This Article  • Full text  • PDF  • Reply to article  • Send to a friend  • Save in My Folder  • Save to citation manager  • Permissions  Citing Articles  • Contact me when this article is cited  Related Content  • Similar articles in this journal  Topic Collections  • Men's Health  • Men's Sexual Function  • Neurology, Other  • Drug Therapy  • Drug Therapy, Other  • Alert me on articles by topic  Social Bookmarking   What's this?

François Giuliano, MD, PhD; Antonio Sanchez-Ramos, MD; Dieter Löchner-Ernst, MD; Giulio Del Popolo, MD; Natalio Cruz, MD; Albert Leriche, MD; Giuseppe Lombardi, MD; Susanne Reichert, MD; Palle Dahl, MSc; Albert Elion-Mboussa, MS; Joaquin Casariego, MD

Arch Neurol. 2007;64:(doi:10.1001/archneur.64.11.nct70001).

Objective  To determine the efficacy and safety of tadalafil when taken on demand by men with erectile dysfunction (ED) secondary to traumatic spinal cord injury (SCI).

Design and Setting  Multicenter, randomized, double-blind, placebo-controlled, flexible dose-titration, parallel-group study in clinical practices in Europe.

Patients  Enrolled patients had ED secondary to SCI (all spinal levels) and sustained 6 months or longer before visit 1.

Interventions  After a 4-week run-in period, patients were randomly assigned to tadalafil, 10 mg, (n = 142) or placebo (n = 44) for a 12-week, on-demand treatment period with assessments at 4-week intervals. The dose of tadalafil was maintained or titrated (10 or 20 mg) at 4 and 8 weeks.

Main Outcome Measures  Efficacy was measured using the International Index of Erectile Function (IIEF), Sexual Encounter Profile (SEP), and Global Assessment Question (GAQ). Treatment-emergent adverse events and vital signs were collected at each visit.

Results  Mean age was 38 years. Mean baseline IIEF erectile function domain score was 13.4, and following 12 weeks of treatment, 22.6 for tadalafil and 13.6 for placebo (P < .001). After treatment, the tadalafil group compared with the placebo group was significantly greater (P < .001) in mean per-patient percentage of successful penetration attempts (SEP question 2; 75.4% vs 41.1%) and intercourse attempts (SEP question 3; 47.6% vs 16.8%); percentage of improved erections (GAQ question 1; 84.6% vs 19.5%); and ejaculatory frequency (IIEF question 9; P = .03). The 2 most common treatment-emergent adverse events in the tadalafil group compared with placebo were headache (8.5% vs 4.5%) and urinary tract infection (7.7% vs 6.8%).

Conclusions  Tadalafil (10 mg and 20 mg) improved erectile function and was well tolerated by men with ED secondary to traumatic SCI.

Trial Registration  clinicaltrials.gov Identifier: NCT00421083.

Author Affiliations: Department of Physical Medicine and Rehabilitation, Raymond Poincaré Hospital, Garches, France (Dr Giuliano); Sexuality and Reproduction, Hospital Nacional De Paraplejicos, Toledo, Spain (Dr Sanchez-Ramos); Urologische Abteilung, Berufsgenossenschaftliche Unfallklinik Murnau, Murnau, Germany (Dr Löchner-Ernst); Neuro-Urology AOU, Careggi, Florence, Italy (Dr Del Popolo); Servicio de Urología, Hospital Universitario Virgen del Rocío, Seville, Spain (Dr Cruz); Service d’Urologie, Hospital Henry Gabriel, Laval, France (Dr Leriche); Spinal Unit, Careggi Hospital, Florence (Dr Lombardi); Urologische Klinik, Krankenhaus Hohe Warte Bayreuth, Bayreuth, Germany (Dr Reichert); Eli Lilly Denmark A/S, Lyngby, Denmark (Mr Dahl); Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, Indiana (Mr Elion-Mboussa); Eli Lilly Spain, Madrid (Dr Casariego).

CiteULike    Connotea    Del.icio.us    Digg    Reddit    Technorati    Twitter     What's this?