With Levomefolate (BAY98-7071 + BAY86-7660) and to Assess Compliance With a Device (CADDY) in Healthy Women Who Desire Contraception.

Trial Profile

A Multicenter, Open-label, 3-arm, Active-controlled, Parallel-group, 1-year Study to Investigate the Efficacy and Safety of a Flexible Regimen of the Combined Oral Contraceptive, With and Without 0.451 mg Levomefolate Calcium (BAY98-7071 and BAY86-5300, Respectively) Versus the Standard 24 + 4 Regimen With Levomefolate (BAY98-7071 + BAY86-7660) and to Assess Compliance With a Device (CADDY) in Healthy Women Who Desire Contraception.

Withdrawn prior to enrolment
Phase of Trial: Phase III

Latest Information Update: 16 Sep 2014

At a glance

  • Drugs Drospirenone/ethinylestradiol; Ethinylestradiol/drospirenone/levomefolic acid; Levomefolic acid
  • Indications Pregnancy
  • Focus Therapeutic Use
  • Sponsors Bayer
  • Most Recent Events

    • 20 Jul 2012 Status changed from not yet recruiting to withdrawn prior to recruitment as reported by ClinicalTrials.gov.
    • 14 Nov 2011 Planned end date changed from 1 Feb 2014 to 1 Nov 2014 as reported by ClinicalTrials.gov.
    • 14 Nov 2011 Planned initiation date changed from 1 Aug 2012 to 1 Apr 2013 as reported by ClinicalTrials.gov.
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