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

• Sponsor: GlaxoSmithKline (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00527605
• Collaborator: (none)
• Enrollment: 253
• Locations: 12
• Arms: 2
• Duration (Months): 17
• Patients Per Site: 21.1
• Patients Per Site Per Month: 1.2

Study Details

Study Description

Brief 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

Condition or Disease	Intervention/Treatment	Phase
Benign Prostatic Hyperplasia; Prostatic Hyperplasia	Drug: Dutasteride 0.5mg capsule; Drug: Dutasteride matched placebo	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 253 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official 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
• Study Start Date: Oct 1, 2007
• Actual Primary Completion Date: Mar 1, 2009
• Actual Study Completion Date: Mar 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: A dutasteride 0.5mg once daily orally	Drug: Dutasteride 0.5mg capsule; Dutasteride 0.5mg once daily orally
Placebo Comparator: B Placebo matched once daily orally	Drug: Dutasteride matched placebo; Dutasteride matched placebo once daily orally

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years and Older
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	GSK Investigational Site	Guangzhou	Guangdong	China	510180
2	GSK Investigational Site	Wuhan	Hubei	China	430030
3	GSK Investigational Site	Nanjing	Jiangsu	China	210006
4	GSK Investigational Site	Hangzhou	Zhejiang	China	310003
5	GSK Investigational Site	Beijing		China	100034
6	GSK Investigational Site	Beijing		China	100050
7	GSK Investigational Site	Beijing		China	100853
8	GSK Investigational Site	Beijing		China
9	GSK Investigational Site	Shanghai		China	200001
10	GSK Investigational Site	Shanghai		China	200025
11	GSK Investigational Site	Shanghai		China	200030
12	GSK Investigational Site	Tianjin		China	300211

Sponsors and Collaborators

• GlaxoSmithKline

Investigators

• Study Director: GSK Clinical Trials, GlaxoSmithKline

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.

• Responsible Party: GlaxoSmithKline
• ClinicalTrials.gov Identifier: NCT00527605
• Other Study ID Numbers: ARI108898
• First Posted: Sep 11, 2007
• Last Update Posted: Mar 21, 2012
• Last Verified: May 1, 2011

• Keywords provided by GlaxoSmithKline: placebo control; Chinese; Dutasteride; Randomized; Benign Prostatic Hyperplasia; Double blind
• Additional relevant MeSH terms: Prostatic Hyperplasia; Hyperplasia; Dutasteride

Study Results

Participant Flow

Arm/Group Title	Dutasteride 0.5 mg	Placebo
Arm/Group Description	Oral dutasteride 0.5 milligrams (mg) once a day for 6 months	Matching oral placebo once a day for 6 months
Period Title: Overall Study
STARTED	126	127
COMPLETED	113	116
NOT COMPLETED	13	11

Baseline Characteristics

Arm/Group Title	Dutasteride 0.5 mg	Placebo	Total
Arm/Group Description	Oral dutasteride 0.5 milligrams (mg) once a day for 6 months	Matching oral placebo once a day for 6 months	Total of all reporting groups
Overall Participants	126	127	253
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	65.8 (7.7)	66.9 (8.2)	66.4 (7.9)
Sex: Female, Male (Count of Participants)
Female	0 0%	0 0%	0 0%
Male	126 100%	127 100%	253 100%
Race/Ethnicity, Customized (participants) [Number]
Chinese	126 100%	127 100%	253 100%

Outcome Measures

1. Primary Outcome

Title	Percent Change From Baseline in the Prostate Volume at Month 6
Description	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

Outcome Measure Data

Analysis Population Description

Intent-to-Treat (ITT) Population: all participants who were randomized to study treatment (after the 4-week placebo run-in) and received at least one dose of study treatment. Some participants were missing Month 6 measurements.

Arm/Group Title	Dutasteride 0.5 mg	Placebo
Arm/Group Description	Oral dutasteride 0.5 milligrams (mg) once a day for 6 months	Matching oral placebo once a day for 6 months
Measure Participants	114	120
Mean (Standard Deviation) [percent change in volume]	-17.00 (21.41)	-2.77 (24.96)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Dutasteride 0.5 mg, Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	t-test, 2 sided
	Comments
Method of Estimation	Estimation Parameter	Median Difference (Final Values)
	Estimated Value	-14.23
	Confidence Interval	() 95%; -20.23 to -8.22
	Parameter Dispersion	Type: Value:
	Estimation Comments	Dutasteride arm minus placebo arm.

