Open Access

ARTICLE

Penetration and maintenance of erection with vardenafil: a time-from-dosing analysis

Luc Valiquette¹, Francesco Montorsi², Wayne J. G. Hellstrom³, Francois Giuliano⁴, Martin Homering⁵, Terry Taylor⁶, Ian Eardley⁷

1 CHUM-Hôpital St-Luc, Montreal, Quebec, Canada
2 Universita’ Vita Salute San Raffaele, Milan, Italy
3 Tulane University School of Medicine, New Orleans, LA, USA
4 Centre Hospitalier Universitaire de Bicetre, AP-HP, Le Kremlin-Bicetre, France
5 Bayer HealthCare AG, Wuppertal, Germany
6 Bayer Healthcare Pharmaceuticals, West Haven, CT, USA
7 St James’ University Hospital, Leeds, UK
Address correspondence to Dr. Luc Valiquette, Service d’urologie, CHUM-Hôpital St-Luc, 1058 rue St-Denis, Montreal, Quebec, H2X 3J4, Canada

Canadian Journal of Urology 2005, 12(3), 2687-2698.

Abstract

Objective: To assess success rates in ability to penetrate (Sexual Encounter Profile question 2 [SEP2]) and maintain erections to completion of intercourse (SEP3) from time of dosing to start of sexual activity in a retrospective analysis of two pivotal trials.
Methods: In two randomized, double-blind studies, men with ED for >6 months received vardenafil 5 mg, 10 mg, or 20 mg or placebo for 12-26 weeks. Patients were instructed to start sexual activity 1 hour after dosing. In this retrospective pooled analysis, patient diary questions through week 12 were analyzed, providing attempt data was recorded 0-12 hours post-dose. Mean per-patient SEP2 and SEP3 success rates (intent-to-treat population) were calculated by time between dosing and start of sexual activity, from 0-12 hours through week 12. Least-square means and nominal p-values for differences versus placebo were derived by analysis of covariance with terms for baseline, study and treatment.
Results: Most attempts at sexual intercourse occurred 30-90 minutes after dosing: 88%-93% of attempts occurred within 120 minutes. SEP2 success rates in patients choosing to attempt sexual activity in each interval from ≤15 minutes through the 4-8-hour interval were higher with vardenafil compared with placebo, while SEP3 success rates were greater with vardenafil for patients choosing to initiate sexual activity from ≤15 min through the 8-12-hour interval. The most commonly reported treatment-emergent adverse events in patients receiving vardenafil included headache (11%-22%), flushing (6%-13%), rhinitis (5%-13%), and dyspepsia (2%-7%).
Conclusion: In this retrospective analysis of two pivotal trials, vardenafil improved success rates compared with placebo in ED patients who attempted intercourse from as early as 15 minutes or less and through 4-8 hours after dosing in ability to penetrate (SEP2) and from as early as 15 minutes or less and through 8-12 hours after dosing in maintenance of erection (SEP3).

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