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A Multi-centre, Randomised, Open-label, Home Use, Parallel Group, Clinical Investigation of Topically-applied MED3000 Gel and Oral Tadalafil (5 mg) Tablets for the Treatment of Erectile Dysfunction (ED) Over a 24 Week Period

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Trial Profile

A Multi-centre, Randomised, Open-label, Home Use, Parallel Group, Clinical Investigation of Topically-applied MED3000 Gel and Oral Tadalafil (5 mg) Tablets for the Treatment of Erectile Dysfunction (ED) Over a 24 Week Period

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 26 Sep 2023

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At a glance

  • Drugs Nitroglycerin (Primary) ; Tadalafil (Primary)
  • Indications Erectile dysfunction
  • Focus Registrational; Therapeutic Use
  • Sponsors Futura Medical

    • Most Recent Events

    • 12 Jun 2023 According to a Futura Medical media release, based on results from this study the US FDA has granted US marketing authorization to MED3000.
    • 31 Aug 2022 According to a Futura Medical media release, the company is on track to file its dossier with the FDA by the end of September, targeting marketing authorization by the FDA of MED3000 in Q1 2023.
    • 31 Aug 2022 Primary endpoint (IIEF-EF questionnaire) has been met, according to a Futura Medical media release.

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