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CompletedNCT00527605Updated Mar 21, 2012Results posted

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

A Phase 3 interventional study of Dutasteride 0.5mg capsule and Dutasteride matched placebo in Benign Prostatic Hyperplasia and Prostatic Hyperplasia, sponsored by GlaxoSmithKline. Completed at 12 sites in China. Open to male participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2012-03-21.

Sponsored by GlaxoSmithKline · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
253
Allocation
Randomized
Ages
50 Years and older
Sex
Male
01

Study 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

02

Conditions studied

  • Benign Prostatic Hyperplasia
  • Prostatic Hyperplasia

Keywords

  • placebo control
  • Chinese
  • Dutasteride
  • Randomized
  • Benign Prostatic Hyperplasia
  • Double blind
03

In context

Prostatic Hyperplasia

783 studies on the registry are indexed under Prostatic Hyperplasia; 174 are open to participants now.

This study's enrollment of 253 is above the median of 97 across 593 interventional studies indexed under Prostatic Hyperplasia.

Browse Prostatic Hyperplasia studies →

Lead sponsor

GlaxoSmithKline is the lead sponsor of 3,562 studies on the registry; 117 are open to participants now.

Of its 258 completed or terminated interventional studies of FDA-regulated products, 232 (90%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years and older
Sexes eligible
Male
Accepts healthy volunteers
No

Inclusion criteria

  • 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 criteria

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.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
253 participants (actual)

Study arms

  • Experimental
    A

    dutasteride 0.5mg once daily orally

    Drug: Dutasteride 0.5mg capsule

  • Placebo comparator
    B

    Placebo matched once daily orally

    Drug: Dutasteride matched placebo

Interventions

  • DrugDutasteride 0.5mg capsule

    Dutasteride 0.5mg once daily orally

  • DrugDutasteride matched placebo

    Dutasteride matched placebo once daily orally

06

What researchers measure

Primary outcomes

  1. Percent Change From Baseline in the Prostate Volume at Month 6

    Percent change from baseline was calculated as the prostate volume at Month 6 minus the volume at baseline, divided by the prostate volume at baseline and multiplied by 100. Prostate volume was measured by transrectal ultrasound.

    Time frame: Baseline and Month 6

Secondary outcomes

  1. Percent Change From Baseline in the Prostate Volume at Month 3

    Percent change from baseline was calculated as the prostate volume at Month 3 minus the volume at baseline, divided by the prostate volume at baseline and multiplied by 100. Prostate volume was measured by transrectal ultrasound.

    Time frame: Baseline and Month 3

  2. Change From Baseline in the Prostate Volume at Month 6

    Change from baseline was calculated as the prostate volume at Month 6 minus the volume at baseline. Prostate volume was measured by transrectal ultrasound.

    Time frame: Baseline and Month 6

  3. Change From Baseline in the Prostate Volume at Month 3

    Change from baseline was calculated as the prostate volume at Month 3 minus the volume at baseline. Prostate volume is measured by transrectal ultrasound.

    Time frame: Baseline and Month 3

  4. Percent Change From Baseline in the Serum Dihydrotestosterone (DHT) at Month 6

    Percent change from baseline was calculated as serum DHT at month 6 minus the value at baseline ,divided by the baseline value and multiplied by 100.

    Time frame: Baseline and Month 6

  5. Percent Change From Baseline in the Serum DHT at Month 3

    Percent change from baseline was calculated as the DHT at Month 3 minus the value at baseline, divided by the baseline value and multiplied by 100.

    Time frame: Baseline and Month 3

  6. Change From Baseline in the Serum DHT at Month 6

    Change from baseline was calculated as the value of DHT at Month 6 minus the baseline value.

    Time frame: Baseline and Month 6

  7. Change From Baseline in the Serum DHT at Month 3

    Change from baseline was calculated as the value of DHT at Month 3 minus the baseline value.

