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Trial Profile

A phase 3 study of Sildenafil Cream for the treatment of Female sexual dysfunction

Status: Planning

Phase of Trial: Phase III

Latest Information Update: 22 Dec 2024

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At a glance

Drugs Sildenafil (Primary)
Indications Female sexual dysfunction
Focus Registrational; Therapeutic Use

Most Recent Events

16 Dec 2024 According to a Dare Bioscience media release, a second confirmatory Phase 3 study will be required to support the New Drug Application (NDA) submission.
21 Nov 2024 New trial record
14 Nov 2024 According to a Dare Bioscience media release, this phase 3 study will be required to support an NDA for Sildenafil Cream for the treatment of FSAD and company anticipates that each Phase 3 study will be approximately $15.0 million in direct costs.

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