## Protocol Section
### Identification Module
**NCT ID:** NCT00368979

**Brief Title:** Dutasteride (GI198745) In Benign Prostatic Hyperplasia Subjects

**Official Title:** Clinical Evaluation of Dutasteride in Benign Prostatic Hyperplasia: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Comparative Study of GI198745 (Dutasteride) in Subjects With Benign Prostatic Hyperplasia.

#### Organization Study ID Info
**ID:** ARI105326
#### Organization
**Class:** INDUSTRY
**Full Name:** GlaxoSmithKline
### Status Module
#### Completion Date
**Date:** 2007-12-06

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2018-09-26

**Type:** ACTUAL

**Last Update Submit Date:** 2018-08-30

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2007-12-01

**Type:** ACTUAL

#### Results First Post Date
**Date:** 2009-04-02

**Type:** ESTIMATED

**Results First Submit Date:** 2008-12-05

**Results First Submit QC Date:** 2009-03-03

#### Start Date
**Date:** 2006-02-17

**Status Verified Date:** 2018-08

#### Study First Post Date
**Date:** 2006-08-29
**Type:** ESTIMATED
**Study First Submit Date:** 2006-08-24
**Study First Submit QC Date:** 2006-08-24
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** GlaxoSmithKline

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** This study will assess the efficacy and safety of GI198745 0.5mg given once daily for 52 weeks to Benign Prostatic Hyperplasia (BPH) patients.

### Conditions Module

**Conditions:**

- Prostatic Hyperplasia

**Keywords:**

- Benign Prostatic Hyperplasia BPH dutasteride

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** DOUBLE

**Who Masked:**

- PARTICIPANT

- INVESTIGATOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 378

**Type:** ACTUAL

**Phases:**

- PHASE3

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Intervention Names:**

- Drug: Dutasteride

**Label:** Dutasteride

**Type:** ACTIVE_COMPARATOR

#### Arm Group 2

**Intervention Names:**

- Drug: Placebo

**Label:** Placebo

**Type:** PLACEBO_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Dutasteride

**Description:** once daily

**Name:** Dutasteride

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- Placebo

**Description:** once daily

**Name:** Placebo

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** The International Prostate Symptom Score (I-PSS) consists of 7 verified questions concerning urinary symptoms and one quality of life question scored from 0 to 5(0=Not at All, to 5=Almost Always). The total score can range from 0 to 35. Score of 1-7=Mild, 8-19=Moderate, 20-35=Severe.

**Measure:** Change From Baseline in International Prostate Symptom Score (IPSS) at Week 52

**Time Frame:** Baseline and Week 52

#### Secondary Outcomes

**Description:** Prostate volume measurements by transrectal ultrasound (TRUS). Average prostate volume (55cc). The Ultrasound scans the prostate in the transverse plane while moving in the cephalocaudal direction of the prostate. The height and width of the prostate section with the greatest surface area is recorded.

**Measure:** Percent Change From Baseline in Prostate Volume at Week 52

**Time Frame:** Baseline and Week 52

**Description:** Improvement is defined as greater than or equal to a 2 point increase in participants total score on the I-PSS questionaire.

**Measure:** Number of Participants With IPSS Improvement From Baseline at Week 52

**Time Frame:** Baseline and Week 52

**Description:** Maximum Urine Flow Rate (Qmax) is the peak flow in milliliters per second.

**Measure:** Change From Baseline in Maximum Urine Flow Rate (Qmax) at Week 52

**Time Frame:** Baseline and Week 52

**Description:** Improvement was defined as an increase in Qmax by greater than or equal to 1 mL/sec

**Measure:** Number of Participants With Qmax Improvement From Baseline at Week 52

**Time Frame:** Baseline and Week 52

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

Only subjects who meet all the following criteria during the screening phase will be enrolled in the study.

1. Diagnosis: BPH
2. Age: ≥50 years
3. Gender: Male
4. Estimated prostate volume ≥30cc (by TRUS)
5. I-PSS Symptom Score (total of 7 items) ≥8 points
6. Maximum flow rate (Qmax) ≤15mL/sec (voided volume measured simultaneously ≤150mL)\*\[1\]
7. Patients who meet either of the following regarding tamsulosin HCl use:

   Patients with tamsulosin HCl use:

   Patients who have received tamsulosin HCl continuously for at least 4 weeks and who are likely to continue to take tamsulosin HCl without any change to the dosage and administration of the drug until the end of study treatment.

