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Phase III trial investigating the efficacy and safety of sildenafil/testosterone [Lybrido] for the treatment of hypoactive sexual desire disorder

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Trial Profile

Phase III trial investigating the efficacy and safety of sildenafil/testosterone [Lybrido] for the treatment of hypoactive sexual desire disorder

Status: Planning
Phase of Trial: Phase III

Latest Information Update: 20 Jun 2023

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At a glance

  • Drugs Sildenafil/testosterone (Primary)
  • Indications Female sexual dysfunction
  • Focus Registrational; Therapeutic Use
  • Acronyms ALETTA

Most Recent Events

  • 19 Jun 2023 According to a Freya Pharma Solutions media release, the company announced that the United States (US) Food and Drug Administration (FDA) has responded with interest and provided valuable input regarding Freya Pharmas request for advice on the US Clinical Development Program of LybridoTM for the treatment of Female Sexual Interest/Arousal Disorder (FSIAD).
  • 19 Jun 2023 According to Freya Pharma Solutions media release, the company expect to initiate this trial in early 2024.
  • 09 May 2023 According to Freya Pharma Solutions media release, on company's request, the FDA has now planned to provide a written response by 4 June 2023.

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