Vardenafil 20mg Improves Satisfaction With Sexual Function and Treatment in Men With Erectile Dysfunction

Journal of Sex Research, Feb, 2006

Vardenafil 20mg Improves Satisfaction With Sexual Function and Treatment in Men With Erectile Dysfunction, Luc Valiquette, Hopital St.-Luc du CHUM, Canada; Vaishali Patel, Sunny Mahajan, Britt-Nicole Stancil, and Katharine Edmunds, GlaxoSmithKline

We evaluated the efficacy, safety, and reliability of vardenafil 20mg compared with placebo in subjects with erectile dysfunction (ED) and a demonstrated successful first response. Satisfaction was assessed as a secondary endpoint using the Treatment Satisfaction Scale (TSS). Men who responded to a single challenge dose of vardenafil 10mg were randomized to receive double-blind vardenafil 20mg or placebo for 12 weeks (primary results presented previously). The unmedicated version of the TSS was administered before the challenge dose (baseline). The on-treatment version was administered at Weeks 4, 8, and 12, or at premature discontinuation. Of the 573 subjects who received the vardenafil challenge dose, 230 responders were randomized to Vardenafil and 233 to placebo. Baseline characteristics were similar between groups. Mean age was 56 years, and most were Caucasian (63%) or Asian (23%). Most men had severe (34%) or moderate (35%) ED, and many had comorbid conditions, including hypertension, dyslipidemia, and diabetes. For the primary endpoint, vardenafil was significantly superior to placebo. At baseline, treatment groups were similar for each of the TSS subscales (LS mean). At study end (LOCF) there was a significant difference between the two groups for vardenafil in all six TSS subscales. Vardenafil was generally well-tolerated. Overall, there was a clinically and statistically significant superiority for vardenafil compared with placebo, both for the primary endpoint of reliability of insertion and the secondary endpoint of treatment satisfaction.