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Improvement in duration of erection following phosphodiesterase type 5 inhibitor therapy with vardenafil in men with erectile dysfunction: the ENDURANCE study.
Int J Clin Pract. 2009 Jan; 63(1):27-34.IJ

Abstract

OBJECTIVE

The ENDURANCE study evaluated the efficacy of vardenafil, a phosphodiesterase type 5 (PDE5) inhibitor, in men with erectile dysfunction (ED), by measuring the duration of erection leading to successful intercourse using a stopwatch as the assessment instrument.

METHODS

This was a randomised, multicentre, double-blind, placebo-controlled, crossover study consisting of a 4-week treatment-free run-in phase after which patients were randomised to either fixed-dose vardenafil 10 mg or placebo (to be administered 60 min prior to intercourse) and entered the first of the two 4-week double-blind treatment periods, separated by a 1-week washout. The primary efficacy end-point was the stopwatch-assessed duration of erection, which was defined as the time from erection perceived hard enough for penetration until withdrawal from the partner's vagina leading to successful intercourse as measured by Sexual Encounter Profile Question 3 (SEP-3). Secondary efficacy end-points included SEP-2 and SEP-3 success rates, the erectile function domain of the International Index of Erectile Function, global assessment questionnaire, change from baseline in duration of erection and duration of erection not leading to successful intercourse. Safety was assessed by adverse events (AEs), laboratory samples, vital signs and ECGs.

RESULTS

Of the 191 men included in the safety population, 40% had moderate ED and 33% had severe ED at baseline. The duration of erection (least squares mean +/- SE) leading to successful intercourse was longer with vardenafil than with placebo (12.81 +/- 1.00 min vs. 5.45 +/- 1.00 min; p < 0.001). The differences recorded for all secondary end-points were statistically significant in favour of vardenafil compared with placebo (p < 0.001), with the exception of duration of erection not leading to successful intercourse. Vardenafil was well tolerated in this study; the majority of AEs being mild-to-moderate in intensity.

CONCLUSION

Vardenafil 10-mg therapy provided a statistically superior duration of erection leading to successful intercourse in men with ED compared with placebo.

Authors+Show Affiliations

Mid-Michigan Health Centers, Jackson, MI 49201, USA. matttoren@yahoo.comNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

19125990

Citation

Rosenberg, M T., et al. "Improvement in Duration of Erection Following Phosphodiesterase Type 5 Inhibitor Therapy With Vardenafil in Men With Erectile Dysfunction: the ENDURANCE Study." International Journal of Clinical Practice, vol. 63, no. 1, 2009, pp. 27-34.
Rosenberg MT, Adams PL, McBride TA, et al. Improvement in duration of erection following phosphodiesterase type 5 inhibitor therapy with vardenafil in men with erectile dysfunction: the ENDURANCE study. Int J Clin Pract. 2009;63(1):27-34.
Rosenberg, M. T., Adams, P. L., McBride, T. A., Roberts, J. N., & McCallum, S. W. (2009). Improvement in duration of erection following phosphodiesterase type 5 inhibitor therapy with vardenafil in men with erectile dysfunction: the ENDURANCE study. International Journal of Clinical Practice, 63(1), 27-34. https://doi.org/10.1111/j.1742-1241.2008.01947.x
Rosenberg MT, et al. Improvement in Duration of Erection Following Phosphodiesterase Type 5 Inhibitor Therapy With Vardenafil in Men With Erectile Dysfunction: the ENDURANCE Study. Int J Clin Pract. 2009;63(1):27-34. PubMed PMID: 19125990.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Improvement in duration of erection following phosphodiesterase type 5 inhibitor therapy with vardenafil in men with erectile dysfunction: the ENDURANCE study. AU - Rosenberg,M T, AU - Adams,P L, AU - McBride,T A, AU - Roberts,J N, AU - McCallum,S W, PY - 2009/1/8/entrez PY - 2009/1/8/pubmed PY - 2009/5/16/medline SP - 27 EP - 34 JF - International journal of clinical practice JO - Int. J. Clin. Pract. VL - 63 IS - 1 N2 - OBJECTIVE: The ENDURANCE study evaluated the efficacy of vardenafil, a phosphodiesterase type 5 (PDE5) inhibitor, in men with erectile dysfunction (ED), by measuring the duration of erection leading to successful intercourse using a stopwatch as the assessment instrument. METHODS: This was a randomised, multicentre, double-blind, placebo-controlled, crossover study consisting of a 4-week treatment-free run-in phase after which patients were randomised to either fixed-dose vardenafil 10 mg or placebo (to be administered 60 min prior to intercourse) and entered the first of the two 4-week double-blind treatment periods, separated by a 1-week washout. The primary efficacy end-point was the stopwatch-assessed duration of erection, which was defined as the time from erection perceived hard enough for penetration until withdrawal from the partner's vagina leading to successful intercourse as measured by Sexual Encounter Profile Question 3 (SEP-3). Secondary efficacy end-points included SEP-2 and SEP-3 success rates, the erectile function domain of the International Index of Erectile Function, global assessment questionnaire, change from baseline in duration of erection and duration of erection not leading to successful intercourse. Safety was assessed by adverse events (AEs), laboratory samples, vital signs and ECGs. RESULTS: Of the 191 men included in the safety population, 40% had moderate ED and 33% had severe ED at baseline. The duration of erection (least squares mean +/- SE) leading to successful intercourse was longer with vardenafil than with placebo (12.81 +/- 1.00 min vs. 5.45 +/- 1.00 min; p < 0.001). The differences recorded for all secondary end-points were statistically significant in favour of vardenafil compared with placebo (p < 0.001), with the exception of duration of erection not leading to successful intercourse. Vardenafil was well tolerated in this study; the majority of AEs being mild-to-moderate in intensity. CONCLUSION: Vardenafil 10-mg therapy provided a statistically superior duration of erection leading to successful intercourse in men with ED compared with placebo. SN - 1742-1241 UR - https://www.unboundmedicine.com/medline/citation/19125990/Improvement_in_duration_of_erection_following_phosphodiesterase_type_5_inhibitor_therapy_with_vardenafil_in_men_with_erectile_dysfunction:_the_ENDURANCE_study_ L2 - https://doi.org/10.1111/j.1742-1241.2008.01947.x DB - PRIME DP - Unbound Medicine ER -