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AMPOWER A Single-arm, Phase III, Open Label, Multi-center, Study in Women Aged 18-35 Years of the Contraceptive Efficacy and Safety of AMPHORA Contraceptive Vaginal Gel

Trial Profile

AMPOWER A Single-arm, Phase III, Open Label, Multi-center, Study in Women Aged 18-35 Years of the Contraceptive Efficacy and Safety of AMPHORA Contraceptive Vaginal Gel

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 26 Nov 2019

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At a glance

  • Drugs Citric acid/lactic acid/potassium bitartrate (Primary)
  • Indications Pregnancy
  • Focus Registrational; Therapeutic Use
  • Acronyms AMPOWER
  • Sponsors Evofem Biosciences
  • Most Recent Events

    • 26 Nov 2019 According to an Evofem Biosciences media release, the company resubmitted the Amphora New Drug Application (NDA).
    • 06 Nov 2019 According to an Evofem Biosciences media release, final results from this study were presented at the 2019 American Society for Reproductive Medicine (ASRM) Scientific Congress.
    • 05 Aug 2019 According to an Evofem Biosciences media release, additional data related to efficacy, safety and patient satisfaction in this trial will be presented at three clinical and medical society conferences in October 2019. Further data related to this studys exploratory endpoint evaluating the impact of Amphora on sexual satisfaction is targeted for presentation in 2020.
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