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A Multicenter, Randomized, Partially Blinded, Placebo-controlled Clinical Trial to Evaluate the Effect on Primary Dysmenorrhea of Vaginal Rings With an Average Daily Release of 700 microg Nomegestrol Acetate (NOMAC) and 300 microg Estradiol (E2), or 900 microg Nomegestrol Acetate (NOMAC) and 300 microg Estradiol (E2), or 100 microg Etonogestrel (ENG) and 300 microg E2, or 125 microg Etonogestrel (ENG) and 300 microg E2. Protocol MK-8175A/MK-8342B 057 (Abbreviated as P057), Also Known as SCH900121/SCH900432 08257 (Abbreviated as P08257)

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Trial Profile

A Multicenter, Randomized, Partially Blinded, Placebo-controlled Clinical Trial to Evaluate the Effect on Primary Dysmenorrhea of Vaginal Rings With an Average Daily Release of 700 microg Nomegestrol Acetate (NOMAC) and 300 microg Estradiol (E2), or 900 microg Nomegestrol Acetate (NOMAC) and 300 microg Estradiol (E2), or 100 microg Etonogestrel (ENG) and 300 microg E2, or 125 microg Etonogestrel (ENG) and 300 microg E2. Protocol MK-8175A/MK-8342B 057 (Abbreviated as P057), Also Known as SCH900121/SCH900432 08257 (Abbreviated as P08257)

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 05 May 2022

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At a glance

  • Drugs Estradiol/etonogestrel (Primary) ; Estradiol/nomegestrol (Primary) ; Ibuprofen
  • Indications Dysmenorrhoea
  • Focus Therapeutic Use
  • Sponsors Organon
  • Most Recent Events

    • 12 Nov 2018 Primary endpoint (Change From Baseline in Mean Menstrual Cramping Pain Score Through Cycle 2) has been met as per results published in the Contraception
    • 12 Nov 2018 Results published in the Contraception
    • 01 Sep 2013 Status changed from recruiting to completed as reported by ClinicalTrials.gov record.
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