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A Phase 1, Multi-site, Randomized, Placebo-Controlled, Double-Blind Study to Evaluate the Pharmacokinetics, Safety and Preliminary Efficacy of Two Strengths of DARE-PDM1 (1% or 3%) Versus Placebo Among Women With Symptomatic Primary Dysmenorrhea

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Trial Profile

A Phase 1, Multi-site, Randomized, Placebo-Controlled, Double-Blind Study to Evaluate the Pharmacokinetics, Safety and Preliminary Efficacy of Two Strengths of DARE-PDM1 (1% or 3%) Versus Placebo Among Women With Symptomatic Primary Dysmenorrhea

Status: Active, no longer recruiting
Phase of Trial: Phase I

Latest Information Update: 17 Jan 2024

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At a glance

  • Drugs Diclofenac (Primary)
  • Indications Dysmenorrhoea
  • Focus Adverse reactions; Pharmacokinetics
  • Acronyms DARE-PDM1
  • Sponsors Dare Bioscience

Most Recent Events

  • 20 Dec 2023 According to a Dare Bioscience media release, DARE-PDM1-001 study was conducted in Australia by the company's subsidiary, DARE Bioscience Australia Pty Ltd.
  • 20 Dec 2023 According to a Dare Bioscience media release, if program is successful, company intends to leverage existing safety and efficacy data for diclofenac to utilize the U.S. Food and Drug Administration's (FDA) 505(b)(2) pathway to obtain marketing approval of DARE-PDM1 in the U.S.
  • 20 Dec 2023 Results presented in a Dare Bioscience media release.

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