NCT01777269

Prospective Sexual Function Study for BPH Subjects

A Prospective Study of Sexual Function in Sexually Active Men Treated for BPH

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 489 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: Male
• Age: 50 Years
• Healthy volunteers: Not accepted

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 .

Detailed description

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. Men eligible at screening will be randomised, after a 4 week placebo run-in, to the 2 treatment groups in a 1:1 ratio. All men will receive standardised lifestyle advice (primarily concerning weight management and exercise) relevant to maintaining sexual function. Men will also receive a standardised lifestyle advice leaflet for BPH. The double blind phase will continue for 12 months, with assessment visits at 2 weeks and at months 1, 3, 6, 9 and a final visit at month 12. Subjects with sexual adverse events during the double blind phase will continue to be followed at scheduled study visits until resolution of the adverse event or at a visit 6 months after the last dose of study medication, whichever is sooner. PRIMARY OBJECTIVE: To assess the change in sexual function from baseline to 1 year in sexually active men with at least moderate BPH (international prostate symptom score - IPSS = or \> 12) who are treated with DUODART, compared to men treated with placebo . Change in sexual function will be assessed by change in total score from the full men's sexual health questionnaire (MSHQ) which has domains for erectile dysfunction, ejaculatory function and libido.

Conditions

• Prostatic Hyperplasia

Interventions

Type	Name	Description
DRUG	Dutasteride plus tamsulosin	Take 1 capsule daily
DRUG	Placebo	Take one capsule daily

Timeline

• Start date: 2013-02-18
• Primary completion: 2016-04-05
• Completion: 2016-04-05
• First posted: 2013-01-28
• Last updated: 2018-08-20
• Results posted: 2017-07-14

Locations

67 sites across 7 countries: Australia, France, Germany, Greece, Hungary, Netherlands, Spain