Phase 3 N=253 Randomized Quadruple-blind Treatment

Dutasteride 0.5mg For The Treatment Of Chinese Patients With Benign Prostatic Hyperplasia (BPH)

Benign Prostatic Hyperplasia · Prostatic Hyperplasia

Bottom Line

View on ClinicalTrials.gov: NCT00527605 ↗

Enrolled (actual)

253

Serious AEs

0.4%

Results posted

Mar 2010

Primary outcome: Primary: Percent Change From Baseline in the Prostate Volume at Month 6 — -17.00; -2.77 percent change in volume — p=<0.0001

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Dutasteride 0.5mg capsule (Drug); Dutasteride matched placebo (Drug)
Age: Adult, Older Adult · 50+ yrs
Sex: Male
Sponsor: GlaxoSmithKline
Primary completion: Mar 2009

Outcome Measures

Outcome	Result	p-value
PRIMARY Percent Change From Baseline in the Prostate Volume at Month 6	-17.00; -2.77	<0.0001 sig
SECONDARY Percent Change From Baseline in the Prostate Volume at Month 3	-12.02; -1.02	—
SECONDARY Change From Baseline in the Prostate Volume at Month 6	-9.16; -1.20	—
SECONDARY Change From Baseline in the Prostate Volume at Month 3	-7.11; -1.06	—
SECONDARY Percent Change From Baseline in the Serum Dihydrotestosterone (DHT) at Month 6	-52.53; 26.78	—
SECONDARY Percent Change From Baseline in the Serum DHT at Month 3	-59.15; 28.33	—
SECONDARY Change From Baseline in the Serum DHT at Month 6	-289.175; -46.099	—
SECONDARY Change From Baseline in the Serum DHT at Month 3	-319.605; -34.400	—
SECONDARY Percent Change From Baseline in the American Urological Association Symptom Index (AUA-SI) Score at Month 6	-26.48; -20.79	—
SECONDARY Percent Change From Baseline in the AUA-SI Score at Month 3	-15.64; -11.91	—
SECONDARY Change From Baseline in the AUA-SI Score at Month 6	-4.9; -4.1	—
SECONDARY Change From Baseline in the AUA-SI Score at Month 3	-2.9; -2.4	—
SECONDARY Percent Change From Baseline in Maximum Urinary Flow Rate (Qmax) at Month 6	16.14; 6.31	—
SECONDARY Percent Change From Baseline in Qmax at Month 3	14.34; 5.85	—
SECONDARY Change From Baseline in Qmax at Month 6	0.75; 0.03	—
SECONDARY Change From Baseline in Qmax at Month 3	0.93; 0.17	—

Summary

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

Eligibility Criteria

Inclusion:

Clinical diagnosis of BPH
AUA-SI >=12 [American Urological Association Symptom Index]
Qmax > 5ml/sec and =125ml
Prostate volume >=30cm(3)

Exclusion:

Post void residual volume >250ml
History or evidence of prostate cancer
Total serum PSA 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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00527605). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.