NCT00701779

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

Dutasteride (0.5mg) Once Daily for One Year and Tamsulosin (0.4mg) Once Daily for 3 Months, Followed by Counseling on Flex Dose Tamsulosin as Needed on Improvement of Symptoms and Outcome in Men With Moderate to Severe Symptomatic BPH

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 63 (actual)
• Sponsor: Siami, Paul F., M.D. · Academic / Other
• Sex: Male
• Age: 50 Years
• Healthy volunteers: Not accepted

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)

Detailed description

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. A recently published, landmark study (MTOPS - Medical Therapy of Prostatic Symptoms), co-sponsored by the National Institute of Health and the National Institute of Diabetes, Digestive and Kidney Diseases (NIH-NIDDK), demonstrated that, in selected patients, combination therapy with Doxazosin and Finasteride provided additive symptomatic improvements, reduced the risk of acute urinary retention (AUR) and surgical intervention, and was a more effective treatment for reduction in the overall risk of BPH clinical progression. The aim of this proposed combination study, in a population of patients at high risk of BPH clinical progression, is to investigate whether combination therapy with Dutasteride and Tamsulosin with the subsequent withdrawal of Tamsulosin can maintain superior symptom improvement. At each scheduled visit (3, 6, and 9 months), the subject will be counseled on withdrawal of Tamsulosin. We hypothesize that patients may start with a combination of Dutasteride and Tamsulosin and eventually may be able to eliminate the use of Tamsulosin and maintain acceptable urinary symptoms on Dutasteride alone.

Conditions

• Benign Prostatic Hyperplasia

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2005-09-01
• Primary completion: 2009-07-01
• Completion: 2009-07-01
• First posted: 2008-06-19
• Last updated: 2018-11-02
• Results posted: 2015-01-01

Locations

1 site across 1 country: United States