A Multicenter, Single-blind, Randomized Study, to Investigate Efficacy of Ethinylestradiol for Intracyclic Bleeding Profile During 24 Weeks (6 Cycles) by Oral Administration of Drospirenone 3 mg/Ethinylestradiol 20 µg and Drospirenone 3 mg/ Ethinylestradiol 30 µg in Patients With Dysmenorrheal and to Investigate the Long Term Safety Oral Administration of Drospirenone 3 mg/Ethinylestradiol 20 µg Administered for 52 Weeks (13 Cycles).

Trial Profile

A Multicenter, Single-blind, Randomized Study, to Investigate Efficacy of Ethinylestradiol for Intracyclic Bleeding Profile During 24 Weeks (6 Cycles) by Oral Administration of Drospirenone 3 mg/Ethinylestradiol 20 µg and Drospirenone 3 mg/ Ethinylestradiol 30 µg in Patients With Dysmenorrheal and to Investigate the Long Term Safety Oral Administration of Drospirenone 3 mg/Ethinylestradiol 20 µg Administered for 52 Weeks (13 Cycles).

Completed
Phase of Trial: Phase II/III

Latest Information Update: 23 Jan 2013

At a glance

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

    • 10 Sep 2010 Trial phase changed from III to II/III as reported by ClinicalTrials.gov.
    • 15 Sep 2009 Actual end date (Aug 2009) added as reported by ClinicalTrials.gov.
    • 15 Sep 2009 Status changed from active, no longer recruiting to completed as reported by ClinicalTrials.gov.
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