Onset of efficacy of tadalafil once daily in men with erectile dysfunction

A randomized, double-blind, placebo controlled trial

Allen Seftel, Evan Goldfischer, Edward Kim, Eugene Dula, Haoyue Zeigler, Patrick Burns

Research output: Contribution to journalArticle

16 Citations (Scopus)

Abstract

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.

Original languageEnglish (US)
Pages (from-to)243-248
Number of pages6
JournalJournal of Urology
Volume185
Issue number1
DOIs
StatePublished - Jan 1 2011
Externally publishedYes

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Erectile Dysfunction
Placebos
Safety
Tadalafil
Vital Signs
Therapeutics

All Science Journal Classification (ASJC) codes

  • Urology

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Onset of efficacy of tadalafil once daily in men with erectile dysfunction : A randomized, double-blind, placebo controlled trial. / Seftel, Allen; Goldfischer, Evan; Kim, Edward; Dula, Eugene; Zeigler, Haoyue; Burns, Patrick.

In: Journal of Urology, Vol. 185, No. 1, 01.01.2011, p. 243-248.

Research output: Contribution to journalArticle

Seftel, Allen ; Goldfischer, Evan ; Kim, Edward ; Dula, Eugene ; Zeigler, Haoyue ; Burns, Patrick. / Onset of efficacy of tadalafil once daily in men with erectile dysfunction : A randomized, double-blind, placebo controlled trial. In: Journal of Urology. 2011 ; Vol. 185, No. 1. pp. 243-248.
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abstract = "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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