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OpenTrials
Completed

NCT Number: NCT00527605

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

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

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Key information

Conditions

Benign Prostatic Hyperplasia Genital Diseases Genital Diseases, Male Male Urogenital Diseases Prostatic Diseases Prostatic Hyperplasia Urogenital Diseases

Age range

50 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 3

Primary location

GSK Investigational Site, Guangzhou, Guangdong, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Dutasteride 0.5mg capsule

Drug

Dutasteride 0.5mg once daily orally

Dutasteride matched placebo

Drug

Dutasteride matched placebo once daily orally

Primary outcomes

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

    Time frame: Baseline and 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.

Secondary outcomes

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

    Time frame: Baseline and 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.

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

    Time frame: Baseline and 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.

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

    Time frame: Baseline and 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.

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

    Time frame: Baseline and 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.

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

    Time frame: Baseline and 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.

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

    Time frame: Baseline and Month 6

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

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

    Time frame: Baseline and Month 3

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

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

    Time frame: Baseline and 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.

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

    Time frame: Baseline and 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.

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

    Time frame: Baseline and 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.

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

    Time frame: Baseline and 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.

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

    Time frame: Baseline and 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.

  13. Percent Change From Baseline in Qmax at Month 3

    Time frame: Baseline and 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.

  14. Change From Baseline in Qmax at Month 6

    Time frame: Baseline and 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.

  15. Change From Baseline in Qmax at Month 3

    Time frame: Baseline and 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.

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

A Randomized, Double-blind, Placebo-controlled, Six-month Parallel-group Study to 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

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Sep 11, 2007
Registry last updated
Mar 21, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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