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
Price :
$35
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At a glance
- Drugs Tramadol (Primary)
- Indications Premature ejaculation
- Focus Registrational; Therapeutic Use
- Sponsors Bausch Health Companies; Biovail Technologies
- 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.