   Patients without tamsulosin HCl use:

   Patients who haven't received tamsulosin HCl in the past 4 weeks and who are unlikely to use tamsulosin HCl until the end of study treatment.
8. Outpatients
9. Patients who in person have given written consent

Exclusion Criteria:

Patients who apply to any of the following criteria during the screening phase will not be enrolled in the study.

1. Post void residual volume \>250mL (by suprapubic ultrasound).
2. History of AUR within the previous 12 weeks.
3. Evidence or history of prostate cancer.
4. PSA \>10ng/mL \[in patients with PSA \>4ng/mL, the presence of prostate cancer should be ruled out by the investigator/subinvestigator. DRE and free/total PSA ratio should be considered, and prostate biopsy be conducted if necessary\].
5. Previous surgery (including balloon dilatation, thermotherapy and stent placement) or minimally invasive techniques for BPH.
6. Any causes other than BPH, which may in the judgment of the investigator/subinvestigator, affect evaluation of symptoms or urine flow (e.g., neurogenic bladder, bladder neck contracture, urethral stricture, bladder malignancy, acute/chronic prostatitis, acute/chronic urinary tract infection).
7. History of any unstable, serious co-existing medical condition(s) including, but not limited to, myocardial infarction, coronary bypass surgery, unstable angina, cardiac arrhythmias\*\[2\], congestive heart failure or cerebrovascular accident within the previous 6 months; or diabetes mellitus or peptic ulcer uncontrollable with medical treatment.
8. Liver function tests (AST, ALT, AL-P) \>2 times the upper limit of normal.
9. Serum cleatinine \>1.8mg/dL.
10. Use of any antiandrogen (e.g., chlormadinone acetate, allylesterenol) for BPH within the previous 12 months.
11. Use of a1-adrenoceptor blockers excluding tamsulosin HCl (e.g., prazosin HCl, urapidil slow-release capsule formulation, terazosin HCl, naftopidil), plant extract preparations for treatment of BPH (e.g., Eviprostat, cernitin pollen extract), herbal medicines (e.g., hachimi-jio-gan, gosha-jinki-gan), other drugs (e.g., Paraprost), and dietary or herbal supplements (e.g., saw palmetto) for relief of BPH symptoms within the previous 4 weeks.

Use of a-adrenoceptor agonists (e.g., pseudoephedrine, phenyle

* \[1\] Subjects with voided volume \<150 mL at Qmax measurement cannot be enrolled in the study and may undergo re-measurement of Qmax before the visit for Week 0 for study entry.
* \[2\] Of "Degree II" according to "Grading of Side Effects (PMSB Notification No. 80 dated June 29, 1992) or equivalent (Appendix 4).

