MedTrace Logo

Dutasteride and Flex Dose of Tamsulosin on as Needed Basis, to Treat Benign Prostatic Hyperplasia

NCT00701779 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 63

Last updated 2018-11-02

Study results available
· View outcomes & findings →

Summary

This study will investigate the efficacy and safety of treatment with Dutasteride (0.5mg), administered once daily for one year in combination with Tamsulosin (0.4mg), administered once daily for 3 months, followed by counseling on flexible dosing of Tamsulosin on an as needed basis, on the improvement of symptoms and clinical outcome in men with moderate to severe symptomatic benign prostatic hyperplasia (BPH). At each scheduled visit (3, 6, and 9 months), the subject will be counseled on withdrawal of Tamsulosin. After randomization, study visits are every 13 weeks for up to 52 Weeks. (Including Screening, (up to 7 clinic visits)

Conditions

  • Benign Prostatic Hyperplasia

Interventions

DRUG

Tamsulosin

Dutasteride 0.5mg once daily for one year and tamsulosin 0.4mg administered once daily for 3 months, followed by counseling on flexible dosing of tamsulosin on an as needed basis.

Sponsors & Collaborators

Principal Investigators

  • Paul F Siami, MD · Deaconess Clinic Research Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
50 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-09-30
Primary Completion
2009-07-31
Completion
2009-07-31

Countries

  • United States

Study Locations

More Related Trials

Entities

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 NCT00701779 on ClinicalTrials.gov