A multicenter, open, randomized, parallel-group comparison to assess the safety and efficacy of the oral contraceptive SH T 00186 D (0.02 mg ethinylestradiol as betadex clathrate and 3 mg drospirenone) in two variations of an extended regimen vs. a standard regimen (24 + 4 days) in 1122 healthy female volunteers for one year, followed by a 1-year safety extension.

Trial Profile

A multicenter, open, randomized, parallel-group comparison to assess the safety and efficacy of the oral contraceptive SH T 00186 D (0.02 mg ethinylestradiol as betadex clathrate and 3 mg drospirenone) in two variations of an extended regimen vs. a standard regimen (24 + 4 days) in 1122 healthy female volunteers for one year, followed by a 1-year safety extension.

Completed
Phase of Trial: Phase III

Latest Information Update: 11 Feb 2013

At a glance

  • Drugs Drospirenone/ethinylestradiol (Primary)
  • Indications Pregnancy
  • Focus Therapeutic Use
  • Sponsors Bayer HealthCare Pharmaceuticals
  • Most Recent Events

    • 12 Jul 2011 New source identified and integrated (European Clinical Trials Database)
    • 09 Mar 2010 Status changed from active, no longer recruiting to completed as reported by ClinicalTrials.gov.
    • 09 Mar 2010 Actual patient number (1166) added as reported by ClinicalTrials.gov.
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