A Multicenter, Open-Label, Randomized Study of the Contraceptive Efficacy and Safety of Amphora Gel Compared to Conceptrol Vaginal Gel.
Phase of Trial: Phase III
Latest Information Update: 20 Nov 2017
At a glance
- Drugs Citric acid/lactic acid/potassium bitartrate (Primary) ; Spermicidal contraceptives
- Indications Pregnancy
- Focus Registrational; Therapeutic Use
- Sponsors Evofem Biosciences
- 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.