Status:
COMPLETED
One-year Prospective Observational Study of BMI Change Effect of 5-alpha Reductase Inhibitor in Korean BPH Patients
Lead Sponsor:
Seoul National University Hospital
Collaborating Sponsors:
GlaxoSmithKline
Seoul National University Bundang Hospital
Conditions:
Benign Prostatic Hyperplasia
Eligibility:
MALE
45-75 years
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 ...
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 che...
Eligibility Criteria
Inclusion
- Male patients with symptomatic BPH
- Prostate volume of 30 cm3 or greater measured by transrectal ultrasound
- International Prostatic Symptom Score(IPSS) of 9 or greater
- Maximum urinary flow rate (Qmax) of 15ml/s or less
- No definite evidence of prostate cancer (on transrectal ultrasound, DRE, or etc.)
- Given Informed consent
Exclusion
- Post-void residual more than 250 mL
- History of cancer (including prostate cancer) or previous prostatic surgery
- Acute urinary retention within 3 months of enrollment
- Chronic alcohol abuser and heavy smoker (\> 10 cigarettes/day)
- History of/current drug abuse including laxatives
- Any previous 5 ARI administration
- Type 1 DM or Type 2 DM regardless of treatment
- Clinically significant endocrine diseases at investigator's discretion including thyroid diseases.
- History of /current bulimia or anorexia nervosa
- Regular use of following prohibited medicines within 3 months prior to screening; A. Medicines which can affect salt/water retention such as diuretics, calcium channel blockers, gabapentin, pregabalin, etc B. Medicines which can affect body weight such as sibutramine, orlistat, phentermine, amphetamine, etc.
- C. Anti-thyroid medication, thyroxine, cyproheptadine, tranquilizers, systemic corticosteroids, testosterone supplement, or other medications that are known to affect body weight or BMI
Key Trial Info
Start Date :
May 1 2006
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT00472251
Start Date
May 1 2006
End Date
December 1 2008
Last Update
July 21 2011
Active Locations (1)
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1
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea, 463-707