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.
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
- 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.