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A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Evaluate the Efficacy and Safety of Two Doses of Tramadol Hydrochloride Orally Disintegrating Tablets in Male Subjects With Premature Ejaculation.

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Trial Profile

A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Evaluate the Efficacy and Safety of Two Doses of Tramadol Hydrochloride Orally Disintegrating Tablets in Male Subjects With Premature Ejaculation.

Status: Discontinued
Phase of Trial: Phase III

Latest Information Update: 02 Aug 2022

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At a glance

  • Drugs Tramadol (Primary)
  • Indications Premature ejaculation
  • Focus Registrational; Therapeutic Use
  • Sponsors Bausch Health Companies; Biovail Technologies

    • Most Recent Events

    • 31 Jul 2022 This trial has been completed in Spain and France, according to European Clinical Trials Database record.
    • 22 Apr 2015 Primary endpoint 'Increase in IELT (Intravaginal ejaculatory time) for 89 mg dose' has been met, according to the Aytu Bioscience company pipeline.
    • 22 Apr 2015 Primary endpoint 'Premature Ejaculation Profile questionnaire' has been met, according to an Aytu Bioscience company pipeline.
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