**Minimum Age:** 50 Years

**Sex:** MALE

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Chiba

**Country:** Japan

**Facility:** GSK Investigational Site

**Zip:** 263-0043

**Location 2:**

**City:** Chiba

**Country:** Japan

**Facility:** GSK Investigational Site

**Zip:** 266-0031

**Location 3:**

**City:** Chiba

**Country:** Japan

**Facility:** GSK Investigational Site

**Zip:** 272-0107

**Location 4:**

**City:** Fukuoka

**Country:** Japan

**Facility:** GSK Investigational Site

**Zip:** 802-0077

**Location 5:**

**City:** Fukuoka

**Country:** Japan

**Facility:** GSK Investigational Site

**Zip:** 810-0001

**Location 6:**

**City:** Fukuoka

**Country:** Japan

**Facility:** GSK Investigational Site

**Zip:** 830-0027

**Location 7:**

**City:** Hyogo

**Country:** Japan

**Facility:** GSK Investigational Site

**Zip:** 660-0052

**Location 8:**

**City:** Kanagawa

**Country:** Japan

**Facility:** GSK Investigational Site

**Zip:** 215-0021

**Location 9:**

**City:** Kanagawa

**Country:** Japan

**Facility:** GSK Investigational Site

**Zip:** 226-0025

**Location 10:**

**City:** Kanagawa

**Country:** Japan

**Facility:** GSK Investigational Site

**Zip:** 229-1103

**Location 11:**

**City:** Kanagawa

**Country:** Japan

**Facility:** GSK Investigational Site

**Zip:** 245-0015

**Location 12:**

**City:** Kanagawa

**Country:** Japan

**Facility:** GSK Investigational Site

**Zip:** 252-0804

**Location 13:**

**City:** Kanagawa

**Country:** Japan

**Facility:** GSK Investigational Site

**Zip:** 259-1132

**Location 14:**

**City:** Kyoto

**Country:** Japan

**Facility:** GSK Investigational Site

**Zip:** 604-8436

**Location 15:**

**City:** Oita

**Country:** Japan

**Facility:** GSK Investigational Site

**Zip:** 871-0012

**Location 16:**

**City:** Oita

**Country:** Japan

**Facility:** GSK Investigational Site

**Zip:** 874-0937

**Location 17:**

**City:** Osaka

**Country:** Japan

**Facility:** GSK Investigational Site

**Zip:** 542-0073

**Location 18:**

**City:** Osaka

**Country:** Japan

**Facility:** GSK Investigational Site

**Zip:** 562-0036

**Location 19:**

**City:** Osaka

**Country:** Japan

**Facility:** GSK Investigational Site

**Zip:** 584-0074

**Location 20:**

**City:** Tokyo

**Country:** Japan

**Facility:** GSK Investigational Site

**Zip:** 130-0026

**Location 21:**

**City:** Tokyo

**Country:** Japan

**Facility:** GSK Investigational Site

**Zip:** 131-0032

**Location 22:**

**City:** Tokyo

**Country:** Japan

**Facility:** GSK Investigational Site

**Zip:** 150-0002

**Location 23:**

**City:** Tokyo

**Country:** Japan

**Facility:** GSK Investigational Site

**Zip:** 152-0001

**Location 24:**

**City:** Tokyo

**Country:** Japan

**Facility:** GSK Investigational Site

**Zip:** 153-0051

**Location 25:**

**City:** Tokyo

**Country:** Japan

**Facility:** GSK Investigational Site

**Zip:** 183-0044

**Location 26:**

**City:** Tokyo

**Country:** Japan

**Facility:** GSK Investigational Site

**Zip:** 186-0011

#### Overall Officials

**Official 1:**

**Affiliation:** GlaxoSmithKline

**Name:** GSK Clinical Trials

**Role:** STUDY_DIRECTOR

### References Module

#### References

**Citation:** Tsukamoto T, Endo Y, Narita M. Efficacy and safety of dutasteride in Japanese men with benign prostatic hyperplasia. Int J Urol. 2009 Sep;16(9):745-50. doi: 10.1111/j.1442-2042.2009.02357.x. Epub 2009 Aug 5.

