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Study Reported Tadalafil Taken Once Daily Improved Erectile Function in Men with ED and Sexual Quality of Life in Couples
Date:5/6/2009

rase-5 (PDE5) inhibitor treatments to be ineffective in treating ED. The 26 investigation sites were located in Austria, France, Germany, Mexico and the United States.

In the first, four-week run-in phase of the study, men remained ED treatment-free and were asked to make a minimum of four sexual attempts with their partners. In the second, 12-week treatment phase of the study, men were randomized to receive either a placebo (N=78) or tadalafil 5 mg (N=264) taken once daily and were asked to make at least one sexual attempt with their partner per week.

Subjects were evaluated throughout the study using the International Index of Erectile Function (IIEF) Erectile Function (EF) Domain,(1) Sexual Encounter Profile (SEP) diary(2) and the Sexual Quality of Life (SQoL) domain of the Sexual Life Quality Questionnaire (SLQQ).(3) Each couple's responses were captured at entry, the end of each phase and following each sexual attempt. Changes in vital signs were also monitored to evaluate safety.

Results showed that tadalafil 5 mg taken daily significantly improved erectile function according to changes from baseline measured by the IIEF and SEP. The average increase from baseline to endpoint in the IIEF-EF domain was 7.9 points in the tadalafil group, compared with 0.7 points in the placebo group. Men in the tadalafil group reported a 28.6 percent increase on average (compared with 2.7 percent in the placebo group) in the ability to achieve an erection sufficient for vaginal penetration. When asked if their erections lasted long enough for successful intercourse, men in the tadalafil group reported a 46 percent increase on average in positive responses from baseline to endpoint, compared with 10.8 percent in the placebo group.

The study also reported a significant improvement in the sexual quality of life scores for men taking tadalafil once daily and their partners. The average increase in SQoL scores
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SOURCE Eli Lilly and Company
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