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
References
Dec 14, 1989·The New England Journal of Medicine·R J KraneI Saenz de Tejada
Jan 1, 1994·The Journal of Urology·H A FeldmanJ B McKinlay
Jul 7, 1993·JAMA : the Journal of the American Medical Association
Jun 1, 1997·Urology·R C RosenA Mishra
Oct 7, 1997·International Journal of Impotence Research·A R Fugl-MeyerK S Fugl-Meyer
May 15, 1998·The New England Journal of Medicine·I GoldsteinP A Wicker
Jul 29, 1998·The Journal of Urology·H WessellsN Levine
Sep 4, 1999·Urology·S W Kim, J S Paick
Oct 6, 2000·Urology·H WessellsN Levine
Aug 8, 2001·The Journal of Urology·R El-GalleyH Clark
Feb 19, 2002·International Journal of Impotence Research·F Giuliano, J Allard
Aug 2, 2002·International Journal of Impotence Research·P C SouvereinH G M Leufkens
Jul 5, 2003·Current Medical Research and Opinion·Andrea SaloniaFrancesco Montorsi
Jul 10, 2003·Annals of the New York Academy of Sciences·P B MolinoffC Y Quon
Feb 14, 2004·International Journal of Impotence Research·L E DiamondP B Molinoff
Mar 5, 2004·International Journal of Impotence Research·R C RosenP B Molinoff
Jun 23, 2004·Journal of Diabetes and Its Complications·Mohammad R Safarinejad
Apr 19, 2005·Urology·L E DiamondC Spana
Jul 6, 2005·Peptides·Mac E Hadley
Citations
Oct 30, 2009·International Journal of Impotence Research·F DadkhahE Amini
Dec 1, 2009·Therapeutic Advances in Urology·Gregory Lowe, Robert Bahnson
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
Aug 7, 2014·Expert Opinion on Investigational Drugs·Stefan ÜckertMarkus A Kuczyk
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
Jan 14, 2010·BJU International·Mohammad Reza Safarinejad
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
Mar 25, 2010·Journal of Medicinal Chemistry·Mark I LansdellSarah Tweedy