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Prospective Sexual Function Study for BPH Subjects

NCT01777269 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 489

Last updated 2018-08-20

Study results available
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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 .

Conditions

  • Prostatic Hyperplasia

Interventions

DRUG

Dutasteride plus tamsulosin

Take 1 capsule daily

DRUG

Placebo

Take one capsule daily

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-02-18
Primary Completion
2016-04-05
Completion
2016-04-05

Countries

  • Australia
  • France
  • Germany
  • Greece
  • Hungary
  • Netherlands
  • Spain

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01777269 on ClinicalTrials.gov