2. Secondary Outcome

Title	Percent Change From Baseline in the Prostate Volume at Month 3
Description	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

Outcome Measure Data

Analysis Population Description

ITT Population. Some participants were missing Month 3 measurements.

Arm/Group Title	Dutasteride 0.5 mg	Placebo
Arm/Group Description	Oral dutasteride 0.5 milligrams (mg) once a day for 6 months	Matching oral placebo once a day for 6 months
Measure Participants	112	118
Mean (Standard Deviation) [percent change in volume]	-12.02 (23.22)	-1.02 (25.79)

3. Secondary Outcome

Title	Change From Baseline in the Prostate Volume at Month 6
Description	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

Outcome Measure Data

Analysis Population Description

ITT Population. Some participants were missing Month 6 measurements.

Arm/Group Title	Dutasteride 0.5 mg	Placebo
Arm/Group Description	Oral dutasteride 0.5 milligrams (mg) once a day for 6 months	Matching oral placebo once a day for 6 months
Measure Participants	114	120
Mean (Standard Deviation) [cubic centimeters]	-9.16 (12.74)	-1.20 (12.77)

4. Secondary Outcome

Title	Change From Baseline in the Prostate Volume at Month 3
Description	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

Outcome Measure Data

Analysis Population Description

ITT Population. Some participants were missing Month 3 measurements.

Arm/Group Title	Dutasteride 0.5 mg	Placebo
Arm/Group Description	Oral dutasteride 0.5 milligrams (mg) once a day for 6 months	Matching oral placebo once a day for 6 months
Measure Participants	112	118
Mean (Standard Deviation) [cubic centimeters]	-7.11 (13.02)	-1.06 (11.48)

5. Secondary Outcome

Title	Percent Change From Baseline in the Serum Dihydrotestosterone (DHT) at Month 6
Description	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

Outcome Measure Data

Analysis Population Description

ITT Population. Some participants were missing Month 6 measurements.

Arm/Group Title	Dutasteride 0.5 mg	Placebo
Arm/Group Description	Oral dutasteride 0.5 milligrams (mg) once a day for 6 months	Matching oral placebo once a day for 6 months
Measure Participants	114	121
Mean (Standard Deviation) [percent change]	-52.53 (44.42)	26.78 (149.07)

6. Secondary Outcome

Title	Percent Change From Baseline in the Serum DHT at Month 3
Description	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

Outcome Measure Data

Analysis Population Description

ITT Population. Some participants were missing Month 3 measurements.

Arm/Group Title	Dutasteride 0.5 mg	Placebo
Arm/Group Description	Oral dutasteride 0.5 milligrams (mg) once a day for 6 months	Matching oral placebo once a day for 6 months
Measure Participants	114	120
Mean (Standard Deviation) [percent change]	-59.15 (37.90)	28.33 (133.71)

7. Secondary Outcome

Title	Change From Baseline in the Serum DHT at Month 6
Description	Change from baseline was calculated as the value of DHT at Month 6 minus the baseline value.
Time Frame	Baseline and Month 6

Outcome Measure Data

Analysis Population Description

ITT Population. Some participants were missing Month 6 measurements.

Arm/Group Title	Dutasteride 0.5 mg	Placebo
Arm/Group Description	Oral dutasteride 0.5 milligrams (mg) once a day for 6 months	Matching oral placebo once a day for 6 months
Measure Participants	114	121
Mean (Standard Deviation) [picograms/milliliter (pg/ml)]	-289.175 (270.610)	-46.099 (399.806)

8. Secondary Outcome

Title	Change From Baseline in the Serum DHT at Month 3
Description	Change from baseline was calculated as the value of DHT at Month 3 minus the baseline value.
Time Frame	Baseline and Month 3

Outcome Measure Data

Analysis Population Description

ITT Population. Some participants were missing Month 3 measurements.

Arm/Group Title	Dutasteride 0.5 mg	Placebo
Arm/Group Description	Oral dutasteride 0.5 milligrams (mg) once a day for 6 months	Matching oral placebo once a day for 6 months
Measure Participants	114	120
Mean (Standard Deviation) [pg/ml]	-319.605 (256.058)	-34.400 (399.633)

9. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

ITT Population. Some participants were missing Month 6 measurements.

