A Prospective, Multicenter Study on Efficacy of Long-Acting Testosterone Undecanoate, If Desired in Combination with Vardenafil, in Late Onset Hypogonadal Patients with Erectile Dysfunction

Introduction: There is substantial evidence suggesting the additive effect on erectile function (ED) of testosterone and phosphodiesterase (PDE)-5 inhibitors. But the combination of long-acting testosterone undecanoate (TU), in combination with the PDE5-I vardenafil men with with late-onset hypogonadal patients (LOH) with (ED) has not yet been studied. Aims: To evaluate the effects of TU i.m., and if desired, the PDE5i vardenafil (PDE-5I) in LOH patients with ED measured with the International Index of Erectile Function (IIEF-5). Methods: A prospective study was performed following four administrations of TU in week 0, 6, 18, 30. If no improvement of ED assessed with IIEF-5 or the Global Assessment Questionnaire (GAQ) in week 12, the PDE5 inhibitor vardenafil was added. The final evaluation was in week 46. Main Outcome Measures: Aging Male Symptom (AMS) score, IIEF-5 score, and International Prostate Symptoms Score (IPSS) at each visit were summarized as mean with standard deviation; while GAQ was summarized using frequency and percentage. Scores at each visit were also categorized into different levels of symptom severity. Results: AMS score decreased significantly at week 12, 30 and 46. IIEF-5 score increased but a significant change was found only at week 30 and 46. The GAQ assessment indicated erection and sexual intercourse already improved at the first assessment continuing thereafter. IPSS score decreased from baseline at week 46. Levels of total, free and bioavailable testosterone had increased significantly from baseline at all visits. Hematocrit, hemoglobin and prostate specific antigen increased significantly from baseline. Adverse events were rare with pain at injection site found in one patient. The two events were non-serious in type, mild in their intensity and recovered. Conclusions: Therapy with TU and, and if desired, combined with the PDE5 inhibitor vardenafil improved sexual activity in LOH patients with ED.