PMID- 19125990
OWN - NLM
STAT- MEDLINE
DCOM- 20090515
LR  - 20211020
IS  - 1742-1241 (Electronic)
IS  - 1368-5031 (Print)
IS  - 1368-5031 (Linking)
VI  - 63
IP  - 1
DP  - 2009 Jan
TI  - Improvement in duration of erection following phosphodiesterase type 5 inhibitor 
      therapy with vardenafil in men with erectile dysfunction: the ENDURANCE study.
PG  - 27-34
LID - 10.1111/j.1742-1241.2008.01947.x [doi]
AB  - 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.
FAU - Rosenberg, M T
AU  - Rosenberg MT
AD  - Mid-Michigan Health Centers, Jackson, MI 49201, USA. matttoren@yahoo.com
FAU - Adams, P L
AU  - Adams PL
FAU - McBride, T A
AU  - McBride TA
FAU - Roberts, J N
AU  - Roberts JN
FAU - McCallum, S W
AU  - McCallum SW
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - India
TA  - Int J Clin Pract
JT  - International journal of clinical practice
JID - 9712381
RN  - 0 (Imidazoles)
RN  - 0 (Phosphodiesterase Inhibitors)
RN  - 0 (Piperazines)
RN  - 0 (Sulfones)
RN  - 0 (Triazines)
RN  - 5O8R96XMH7 (Vardenafil Dihydrochloride)
SB  - IM
CIN - Int J Clin Pract. 2009 Jan;63(1):1. PMID: 19125984
MH  - Adult
MH  - *Coitus
MH  - Cross-Over Studies
MH  - Double-Blind Method
MH  - Erectile Dysfunction/*drug therapy
MH  - Humans
MH  - Imidazoles/adverse effects/*therapeutic use
MH  - Male
MH  - Middle Aged
MH  - Patient Satisfaction
MH  - Penile Erection/*drug effects
MH  - Phosphodiesterase Inhibitors/adverse effects/*therapeutic use
MH  - Piperazines/adverse effects/*therapeutic use
MH  - Severity of Illness Index
MH  - Sulfones/adverse effects/therapeutic use
MH  - Surveys and Questionnaires
MH  - Time Factors
MH  - Treatment Outcome
MH  - Triazines/adverse effects/therapeutic use
MH  - Vardenafil Dihydrochloride
MH  - Young Adult
PMC - PMC2705823
EDAT- 2009/01/08 09:00
MHDA- 2009/05/16 09:00
CRDT- 2009/01/08 09:00
PHST- 2009/01/08 09:00 [entrez]
PHST- 2009/01/08 09:00 [pubmed]
PHST- 2009/05/16 09:00 [medline]
AID - IJCP1947 [pii]
AID - 10.1111/j.1742-1241.2008.01947.x [doi]
PST - ppublish
SO  - Int J Clin Pract. 2009 Jan;63(1):27-34. doi: 10.1111/j.1742-1241.2008.01947.x.