Trial · NCT01294592

Comparative Efficacy of Dutasteride Plus Tamulosin With Lifestyle Advice Versus Watchful Waiting Plus Lifestyle Advice in the Management of Treatment naïve Men With Moderately Symptomatic Benign Prostatic Hyperplasia and Prostate Enlargement

NCT01294592, Phase 4, Completed, GlaxoSmithKline; results first posted 2014-06-16

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Comparative Efficacy of Dutasteride Plus Tamulosin With Lifestyle Advice Versus Watchful Waiting Plus Lifestyle Advice in the Management of Treatment naïve Men With Moderately Symptomatic Benign Prostatic Hyperplasia and Prostate Enlargement. Trials, record NCT01294592. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01294592

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Trial

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

Title: Comparative Efficacy of Dutasteride Plus Tamulosin With Lifestyle Advice Versus Watchful Waiting Plus Lifestyle Advice in the Management of Treatment naïve Men With Moderately Symptomatic Benign Prostatic Hyperplasia and Prostate Enlargement
NCT number: NCT01294592
Status: Completed
Phases: Phase 4
Enrollment: 742 participants, actual
Lead sponsor: GlaxoSmithKline
Conditions: Prostatic Hyperplasia
Interventions: Dutasteride plus tamsulosin, tamsulosin
First posted: 2011-02-11
Last updated: 2018-08-20
Results first posted: 2014-06-16

