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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) [estradiol/nomegestrol], Compared to a Monophasic COC Containing 3 mg Drospirenone (DRSP) and 30 µg Ethinyl Estradiol (EE) [ethinylestradiol/drospirenone]

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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) [estradiol/nomegestrol], Compared to a Monophasic COC Containing 3 mg Drospirenone (DRSP) and 30 µg Ethinyl Estradiol (EE) [ethinylestradiol/drospirenone]

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 Samba
  • Sponsors Organon

    • Most Recent Events

    • 13 Jun 2019 Trial has been completed in UK and Spain.
    • 20 Dec 2016 Results of pooled analysis of two studies (RUMBA and Samba) published in the Contraception
    • 23 Jun 2012 Moos Menstrual Distress Questionnaire results presented at the 12th Congress of the European Society of Contraception.

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