Salvage of sildenafil failures with bremelanotide: a randomized, double-blind, placebo controlled study

The Journal of Urology
Mohammad Reza Safarinejad, Seyyed Yousof Hosseini

Abstract

We evaluated the safety and efficacy of intranasal bremelanotide in men with erectile dysfunction who did not respond to sildenafil. A total of 342 married men (28 to 59 years old) with erectile dysfunction who did not respond to sildenafil were randomly assigned to receive 10 mg bremelanotide as an intranasal spray (group 1, 172) 45 minutes to 2 hours prior to sexual stimulation, or a similar regimen of placebo (group 2, 170). Patients were asked to use at least 16 doses/attempts at home. They underwent preliminary assessment, including medical and sexual history, and self-administered International Index of Erectile Function. The efficacy of 2 treatments was assessed every 4 attempts during treatment and at the end of study, using responses to International Index of Erectile Function, and evaluation of mean intercourse satisfaction domain, mean weekly coitus episodes and adverse drug effects. Positive clinical results were seen in 51 (33.5%) patients in the bremelanotide group compared with 13 (8.5%) patients in the placebo group (p = 0.03). Patients in the bremelanotide group reported significantly greater intercourse satisfaction than those in placebo group (p = 0.03). More drug related adverse effects occurred in the breme...Continue Reading

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Citations

Nov 17, 2011·Drug Design, Development and Therapy·Amjad AlwaalSerge Carrier
Sep 16, 2011·Parkinson's Disease·Ryuji SakakibaraTomonori Yamanishi
Mar 6, 2015·Expert Opinion on Emerging Drugs·Taylor C PeakWayne J G Hellstrom
Apr 27, 2010·Expert Opinion on Emerging Drugs·Maarten AlbersenTom F Lue
Apr 25, 2008·The Journal of Urology·Culley C Carson
Sep 30, 2016·Expert Opinion on Pharmacotherapy·Igor VoznesenskyWayne J G Hellstrom
Aug 16, 2018·Physiological Reviews·Jennifer W Hill, Carol F Elias
Dec 7, 2018·Expert Opinion on Emerging Drugs·U MilenkovicM Albersen
Jun 19, 2010·CNS Neuroscience & Therapeutics·Tracey A Baskerville, Alison J Douglas
Oct 24, 2017·Endocrinology·Erin Semple, Jennifer W Hill
Oct 20, 2015·Biomolecular Concepts·Sheila LeoneAlfio Bertolini
Feb 14, 2019·Molecular Neurobiology·Erin SempleJennifer W Hill
Mar 24, 2020·The World Journal of Men's Health·Soyeun KimMahadevan Raj Rajasekaran
Nov 12, 2020·International Journal of Impotence Research·Darshan P PatelJames M Hotaling

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