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Extended duration of efficacy of vardenafil when taken 8 hours before intercourse: a randomized, double-blind, placebo-controlled study.
Eur Urol. 2006 Nov; 50(5):1086-94; discussion 1094-5.EU

Abstract

OBJECTIVES

This study explored the efficacy of vardenafil in men with erectile dysfunction (ED) when taken 8 hours before sexual intercourse.

METHODS

A 10-week, randomized, double-blind, placebo-controlled, parallel-group, flexible-dose study of vardenafil (5, 10 or 20mg) was conducted in men with ED for >6 months who failed >or=50% of intercourse attempts during a 4-week treatment-free run-in period. Sexual Encounter Profile Question 3 (SEP3) was the primary efficacy measure; secondary measures included SEP2, International Index of Erectile Function-Erectile Function (IIEF-EF) domain score, Global Assessment Question (GAQ), Global Confidence Question (GCQ) and Erection Quality Scale (EQS). Adverse-event and safety monitoring were conducted throughout.

RESULTS

383 patients were randomized to vardenafil (n=194) or placebo (n=189). Patients treated with vardenafil 8 hours before sexual activity achieved clinically meaningful (>or=18%) and statistically significantly greater least-squares mean per-patient SEP3 and SEP2 success rates over weeks 2-10, compared with patients receiving placebo (SEP3 69% vs 34%; SEP2 81% vs 51%; both p<0.001). SEP3 and SEP2 measures demonstrated the significant superiority of vardenafil over placebo from week 2 onwards (p<0.001). Measurements of IIEF-EF domain score, GAQ, GCQ and EQS showed that vardenafil led to significantly greater improvements in erectile function, compared with placebo (all p<0.001). Vardenafil was generally well tolerated.

CONCLUSIONS

The extended duration of efficacy of vardenafil up to 8 hours postdose may provide couples with more flexibility in their sexual life than anticipated.

Links

Publisher Full Text

Authors+Show Affiliations

Porst H
Urological Practice, Hamburg, Germany. Porst20354@aol.com
Sharlip ID
No affiliation info available
Hatzichristou D
No affiliation info available
Rubio-Aurioles E
No affiliation info available
Gittelman M
No affiliation info available
Stancil BN
No affiliation info available
Smith PM
No affiliation info available
Wilkins HJ
No affiliation info available
Pommerville P
No affiliation info available
Vardenafil Study Group
No affiliation info available

MeSH

AdultAgedCoitusDouble-Blind MethodDrug Administration ScheduleErectile DysfunctionHumansImidazolesMaleMiddle AgedPiperazinesSulfonesTime FactorsTreatment OutcomeTriazinesVardenafil Dihydrochloride

Pub Type(s)

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

Language

eng

PubMed ID

16820261

Citation

Porst, Hartmut, et al. "Extended Duration of Efficacy of Vardenafil when Taken 8 Hours Before Intercourse: a Randomized, Double-blind, Placebo-controlled Study." European Urology, vol. 50, no. 5, 2006, pp. 1086-94; discussion 1094-5.
Porst H, Sharlip ID, Hatzichristou D, et al. Extended duration of efficacy of vardenafil when taken 8 hours before intercourse: a randomized, double-blind, placebo-controlled study. Eur Urol. 2006;50(5):1086-94; discussion 1094-5.
Porst, H., Sharlip, I. D., Hatzichristou, D., Rubio-Aurioles, E., Gittelman, M., Stancil, B. N., Smith, P. M., Wilkins, H. J., & Pommerville, P. (2006). Extended duration of efficacy of vardenafil when taken 8 hours before intercourse: a randomized, double-blind, placebo-controlled study. European Urology, 50(5), 1086-94; discussion 1094-5.
Porst H, et al. Extended Duration of Efficacy of Vardenafil when Taken 8 Hours Before Intercourse: a Randomized, Double-blind, Placebo-controlled Study. Eur Urol. 2006;50(5):1086-94; discussion 1094-5. PubMed PMID: 16820261.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Extended duration of efficacy of vardenafil when taken 8 hours before intercourse: a randomized, double-blind, placebo-controlled study. AU - Porst,Hartmut, AU - Sharlip,Ira D, AU - Hatzichristou,Dimitris, AU - Rubio-Aurioles,Eusebio, AU - Gittelman,Marc, AU - Stancil,Britt-Nicole, AU - Smith,Peter M, AU - Wilkins,H Jeffrey, AU - Pommerville,Peter, AU - ,, Y1 - 2006/06/08/ PY - 2006/01/13/received PY - 2006/05/18/accepted PY - 2006/7/6/pubmed PY - 2007/1/11/medline PY - 2006/7/6/entrez SP - 1086-94; discussion 1094-5 JF - European urology JO - Eur Urol VL - 50 IS - 5 N2 - OBJECTIVES: This study explored the efficacy of vardenafil in men with erectile dysfunction (ED) when taken 8 hours before sexual intercourse. METHODS: A 10-week, randomized, double-blind, placebo-controlled, parallel-group, flexible-dose study of vardenafil (5, 10 or 20mg) was conducted in men with ED for >6 months who failed >or=50% of intercourse attempts during a 4-week treatment-free run-in period. Sexual Encounter Profile Question 3 (SEP3) was the primary efficacy measure; secondary measures included SEP2, International Index of Erectile Function-Erectile Function (IIEF-EF) domain score, Global Assessment Question (GAQ), Global Confidence Question (GCQ) and Erection Quality Scale (EQS). Adverse-event and safety monitoring were conducted throughout. RESULTS: 383 patients were randomized to vardenafil (n=194) or placebo (n=189). Patients treated with vardenafil 8 hours before sexual activity achieved clinically meaningful (>or=18%) and statistically significantly greater least-squares mean per-patient SEP3 and SEP2 success rates over weeks 2-10, compared with patients receiving placebo (SEP3 69% vs 34%; SEP2 81% vs 51%; both p<0.001). SEP3 and SEP2 measures demonstrated the significant superiority of vardenafil over placebo from week 2 onwards (p<0.001). Measurements of IIEF-EF domain score, GAQ, GCQ and EQS showed that vardenafil led to significantly greater improvements in erectile function, compared with placebo (all p<0.001). Vardenafil was generally well tolerated. CONCLUSIONS: The extended duration of efficacy of vardenafil up to 8 hours postdose may provide couples with more flexibility in their sexual life than anticipated. SN - 0302-2838 UR - https://www.unboundmedicine.com/medline/citation/16820261/Extended_duration_of_efficacy_of_vardenafil_when_taken_8_hours_before_intercourse:_a_randomized_double_blind_placebo_controlled_study_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0302-2838(06)00651-8 DB - PRIME DP - Unbound Medicine ER -