Source ClinicalTrials.gov

Registered outcomes11

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

List	Outcome	Time frame	Description
Primary	Change From Baseline in the Total International Prostate Symptom Score (IPSS) at Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the Last Observation Carried Forward (LOCF) Approach	Baseline and Months 1, 3, 6, 9, 12, 15, 18, 21, and 24	The IPSS questionnaire is a 7-item self-administered questionnaire designed to quantify the following urinary symptoms: Question 1 (Q1), incomplete emptying; Q2, frequency; Q3, intermittency; Q4, urgency; Q5, weak stream; Q6, straining; Q7, nocturia. It has an additional, independent eighth question to assess change in BPH-related health status (BHS) and quality of life. BHS scores range from 0 to 6, where 0 indicates "delighted" and 6 indicates "terrible." The 7 items in the IPSS questionnaire quantitatively measure the level of urinary symptoms reported as a total IPSS. The total IPSS (sum of the first 7 items) can range from 0 to 35: mild (0 to 7), moderate (8 to 19), or severe (20 to 35). Change from Baseline in IPSS total score was calculated as the Month 24 value minus the Baseline value. LOCF analysis involves bringing forward the last non-missing post-Baseline assessment for a participant with missing data and/or for a participant who discontinued from the study.
Secondary	Number of Participants With Change From Baseline in the Indicated Improvement Categories in the IPSS at Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach	Baseline and Months 1, 3, 6, 9, 12, 15, 18, 21, and 24	Symptom improvement was assessed using IPSS categorical changes from Baseline. Change from Baseline categories were summarized by treatment group using five improvement levels: \>=1 point through \>=5 points. IPSS percent change from Baseline was summarized using seven improvement levels: \>0 percent, \>=10 percent, \>=20 percent, \>=25 percent, \>=30 percent, \>=40 percent, and \>=50 percent. Change in IPSS from Baseline was analysed using the LOCF method and is summarized for the following categories: \>=2 points, \>=3 points, and percent change \>=25. The 7 items in the IPSS questionnaire quantitatively measure the level of urinary symptoms reported as a total IPSS. The total IPSS (sum of the first 7 items) can range from 0 to 35: mild (0 to 7), moderate (8 to 19), or severe (20 to 35).
Secondary	Change From Baseline in the BPH Impact Index (BII) Score at Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach	Baseline and Months 1, 3, 6, 9, 12, 15, 18, 21, and 24	The BII is a 4-item questionnaire covering physical discomfort, worry, bother, and impact on usual activities, with a minimum score of 0 (best) and a maximum score (worst) of 13 points. Individual missing questionnaire responses were imputed, as applicable. Change from Baseline in the BII score was summarized by treatment group using the LOCF approach at each scheduled post-Baseline assessment. LOCF analysis involves bringing forward the last non-missing post-Baseline assessment for a participant with missing data and/or for a participant who discontinued from the study. Estimates are based on the adjusted means from the general linear model: Change from Baseline =Treatment + Cluster + Baseline Value. Baseline is defined as the Visit 2 value if it exists; otherwise, it is the latest of all Screening values. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Secondary	Change From Baseline in the BPH-related Health Status (BHS) Score at Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach	Baseline and Months 1, 3, 6, 9, 12, 15, 18, 21, and 24	Each participant was asked the following question "If you were to spend the rest of your life with your urinary condition just the way it is now, how would you feel about that?". This response was rated from 0 ("delighted") to 6 ("terrible"). Change from Baseline in the BHS score was summarized by treatment group using the LOCF approach at each scheduled post-Baseline assessment. LOCF analysis involves bringing forward the last non-missing post-Baseline assessment for a participant with missing data and/or for a participant who discontinued from the study. Estimates are based on the adjusted means from the general linear model: Change from Baseline =Treatment + Cluster + Baseline Value. Baseline is defined as the Visit 2 value if it exists; otherwise, it is the latest of all Screening values. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Secondary	Number of Events of Clinical Progression (CP) of BPH	Up to 2 years	The number of participants with the first occurrence of clinical progression (CP) of BPH occurring on or after the randomization date are summarized by treatment and year. Time is based on the date of the first-occurring CP event, and is relative to the randomization date. CP of BPH is a composite of five endpoints assessed through the end of the study, including: symptom deterioration by IPSS \>=3 points from Baseline (Visit 2); acute urinary retention related to BPH; incontinence (overflow or urge) related to BPH; recurrent urinary tract infection (UTI) or urosepsis related to BPH; renal insufficiency related to BPH (a single \>=50% rise from Baseline serum creatinine and a total value \>=1.5 milligrams/deciliter). For components that required multiple episodes, the first of the multiple episodes was utilized in terms of timing.
Secondary	Number of Participants With the Indicated First-occurring Component of Clinical Progression (CP) of BPH	Up to Month 24	CP of BPH is a composite of five endpoints assessed through the end of the study, including: symptom progression (symptom deterioration by IPSS \>=3 points from Baseline \[Visit 2\]); acute urinary retention (AUR) related to BPH; incontinence (overflow or urge) related to BPH; recurrent urinary tract infection (UTI) or urosepsis related to BPH; renal insufficiency related to BPH (a single \>=50% rise from Baseline serum creatinine and a total value \>=1.5 milligrams/deciliter). The number of participants with CP of BPH, the number of participants with the indicated first-occurring component of CP of BPH, the number of participants with two simultaneously first-occurring components ("Tied for first component"), and the number of participants with multiple first-occurring components were summarized by treatment group.
Secondary	Number of Participants Who Had Any BPH-related Surgery, Who Had the Indicated Type of Surgery, Who Had 2 BPH-related Surgeries, and Who Had >=3 BPH-related Surgeries	Up to Month 24	BPH-related surgery was summarized for events occurring on or after the date of randomization. The number of participants who had any BPH-related surgery, the indicated type of surgery, and multiple surgeries was summarized by treatment. Type of surgery data (cystoscopy, transurethral resection of the prostate \[TURP\], and prostatectomy) are presented in terms of the first-occurring BPH-related surgery after randomization. It was possible for a single participant to have multiple surgeries.
Secondary	Number of Participants With the Indicated Responses to Question 1 of the Patient Perception of Study Treatment (PPST) Questionnaire at Baseline and Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach	Baseline and Months 1, 3, 6, 9, 12, 15, 18, 21, and 24	The PPST questionnaire consists of two questions (asked to determine how satisfied participants are with the treatment received) and was administered at Baseline and all post-Baseline visits. Question 1 was: "Overall, how satisfied are you with the treatment and its effect on your urinary problems?" There were seven possible responses, including: "very satisfied," "satisfied," "somewhat satisfied," neutral," "somewhat dissatisfied," "dissatisfied," and "very dissatisfied." Response categories were created by grouping together "very satisfied," "satisfied," and "somewhat satisfied" responses into the category of "Any Satisfaction (AS)," and separately grouping "neutral," "somewhat dissatisfied," "dissatisfied," and "very dissatisfied" responses into the category of "Neutral or Any Dissatisfaction (N/AD)." The LOCF method involves bringing forward the last non-missing post-Baseline assessment for a participant with missing data and/or for a participant who discontinued from the study.
Secondary	Number of Participants With the Indicated Responses to Question 2 of the Patient Perception of Study Treatment (PPST) Questionnaire at Baseline and Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach	Baseline and Months 1, 3, 6, 9, 12, 15, 18, 21, and 24	The PPST questionnaire consists of two questions (asked to determine how satisfied participants are with the treatment received) and was administered at Baseline and all post-Baseline visits. Question 2 was: "Would you ask your doctor for the treatment you received in this study?" There were three possible responses, including: "Yes," "No," and "Not sure." Response categories included "Yes" and "No or Not Sure," created by grouping together "No" and "Not sure." The LOCF method involves bringing forward the last non-missing post-Baseline assessment for a participant with missing data and/or for a participant who discontinued from the study.
Secondary	Exposure to Study Drug	Up to 2 years	Study drug exposure (days) = treatment stop date - treatment start date + 1. Participants in the Watchful Waiting Escalated=Yes subgroup could have been escalated to study drug at any time during the study. Therefore, it is possible that participants were exposed to tamsulosin for a shorter length of time than participants in the dutasteride plus tamsulosin group.

