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Pivotal phase III trial of ODT tramadol [Zertane] for the treatment of premature ejaculation (second US trial).

Trial Profile

Pivotal phase III trial of ODT tramadol [Zertane] for the treatment of premature ejaculation (second US trial).

Status: Not yet recruiting
Phase of Trial: Phase III

Latest Information Update: 11 Mar 2013

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At a glance

  • Drugs Tramadol (Primary)
  • Indications Premature ejaculation
  • Focus Registrational; Therapeutic Use
  • Most Recent Events

    • 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.
    • 25 Jun 2012 New trial record
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