**PMID:** 19674165

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000010335

- Term: Pathologic Processes

- ID: D000011469

- Term: Prostatic Diseases

- ID: D000005832

- Term: Genital Diseases, Male

- ID: D000091662

- Term: Genital Diseases

- ID: D000091642

- Term: Urogenital Diseases

- ID: D000052801

- Term: Male Urogenital Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BXS

- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

### Condition Browse Module - Browse Leaves

- ID: M14334

- Name: Prostatic Hyperplasia

- Relevance: HIGH

- As Found: Prostatic Hyperplasia

- ID: M10016

- Name: Hyperplasia

- Relevance: HIGH

- As Found: Hyperplasia

- ID: M14333

- Name: Prostatic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M2876

- Name: Genital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8944

- Name: Genital Diseases, Male

- Relevance: LOW

- As Found: Unknown

- ID: M2875

- Name: Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M27095

- Name: Male Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000011470

- Term: Prostatic Hyperplasia

- ID: D000006965

- Term: Hyperplasia

### Intervention Browse Module - Ancestors

- ID: D000058891

- Term: 5-alpha Reductase Inhibitors

- ID: D000065088

- Term: Steroid Synthesis Inhibitors

- ID: D000004791

- Term: Enzyme Inhibitors

- ID: D000045504

- Term: Molecular Mechanisms of Pharmacological Action

- ID: D000006727

- Term: Hormone Antagonists

- ID: D000006730

- Term: Hormones, Hormone Substitutes, and Hormone Antagonists

- ID: D000045505

- Term: Physiological Effects of Drugs

### Intervention Browse Module - Browse Branches

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M270

- Name: Dutasteride

- Relevance: HIGH

- As Found: Cells/kg

- ID: M29274

- Name: 5-alpha Reductase Inhibitors

- Relevance: LOW

- As Found: Unknown

- ID: M7951

- Name: Enzyme Inhibitors

- Relevance: LOW

- As Found: Unknown

- ID: M9789

- Name: Hormones

- Relevance: LOW

- As Found: Unknown

- ID: M9788

- Name: Hormone Antagonists

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000068538

- Term: Dutasteride

### Misc Info Module

- Version Holder: 2024-05-24

## Results Section

### Adverse Events Module

**Description:** Serious adverse events (SAEs) and non-serious AEs were collected in all participants who received at least one dose of the investigational product.

#### Event Groups

**Group ID:** EG000

**Title:** Placebo

**Description:** Subjects who took no study medication capsule once daily for 52 weeks followed by up to 16 weeks of post-dosing assessments.

**ID:** EG000

**Other Num Affected:** 116

**Other Num at Risk:** 184

**Serious Number Affected:** 8

**Serious Number At Risk:** 184

**Title:** Placebo

**Group ID:** EG001

**Title:** Dutasteride

**Description:** Subjects who took dutasteride, study medication of 0.5 mg capsule once daily for 52 weeks followed by up to 16 weeks of post-dosing assessments.

**ID:** EG001

**Other Num Affected:** 124

**Other Num at Risk:** 193

**Serious Number Affected:** 20

**Serious Number At Risk:** 193

**Title:** Dutasteride

**Frequency Threshold:** 5

#### Other Events

**Term:** Nasopharyngitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA (9.0)

**Term:** Diarrhoea

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA (9.0)

**Term:** Upper respiratory tract inflammation

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** MedDRA (9.0)

**Term:** Back pain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** MedDRA (9.0)

**Term:** Constipation

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA (9.0)

**Term:** Eczema

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** MedDRA (9.0)

**Term:** Headache

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA (9.0)

**Term:** Arthralgia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** MedDRA (9.0)

**Term:** Gastritis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA (9.0)

#### Serious Events

**Term:** Colonic polyp

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA (9.0)

##### Stats

**Group ID:** EG000

**Num At Risk:** 184

**Group ID:** EG001

**Num Affected:** 3

**Num At Risk:** 193

**Term:** Inguinal hernia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA (9.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 184

**Group ID:** EG001

**Num At Risk:** 193

**Term:** Enterocolitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA (9.0)

##### Stats

**Group ID:** EG000

**Num At Risk:** 184

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 193

**Term:** Haemorrhoids

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA (9.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 184

**Group ID:** EG001

**Num At Risk:** 193

**Term:** Intestinal obstruction

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA (9.0)

##### Stats

**Group ID:** EG000

**Num At Risk:** 184

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 193

**Term:** Gastric cancer

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps)

**Source Vocabulary:** MedDRA (9.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 184

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 193

**Term:** Bladder cancer

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps)

**Source Vocabulary:** MedDRA (9.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 184

**Group ID:** EG001

**Num At Risk:** 193

**Term:** Lymph node cancer metastatic

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps)

**Source Vocabulary:** MedDRA (9.0)

##### Stats

**Group ID:** EG000

**Num At Risk:** 184

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 193

**Term:** Meningioma

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps)

**Source Vocabulary:** MedDRA (9.0)

##### Stats

**Group ID:** EG000

**Num At Risk:** 184

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 193

**Term:** Pancreatic carcinoma

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps)

**Source Vocabulary:** MedDRA (9.0)

##### Stats

**Group ID:** EG000

**Num At Risk:** 184

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 193

**Term:** Cerebral infarction

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA (9.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 184

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 193

**Term:** Dementia Alzheimer's type

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA (9.0)

##### Stats

**Group ID:** EG000

**Num At Risk:** 184

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 193

**Term:** Thrombotic stroke

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA (9.0)

##### Stats

**Group ID:** EG000

**Num At Risk:** 184

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 193

**Term:** Intervertebral disc protrusion

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** MedDRA (9.0)

