A multicenter, randomized, double-blind, active-controlled, parallel group, 2-arm study to investigate the effect of estradiol valerate/dienogest compared to Microgynon on hormone withdrawal associated symptoms in otherwise healthy women after 6 cycles of treatment.

Trial Profile

A multicenter, randomized, double-blind, active-controlled, parallel group, 2-arm study to investigate the effect of estradiol valerate/dienogest compared to Microgynon on hormone withdrawal associated symptoms in otherwise healthy women after 6 cycles of treatment.

Completed
Phase of Trial: Phase III

Latest Information Update: 29 Jan 2016

At a glance

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

    • 23 Jun 2012 Results presented at the 12th Congress of the European Society of Contraception.
    • 24 Mar 2012 Official Title amended as reported by European Clinical Trials Database record.
    • 24 Mar 2012 Planned number of patients changed from 440 to 880 as reported by European Clinical Trials Database record.
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