Pivotal phase III trial of ODT tramadol [Zertane] for the treatment of premature ejaculation (first US trial).
Not yet recruiting
Phase of Trial: Phase III
Latest Information Update: 11 Mar 2013
At a glance
- Drugs Tramadol (Primary)
- Indications Premature ejaculation
- Focus Registrational; Therapeutic Use
- 11 Mar 2013 The FDA has accepted Ampio Pharmaceuticals' Patient Outcome for Premature Ejaculation (POPE) Questionnaire, which allows filing of an IND in the US for a pivotal trial with POPE as a co-primary endpoint, according to a company media release.
- 14 Nov 2012 Sites to conduct pivotal trials in the US have been identified, according to an Ampio Pharmaceuticals media release.
- 22 Jun 2012 New trial record