A randomized open-label trial with a crossover comparison of sexual self-confidence and other treatment outcomes following tadalafil once a day vs. tadalafil or sildenafil on-demand in men with erectile dysfunction.

Aim: To compare Sexual Self-Confidence and other treatment outcomes following 8 weeks of treatment with tadalafil 5 mg once a day (OaD) vs. tadalafil 20 mg or sildenafil 100 mg as needed (pro re nata [PRN]) in patients with erectile dysfunction (ED).

Methods: A randomized, open-label, crossover study in men ≥18 years of age with history of ED and satisfactory response to current oral phosphodiesterase 5 (PDE5) inhibitor PRN.

Efficacy and safety of tadalafil taken as needed for the treatment of erectile dysfunction in Asian men: results of an integrated analysis.

We evaluated the efficacy and safety of as-needed tadalafil in a diverse clinical population (with varying patient demographics, disease severity, and comorbid medical conditions) of Asian men with erectile dysfunction (ED). An integrated analysis of five double-blind, placebo-controlled trials (N = 1 046) was performed. Patients were randomly assigned to receive 10 mg tadalafil (N = 185), 20 mg tadalafil (N = 510), or placebo (N = 351).

Likelihood of tadalafil-associated adverse events in integrated multiclinical trial database: classification tree analysis in men with erectile dysfunction.

Objectives: To identify the patient demographic factors, comorbidities, and concomitant medications associated with a change in the likelihood of tadalafil-associated adverse events (AEs) in men with erectile dysfunction.

Methods: Pooled safety data were analyzed from 3488 tadalafil-treated men who participated in 21 placebo-controlled clinical trials of tadalafil taken as needed or once daily. Three categories of tadalafil-associated AEs were defined: vasodilatory (headache, flushing, nasal congestion, nasopharyngitis, and dizziness); musculoskeletal (back pain and myalgia); and gastrointestinal (dyspepsia).

Psychosocial impact and effectiveness of tadalafil among treatment-naïve and previously-treated men with erectile dysfunction in Saudi Arabia and other Gulf-region countries.

Objective: This observational, comparative study, conducted in Saudi Arabia, Kuwait, and the United Arab Emirates, assessed psychosocial and efficacy outcomes of tadalafil 20 mg on demand, over a period of 20 weeks, in men with erectile dysfunction (ED) who were treatment-naïve versus pretreated with an ED treatment other than tadalafil.

Methods: The short form of the Psychological and Interpersonal Relationship Scales (SF-PAIRS) was used to assess psychosocial outcomes (Time Concerns, Spontaneity, and Sexual Self-Confidence). Change from baseline in the International Index of Erectile Function (IIEF) erectile function (EF) domain score was used to assess effectiveness, and Global Assessment Question (GAQ) was asked to determine improvement in erections.

Efficacy and safety of tadalafil in the treatment of Latin American men with erectile dysfunction: results of integrated analyses.

Introduction: Available information on the efficacy and safety of tadalafil on Latin American men comes from reports where data is mixed with other populations.

Aim: To assess the efficacy and safety of tadalafil in Latin American men with erectile dysfunction (ED).

Methods: Integrated analyses of data from four 12-week, randomized, double-blind, parallel, placebo-controlled trials conducted in Latin America that assessed the efficacy and safety of tadalafil in 406 Latin American men with ED of diverse etiology and severity assigned to placebo (N = 113), 10-mg tadalafil (N = 39), or 20-mg tadalafil (N = 254).

Efficacy and safety of on demand tadalafil in the treatment of East and Southeast Asian men with erectile dysfunction: a randomized double-blind, parallel, placebo-controlled clinical study.

Aim: To assess the efficacy and safety of tadalafil in comparison to a placebo, when taken on demand for 12 weeks by East/Southeast Asian men with erectile dysfunction (ED).

Methods: This multicenter, randomized, double-blind, parallel group, placebo-controlled study was conducted at 17 centers across East and Southeast Asia between August 2002 and February 2003. Men more than 18 years of age with mild to severe ED of various etiologies were randomized to receive a placebo or 20 mg of tadalafil taken as needed (maximum once daily).

Timing of dose relative to sexual intercourse attempt in previous sildenafil citrate users treated with tadalafil.

Objectives: Tadalafil, a phosphodiesterase type 5 inhibitor, has an extended period of effectiveness, up to 36 hours, for the treatment of erectile dysfunction (ED). Changes in behavior of long-term sildenafil users were evaluated by assessing time of dose relative to sexual intercourse attempts during treatment with sildenafil and tadalafil.

Materials And Methods: This open-label study was conducted in men with ED and a history of >or=6-week prior sildenafil use in Australia, New Zealand, Asia, Central and Eastern Europe, the Middle East, and Latin America.

Efficacy and treatment satisfaction with on-demand tadalafil (Cialis) in men with erectile dysfunction.

Objective: Tadalafil (Cialis) is an inhibitor of phosphodiesterase type 5, which mediates relaxation of vascular smooth muscle in the corpus cavernosum thus facilitating erection. The purpose of this multicentre, randomized, double-blind, parallel group, placebo-controlled study was to evaluate efficacy and treatment satisfaction of on-demand Cialis in men with mild-to-severe erectile dysfunction (ED).

Methods: Following a 4-week treatment-free run in period, patients stratified into three severity groups by the International Index of Erectile Function (IIEF) Erectile Function (EF) domain score were randomized to receive either placebo or Cialis 20 mg taken on demand over a 12-week period.