The efficacy of tadalafil in improving sexual satisfaction and overall satisfaction in men with mild, moderate, and severe erectile dysfunction: a retrospective pooled analysis of data from randomized, placebo-controlled clinical trials.
BACKGROUND
Satisfaction with the sexual experience is considered important when evaluating the impact of treatments for erectile dysfunction (ED), yet satisfaction has been infrequently assessed in clinical trials.


OBJECTIVE
To evaluate satisfaction with, and enjoyment of, the sexual experience in men with ED enrolled in 11 placebo-controlled clinical trials of tadalafil.


METHODS
Retrospective pooled analysis of data from 11 randomized, double blind, placebo-controlled clinical trials of tadalafil. Men with mild (N = 838), moderate (N = 558), or severe (N = 703) ED who were randomized to tadalafil 10 mg or 20 mg or placebo taken as needed for 12 weeks were included in this analysis. Efficacy measures included the International Index of Erectile Function (IIEF). Reported herein are the scores on the IIEF overall satisfaction domain and individual IIEF questions (IIEF-Q7, satisfaction with intercourse; and IIEF-Q8, enjoyment of intercourse).


RESULTS
At least moderate satisfaction (IIEF overall satisfaction domain) was reported by 55% and 72% of patients with mild ED taking tadalafil 10 mg and 20 mg, respectively, compared with 33% taking placebo (p < 0.002); 60% and 65% vs. 19% of patients with moderate ED (p < 0.001); and 32% and 49% vs. 9% with severe ED (p < 0.001). Satisfactory intercourse during most attempts or almost always/always (IIEF-Q7) was reported by 59% and 79% of patients with mild ED taking tadalafil 10 mg and 20 mg vs. 32% taking placebo (p < 0.001); 52% and 65% vs. 18% with moderate ED (p < 0.001); and 28% and 49% vs. 5% with severe ED (p < 0.001). Highly or very highly enjoyable intercourse (IIEF-Q8) was reported by 45% and 63% of patients with mild ED taking tadalafil 10 mg and 20 mg vs. 21% taking placebo (p < 0.001); 43% and 56% vs. 16% with moderate ED (p < 0.001); and 19% and 44% vs. 5% with severe ED (p < 0.001).


CONCLUSIONS
Compared with placebo, tadalafil 10 mg and 20 mg improved overall satisfaction with the sexual experience, intercourse satisfaction, and intercourse enjoyment in men with mild, moderate, and severe ED.
Rosen
Raymond C
RC
Department of Psychiatry, University of Medicine and Dentistry of New Jersey, Robert Wood Johnson Medical School, Piscataway, NJ 08854, USA.
Shabsigh
Ridwan
R
Kuritzky
Louis
L
Wang
Wei Christine
WC
Sides
Gregory D
GD
D000328:Adult; D000368:Aged; D002243:Carbolines / Q000627:therapeutic use*; D003075:Coitus; D004311:Double-Blind Method; D007172:Erectile Dysfunction / Q000188:drug therapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D017060:Patient Satisfaction; D010410:Penile Erection / Q000502:physiology; D010549:Personal Satisfaction; D010726:Phosphodiesterase Inhibitors / Q000627:therapeutic use*; D010919:Placebos; D016032:Randomized Controlled Trials as Topic; D012189:Retrospective Studies; D011795:Surveys and Questionnaires; D000068581:Tadalafil
D002243:Carbolines; D010726:Phosphodiesterase Inhibitors; D010919:Placebos; D000068581:Tadalafil