Penetration and maintenance of erection with vardenafil: a time-from-dosing analysis.
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 < or = 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 < or = 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%).


CONCLUSIONS
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).
Valiquette
Luc
L
Service d'urologie, CHUM-Hôpital St-Luc, Montreal, Quebec, Canada.
Montorsi
Francesco
F
Hellstrom
Wayne J G
WJ
Giuliano
Francois
F
Homering
Martin
M
Taylor
Terry
T
Eardley
Ian
I
D003075:Coitus; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D007172:Erectile Dysfunction / Q000188:drug therapy*; D006261:Headache / Q000209:etiology; D006801:Humans; D007093:Imidazoles / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology* / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D017060:Patient Satisfaction; D010410:Penile Erection / Q000187:drug effects*; D010726:Phosphodiesterase Inhibitors / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology* / Q000627:therapeutic use*; D010879:Piperazines / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology* / Q000627:therapeutic use*; D010919:Placebos; D012189:Retrospective Studies; D013450:Sulfones / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use; D014227:Triazines / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use; D000069058:Vardenafil Dihydrochloride
D007093:Imidazoles; D010726:Phosphodiesterase Inhibitors; D010879:Piperazines; D010919:Placebos; D013450:Sulfones; D014227:Triazines; D000069058:Vardenafil Dihydrochloride