##### Stats

**Group ID:** EG000

**Num At Risk:** 184

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 193

**Term:** Lumbar spinal stenosis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** MedDRA (9.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 184

**Group ID:** EG001

**Num At Risk:** 193

**Term:** Synovitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** MedDRA (9.0)

##### Stats

**Group ID:** EG000

**Num At Risk:** 184

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 193

**Term:** Acute myocardial infarction

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA (9.0)

##### Stats

**Group ID:** EG000

**Num At Risk:** 184

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 193

**Term:** Coronary artery stenosis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** MedDRA (9.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 184

**Group ID:** EG001

**Num At Risk:** 193

**Term:** Pneumonia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA (9.0)

##### Stats

**Group ID:** EG000

**Num At Risk:** 184

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 193

**Term:** Urinary tract infection

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

**Source Vocabulary:** MedDRA (9.0)

##### Stats

**Group ID:** EG000

**Num At Risk:** 184

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 193

**Term:** Aortic dissection

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Vascular disorders

**Source Vocabulary:** MedDRA (9.0)

##### Stats

**Group ID:** EG000

**Num At Risk:** 184

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 193

**Term:** Microscopic polyangiitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Vascular disorders

**Source Vocabulary:** MedDRA (9.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 184

**Group ID:** EG001

**Num At Risk:** 193

**Term:** Macular degeneration

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Eye disorders

**Source Vocabulary:** MedDRA (9.0)

##### Stats

**Group ID:** EG000

**Num At Risk:** 184

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 193

**Term:** Cholangitis

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Hepatobiliary disorders

**Source Vocabulary:** MedDRA (9.0)

##### Stats

**Group ID:** EG000

**Num At Risk:** 184

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 193

## Results Section - Baseline Characteristics Module

### Denomination Counts

**Group ID:** BG000

**Value:** 181

**Group ID:** BG001

**Value:** 184

**Group ID:** BG002

**Value:** 365

**Units:** Participants

### Group

**ID:** BG000

**Title:** Placebo

**Description:** Subjects who took no study medication capsule once daily for 52 weeks followed by up to 16 weeks of post-dosing assessments.

### Group

**ID:** BG001

**Title:** Dutasteride

**Description:** Subjects who took dutasteride, study medication of 0.5 mg capsule once daily for 52 weeks followed by up to 16 weeks of post-dosing assessments.