Arm/Group Title	Dutasteride 0.5 mg	Placebo
Arm/Group Description	Oral dutasteride 0.5 milligrams (mg) once a day for 6 months	Matching oral placebo once a day for 6 months
Measure Participants	113	121
Mean (Standard Deviation) [percent change]	-26.48 (26.01)	-20.79 (30.18)

10. Secondary Outcome

Title	Percent Change From Baseline in the AUA-SI Score at Month 3
Description	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

Outcome Measure Data

Analysis Population Description

ITT Population. Some participants were missing Month 3 measurements.

Arm/Group Title	Dutasteride 0.5 mg	Placebo
Arm/Group Description	Oral dutasteride 0.5 milligrams (mg) once a day for 6 months	Matching oral placebo once a day for 6 months
Measure Participants	113	121
Mean (Standard Deviation) [percent change]	-15.64 (24.59)	-11.91 (21.55)

11. Secondary Outcome

Title	Change From Baseline in the AUA-SI Score at Month 6
Description	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

Outcome Measure Data

Analysis Population Description

ITT Population. Some participants were missing Month 6 measurements.

Arm/Group Title	Dutasteride 0.5 mg	Placebo
Arm/Group Description	Oral dutasteride 0.5 milligrams (mg) once a day for 6 months	Matching oral placebo once a day for 6 months
Measure Participants	113	121
Mean (Standard Deviation) [points on a scale]	-4.9 (4.8)	-4.1 (5.4)

12. Secondary Outcome

Title	Change From Baseline in the AUA-SI Score at Month 3
Description	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

Outcome Measure Data

Analysis Population Description

ITT Population. Some participants were missing Month 3 measurements.

Arm/Group Title	Dutasteride 0.5 mg	Placebo
Arm/Group Description	Oral dutasteride 0.5 milligrams (mg) once a day for 6 months	Matching oral placebo once a day for 6 months
Measure Participants	113	121
Mean (Standard Deviation) [points on a scale]	-2.9 (3.9)	-2.4 (3.9)

13. Secondary Outcome

Title	Percent Change From Baseline in Maximum Urinary Flow Rate (Qmax) at Month 6
Description	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

Outcome Measure Data

Analysis Population Description

ITT Population. Some participants were missing Month 6 measurements.

Arm/Group Title	Dutasteride 0.5 mg	Placebo
Arm/Group Description	Oral dutasteride 0.5 milligrams (mg) once a day for 6 months	Matching oral placebo once a day for 6 months
Measure Participants	113	119
Mean (Standard Deviation) [percent change]	16.14 (57.43)	6.31 (47.55)

14. Secondary Outcome

Title	Percent Change From Baseline in Qmax at Month 3
Description	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

Outcome Measure Data

Analysis Population Description

ITT Population. Some participants were missing Month 3 measurements.

Arm/Group Title	Dutasteride 0.5 mg	Placebo
Arm/Group Description	Oral dutasteride 0.5 milligrams (mg) once a day for 6 months	Matching oral placebo once a day for 6 months
Measure Participants	111	117
Mean (Standard Deviation) [percent change]	14.34 (42.86)	5.85 (34.69)

15. Secondary Outcome

Title	Change From Baseline in Qmax at Month 6
Description	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

Outcome Measure Data

Analysis Population Description

ITT Population. Some participants were missing Month 6 measurements.

Arm/Group Title	Dutasteride 0.5 mg	Placebo
Arm/Group Description	Oral dutasteride 0.5 milligrams (mg) once a day for 6 months	Matching oral placebo once a day for 6 months
Measure Participants	113	119
Mean (Standard Deviation) [milliliters/second (ml/s)]	0.75 (5.61)	0.03 (5.35)

16. Secondary Outcome

Title	Change From Baseline in Qmax at Month 3
Description	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

Outcome Measure Data

Analysis Population Description

ITT Population. Some participants were missing Month 3 measurements.

