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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.
Curr Med Res Opin. 2005 Nov; 21(11):1701-9.CM

Abstract

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.

STUDY DESIGN AND 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.

Authors+Show Affiliations

Department of Psychiatry, University of Medicine and Dentistry of New Jersey, Robert Wood Johnson Medical School, Piscataway, NJ 08854, USA.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

16307689

Citation

Rosen, Raymond C., et al. "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." Current Medical Research and Opinion, vol. 21, no. 11, 2005, pp. 1701-9.
Rosen RC, Shabsigh R, Kuritzky L, et al. 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. Curr Med Res Opin. 2005;21(11):1701-9.
Rosen, R. C., Shabsigh, R., Kuritzky, L., Wang, W. C., & Sides, G. D. (2005). 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. Current Medical Research and Opinion, 21(11), 1701-9.
Rosen RC, et al. 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. Curr Med Res Opin. 2005;21(11):1701-9. PubMed PMID: 16307689.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - 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. AU - Rosen,Raymond C, AU - Shabsigh,Ridwan, AU - Kuritzky,Louis, AU - Wang,Wei Christine, AU - Sides,Gregory D, PY - 2005/11/26/pubmed PY - 2006/2/14/medline PY - 2005/11/26/entrez SP - 1701 EP - 9 JF - Current medical research and opinion JO - Curr Med Res Opin VL - 21 IS - 11 N2 - 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. STUDY DESIGN AND 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. SN - 0300-7995 UR - https://www.unboundmedicine.com/medline/citation/16307689/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_ L2 - http://www.tandfonline.com/doi/full/10.1185/030079905X65538 DB - PRIME DP - Unbound Medicine ER -