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Randomized, double-blind, crossover trial of sildenafil in men with mild to moderate erectile dysfunction: efficacy at 8 and 12 hours postdose.
Urology. 2008 Apr; 71(4):686-92.U

Abstract

OBJECTIVES

To clarify the period of responsiveness to sildenafil.

METHODS

Under a double-blind protocol, men with mild to moderate erectile dysfunction (International Index of Erectile Function [IIEF] Erectile Function domain score, 11 to 25) were randomized to sildenafil (100 mg) or placebo and attempted intercourse 8 hours (range, 7 to 9 hours) postdose (first 4-week phase) and 12 hours (11 to 13 hours) postdose (second 4-week phase after treatment crossover). The primary outcome was the per-patient proportion (PPP; least squares means [95% confidence interval]) of affirmative responses to the Sexual Encounter Profile question 3 (SEP3: "Did your erection last long enough for you to have successful intercourse?").

RESULTS

For sildenafil (n = 174) versus placebo (n = 177), baseline values were similar but the PPP of successful intercourse attempts increased to 76% (69% to 82%) versus 50% (43% to 57%) in phase 1 (odds ratio [OR] = 3.2) and 79% (72% to 85%) versus 52% (44% to 60%) in phase 2 (OR = 3.5), and the PPP of Erection Hardness Score 4 erections (completely hard and fully rigid) was 41% (34% to 48%) versus 10% (7% to 15%) in phase 1 (OR = 6.2) and 44% (37% to 51%) versus 17% (12% to 23%) in phase 2 (OR = 4.0). Thus, at 12 hours, the odds of successful intercourse tripled and of a completely hard erection quadrupled. The sildenafil group achieved greater (P <0.001) PPP of successful penetration (SEP2), satisfaction with erection hardness (SEP4), and satisfaction with the sexual experience (SEP5); improvement in IIEF domain scores; and treatment satisfaction on the Erectile Dysfunction Inventory of Treatment Satisfaction.

CONCLUSIONS

In men with mild to moderate ED, responsiveness to sildenafil may persist much longer than 4 hours.

Authors+Show Affiliations

New York University School of Medicine, New York, New York 10016, USA. andy.mccullough@nyumc.orgNo 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

18387397

Citation

McCullough, Andrew R., et al. "Randomized, Double-blind, Crossover Trial of Sildenafil in Men With Mild to Moderate Erectile Dysfunction: Efficacy at 8 and 12 Hours Postdose." Urology, vol. 71, no. 4, 2008, pp. 686-92.
McCullough AR, Steidle CP, Klee B, et al. Randomized, double-blind, crossover trial of sildenafil in men with mild to moderate erectile dysfunction: efficacy at 8 and 12 hours postdose. Urology. 2008;71(4):686-92.
McCullough, A. R., Steidle, C. P., Klee, B., & Tseng, L. J. (2008). Randomized, double-blind, crossover trial of sildenafil in men with mild to moderate erectile dysfunction: efficacy at 8 and 12 hours postdose. Urology, 71(4), 686-92. https://doi.org/10.1016/j.urology.2007.12.025
McCullough AR, et al. Randomized, Double-blind, Crossover Trial of Sildenafil in Men With Mild to Moderate Erectile Dysfunction: Efficacy at 8 and 12 Hours Postdose. Urology. 2008;71(4):686-92. PubMed PMID: 18387397.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Randomized, double-blind, crossover trial of sildenafil in men with mild to moderate erectile dysfunction: efficacy at 8 and 12 hours postdose. AU - McCullough,Andrew R, AU - Steidle,Christopher P, AU - Klee,Brian, AU - Tseng,Li-Jung, PY - 2007/07/24/received PY - 2007/11/30/revised PY - 2007/12/04/accepted PY - 2008/4/5/pubmed PY - 2008/5/8/medline PY - 2008/4/5/entrez SP - 686 EP - 92 JF - Urology JO - Urology VL - 71 IS - 4 N2 - OBJECTIVES: To clarify the period of responsiveness to sildenafil. METHODS: Under a double-blind protocol, men with mild to moderate erectile dysfunction (International Index of Erectile Function [IIEF] Erectile Function domain score, 11 to 25) were randomized to sildenafil (100 mg) or placebo and attempted intercourse 8 hours (range, 7 to 9 hours) postdose (first 4-week phase) and 12 hours (11 to 13 hours) postdose (second 4-week phase after treatment crossover). The primary outcome was the per-patient proportion (PPP; least squares means [95% confidence interval]) of affirmative responses to the Sexual Encounter Profile question 3 (SEP3: "Did your erection last long enough for you to have successful intercourse?"). RESULTS: For sildenafil (n = 174) versus placebo (n = 177), baseline values were similar but the PPP of successful intercourse attempts increased to 76% (69% to 82%) versus 50% (43% to 57%) in phase 1 (odds ratio [OR] = 3.2) and 79% (72% to 85%) versus 52% (44% to 60%) in phase 2 (OR = 3.5), and the PPP of Erection Hardness Score 4 erections (completely hard and fully rigid) was 41% (34% to 48%) versus 10% (7% to 15%) in phase 1 (OR = 6.2) and 44% (37% to 51%) versus 17% (12% to 23%) in phase 2 (OR = 4.0). Thus, at 12 hours, the odds of successful intercourse tripled and of a completely hard erection quadrupled. The sildenafil group achieved greater (P <0.001) PPP of successful penetration (SEP2), satisfaction with erection hardness (SEP4), and satisfaction with the sexual experience (SEP5); improvement in IIEF domain scores; and treatment satisfaction on the Erectile Dysfunction Inventory of Treatment Satisfaction. CONCLUSIONS: In men with mild to moderate ED, responsiveness to sildenafil may persist much longer than 4 hours. SN - 1527-9995 UR - https://www.unboundmedicine.com/medline/citation/18387397/Randomized_double_blind_crossover_trial_of_sildenafil_in_men_with_mild_to_moderate_erectile_dysfunction:_efficacy_at_8_and_12_hours_postdose_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0090-4295(07)02594-0 DB - PRIME DP - Unbound Medicine ER -