### Group

**ID:** BG002

**Title:** Total

**Description:** Total of all reporting groups

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 6.76

**Value:** 66.9

#### Measurement

**Group ID:** BG001

**Spread:** 6.07

**Value:** 68.0

#### Measurement

**Group ID:** BG002

**Spread:** 6.44

**Value:** 67.4

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

**Category Title:** Female

#### Measurement

**Group ID:** BG000

**Value:** 181

#### Measurement

**Group ID:** BG001

**Value:** 184

#### Measurement

**Group ID:** BG002

**Value:** 365

**Category Title:** Male

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 181

#### Measurement

**Group ID:** BG001

**Value:** 184

#### Measurement

**Group ID:** BG002

**Value:** 365

**Class Title:** Asian-Japanese

**Denomination Units Selected:** 

## Results Section - Baseline Characteristics Module

### Measure 1
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Title:** Age, Continuous
**Unit of Measure:** years
### Measure 2
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Sex: Female, Male
**Unit of Measure:** Participants
### Measure 3
**Parameter Type:** NUMBER
**Title:** Race/Ethnicity, Customized
**Unit of Measure:** participants
## Results Section - More Information Module
### Certain Agreement
**Other Details:** 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.
**Restriction Type:** OTHER
**Restrictive Agreement:** True
### Point of Contact
**Organization:** GlaxoSmithKline
**Phone:** 866-435-7343
**Title:** GSK Response center
## Results Section - Outcome Measures Module
### Outcome Measure 1
#### Analysis
**CI Lower Limit:** -2.7
**CI Number of Sides:** 
**CI Percentage Value:** 95
**CI Upper Limit:** -0.5
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.003
**P-Value Comment:** 
**Parameter Type:** Mean Difference (Net)
**Parameter Value:** -1.6
**Statistical Comment:** 
**Statistical Method:** ANCOVA
**Tested Non-Inferiority:** 
### Outcome Measure 2
### Outcome Measure 3
### Outcome Measure 4
### Outcome Measure 5
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 5.72
- **Upper Limit:** 
- **Value:** -3.6
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 5.94
- **Upper Limit:** 
- **Value:** -5.5
**Title:** 
#### Outcome Measure 2
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 18.76
- **Upper Limit:** 
- **Value:** -8.9
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 16.85
- **Upper Limit:** 
- **Value:** -31.5
**Title:** 
#### Outcome Measure 3
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 113
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 139
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 102
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 128
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 82
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 115
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 75
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 94
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 62
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 82
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 99
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 122
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 84
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 114
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 71
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 106
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 54
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 86
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 39
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 67
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 7
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 17
**Title:** 
#### Outcome Measure 4
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 3.82
- **Upper Limit:** 
- **Value:** 0.6
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 4.89
- **Upper Limit:** 
- **Value:** 2.2
**Title:** 
#### Outcome Measure 5
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 79
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 103
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 56
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 86
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 45
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 73
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 44
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 70
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 29
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 53
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 22
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 44
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 4
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 11
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 41
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 63
**Title:** 
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Description:** The International Prostate Symptom Score (I-PSS) consists of 7 verified questions concerning urinary symptoms and one quality of life question scored from 0 to 5(0=Not at All, to 5=Almost Always). The total score can range from 0 to 35. Score of 1-7=Mild, 8-19=Moderate, 20-35=Severe.
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** The Full Analysis Set (FAS) which consisted of all randomized participants with a history excluding those who received no dose of the investigational product and who had no baseline or post baseline IPSS data. Last Observation Carried Forward (LOCF) method for lost data.
