One-year Prospective Observational Study of BMI Change Effect of 5-alpha Reductase Inhibitor in Korean BPH Patients
45 Years
75 Years
Male
Benign Prostatic Hyperplasia
Trial Information
One-year Prospective Observational Study of BMI Change Effect of 5-alpha Reductase Inhibitor in Korean BPH Patients
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
Inclusion Criteria:
- 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 Criteria:
- 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
Type of Study:
Observational
Study Design:
Observational Model: Cohort, Time Perspective: Prospective
Outcome Measure:
body mass index
Outcome Time Frame:
after 1 year of treatment
Safety Issue:
No
Principal Investigator
Sang Eun Lee, MD, PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Seoul National University Bundang Hospital
Authority:
Korea: Food and Drug Administration
Study ID:
CRT110446
NCT ID:
NCT00472251
Start Date:
May 2006
Completion Date:
December 2008
Related Keywords:
- Benign Prostatic Hyperplasia
- dutasteride
- body mass index
- testosterone
- Prostatic Hyperplasia
- Hyperplasia
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