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Tracking Information | |||||
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First Received Date † | May 10, 2007 | ||||
Last Updated Date | May 10, 2007 | ||||
Start Date † | May 2007 | ||||
Current Primary Outcome Measures † | |||||
Original Primary Outcome Measures † | |||||
Change History | No Changes Posted | ||||
Current Secondary Outcome Measures † | |||||
Original Secondary Outcome Measures † | |||||
Descriptive Information | |||||
Brief Title † | One-Year Prospective Observational Study of BMI Change Effect of 5-Alpha Reductase Inhibitor in Korean BPH Patients | ||||
Official Title † | One-Year Prospective Observational Study of BMI Change Effect of 5-Alpha Reductase Inhibitor in Korean BPH Patients | ||||
Brief Summary | It is widely-accepted that serum testosterone level and BMI (body mass index) representative of the degree of obesity has negative correlation. Considering the fact that obesity is being mentioned as a risk factor for development of prostate cancer as well as other various life-threatening diseases (example: cardiovascular problems), the effect of BPH treatment agents on BMI is a subject that should certainly be elucidated. Meanwhile, to our knowledge, no prospective study has so far been performed on such issue in Asian population. Prior to generating hypothesis of the effect of 5 alpha reductase inhibitor on BMI, the real effect of 5 alpha reductase inhibitor on BMI change in Korean BPH patients has to be observed in real clinical practice. This study will test the effects of one-year medication of 5 alpha reductase inhibitor on BMI among Korean men with BPH. |
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Detailed Description | 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. composed of |
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Study Phase | |||||
Study Type † | Observational | ||||
Study Design † | Natural History, Longitudinal, Random Sample, Prospective Study | ||||
Condition † | Benign Prostatic Hyperplasia | ||||
Intervention † | |||||
Study Arms / Comparison Groups | |||||
Publications * | Roehrborn CG, Lee M, Meehan A, Waldstreicher J; PLESS Study Group. Effects of finasteride on serum testosterone and body mass index in men with benign prostatic hyperplasia. Urology. 2003 Nov;62(5):894-9. | ||||
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |||||
Recruitment Status † | Recruiting | ||||
Estimated Enrollment † | 100 | ||||
Estimated Completion Date | November 2008 | ||||
Primary Completion Date | |||||
Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
C. Anti-thyroid medication, thyroxine, cyproheptadine, tranquilizers, systemic corticosteroids, testosterone supplement, or other medications that are known to affect body weight or BMI |
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Gender | Male | ||||
Ages | |||||
Accepts Healthy Volunteers | No | ||||
Contacts †† |
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Location Countries † | Korea, Republic of | ||||
Expanded Access Status | |||||
Administrative Information | |||||
NCT ID † | NCT00472251 | ||||
Responsible Party | |||||
Secondary IDs †† | |||||
Study Sponsor † | Seoul National University Hospital | ||||
Collaborators †† |
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Investigators † |
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Information Provided By | Seoul National University Hospital | ||||
Verification Date | May 2007 | ||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |