ORIGINAL RESEARCH—COUPLES’ SEXUAL DYSFUNCTION: Vardenafil Improves Sexual Function and Treatment Satisfaction in Couples Affected by Erectile Dysfunction (ED): A Randomized, Double‐Blind, Placebo‐Controlled Trial in PDE5 Inhibitor‐Naïve Men with ED and Their Partners

Abstract

Erectile dysfunction (ED) is a common condition with diverse sequelae affecting men and their women partners. The FINDER study aimed to evaluate the efficacy and tolerability of the phosphodiesterase type-5 (PDE5) inhibitor, vardenafil, in a broad population of PDE5-naïve men with ED of different etiologies and severity and included their partners' assessments of treatment with vardenafil. Men with ED (N = 260) were randomized to receive either vardenafil or placebo in a multicenter, flexible-dose study. Primary efficacy variables were patients' responses to the Global Assessment Question (GAQ), and Sexual Encounter Profile questions 2 and 3 (SEP2 and SEP3). Compared with placebo, vardenafil significantly improved rates of successful "Yes" responses to SEP3 ("Did your erection last long enough for you to have successful intercourse?") (49% placebo vs. 78% vardenafil at last period carried forward [LPCF]; P < 0.0001), SEP2 ("Were you able to insert your penis into your partner's vagina?") (65% placebo vs. 85% vardenafil at LPCF; P < 0.0001), and GAQ (36% placebo vs. 83% vardenafil at last observation carried forward; P < 0.0001). In addition, patients' and their partners' Treatment Satisfaction Scale (TSS) scores were statistically significantly improved across each of the TSS domains (satisfaction with orgasm, ease with erection, confidence, pleasure, erectile function satisfaction, and satisfaction with medication) in the vardenafil group compared with the placebo group. Vardenafil improved sexual function to the extent that both patients and their partners expressed a considerable and agreed level of satisfaction with treatment.