Dutasteride 0.5mg For The Treatment Of Chinese Patients With Benign Prostatic Hyperplasia (BPH)
Status and phase
Completed
Phase 3
Conditions
Benign Prostatic Hyperplasia
Prostatic Hyperplasia
Treatments
Drug: Dutasteride 0.5mg capsule
Drug: Dutasteride matched placebo
Details and patient eligibility
About
This randomized, double-blind, placebo-controlled, six-month parallel-group study assess efficacy and safety of dutasteride 0.5mg once daily in Chinese patients with Benign Prostatic Hyperplasia (BPH) , followed by a 12-month open-label treatment phase
Enrollment
253 patients
Sex
Male
Ages
50+ years old
Volunteers
No Healthy Volunteers
Inclusion and exclusion criteria
Inclusion:
- Clinical diagnosis of BPH
- AUA-SI >=12 [American Urological Association Symptom Index]
- Qmax > 5ml/sec and <=15ml/sec and minimum voided volume of >=125ml
- Prostate volume >=30cm(3)
Exclusion:
- Post void residual volume >250ml
- History or evidence of prostate cancer
- Total serum PSA <1.5ng/ml or >10.0ng/ml (Prostate specific antigen)
- Previous prostatic surgery or other invasive procedures to treat BPH.
- History of AUR (Acute Urinary Retention) within 3 months
- History of flexible/rigid cystoscopy or other instrumentation of the urethra within 7 days
- Any causes other than BPH, which may in the judgement of the investigator, result in urinary symptoms or changes in flow rate
- History of hepatic impairment or abnormal liver function tests
- Use of any 5a-reductase inhibitors ,any drugs with antiandrogenic properties or other drugs noted for gynaecomastia effects, or could affect prostate volume, within past 6 months and throughout the study
- Use of alpha-receptor blockers within 2 weeks and throughout the study.
- Use of phytotherapy for BPH within 2 weeks and/or predicted to need phytotherapy during the study.
- Concurrent use of anabolic steroids
- Use of any alpha-adrenergic agonists or cholinergics within 48 hours prior to uroflowmetry assessment.
- Hypersensitivity to any 5a-reductase inhibitor or other chemically-related drugs.
- Actively trying to procreate or unwilling to wear a condom during intercourse with a woman of childbearing potential for duration of participation in this study and 16 weeks following treatment.
- History or current evidence of drug or alcohol abuse within the previous 12 months.
- History of any illness that in the opinion of the investigator might confound the results of the study or poses additional risk to the patient.
- Any unstable, serious co-existing medical condition(s) including, but not limited to, myocardial infarction, coronary bypass surgery, unstable angina, cardiac arrhythmias, clinically evident congestive heart failure, of cerebrovascular accident within 6 months prior to Screening visit; uncontrolled diabetes or peptic ulcer disease which is uncontrolled by medical management.
- History of renal insufficiency, or serum creatinine >1.5xULN (Upper Limit of Normal )
- Participation in any investigational or marketed drug trial within 30 days and during the course of the study.
Trial design
Primary purpose
Treatment
Allocation
Randomized
Interventional model
Parallel Assignment
Masking
Quadruple Blind
253 participants in 2 patient groups, including a placebo group
A
Experimental group
Description:
dutasteride 0.5mg once daily orally
Treatment:
Drug: Dutasteride 0.5mg capsule
B
Placebo Comparator group
Description:
Placebo matched once daily orally
Treatment:
Drug: Dutasteride matched placebo
Trial contacts and locations
12
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Data sourced from clinicaltrials.gov
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