Journal
JOURNAL OF UROLOGY
Volume 185, Issue 1, Pages 243-248Publisher
ELSEVIER SCIENCE INC
DOI: 10.1016/j.juro.2010.09.035
Keywords
penis; erectile dysfunction; tadalafil; coitus; treatment outcome
Categories
Funding
- Lilly
- Pfizer
- Astellas
- GlaxoSmithKline
- Ferring
- Lilly USA, L. L. C
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Purpose: We evaluated the efficacy onset and safety of tadalafil 2.5 and 5 mg once daily for 14 days compared with placebo in men with erectile dysfunction. Materials and Methods: In this randomized, double-blind, placebo controlled, parallel group study we randomized 372 men after a 4-week run-in period to receive placebo, or tadalafil 2.5 or 5 mg once daily for 14 days, followed by a 14-day open label extension period of tadalafil 5 mg once daily. Primary analysis focused on the cumulative percent of men with a successful intercourse attempt during the first 4 days of treatment. On secondary analysis we evaluated the percent of successful attempts during the study. The Sexual Encounter Profile diary question 3 was used to assess efficacy. Safety was assessed by monitoring adverse events and vital signs. Results: Significantly more men in the tadalafil 5 mg group achieved successful intercourse, as indicated by a yes response to diary question 3, than those on placebo by day 2 (48.6% vs 36.6%, p < 0.025). The tadalafil 2.5 mg group did not separate from the placebo group on primary analysis. Secondary analysis showed that men on tadalafil 2.5 mg achieved a significantly higher percent of successful intercourse attempts than those on placebo by day 3 (35.5% vs 27.2%, p < 0.025). All groups further improved during the open label extension period. Tadalafil was well tolerated. Conclusions: This prospective trial shows the onset of efficacy of tadalafil 2.5 and 5 mg once daily within a few days of initiating therapy.
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