A Multicenter, Open-Label, Randomized Study of the Contraceptive Efficacy and Safety of Amphora Gel Compared to Conceptrol Vaginal Gel.

Trial Profile

A Multicenter, Open-Label, Randomized Study of the Contraceptive Efficacy and Safety of Amphora Gel Compared to Conceptrol Vaginal Gel.

Completed
Phase of Trial: Phase III

Latest Information Update: 11 Jan 2016

At a glance

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

    • 11 Jan 2016 Status changed from active, no longer recruiting to completed, according to an Evofem Inc media release.
    • 23 Sep 2015 According to an Evofem, Inc media release, a New Drug Application for Amphora has been accepted for filing by the United States Food and Drug Administration (FDA).
    • 12 Jun 2013 Planned number of patients changed from 2800 to 3300 as reported by ClinicalTrials.gov.
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