By Aude Lecrubier

PARIS (Reuters Health) Apr 07 - A 12-week multicenter, double-blind study, presented at the 21st meeting of the European Urology Association, demonstrated that vardenafil (Levitra) for erectile dysfunction (ED) significantly improves rates of penetration and intercourse completion compared with placebo in PDE-5-naive men, and significantly improves partner satisfaction as well.

“I think that over the years, trials of erectile dysfunction have not attributed enough consideration to the couple component. Our new trial shows that successful therapy for erectile dysfunction with Levitra benefits both partners,” primary investigator Dr. David Edwards of White House Surgery, Chipping Norton, UK, said.

To further examine this area, Dr. Edwards and his colleagues randomised 260 men who had never been treated with PDE-5 inhibitors to a starting dose of vardenafil of 10 mg that could be titrated to 5 mg or 20 mg at week 4 and 8 if necessary or placebo. Every 4 weeks, the men completed the Global Assessment Questionnaire and the Sexual Encounter Profile (the primary efficacy measures), and the men, along with their partners, completed questions on the Treatment Satisfaction Scale (the secondary efficacy measure).

The investigators found that vardenafil treatment was associated with 81% improved erection compared to 30% with placebo. Also, 78% of men who received vardenafil were able to maintain their erections to complete intercourse, compared with 41% with placebo. Vardenafil was generally well tolerated with most common adverse events being flushing and headache.

When the effects of treatment on men and their partners were considered, vardenafil significantly improved Treatment Satisfaction Scale scores compared with placebo in six domains: orgasm satisfaction (60% vs 32% for men, 56% vs 32% for partners), confidence (62% vs 34% for men; 59% vs 30% for women), pleasure (67% vs 44% for men; 64% vs 38% for partners), ease of erection (64% vs 41% for men and 60 vs 37% for partners), satisfaction with erection (60% vs 28% for men; 58% vs 27% for partners) and satisfaction with the medication (62% vs 31% for men; 58% vs 30% for partners).

“Both men and partners expressed a considerable and mutually agreed level of treatment satisfaction,” Dr. Edwards concluded.