Phase 3, Active-Controlled, Safety and Efficacy Trial of Oral Testosterone Undecanoate (TU, LPCN 1021) in Hypogonadal Men

Trial Profile

Phase 3, Active-Controlled, Safety and Efficacy Trial of Oral Testosterone Undecanoate (TU, LPCN 1021) in Hypogonadal Men

Completed
Phase of Trial: Phase III

Latest Information Update: 09 Aug 2017

At a glance

  • Drugs Testosterone undecanoate (Primary) ; Testosterone
  • Indications Hypogonadism
  • Focus Registrational; Therapeutic Use
  • Acronyms SOAR
  • Sponsors Lipocine
  • Most Recent Events

    • 09 Aug 2017 According to a Lipocine media release, based on the data from dosing validation study (see profile 280522) and integrated safety set (ISS) from all previously conducted clinical trials including SOAR study, the company has resubmitted a New Drug Application (NDA) for LPCN 1021 for testosterone replacement therapy (TRT) in adult males for hypogonadism. Six-month review by the FDA and PDUFA date expected in the first quarter of 2018.
    • 29 Jun 2016 According to a Lipocine media release, the company has received a Complete Response Letter (CRL) from the United States Food and Drug Administration regarding its New Drug Application (NDA) for LPCN 1021, for the testosterone replacement therapy (TRT) in adult males for hypogonadism.
    • 10 May 2016 Results of long-term safety and tolerability presented at the 111th Annual Meeting of the American Urological Association
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