PMID: 12757058May 22, 2003Paper

The efficacy and safety of oral sildenafil in Thai men with erectile dysfunction: a randomized, double-blind, placebo controlled, flexible-dose study

Journal of the Medical Association of Thailand = Chotmaihet Thangphaet
Apichat KongkanandThai investigators in ASSESS-2 Study Group

Abstract

To evaluate the efficacy and safety of sildenafil citrate (Viagra) in a randomized, double-blind, placebo-controlled, flexible-dose study in Thai men with erectile dysfunction of broad-spectrum etiology and more than 6 months' duration. 125 patients aged 26 to 77 years were randomized at 4 centers in Thailand to receive either sildenafil citrate (50 mg initially, increased if necessary up to 100 mg or decreased to 25 mg depending on efficacy and/or tolerability) (n = 63) or a matching placebo (n = 62) taken on an 'as needed' basis approximately 1 hour prior to anticipated sexual activity for a period of 12 weeks. Efficacy was assessed by the patients' responses to the 15-question International Index of Erectile Function (IIEF), to questions on the event log of sexual activity, and to the global efficacy assessment question concerning improvement in erections. At the conclusion of the study, both the primary efficacy variables relating to the achievement and maintenance of erections sufficient for sexual intercourse and the secondary efficacy variables, which included the 5 separate domains of sexual functioning of the IIEF, the percentage of successful attempts at sexual intercourse, and the global efficacy assessment question ...Continue Reading

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