    Time frame: Baseline and Month 3

  8. Percent Change From Baseline in the American Urological Association Symptom Index (AUA-SI) Score at Month 6

    Percent change from baseline is calculated as the AUA-SI score at month 6 minus the baseline AUA-SI score, divided by the baseline score and multiplied by 100. AUA-SI is a self-administered questionnaire that assesses the severity of benign prostatic hyperplasia symptoms. Scores range from 0 to 35; mild, 0-7; moderate, 8-19; severe, 20-35.

    Time frame: Baseline and Month 6

  9. Percent Change From Baseline in the AUA-SI Score at Month 3

    Percent change from baseline is calculated as the AUA-SI score at month 3 minus the baseline AUA-SI score, divided by the baseline score and multiplied by 100. AUA-SI is a self-administered questionnaire that assesses the severity of benign prostatic hyperplasia symptoms. Scores range from 0 to 35; mild, 0-7; moderate, 8-19; severe, 20-35.

    Time frame: Baseline and Month 3

  10. Change From Baseline in the AUA-SI Score at Month 6

    Change from baseline was calculated as the AUS-SI score at month 6 minus the baseline score. AUA-SI is a self-administered questionnaire that assesses the severity of benign prostatic hyperplasia symptoms. Scores range from 0 to 35; mild, 0-7; moderate, 8-19; severe, 20-35.

    Time frame: Baseline and Month 6

  11. Change From Baseline in the AUA-SI Score at Month 3

    Change from baseline was calculated as the AUA-SI score at month 3 minus the baseline score. AUA-SI is a self-administered questionnaire that assesses the severity of benign prostate hyperplasia symptoms. Scores range from 0 to 35; mild, 0-7; moderate, 8-19; severe, 20-35.

    Time frame: Baseline and Month 3

  12. Percent Change From Baseline in Maximum Urinary Flow Rate (Qmax) at Month 6

    Percent change from baseline was calculated as Qmax at Month 6 minus Qmax at baseline, divided by baseline Qmax and multiplied by 100. Qmax is the peak urinary flow measured by a uroflow meter.

    Time frame: Baseline and Month 6

  13. Percent Change From Baseline in Qmax at Month 3

    Percent change from baseline was calculated as Qmax at Month 3 minus Qmax at baseline, divided by baseline Qmax and multiplied by 100. Qmax is the peak urinary flow measured by a uroflow meter.

    Time frame: Baseline and Month 3

  14. Change From Baseline in Qmax at Month 6

    Change from baseline was calculated as Qmax at Month 6 minus Qmax at baseline. Qmax is the peak urinary flow measured by a uroflow meter.

    Time frame: Baseline and Month 6

  15. Change From Baseline in Qmax at Month 3

    Change from baseline was calculated as Qmax at Month 3 minus Qmax at baseline. Qmax is the peak urinary flow measured by a uroflow meter.

    Time frame: Baseline and Month 3

07

Results

Posted Mar 11, 2010

Participant flow

Participant flow — Overall Study
MilestoneDutasteride 0.5 mgPlacebo
Started126127
Completed113116
Not completed1311
Withdrew: Adverse event30
Withdrew: Withdrawal by subject37
Withdrew: Lost to follow-up62
Withdrew: Protocol violation12

Outcome measures

PrimaryPercent Change From Baseline in the Prostate Volume at Month 6

Percent change from baseline was calculated as the prostate volume at Month 6 minus the volume at baseline, divided by the prostate volume at baseline and multiplied by 100. Prostate volume was measured by transrectal ultrasound.

Time frame:
Baseline and Month 6
Reported as:
Mean · percent change in volume
Percent Change From Baseline in the Prostate Volume at Month 6
percent change in volumeDutasteride 0.5 mgPlacebo
Percent Change From Baseline in the Prostate Volume at Month 6-17.00 ± 21.41-2.77 ± 24.96
Statistical analysis
  • Dutasteride 0.5 mg vs Placebo · t-test, 2 sided · p = <0.0001 · Median difference (final values): -14.23 · 95% CI -20.23 to -8.22Dutasteride arm minus placebo arm.
SecondaryPercent Change From Baseline in the Prostate Volume at Month 3

Percent change from baseline was calculated as the prostate volume at Month 3 minus the volume at baseline, divided by the prostate volume at baseline and multiplied by 100. Prostate volume was measured by transrectal ultrasound.

