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A Phase 3, Open-label, Multi-center, Single Arm Study to Assess Contraceptive Efficacy and Safety of the Etonogestrel (MK-8415) Implant During Extended Use From 3 Years After Insertion in Females 35 Years of Age or Younger

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Trial Profile

A Phase 3, Open-label, Multi-center, Single Arm Study to Assess Contraceptive Efficacy and Safety of the Etonogestrel (MK-8415) Implant During Extended Use From 3 Years After Insertion in Females 35 Years of Age or Younger

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 03 Feb 2026

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At a glance

  • Drugs Etonogestrel (Primary)
  • Indications Pregnancy
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Sponsors Merck Sharp & Dohme Corp.; Organon

Most Recent Events

  • 17 Jan 2026 Results presented in the Organon Media Release.
  • 16 Jan 2026 According to Organon media release, the company has announced today that the US Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for NEXPLANON (etonogestrel implant), which is indicated for use by women of reproductive potential to prevent pregnancy. this sNDA extends the duration of use of NEXPLANON for up to five years.
  • 13 Jan 2025 Status changed from active, no longer recruiting to completed.

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