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A randomized, open-label, comparative, multi-center trial to evaluate contraceptive efficacy, cycle control, safety and acceptability of a monophasic combined oral contraceptive (COC) containing 2.5 mg nomegestrol acetate (NOMAC) and 1.5 mg estradiol (E2), compared to a monophasic COC containing 3 mg drosperinone (DRSP) and 30 micrograms ethinyl estradiol (EE)

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Trial Profile

A randomized, open-label, comparative, multi-center trial to evaluate contraceptive efficacy, cycle control, safety and acceptability of a monophasic combined oral contraceptive (COC) containing 2.5 mg nomegestrol acetate (NOMAC) and 1.5 mg estradiol (E2), compared to a monophasic COC containing 3 mg drosperinone (DRSP) and 30 micrograms ethinyl estradiol (EE)

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 11 Feb 2022

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At a glance

  • Drugs Estradiol/nomegestrol (Primary) ; Drospirenone/ethinylestradiol
  • Indications Pregnancy
  • Focus Therapeutic Use
  • Acronyms RUMBA
  • Sponsors Merck & Co; Merck Sharp & Dohme; Organon; Schering-Plough

Most Recent Events

  • 20 Dec 2016 Results of pooled analysis of two studies (RUMBA and Samba) published in the Contraception
  • 18 May 2012 Results assessing the effects of treatment on dysmenorrhoea outcomes presented at the 60th Annual Clinical Meeting of the American College of Obstetricians and Gynecologists.
  • 19 Oct 2011 Results presented at the 67th Annual Meeting of the American Society for Reproductive Medicine.

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