Time frame:
Baseline and Month 3
Reported as:
Mean · percent change in volume
Percent Change From Baseline in the Prostate Volume at Month 3
percent change in volumeDutasteride 0.5 mgPlacebo
Percent Change From Baseline in the Prostate Volume at Month 3-12.02 ± 23.22-1.02 ± 25.79
SecondaryChange From Baseline in the Prostate Volume at Month 6

Change from baseline was calculated as the prostate volume at Month 6 minus the volume at baseline. Prostate volume was measured by transrectal ultrasound.

Time frame:
Baseline and Month 6
Reported as:
Mean · cubic centimeters
Change From Baseline in the Prostate Volume at Month 6
cubic centimetersDutasteride 0.5 mgPlacebo
Change From Baseline in the Prostate Volume at Month 6-9.16 ± 12.74-1.20 ± 12.77
SecondaryChange From Baseline in the Prostate Volume at Month 3

Change from baseline was calculated as the prostate volume at Month 3 minus the volume at baseline. Prostate volume is measured by transrectal ultrasound.

Time frame:
Baseline and Month 3
Reported as:
Mean · cubic centimeters
Change From Baseline in the Prostate Volume at Month 3
cubic centimetersDutasteride 0.5 mgPlacebo
Change From Baseline in the Prostate Volume at Month 3-7.11 ± 13.02-1.06 ± 11.48
SecondaryPercent Change From Baseline in the Serum Dihydrotestosterone (DHT) at Month 6

Percent change from baseline was calculated as serum DHT at month 6 minus the value at baseline ,divided by the baseline value and multiplied by 100.

Time frame:
Baseline and Month 6
Reported as:
Mean · percent change
Percent Change From Baseline in the Serum Dihydrotestosterone (DHT) at Month 6
percent changeDutasteride 0.5 mgPlacebo
Percent Change From Baseline in the Serum Dihydrotestosterone (DHT) at Month 6-52.53 ± 44.4226.78 ± 149.07
SecondaryPercent Change From Baseline in the Serum DHT at Month 3

Percent change from baseline was calculated as the DHT at Month 3 minus the value at baseline, divided by the baseline value and multiplied by 100.

Time frame:
Baseline and Month 3
Reported as:
Mean · percent change
Percent Change From Baseline in the Serum DHT at Month 3
percent changeDutasteride 0.5 mgPlacebo
Percent Change From Baseline in the Serum DHT at Month 3-59.15 ± 37.9028.33 ± 133.71
SecondaryChange From Baseline in the Serum DHT at Month 6

Change from baseline was calculated as the value of DHT at Month 6 minus the baseline value.

Time frame:
Baseline and Month 6
Reported as:
Mean · picograms/milliliter (pg/ml)
Change From Baseline in the Serum DHT at Month 6
picograms/milliliter (pg/ml)Dutasteride 0.5 mgPlacebo
Change From Baseline in the Serum DHT at Month 6-289.175 ± 270.610-46.099 ± 399.806
SecondaryChange From Baseline in the Serum DHT at Month 3

Change from baseline was calculated as the value of DHT at Month 3 minus the baseline value.

Time frame:
Baseline and Month 3
Reported as:
Mean · pg/ml
Change From Baseline in the Serum DHT at Month 3
pg/mlDutasteride 0.5 mgPlacebo
Change From Baseline in the Serum DHT at Month 3-319.605 ± 256.058-34.400 ± 399.633
SecondaryPercent Change From Baseline in the American Urological Association Symptom Index (AUA-SI) Score at Month 6

Percent change from baseline is calculated as the AUA-SI score at month 6 minus the baseline AUA-SI score, divided by the baseline score and multiplied by 100. AUA-SI is a self-administered questionnaire that assesses the severity of benign prostatic hyperplasia symptoms. Scores range from 0 to 35; mild, 0-7; moderate, 8-19; severe, 20-35.

