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A Phase 2b, Multi-Center, Multiple-Dose, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Sildenafil Cream, 3.6% in Premenopausal Patients With Female Sexual Arousal Disorder (FSAD)

Trial Profile

A Phase 2b, Multi-Center, Multiple-Dose, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Sildenafil Cream, 3.6% in Premenopausal Patients With Female Sexual Arousal Disorder (FSAD)

Status: Recruiting
Phase of Trial: Phase II

Latest Information Update: 26 Feb 2024

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At a glance

  • Drugs Sildenafil (Primary)
  • Indications Female sexual dysfunction
  • Focus Therapeutic Use
  • Acronyms RESPOND
  • Sponsors Strategic Science & Technologies
  • Most Recent Events

    • 22 Feb 2024 According to the Dare Bioscience media release,the FDA recently confirmed that it aims to complete its review of the Phase 2b RESPOND study data and provide comments within the second quarter of 2024 on the proposed primary and secondary patient reported outcome endpoints for the planned Phase 3 pivotal trials of Sildenafil Cream to support potential product registration and labeling.
    • 22 Feb 2024 Results presented in a Dare Bioscience Media Release.
    • 22 Feb 2024 According to the Dare Bioscience media release, data from this study will be presented at the upcoming International Society for the Study of Women's Sexual Health (ISSWSH) Annual Meeting.
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