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Phase IIIB, Double Blind, Placebo Controlled, International, Multicenter, Parallel Group Study, to Assess the Efficacy and Safety of Testim Gel in Combination with a Phosphodiesterase V Inhibitor (Tad...

Mise à jour : Il y a 4 ans
Référence : EUCTR2005-005060-92

Phase IIIB, Double Blind, Placebo Controlled, International, Multicenter, Parallel Group Study, to Assess the Efficacy and Safety of Testim Gel in Combination with a Phosphodiesterase V Inhibitor (Tadalafil), in Male Patients with Low or <Borderline> Baseline Serum Testosterone Levels and Erectile Dysfunction

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Extrait

To demonstrate that in patients with erectile dysfunction (ED) who are found to have low (<8 nmol/L or 231 ng/dL) or <borderline> (<12 nmol/L or 346 ng/dL) baseline total testosterone levels, Testim Gel significantly improves the patient response to tadalafil using the International Index of Erectile Function (IIEF) scale

Critère d'inclusion

  • To demonstrate that in patients with erectile dysfunction who have low or borderline baseline total testosterone levels, that Testim 50 mg Gel, indicated for male hypogonadism when testosterone deficiency has been confirmed, significantly improves the patient response to tadalafil (used to treat erectile dysfunction) using the Internal Index of Erectile Function (IIEF) scale

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