Time frame:
Baseline and Month 6
Reported as:
Mean · percent change
Percent Change From Baseline in the American Urological Association Symptom Index (AUA-SI) Score at Month 6
percent changeDutasteride 0.5 mgPlacebo
Percent Change From Baseline in the American Urological Association Symptom Index (AUA-SI) Score at Month 6-26.48 ± 26.01-20.79 ± 30.18
SecondaryPercent Change From Baseline in the AUA-SI Score at Month 3

Percent change from baseline is calculated as the AUA-SI score at month 3 minus the baseline AUA-SI score, divided by the baseline score and multiplied by 100. AUA-SI is a self-administered questionnaire that assesses the severity of benign prostatic hyperplasia symptoms. Scores range from 0 to 35; mild, 0-7; moderate, 8-19; severe, 20-35.

Time frame:
Baseline and Month 3
Reported as:
Mean · percent change
Percent Change From Baseline in the AUA-SI Score at Month 3
percent changeDutasteride 0.5 mgPlacebo
Percent Change From Baseline in the AUA-SI Score at Month 3-15.64 ± 24.59-11.91 ± 21.55
SecondaryChange From Baseline in the AUA-SI Score at Month 6

Change from baseline was calculated as the AUS-SI score at month 6 minus the baseline score. AUA-SI is a self-administered questionnaire that assesses the severity of benign prostatic hyperplasia symptoms. Scores range from 0 to 35; mild, 0-7; moderate, 8-19; severe, 20-35.

Time frame:
Baseline and Month 6
Reported as:
Mean · points on a scale
Change From Baseline in the AUA-SI Score at Month 6
points on a scaleDutasteride 0.5 mgPlacebo
Change From Baseline in the AUA-SI Score at Month 6-4.9 ± 4.8-4.1 ± 5.4
SecondaryChange From Baseline in the AUA-SI Score at Month 3

Change from baseline was calculated as the AUA-SI score at month 3 minus the baseline score. AUA-SI is a self-administered questionnaire that assesses the severity of benign prostate hyperplasia symptoms. Scores range from 0 to 35; mild, 0-7; moderate, 8-19; severe, 20-35.

Time frame:
Baseline and Month 3
Reported as:
Mean · points on a scale
Change From Baseline in the AUA-SI Score at Month 3
points on a scaleDutasteride 0.5 mgPlacebo
Change From Baseline in the AUA-SI Score at Month 3-2.9 ± 3.9-2.4 ± 3.9
SecondaryPercent Change From Baseline in Maximum Urinary Flow Rate (Qmax) at Month 6

Percent change from baseline was calculated as Qmax at Month 6 minus Qmax at baseline, divided by baseline Qmax and multiplied by 100. Qmax is the peak urinary flow measured by a uroflow meter.

Time frame:
Baseline and Month 6
Reported as:
Mean · percent change
Percent Change From Baseline in Maximum Urinary Flow Rate (Qmax) at Month 6
percent changeDutasteride 0.5 mgPlacebo
Percent Change From Baseline in Maximum Urinary Flow Rate (Qmax) at Month 616.14 ± 57.436.31 ± 47.55
SecondaryPercent Change From Baseline in Qmax at Month 3

Percent change from baseline was calculated as Qmax at Month 3 minus Qmax at baseline, divided by baseline Qmax and multiplied by 100. Qmax is the peak urinary flow measured by a uroflow meter.

Time frame:
Baseline and Month 3
Reported as:
Mean · percent change
Percent Change From Baseline in Qmax at Month 3
percent changeDutasteride 0.5 mgPlacebo
Percent Change From Baseline in Qmax at Month 314.34 ± 42.865.85 ± 34.69
SecondaryChange From Baseline in Qmax at Month 6

Change from baseline was calculated as Qmax at Month 6 minus Qmax at baseline. Qmax is the peak urinary flow measured by a uroflow meter.

Time frame:
Baseline and Month 6
Reported as:
Mean · milliliters/second (ml/s)
Change From Baseline in Qmax at Month 6
milliliters/second (ml/s)Dutasteride 0.5 mgPlacebo
Change From Baseline in Qmax at Month 60.75 ± 5.610.03 ± 5.35
SecondaryChange From Baseline in Qmax at Month 3

Change from baseline was calculated as Qmax at Month 3 minus Qmax at baseline. Qmax is the peak urinary flow measured by a uroflow meter.

