A Phase 4 interventional study of Tamsulosin and Finasteride in Benign Prostate Hyperplasia, sponsored by Seoul National University Hospital. Status unknown at 11 sites in South Korea. Open to male participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2014-05-14.
Sponsored by Seoul National University Hospital · Phase 4, Interventional, and Treatment
The purpose of this study is to evaluate the clinical efficacy of alpha-blocker monotherapy and alpha-blocker + 5-alpha reductase inhibitor combination therapy in benign prostate hyperplasia patients, and suggest guidelines of the combination therapy.
Even though it should be decided on patients cautiously under careful consideration about prostate volume, Prostate Specific Antigen(PSA) level, symptom score and maximum uroflow, recently the combination therapy of alpha-blocker and 5-alpha reductase inhibitor has been tried imprudently in Korea.
As a result of several clinical trials which had conducted overseas for releasing the combination drug of alpha-blocker and 5-alpha reductase inhibitor, the superiority of the combination therapy has been proved, however, plenty of patients still don't derive additional profit from it.
Therefore, in this study, the investigators anticipate to meet with meaningful results on the clinical efficacy of alpha-blocker monotherapy and alpha-blocker + 5-alpha reductase inhibitor combination therapy in Korean benign prostate hyperplasia patients, and provide guidelines of the combination therapy.
803 studies on the registry are indexed under Prostatic Hyperplasia; 174 are open to participants now.
This study's enrollment of 545 is above the median of 96 across 610 interventional studies indexed under Prostatic Hyperplasia.
Browse Prostatic Hyperplasia studies →Seoul National University Hospital is the lead sponsor of 1,897 studies on the registry; 273 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 2 (17%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Unstable and significant medical condition including below
Tamsulosin 0.2mg + Placebo 5 mg daily until clinical progression
Drug: Tamsulosin · Drug: Placebo
Tamsulosin 0.2mg + Finasteride 5 mg daily until clinical progression
Drug: Tamsulosin · Drug: Finasteride
1 tablet(0.2mg) orally q.d.
Also known as: Harnal D (brand name in Asia), Flomax
1 tablet(5mg) orally q.d.
Also known as: Proscar
1 tablet(0.2mg) orally q.d.
Clinical Progression
One of below * Deterioration of the symptoms * Acute urinary retention * Renal failure * Recurrent urinary tract infection * Urinary incontinence * Surgical procedure related to benign prostate hyperplasia
Time frame: 1 & 2 months after baseline, and then every 3 months up to 4 years
International Prostate Symptom Score(IPSS)
Time frame: 1 & 2 months after baseline, and then every 3 months up to 4 years
International Consultation on Incontinence Modular Questionnaire(ICIQ) male LUTS-short form
Time frame: every 6 months up to 4 years
Uroflowmetry
including Qmax, voided volume and post-void residual volume(PVR)
Time frame: every 6 months up to 4 years
Prostate volume
Time frame: every 1 year up to 4 years
Global Response Assessment(GRA)
Time frame: every 1 year up to 4 years
PSA level
PSA level will be examined in the central laboratory and be reported to each center as an adjusted number. It is because PSA level tends to decrease to 50% of baseline after taking finasteride for 1\~4 years, so there is possibilities that the blindedness is broken with the actual result.
Time frame: every 1 year up to 4 years
Blood Chemistry
including Sodium, Potassium, Glucose, Urea nitrogen, Creatinine, ASpartate Transaminase(AST), ALanine Transaminase(ALT), Total bilirubin
Time frame: every 1 year up to 4 years
Adverse Events
Time frame: every visit up to 4 years
Physical examination
Digital Rectal Exam, Breast exam
Time frame: every 1 year up to 4 years
Male Sexual Health Questionnaire
Time frame: every 6 months up to 4 years
This study is status unknown, as verified in May 2014. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Finasteride
Seoul National University Hospital →