A Phase III, dose ranging, multi-centre, randomised, double blind, placebo controlled, home use, parallel group clinical trial of topically-applied glyceryl trinitrate (GTN) for the treatment of erectile dysfunction (ED) with an open label extension
Status: Active, no longer recruiting
Phase of Trial: Phase III
Latest Information Update: 11 Sep 2019
Price : $35 *
At a glance
- Drugs Nitroglycerin (Primary)
- Indications Erectile dysfunction
- Focus Registrational; Therapeutic Use
- Sponsors Futura Medical
- 11 Sep 2019 According to a Futura Medical media release, over 500 patients had completed the 12 week double-blind phase of the study with 80% of these patients having elected to continue into the open label extension to study long term safety of the highest dose at the end of August.
- 19 Jun 2019 According to a Futura Medical media release, this trials protocol incorporates feedback received from world leading key opinion leaders he US and EU regulatory agencies, as well as potential commercial partners, to increase the chances of regulatory approval as well as optimising the commercial value.
- 19 Jun 2019 According to a Futura Medical media release, headline data will be delivered by the end of 2019. The trial has completed recruitment of over 1,000 patients in the study.