Arm/Group Title	Dutasteride 0.5 mg	Placebo
Arm/Group Description	Oral dutasteride 0.5 milligrams (mg) once a day for 6 months	Matching oral placebo once a day for 6 months
Measure Participants	111	117
Mean (Standard Deviation) [ml/s]	0.93 (4.74)	0.17 (4.56)

Adverse Events

Time Frame	The Serious Adverse Events (SAEs) and Adverse Events (AEs) presented were collected in the 6-month Double-Blind Phase only.
Arm/Group Title	Dutasteride 0.5 mg		Placebo
Arm/Group Description	Oral dutasteride 0.5 milligrams (mg) once a day for 6 months		Matching oral placebo once a day for 6 months
All Cause Mortality
	Dutasteride 0.5 mg		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Dutasteride 0.5 mg		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/126 (0%)		1/127 (0.8%)
Eye disorders
Glaucoma	0/126 (0%)		1/127 (0.8%)
Other (Not Including Serious) Adverse Events
	Dutasteride 0.5 mg		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	27/126 (21.4%)		25/127 (19.7%)
Cardiac disorders
Palpitations	0/126 (0%)		1/127 (0.8%)
Eye disorders
Dry eye	1/126 (0.8%)		0/127 (0%)
Keratitis	1/126 (0.8%)		0/127 (0%)
Gastrointestinal disorders
Abdominal distension	1/126 (0.8%)		0/127 (0%)
Abdominal pain	1/126 (0.8%)		0/127 (0%)
Abdominal pain upper	0/126 (0%)		1/127 (0.8%)
Diarrhoea	0/126 (0%)		2/127 (1.6%)
Dry mouth	1/126 (0.8%)		0/127 (0%)
Dysgeusia	1/126 (0.8%)		0/127 (0%)
Pharyngitis	0/126 (0%)		1/127 (0.8%)
Stomach discomfort	3/126 (2.4%)		3/127 (2.4%)
Throat irritation	1/126 (0.8%)		0/127 (0%)
Vomiting	0/126 (0%)		1/127 (0.8%)
Infections and infestations
Erysipelas	1/126 (0.8%)		0/127 (0%)
Alanine aminotransferase increased	0/126 (0%)		1/127 (0.8%)
Aspartate aminotransferase increased	0/126 (0%)		1/127 (0.8%)
Blood glucose increased	2/126 (1.6%)		0/127 (0%)
Prostatic specific antigen increased	1/126 (0.8%)		0/127 (0%)
White blood cell count decreased	1/126 (0.8%)		0/127 (0%)
Red blood cells urine	1/126 (0.8%)		1/127 (0.8%)
Transaminases increased	1/126 (0.8%)		0/127 (0%)
Metabolism and nutrition disorders
Decreased appetite	1/126 (0.8%)		0/127 (0%)
Musculoskeletal and connective tissue disorders
Arthralgia	0/126 (0%)		1/127 (0.8%)
Arthritis	0/126 (0%)		1/127 (0.8%)
Back pain	2/126 (1.6%)		2/127 (1.6%)
Musculoskeletal pain	1/126 (0.8%)		0/127 (0%)
Contusion	0/126 (0%)		1/127 (0.8%)
Nervous system disorders
Tinnitus	1/126 (0.8%)		0/127 (0%)
Vertigo	0/126 (0%)		1/127 (0.8%)
Psychiatric disorders
Poor quality sleep	0/126 (0%)		1/127 (0.8%)
Renal and urinary disorders
Calculus bladder	0/126 (0%)		1/127 (0.8%)
Urethral pain	0/126 (0%)		1/127 (0.8%)
Urinary incontinence	0/126 (0%)		1/127 (0.8%)
Urinary retention	1/126 (0.8%)		0/127 (0%)
Urinary tract infection	0/126 (0%)		1/127 (0.8%)
Reproductive system and breast disorders
Breast pain	1/126 (0.8%)		0/127 (0%)
Libido decreased	3/126 (2.4%)		0/127 (0%)
Erectile dysfunction	0/126 (0%)		1/127 (0.8%)
Respiratory, thoracic and mediastinal disorders
Cough	0/126 (0%)		1/127 (0.8%)
Dyspnoea	1/126 (0.8%)		0/127 (0%)
Nasopharyngitis	2/126 (1.6%)		3/127 (2.4%)
Pharyngolaryngeal pain	2/126 (1.6%)		0/127 (0%)
Upper respiratory tract infection	3/126 (2.4%)		5/127 (3.9%)
Respiratory tract infection	1/126 (0.8%)		0/127 (0%)
Skin and subcutaneous tissue disorders
Rash	0/126 (0%)		1/127 (0.8%)
Pigmentation disorder	1/126 (0.8%)		0/127 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.