One-year Prospective Observational Study of BMI Change Effect of 5-alpha Reductase Inhibitor in Korean BPH Patients
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|ClinicalTrials.gov Identifier: NCT00472251|
Recruitment Status : Completed
First Posted : May 11, 2007
Last Update Posted : July 21, 2011
|Condition or disease|
|Benign Prostatic Hyperplasia|
This study is a prospective, 1-year follow-up, observational study. We are planning to enroll 100 Korean patients with BPH. At each visit, patients' height, weight, abdominal circumference will be checked. Laboratory parameters including fasting glucose, HbA1c, serum testosterone, free testosterone, sex hormone-binding globulin, estradiol, maximum flow rate (measured by flowmetry) will be tested. Blood test will be performed twice (at baseline and at the end of study). 5mL of blood will be needed at each time from one subject. And total IPSS score will be evaluated after 1 year of treatment of 5 ARI. At every visit, use of above prohibited medicines and other medications will be investigated. In addition, any surgical procedures undertaken during study period will be asked and recorded.
Subjects of study will be allocated into 3 separate groups. Group 1 will be those taking 5 alpha reductase inhibitor (dutasteride) only for 1 year. Group2 will be those who switch from alpha blocker to dutasteride and take dutasteride for 1 year. Group 3 will be composed of those taking both alpha blocker and dutasteride for 1 year.
|Study Type :||Observational|
|Actual Enrollment :||120 participants|
|Official Title:||One-year Prospective Observational Study of BMI Change Effect of 5-alpha Reductase Inhibitor in Korean BPH Patients|
|Study Start Date :||May 2006|
|Actual Primary Completion Date :||September 2008|
|Actual Study Completion Date :||December 2008|
- body mass index [ Time Frame: after 1 year of treatment ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00472251
|Korea, Republic of|
|Seoul National University Bundang Hospital|
|Seongnam-si, Kyunggi-do, Korea, Republic of, 463-707|
|Principal Investigator:||Sang Eun Lee, MD, PhD||Seoul National University Bundang Hospital|