Study design: This was a two-part pilot study in men with erectile dysfunction (ED) due to spinal cord injury (SCI: cord level range T6-L5). Part I was a randomised, double-blind, twoway cross-over study comparing a single dose of sildena®l 50 mg or placebo. Part II was a randomised, double-blind, parallel-group evaluation of sildena®l 50 mg or placebo, taken as required (not more than once daily) approximately 1 h prior to sexual activity, over a period of 28 days. Objectives: To assay the e cacy and safety of sildena®l 50 mg and placebo. Setting: Clinic-and home-based assessments in the United Kingdom. Methods: A total of 27 subjects who were able to achieve at least a grade 2 erection (hard, but not hard enough for penetration) in response to penile vibratory stimulation (PVS) were recruited. In Part I, the re¯exogenic response of the penis to PVS was evaluated in the clinic while in Part II, the response to treatment was assessed in the home (global e cacy, questionniare, diary). Results: In Part I, 17/26 (65%) subjects had erections of 460% rigidity at the penile base (median duration 3.5 min) after sildena®l compared with 2/26 (8%) (median duration 0 min) after placebo (P=0.0003). In Part II, 9/12 (75%) subjects on sildena®l and 1/14 (7%) subjects on placebo reported that the treatment had improved their erections (P50.005), and 8/12 (67%) and 2/13 (15%) men, respectively, indicated that they wished to continue treatment (P50.02). An analysis of diary data showed no di erence between the groups with respect to the mean number of erections hard enough for penetration (P=0.08). The mean proportion of attempts at sexual intercourse that were successful was 30 and 15%, respectively (P=0.21). Similarly, responses to the end-of-treatment questionnaire indicated that there were no signi®cant di erences between the groups with respect to the frequency of erections hard enough for sexual intercourse (P=0.47) or that lasted as long as the subject would have liked (P=0.11). No subject discontinued sildena®l due to adverse events. Conclusion: Sildena®l is an e ective, well-tolerated oral treatment for ED in SCI subjects. Sponsorship: This study was funded by P®zer Inc.
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