Benign Prostatic Hyperplasia Clinical Trial
Official title:
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
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)
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.
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