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A phase III study assessing the safety and efficacy of Sildenafil Cream

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Trial Profile

A phase III study assessing the safety and efficacy of Sildenafil Cream

Status: Planning
Phase of Trial: Phase III

Latest Information Update: 20 May 2025

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At a glance

  • Drugs Sildenafil (Primary)
  • Indications Female sexual dysfunction
  • Focus Registrational; Therapeutic Use
  • Sponsors Dare Bioscience

Most Recent Events

  • 13 May 2025 According to a Dare Bioscience media release, Dare is targeting submission of additional information requested by the FDA, along with the protocol and statistical analysis plan for the Phase 3 study, to the FDA by the end of the second quarter of 2025.
  • 13 May 2025 According to a Dare Bioscience media release, company continued interactions with the FDA regarding planned Phase 3 study; Phase 3 study design, development, and collaboration strategy updates expected throughout 2025.
  • 31 Mar 2025 According to a Dare Bioscience media release, the company announced that continued operational progress toward a planned Phase 3 study, including constructive discussions with FDA; Phase 3 design, development, and collaboration strategy updates expected throughout 2025.

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