Effect of tadalafil on sexual timing behavior patterns in men with erectile dysfunction: integrated analysis of randomized, placebo controlled trials.

Abstract

Tadalafil, a new phosphodiesterase type 5 inhibitor, has an extended period of responsiveness compared with other agents in this class. The distinct pharmacological profile of tadalafil may allow more flexibility for men to establish individual sexual timing behavior patterns. We determined if patients took advantage of the pharmacological profile of tadalafil by assessing the frequency, timing and success of intercourse attempts in men with erectile dysfunction. Data on Eastern European countries were combined from 2 identically designed, randomized, double-blind, placebo controlled, parallel group studies. Patients self-administered 20 mg tadalafil (406) or placebo (108) as needed for 12 weeks. Of the men 63% made at least a quarter of their attempts and 42% made at least half of their attempts more than 4 hours after dose. At least 1 attempt was made after 8, 12 or 24 hours after dose by 87%, 75% and 52% of the men, respectively. Throughout a 36-hour post-dose period tadalafil was associated with significantly higher intercourse success rates than placebo (p <0.001) with 61% to 69% of tadalafil treated patients reporting success rates of greater than 75% compared with 19% to 30% of those on placebo (p <0.001). Tadalafil was well tolerated. In this study various use patterns of the tadalafil period of effectiveness were apparent, reflecting differences in the sexual timing behavior of patients. Tadalafil may provide men with erectile dysfunction more flexibility in deciding when to attempt intercourse in accordance with their sexual habits and attitudes.