Combined Testosterone and Vardenafil Treatment for Restoring Erectile Function in Hypogonadal Patients who Failed to Respond to Testosterone Therapy Alone

Abstract Introduction The role of testosterone in erectile dysfunction (ED) is increasingly recognized. It is suggested that assessment of testosterone deficiency in men with ED and symptoms of hypogonadism, prior to first‐line treatment, may be a useful tool for improving therapy. Aim In this prospective, observational, and longitudinal study, we investigated the effects of vardenafil treatment as adjunctive therapy to testosterone undecanoate in hypogonadal ED patients who failed to respond to testosterone treatment alone. Methods One hundred twenty‐nine testosterone deficient (serum total testosterone ≤3.4 ng/mL) patients aged 56 ± 3.9 years received intramuscular injections of long‐acting parenteral testosterone undecanoate at 3‐month intervals for 8 months mean follow‐up. Main Outcome Measures Scores on the International Index of Erectile Function Questionnaire‐five items (IIEF‐5) and partner survey scores were compared at baseline and posttreatment with testosterone therapy alone or in combination with vardenafil. Patient baseline demographics and concomitant disease were correlated with patients' IIEF‐5 scores. Results Seventy one (58.2%) responded well to monotherapy within 3 months. Nonresponders had lower testosterone levels and higher rates of concomitant diseases and smoking. Thirty‐four of the 51 nonresponders accepted the addition of 20 mg vardenafil on demand. Efficacy assessments were measured by the IIEF–erectile function domain (IIEF‐EF, questions 1–5 plus 15, 30 points) and partner self‐designed survey at baseline after 4–6 weeks and at study end point. Thirty out of 34 patients responded well to this combination. IIEF‐EF Sexual Health Inventory for Men score improved from 12 to 24 ( P P Conclusions These data suggest that combination therapy of testosterone and vardenafil is safe and effective in treating hypogonadal ED patients who failed to respond to testosterone monotherapy. Yassin D‐J, Yassin AA, and Hammerer PG. Combined testosterone and vardenafil treatment for restoring erectile function in hypogonadal patients who failed to respond to testosterone therapy alone. J Sex Med 2014;11:543–552.