NCT02450188 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Banner LL, Anderson RU
Integrated sildenafil and cognitive-behavior sex therapy for psychogenic erectile dysfunction: a pilot study. J Sex Med. 2007 Jul;4(4 Pt 2):1117-25.
Boddi V, Castellini G, Casale H, Rastrelli G, Boni L, Corona G, Maggi M
An integrated approach with vardenafil orodispersible tablet and cognitive behavioral sex therapy for treatment of erectile dysfunction: a randomized controlled pilot study. Androlog
Dean J, Rubio-Aurioles E, McCabe M, Eardley I, Speakman M, Buvat J, de Tejada IS, Fisher W
Integrating partners into erectile dysfunction treatment: improving the sexual experience for the couple. Int J Clin Pract. 2008 Jan;62(1):127-33. Epub 2007 Nov 19. Review.
Montorsi F, Adaikan G, Becher E, Giuliano F, Khoury S, Lue TF, Sharlip I, Althof SE, Andersson KE, Brock G, Broderick G, Burnett A, Buvat J, Dean J, Donatucci C, Eardley I, Fugl-Meyer KS, Goldstein I, Hackett G, Hatzichristou D, Hellstrom W, Incrocci L, Jackson G, Kadioglu A, Levine L, Lewis RW, Maggi M, McCabe M, McMahon CG, Montague D, Montorsi P, Mulhall J, Pfaus J, Porst H, Ralph D, Rosen R, Rowland D, Sadeghi-Nejad H, Shabsigh R, Stief C, Vardi Y, Wallen K, Wasserman M
Summary of the recommendations on sexual dysfunctions in men. J Sex Med. 2010 Nov;7(11):3572-88. doi: 10.1111/j.1743-6109.2010.02062.x. Review.
Petrone L, Mannucci E, Corona G, Bartolini M, Forti G, Giommi R, Maggi M
Structured interview on erectile dysfunction (SIEDY): a new, multidimensional instrument for quantification of pathogenetic issues on erectile dysfunction. Int J Impot Res. 2003 Jun;15(3):210-20.

An Integrated Approach With Vardenafil Orodispersible and Cognitive-behavioral Sex Therapy for the Treatment of Erectile Dysfunction (STEDOV)

Details for clinical trial NCT02450188

Clinical trial NCT02450188 - References