**Reporting Status:** POSTED
**Time Frame:** Baseline and Week 52
**Title:** Change From Baseline in International Prostate Symptom Score (IPSS) at Week 52
**Type:** PRIMARY
**Unit of Measure:** score on a scale
##### Group
**Description:** Subjects who took no study medication capsule once daily for 52 weeks followed by up to 16 weeks of post-dosing assessments.
**ID:** OG000
**Title:** Placebo
##### Group
**Description:** Subjects who took dutasteride, study medication of 0.5 mg capsule once daily for 52 weeks followed by up to 16 weeks of post-dosing assessments.
**ID:** OG001
**Title:** Dutasteride
#### Outcome Measure 2
**Description:** Prostate volume measurements by transrectal ultrasound (TRUS). Average prostate volume (55cc). The Ultrasound scans the prostate in the transverse plane while moving in the cephalocaudal direction of the prostate. The height and width of the prostate section with the greatest surface area is recorded.
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** The Full Analysis Set (FAS) which consisted of all randomized participants with a history excluding those who received no dose of the investigational product and who had no baseline or post baseline IPSS data. Last Observation Carried Forward (LOCF) method for lost data.
**Reporting Status:** POSTED
**Time Frame:** Baseline and Week 52
**Title:** Percent Change From Baseline in Prostate Volume at Week 52
**Type:** SECONDARY
**Unit of Measure:** cubic centimeters (cc)
##### Group
**Description:** Subjects who took no study medication capsule once daily for 52 weeks followed by up to 16 weeks of post-dosing assessments.
**ID:** OG000
**Title:** Placebo
##### Group
**Description:** Subjects who took dutasteride, study medication of 0.5 mg capsule once daily for 52 weeks followed by up to 16 weeks of post-dosing assessments.
**ID:** OG001
**Title:** Dutasteride
#### Outcome Measure 3
**Description:** Improvement is defined as greater than or equal to a 2 point increase in participants total score on the I-PSS questionaire.
**Parameter Type:** NUMBER
**Population Description:** The Full Analysis Set (FAS) which consisted of all randomized participants with a history excluding those who received no dose of the investigational product and who had no baseline or post baseline IPSS data. Last Observation Carried Forward (LOCF) method for lost data.
**Reporting Status:** POSTED
**Time Frame:** Baseline and Week 52
**Title:** Number of Participants With IPSS Improvement From Baseline at Week 52
**Type:** SECONDARY
**Unit of Measure:** participants
##### Group
**Description:** Subjects who took no study medication capsule once daily for 52 weeks followed by up to 16 weeks of post-dosing assessments.
**ID:** OG000
**Title:** Placebo
##### Group
**Description:** Subjects who took dutasteride, study medication of 0.5 mg capsule once daily for 52 weeks followed by up to 16 weeks of post-dosing assessments.
**ID:** OG001
**Title:** Dutasteride
#### Outcome Measure 4
**Description:** Maximum Urine Flow Rate (Qmax) is the peak flow in milliliters per second.
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** The Full Analysis Set (FAS) which consisted of all randomized participants with a history excluding those who received no dose of the investigational product and who had no baseline or post baseline IPSS data. Last Observation Carried Forward (LOCF) method for lost data.
**Reporting Status:** POSTED
**Time Frame:** Baseline and Week 52
**Title:** Change From Baseline in Maximum Urine Flow Rate (Qmax) at Week 52
**Type:** SECONDARY
**Unit of Measure:** milliliters per second (mL/sec)
##### Group
**Description:** Subjects who took no study medication capsule once daily for 52 weeks followed by up to 16 weeks of post-dosing assessments.
**ID:** OG000
**Title:** Placebo
##### Group
**Description:** Subjects who took dutasteride, study medication of 0.5 mg capsule once daily for 52 weeks followed by up to 16 weeks of post-dosing assessments.
**ID:** OG001
**Title:** Dutasteride
#### Outcome Measure 5
**Description:** Improvement was defined as an increase in Qmax by greater than or equal to 1 mL/sec
**Parameter Type:** NUMBER
**Population Description:** The Full Analysis Set (FAS) which consisted of all randomized participants with a history excluding those who received no dose of the investigational product and who had no baseline or post baseline IPSS data. Last Observation Carried Forward (LOCF) method for lost data.
**Reporting Status:** POSTED
**Time Frame:** Baseline and Week 52
**Title:** Number of Participants With Qmax Improvement From Baseline at Week 52
**Type:** SECONDARY
**Unit of Measure:** participants
##### Group
**Description:** Subjects who took no study medication capsule once daily for 52 weeks followed by up to 16 weeks of post-dosing assessments.
**ID:** OG000
**Title:** Placebo
##### Group
**Description:** Subjects who took dutasteride, study medication of 0.5 mg capsule once daily for 52 weeks followed by up to 16 weeks of post-dosing assessments.
**ID:** OG001
**Title:** Dutasteride
### Participant Flow Module
#### Group
**Description:** Subjects who took no study medication capsule once daily for 52 weeks followed by up to 16 weeks of post-dosing assessments.
**ID:** FG000
**Title:** Placebo
#### Group
**Description:** Subjects who took dutasteride, study medication of 0.5 mg capsule once daily for 52 weeks followed by up to 16 weeks of post-dosing assessments.
**ID:** FG001
**Title:** Dutasteride
#### Period
**Title:** Overall Study
##### Withdraw
**Type:** Adverse Event
###### Reason
**Group ID:** FG000
**Number of Subjects:** 9
###### Reason
**Group ID:** FG001
**Number of Subjects:** 16
##### Withdraw
**Type:** Lack of Efficacy
###### Reason
**Group ID:** FG000
**Number of Subjects:** 5
###### Reason
**Group ID:** FG001
**Number of Subjects:** 3
##### Withdraw
**Type:** Other
###### Reason
**Group ID:** FG000
**Number of Subjects:** 3
###### Reason
**Group ID:** FG001
**Number of Subjects:** 1
##### Withdraw
**Type:** Lost to Follow-up
###### Reason
**Group ID:** FG000
**Number of Subjects:** 1
###### Reason
**Group ID:** FG001
**Number of Subjects:** 0
##### Withdraw
**Type:** Protocol Violation
###### Reason
**Group ID:** FG000
**Number of Subjects:** 2
###### Reason
**Group ID:** FG001
**Number of Subjects:** 1
##### Withdraw
**Type:** Withdrawal by Subject
###### Reason
**Group ID:** FG000
**Number of Subjects:** 5
###### Reason
**Group ID:** FG001
**Number of Subjects:** 9
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 185
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 193
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 160
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 163
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 25
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 30
**Has Results:** True