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.
BACKGROUND
Erectile dysfunction (ED) is a common condition with diverse sequelae affecting men and their women partners.


OBJECTIVE
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.


METHODS
Men with ED (N = 260) were randomized to receive either vardenafil or placebo in a multicenter, flexible-dose study.


METHODS
Primary efficacy variables were patients' responses to the Global Assessment Question (GAQ), and Sexual Encounter Profile questions 2 and 3 (SEP2 and SEP3).


RESULTS
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.


CONCLUSIONS
Vardenafil improved sexual function to the extent that both patients and their partners expressed a considerable and agreed level of satisfaction with treatment.
Edwards
David
D
The White House Surgery, Chipping Norton, Oxfordshire,. Electronic address: david.edwards@gp-k84039.nhs.uk.
Hackett
Geoff
G
Good Hope Hospital, Sutton Coldfield.
Collins
Owen
O
Bayer, Inc., Newbury, UK.
Curram
John
J
Bayer, Inc., Newbury, UK.
D000328:Adult; D004311:Double-Blind Method; D007172:Erectile Dysfunction / Q000188:drug therapy*; D005260:Female; D006801:Humans; D007093:Imidazoles / Q000008:administration & dosage*; D008297:Male; D008875:Middle Aged; D010549:Personal Satisfaction; D010726:Phosphodiesterase Inhibitors / Q000008:administration & dosage*; D010879:Piperazines / Q000008:administration & dosage*; D011788:Quality of Life; D012107:Research Design; D012747:Sexual Partners; D013450:Sulfones / Q000008:administration & dosage; D011795:Surveys and Questionnaires; D016896:Treatment Outcome; D014227:Triazines / Q000008:administration & dosage; D000069058:Vardenafil Dihydrochloride; D014665:Vasodilator Agents / Q000008:administration & dosage*
D007093:Imidazoles; D010726:Phosphodiesterase Inhibitors; D010879:Piperazines; D013450:Sulfones; D014227:Triazines; D014665:Vasodilator Agents; D000069058:Vardenafil Dihydrochloride