Trial · NCT00368979

Dutasteride (GI198745) In Benign Prostatic Hyperplasia Subjects

NCT00368979, Phase 3, Completed, GlaxoSmithKline; results first posted 2009-04-02

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Dutasteride (GI198745) In Benign Prostatic Hyperplasia Subjects. Trials, record NCT00368979. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00368979

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Dutasteride (GI198745) In Benign Prostatic Hyperplasia Subjects
NCT number: NCT00368979
Status: Completed
Phases: Phase 3
Enrollment: 378 participants, actual
Lead sponsor: GlaxoSmithKline
Conditions: Prostatic Hyperplasia
Interventions: Dutasteride, Placebo
First posted: 2006-08-29
Last updated: 2018-09-26
Results first posted: 2009-04-02

Source ClinicalTrials.gov

Registered outcomes5

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change From Baseline in International Prostate Symptom Score (IPSS) at Week 52	Baseline and Week 52	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.
Secondary	Percent Change From Baseline in Prostate Volume at Week 52	Baseline and Week 52	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.
Secondary	Number of Participants With IPSS Improvement From Baseline at Week 52	Baseline and Week 52	Improvement is defined as greater than or equal to a 2 point increase in participants total score on the I-PSS questionaire.
Secondary	Change From Baseline in Maximum Urine Flow Rate (Qmax) at Week 52	Baseline and Week 52	Maximum Urine Flow Rate (Qmax) is the peak flow in milliliters per second.
Secondary	Number of Participants With Qmax Improvement From Baseline at Week 52	Baseline and Week 52	Improvement was defined as an increase in Qmax by greater than or equal to 1 mL/sec

Source ClinicalTrials.gov

Outcomes5

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change From Baseline in International Prostate Symptom Score (IPSS) at Week 52	Baseline and Week 52	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.	score on a scale	MEAN
SECONDARY	Percent Change From Baseline in Prostate Volume at Week 52	Baseline and Week 52	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.	cubic centimeters (cc)	MEAN
SECONDARY	Number of Participants With IPSS Improvement From Baseline at Week 52	Baseline and Week 52	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.	participants	NUMBER
SECONDARY	Change From Baseline in Maximum Urine Flow Rate (Qmax) at Week 52	Baseline and Week 52	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.	milliliters per second (mL/sec)	MEAN
SECONDARY	Number of Participants With Qmax Improvement From Baseline at Week 52	Baseline and Week 52	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.	participants	NUMBER

Source ClinicalTrials.gov

Results by group44

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Change From Baseline in International Prostate Symptom Score (IPSS) at Week 52	Placebo		-3.6	Standard Deviation 5.72	score on a scale
Change From Baseline in International Prostate Symptom Score (IPSS) at Week 52	Dutasteride		-5.5	Standard Deviation 5.94	score on a scale
Percent Change From Baseline in Prostate Volume at Week 52	Placebo		-8.9	Standard Deviation 18.76	cubic centimeters (cc)
Percent Change From Baseline in Prostate Volume at Week 52	Dutasteride		-31.5	Standard Deviation 16.85	cubic centimeters (cc)
Number of Participants With IPSS Improvement From Baseline at Week 52	Placebo	Improvement >=2 Points	113		participants
Number of Participants With IPSS Improvement From Baseline at Week 52	Dutasteride	Improvement >=2 Points	139		participants
Number of Participants With IPSS Improvement From Baseline at Week 52	Placebo	Improvement >=3 Points	102		participants
Number of Participants With IPSS Improvement From Baseline at Week 52	Dutasteride	Improvement >=3 Points	128		participants
Number of Participants With IPSS Improvement From Baseline at Week 52	Placebo	Improvement >=4 Points	82		participants
Number of Participants With IPSS Improvement From Baseline at Week 52	Dutasteride	Improvement >=4 Points	115		participants

1 to 10 of 44Source ClinicalTrials.gov

See all 44 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Placebo	185
Overall Study	STARTED	Dutasteride	193
Overall Study	COMPLETED	Placebo	160
Overall Study	COMPLETED	Dutasteride	163
Overall Study	NOT COMPLETED	Placebo	25
Overall Study	NOT COMPLETED	Dutasteride	30

Source ClinicalTrials.gov

Adverse events66

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Nasopharyngitis	Infections and infestations	Placebo	78	184
other	Nasopharyngitis	Infections and infestations	Dutasteride	80	193
other	Diarrhoea	Gastrointestinal disorders	Placebo	16	184
other	Diarrhoea	Gastrointestinal disorders	Dutasteride	19	193
other	Upper respiratory tract inflammation	Respiratory, thoracic and mediastinal disorders	Placebo	14	184
other	Upper respiratory tract inflammation	Respiratory, thoracic and mediastinal disorders	Dutasteride	19	193
other	Back pain	Musculoskeletal and connective tissue disorders	Placebo	14	184
other	Back pain	Musculoskeletal and connective tissue disorders	Dutasteride	12	193
other	Constipation	Gastrointestinal disorders	Placebo	12	184
other	Constipation	Gastrointestinal disorders	Dutasteride	13	193

1 to 10 of 66Source ClinicalTrials.gov

See all 66 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Placebo
Total, all-cause mortality	Dutasteride
Total, other adverse events	Placebo	116	184
Total, other adverse events	Dutasteride	124	193
Total, serious adverse events	Placebo	8	184
Total, serious adverse events	Dutasteride	20	193

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
19674165	BACKGROUND

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
Dutasteride vs Placebo: serious adverse events

Source Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

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