Time frame:
Baseline and Month 3
Reported as:
Mean · ml/s
Change From Baseline in Qmax at Month 3
ml/sDutasteride 0.5 mgPlacebo
Change From Baseline in Qmax at Month 30.93 ± 4.740.17 ± 4.56

Adverse events

Collected over The Serious Adverse Events (SAEs) and Adverse Events (AEs) presented were collected in the 6-month Double-Blind Phase only.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Dutasteride 0.5 mg—0/126 (0%)27/126 (21.4%)
Placebo—1/127 (0.8%)25/127 (19.7%)
Most frequent serious events
Most frequent serious events
EventDutasteride 0.5 mgPlacebo
GlaucomaEye disorders0/1261/127
Most frequent other events
Showing 10 of 46
Most frequent other events
EventDutasteride 0.5 mgPlacebo
Upper respiratory tract infectionRespiratory, thoracic and mediastinal disorders3/1265/127
Stomach discomfortGastrointestinal disorders3/1263/127
Libido decreasedReproductive system and breast disorders3/1260/127
NasopharyngitisRespiratory, thoracic and mediastinal disorders2/1263/127
Blood glucose increasedInfections and infestations2/1260/127
Back painMusculoskeletal and connective tissue disorders2/1262/127
Pharyngolaryngeal painRespiratory, thoracic and mediastinal disorders2/1260/127
DiarrhoeaGastrointestinal disorders0/1262/127
Dry eyeEye disorders1/1260/127
KeratitisEye disorders1/1260/127

Baseline characteristics

Age Continuous
Age Continuous(years)Dutasteride 0.5 mgPlaceboTotal
Mean65.8 ± 7.766.9 ± 8.266.4 ± 7.9
Sex: Female, Male
Sex: Female, Male(Participants)Dutasteride 0.5 mgPlaceboTotal
Female000
Male126127253
Race/Ethnicity, Customized
Race/Ethnicity, Customized(participants)Dutasteride 0.5 mgPlaceboTotal
Chinese126127253
08

Study locations

12 sites
  • GSK Investigational Site
    Guangzhou, Guangdong 510180, China
  • GSK Investigational Site
    Wuhan, Hubei 430030, China
  • GSK Investigational Site
    Nanjing, Jiangsu 210006, China
  • GSK Investigational Site
    Hangzhou, Zhejiang 310003, China
  • GSK Investigational Site
    Beijing, 100034, China
  • GSK Investigational Site
    Beijing, 100050, China
  • GSK Investigational Site
    Beijing, 100853, China
  • GSK Investigational Site
    Beijing, China
  • GSK Investigational Site
    Shanghai, 200001, China
  • GSK Investigational Site
    Shanghai, 200025, China
  • GSK Investigational Site
    Shanghai, 200030, China
  • GSK Investigational Site
    Tianjin, 300211, China
09

References and documents

Publications

  • Na Y, Ye Z, Zhang S. Efficacy and Safety of Dutasteride in Chinese Adults with Symptomatic Benign Prostatic Hyperplasia : A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study with an Open-Label Extension. Clin Drug Investig. 2012 Jan;32(1):29-39. doi: 10.2165/11593750-000000000-00000. PubMed 27933597 ↗
  • Na Y, Ye Z, Zhang S; Chinese Dutasteride Phase III Trial (ARIA108898) Study Group. Efficacy and safety of dutasteride in Chinese adults with symptomatic benign prostatic hyperplasia: a randomized, double-blind, parallel-group, placebo-controlled study with an open-label extension. Clin Drug Investig. 2012 Jan 1;32(1):29-39. doi: 10.2165/11593750-000000000-00000. PubMed 22017520 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 21, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00527605
Lead sponsor
GlaxoSmithKline
Responsible party
Sponsor
First posted
Sep 11, 2007
Start date
Oct 2007
Primary completion
Mar 2009
Completion
Mar 2009
Results posted
Mar 11, 2010
Last update
Mar 21, 2012

Study contacts

GSK Clinical Trials
study director · GlaxoSmithKline

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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