Evaluation of the Efficacy and Safety of Once-a-Day Dosing of Tadalafil 5mg and 10mg in the Treatment of Erectile Dysfunction: Results of a Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial.

Evaluation of the Efficacy and Safety of Once-a-Day Dosing of Tadalafil 5mg and 10mg in the Treatment of Erectile Dysfunction: Results of a Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial. Research Abstract Details 

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Evaluation of the Efficacy and Safety of Once-a-Day Dosing of Tadalafil 5mg and 10mg in the Treatment of Erectile Dysfunction: Results of a Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial. Abstract Text:

Hartmut Porst, Giuliano,Sidney Glina,David Ralph,Adolfo R ,Albert Elion-Mboussa,Wei Shen,J Steve Whitaker,Hartmut Porst, Giuliano,Sidney Glina,David Ralph,Adolfo R ,Albert Elion-Mboussa,Wei Shen,J Steve Whitaker,Hartmut Porst,François Giuliano,Sidney Glina,David Ralph,Adolfo R Casabé,Albert Elion-Mboussa,Wei Shen,J Steve Whitaker,

BACKGROUND: Erectile dysfunction (ED) is a chronic disease; however, therapy is currently administered as needed with oral phosphodiesterase 5 (PDE5) inhibitors like tadalafil. Because the 17.5-h half-life of tadalafil enables therapeutic plasma levels to be sustained with daily administration, tadalafil is a good candidate for once daily dosing therapy. METHODS: This multicenter, randomized, double-blind, placebo-controlled, parallel-group, 12-week study enrolled 268 men 1:2:2 to placebo, tadalafil 5mg, and tadalafil 10mg taken once daily. Primary efficacy measures included changes in the International Index of Erectile Function Erectile Function domain (IIEF EF), Sexual Encounter Profile diary Questions 2 (SEP2: successful penetration), and 3 (SEP3: successful completion of intercourse), and tolerability. Secondary measures included percentage of patients at endpoint who reported improved erectile function (EF), and percentage who reported "no ED" (IIEF EF score 26-30). RESULTS: For patients who took placebo, tadalafil 5mg, and tadalafil 10mg, changes from baseline to endpoint were, respectively, 0.9, 9.7, and 9.4 for IIEF EF; 11.2, 36.5, and 39.4 for SEP2; and 13.2, 45.5, and 50.1 for SEP3. At endpoint, 28.3%, 84.5%, and 84.6% reported improved erections, and 8.3%, 51.5%, and 50.5% reported "no ED," respectively. All comparisons between tadalafil and placebo were significant (p<0.001). Adverse events that occurred in at least 5% of patients were dyspepsia, headache, back pain, upper abdominal pain, and myalgia; nine patients (3.4%) discontinued because of adverse events. CONCLUSIONS: Once-a-day tadalafil 5mg or 10mg was well tolerated and significantly improved EF in men with ED.

Evaluation of the Efficacy and Safety of Once-a-Day Dosing of Tadalafil 5mg and 10mg in the Treatment of Erectile Dysfunction: Results of a Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial. Publishing Authors By Initials

H Porst,F Giuliano,S Glina,D Ralph,AR ,A Elion-Mboussa,W Shen,JS Whitaker,H Porst,F Giuliano,S Glina,D Ralph,AR ,A Elion-Mboussa,W Shen,JS Whitaker,H Porst,F Giuliano,S Glina,D Ralph,AR Casabé,A Elion-Mboussa,W Shen,JS Whitaker,

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Evaluation of the Efficacy and Safety of Once-a-Day Dosing of Tadalafil 5mg and 10mg in the Treatment of Erectile Dysfunction: Results of a Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial. Journal Published:

PUBLICATION TYPE: Journal Article

Journal: European urology

VOLUME: 50

Page Numbers: 351-9

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ISSN: 0302-2838

DAY: 20

MONTH: 03

YEAR: 2006

Evaluation of the Efficacy and Safety of Once-a-Day Dosing of Tadalafil 5mg and 10mg in the Treatment of Erectile Dysfunction: Results of a Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial. Information

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LANGUAGE: eng

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AFFILIATION: Private Practice of Urology and Andrology, Hamburg, Germany.

Country: Switzerland

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MEDLINETA: Eur Urol

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