Prospective Sexual Function Study for BPH Subjects

Summary

This is an European double-blind, placebo controlled parallel group comparison of DUODART (fixed dose combination of dutasteride 0.5mg and tamsulosin 0.4mg, one capsule daily) and placebo. PRIMARY OBJECTIVE: To assess the change in sexual function from baseline to 1 year in sexually active men with at least moderate BPH who are treated with DUODART, compared to men treated with placebo .

Timeline

Start

2013-02-18

Primary completion

2016-04-05

Completion

2016-04-05

Outcome

Missed primary endpoint

paper A significant decrease (worsening) was observed with DUT-TAM FDC therapy versus placebo on the total MSHQ score (-8.7 vs -0.7; PMID 29044968 ↗

registry analysis (superiority or other test); Placebo vs Duodart; p <0.001; Adjusted mean difference -8.00 (95% CI -10.22 to -5.79); mixed-model repeated-measures NCT01777269 ↗

Publications

• Roehrborn CG, Manyak MJ, Palacios-Moreno JM, Wilson TH, Roos EPM, Santos JC, Karanastasis D, Plastino J, Giuliano F, Rosen RC. A prospective randomised placebo-controlled study of the impact of dutasteride/tamsulosin combination therapy on sexual function domains in sexually active men with lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH). BJU Int. 2018 Apr;121(4):647-658. doi: 10.1111/bju.14057. Epub 2017 Nov 16.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Dutasteride	Small molecule	0.5 mg	—
Subject	Tamsulosin	Other / unclassified	0.4 mg	—

Indications