A Study in the Treatment of Erectile Dysfunction and Benign Prostate Hyperplasia
Summary
Study LVHR is a Phase 3 study which will examine the efficacy and safety of tadalafil 2.5 and 5 mg once daily versus placebo for the treatment of erectile dysfunction (ED) and signs and symptoms of benign prostatic hyperplasia (BPH) in men with both ED and signs and symptoms of BPH.
Timeline
- Start
- 2009-03
- Primary completion
- 2010-07
- Completion
- 2010-07
Outcome
Sources disagree · no verdict is set; each source's reading is shown below
registry LEAST_SQUARES_MEAN Tadalafil 5 mg: -6.1 (Standard Error 0.43) units on a scale reads as mixed primary results NCT00855582 ↗
registry LEAST_SQUARES_MEAN Placebo: -3.8 (Standard Error 0.45) units on a scale reads as mixed primary results NCT00855582 ↗
registry Tadalafil 5 mg vs Placebo; p <0.001; Median Difference (Final Values) -2.3 reads as mixed primary results NCT00855582 ↗
registry LEAST_SQUARES_MEAN Tadalafil 5 mg: 6.5 (Standard Error 0.49) units on a scale reads as mixed primary results NCT00855582 ↗
registry LEAST_SQUARES_MEAN Placebo: 1.8 (Standard Error 0.51) units on a scale reads as mixed primary results NCT00855582 ↗
registry Tadalafil 5 mg vs Placebo; p <0.001; Mean Difference (Final Values) 4.7 reads as mixed primary results NCT00855582 ↗
registry LEAST_SQUARES_MEAN Tadalafil 2.5 mg: -4.6 (Standard Error 0.44) units on a scale reads as mixed primary results NCT00855582 ↗
registry Tadalafil 2.5 mg vs Placebo; p = 0.181; Mean Difference (Final Values) -0.8 reads as mixed primary results NCT00855582 ↗
registry LEAST_SQUARES_MEAN Tadalafil 2.5 mg: 5.2 (Standard Error 0.5) units on a scale reads as mixed primary results NCT00855582 ↗
registry Tadalafil 2.5 mg vs Placebo; p <0.001; Mean Difference (Final Values) 3.4 reads as mixed primary results NCT00855582 ↗
release “a pivotal Phase III study of Cialis® (tadalafil) tablets 5 mg for once daily use met its co-primary endpoints” reads as met primary endpoint lilly.com ↗
Publications
- Vlachopoulos C, Oelke M, Maggi M, Mulhall JP, Rosenberg MT, Brock GB, Esler A, Buttner H. Impact of cardiovascular risk factors and related comorbid conditions and medical therapy reported at baseline on the treatment response to tadalafil 5 mg once-daily in men with lower urinary tract symptoms associated with benign prostatic hyperplasia: an integrated analysis of four randomised, double-blind, placebo-controlled, clinical trials. Int J Clin Pract. 2015 Dec;69(12):1496-507. doi: 10.1111/ijcp.12722. Epub 2015 Aug 24.
- 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Tadalafil | Small molecule | 2.5 mg | Oral |
| Subject | Tadalafil | Small molecule | 5 mg | Oral |