Effect of Tadalafil Once a Day in Men With Erectile Dysfunction
Summary
The primary aim of this study is to assess the efficacy and safety of tadalafil 5 mg administered once a day in patients with erectile dysfunction (ED) who are naïve to PDE5 (phosphodiesterase type 5) inhibitors. Patients may be dose reduced to 2.5mg based on tolerability.
Timeline
- Start
- 2009-01
- Primary completion
- 2010-01
- Completion
- 2010-01
Outcome
Met primary endpoint
registry analysis (superiority or other test); Tadalafil vs Placebo; p <0.001; Mean Difference (Final Values) 3.9 (95% CI 2.2 to 5.5); ANCOVA; note: p-value is for Week 12 Change. NCT00836693 ↗
registry analysis (superiority or other test); Tadalafil vs Placebo; p <0.001; Mean Difference (Final Values) 11.7 (95% CI 5.1 to 18.3); ANCOVA; note: p-value is for Week 12 Change. NCT00836693 ↗
registry analysis (superiority or other test); Tadalafil vs Placebo; p <0.001; Mean Difference (Final Values) 18.0 (95% CI 8.9 to 27.0); ANCOVA; note: p-value is for Week 12 Change. NCT00836693 ↗
Publications
- Porst H, Gacci M, Buttner H, Henneges C, Boess F. Tadalafil once daily in men with erectile dysfunction: an integrated analysis of data obtained from 1913 patients from six randomized, double-blind, placebo-controlled, clinical studies. Eur Urol. 2014 Feb;65(2):455-64. doi: 10.1016/j.eururo.2013.09.037. Epub 2013 Oct 2.
- Porst H, Brock GB, Kula K, Moncada I, Montorsi F, Basson BR, Kinchen K, Aversa A. Effects of once-daily tadalafil on treatment satisfaction, psychosocial outcomes, spontaneous erections, and measures of endothelial function in men with erectile dysfunction but naive to phosphodiesterase type 5 inhibitors. J Androl. 2012 Nov-Dec;33(6):1305-22. doi: 10.2164/jandrol.111.015289. Epub 2012 Jul 12.
- Montorsi F, Aversa A, Moncada I, Perimenis P, Porst H, Barker C, Shane MA, Sorsaburu S. A randomized, double-blind, placebo-controlled, parallel study to assess the efficacy and safety of once-a-day tadalafil in men with erectile dysfunction who are naive to PDE5 inhibitors. J Sex Med. 2011 Sep;8(9):2617-24. doi: 10.1111/j.1743-6109.2011.02353.x. Epub 2011 Jun 27.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Tadalafil | Small molecule | 5 mg | Oral |