Dutasteride and Flex Dose of Tamsulosin on as Needed Basis, to Treat Benign Prostatic Hyperplasia
Status:
Completed
Trial end date:
2009-07-01
Target enrollment:
Participant gender:
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)