A Multicenter, Randomized, Double-Blind, Active-Controlled, Parallel Group, 2-Arm Study to Show Superiority of the Oral Contraceptive SH T00658ID Over Ortho Tri-Cyclen Lo on Hormone Withdrawal-Associated Symptoms After 6 Cycles of Treatment.

Trial Profile

A Multicenter, Randomized, Double-Blind, Active-Controlled, Parallel Group, 2-Arm Study to Show Superiority of the Oral Contraceptive SH T00658ID Over Ortho Tri-Cyclen Lo on Hormone Withdrawal-Associated Symptoms After 6 Cycles of Treatment.

Completed
Phase of Trial: Phase III

Latest Information Update: 01 Aug 2013

At a glance

  • Drugs Estradiol valerate/dienogest (Primary) ; Ethinylestradiol/norgestimate
  • Indications Pregnancy
  • Focus Therapeutic Use
  • Acronyms HARMONY-I
  • Sponsors Bayer
  • Most Recent Events

    • 05 May 2012 Results presented at the 60th Annual Meeting of the American College of Obstetricians and Gynecologists.
    • 20 May 2011 Actual end date (May 2011) added as reported by ClinicalTrials.gov.
    • 20 May 2011 Status changed from active, no longer recruiting to completed as reported by ClinicalTrials.gov.
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