Time from dosing to sexual intercourse attempts in men taking tadalafil in clinical trials

• Published in: BJU international Vol. 96; no. 6; pp. 857 - 863
• Main Authors: Shabsigh, Ridwan, Burnett, Arthur L., Eardley, Ian, Sharlip, Ira D., Ellsworth, Pamela I., Garcia, Carmen S., Natanegara, Fanni, Ahuja, Sanjeev
• Format: Journal Article
• Language: English
• Published: Oxford, UK Blackwell Science Ltd 01.10.2005; Blackwell
• Subjects: Adult; Aged; Aged, 80 and over; Biological and medical sciences; Carbolines - administration & dosage; Coitus - physiology; Double-Blind Method; duration of effectiveness; Erectile Dysfunction - drug therapy; erectile function; Genital system. Reproduction; Humans; Male; Medical sciences; Middle Aged; Multicenter Studies as Topic; Nephrology. Urinary tract diseases; Pharmacology. Drug treatments; phosphodiesterase inhibitors; Phosphodiesterase Inhibitors - administration & dosage; Randomized Controlled Trials as Topic; Sexual Encounter Profile diary; Tadalafil; Time Factors; timing of intercourse attempts; Treatment Outcome; Nephrology; erectile function; Vasodilator agent; 3',5'-Cyclic-GMP phosphodiesterase; Male; Esterases; Sexual intercourse; Phosphoric diester hydrolases; Posology; Urology; Sexual Encounter Profile diary; duration of effectiveness; timing of intercourse attempts; Adult; Clinical trial; Male genital diseases; Human; Erection disorders; Enzyme; Treatment efficiency; Enzyme inhibitor; Duration; Tadalafil; Chemotherapy; Carboline derivatives; Treatment; Hydrolases; Timing; phosphodiesterase inhibitors
• ISSN: 1464-4096; 1464-410X
• DOI: 10.1111/j.1464-410X.2005.05750.x

Associate Editor 
Michael G. Wyllie Editorial Board 
Ian Eardley, UK 
Jean Fourcroy, USA 
Sidney Glina, Brazil 
Julia Heiman, USA 
Chris McMahon, Australia 
Bob Millar, UK 
Alvaro Morales, Canada 
Michael Perelman, USA 
Marcel Waldinger, Netherlands OBJECTIVE To determine whether patients with erectile dysfunction (ED) and treated with tadalafil use the 36‐h duration of effect of the drug, and to discern if the timing of intercourse attempts is influenced by patient age, baseline severity of ED, or previous experience with sildenafil citrate. PATIENTS AND METHODS In 11 multicentre, double‐blind, placebo‐controlled studies, 2102 patients with ED were randomized to a maximum of one dose per day of tadalafil 10 or 20 mg (1464 men), or placebo (638 men) with no time restrictions before attempting sexual activity after the dose. A post hoc analysis was used to determine the proportion of men with ED who attempted sexual intercourse during various intervals (>0 to ≤ 1, >1 to ≤ 4, and >4 to ≤ 36, including >12 to ≤ 36 h) after dosing with tadalafil or placebo over a 12‐week period. Patients were stratified by age, baseline severity of ED, and previous history of sildenafil use. RESULTS Of patients in different age groups and various ED severity, ≥ 79% and ≥ 53% chose to attempt sexual intercourse at least once during the 12‐week treatment period at 4–36 and 12–36 h, respectively, after taking tadalafil. Regardless of previous experience with sildenafil, about a third of patients using tadalafil attempted intercourse a mean of at least once per week at 4–36 h after the dose over 12 weeks. Furthermore, 58% of patients attempted intercourse at least once during two intervals (>1 to ≤ 4 h and >12 to ≤ 36 h) after separate doses of tadalafil. CONCLUSION Regardless of age, ED severity, or previous experience with sildenafil, most patients attempted sexual intercourse at least once at 12–36 h after one dose of tadalafil over a 12‐week treatment period. Furthermore, by engaging in sexual intercourse at both earlier and later intervals after separate doses, most patients on treatment did not adhere to a fixed schedule of intimacy and thus took advantage of the 36‐h duration.