1 to 10 of 11Source ClinicalTrials.gov

See all 11 registered outcomes

Outcomes11

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 the Total International Prostate Symptom Score (IPSS) at Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the Last Observation Carried Forward (LOCF) Approach	Baseline and Months 1, 3, 6, 9, 12, 15, 18, 21, and 24	Intent-to-Treat (ITT) Population: all randomized participants regardless of whether or not treatment was administered. Any participant who received a treatment randomization number was considered to have been randomized. Participants with data available at the specified time point or using LOCF (post-Baseline) were summarized.	Scores on a scale	LEAST_SQUARES_MEAN
SECONDARY	Number of Participants With Change From Baseline in the Indicated Improvement Categories in the IPSS at Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach	Baseline and Months 1, 3, 6, 9, 12, 15, 18, 21, and 24	ITT Population. Participants with data available at the specified time point or using LOCF (post-Baseline) were summarized. LOCF analysis involves bringing forward the last non-missing post-Baseline assessment for a participant with missing data and/or for a participant who discontinued from the study.	Participants	NUMBER
SECONDARY	Change From Baseline in the BPH Impact Index (BII) Score at Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach	Baseline and Months 1, 3, 6, 9, 12, 15, 18, 21, and 24	ITT Population. Participants with data available at the specified time point or using LOCF (post-Baseline) were summarized.	Scores on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in the BPH-related Health Status (BHS) Score at Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach	Baseline and Months 1, 3, 6, 9, 12, 15, 18, 21, and 24	ITT Population. Participants with data available at the specified time point or using LOCF (post-Baseline) were summarized.	Scores on a scale	LEAST_SQUARES_MEAN
SECONDARY	Number of Events of Clinical Progression (CP) of BPH	Up to 2 years	ITT Population. Only those participants at risk for CP at the specified visit were analyzed.	Events	NUMBER
SECONDARY	Number of Participants With the Indicated First-occurring Component of Clinical Progression (CP) of BPH	Up to Month 24	ITT Population	Participants	NUMBER
SECONDARY	Number of Participants Who Had Any BPH-related Surgery, Who Had the Indicated Type of Surgery, Who Had 2 BPH-related Surgeries, and Who Had >=3 BPH-related Surgeries	Up to Month 24	ITT Population	Participants	NUMBER
SECONDARY	Number of Participants With the Indicated Responses to Question 1 of the Patient Perception of Study Treatment (PPST) Questionnaire at Baseline and Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach	Baseline and Months 1, 3, 6, 9, 12, 15, 18, 21, and 24	ITT Population. Participants with data available at the specified time point or using LOCF (post-Baseline) were summarized.	Participants	NUMBER
SECONDARY	Number of Participants With the Indicated Responses to Question 2 of the Patient Perception of Study Treatment (PPST) Questionnaire at Baseline and Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the LOCF Approach	Baseline and Months 1, 3, 6, 9, 12, 15, 18, 21, and 24	ITT Population. Participants with data available at the specified time point or using LOCF (post-Baseline) were summarized.	Participants	NUMBER
SECONDARY	Exposure to Study Drug	Up to 2 years	Treated Subjects Population: all participants starting protocol pharmacological treatment, either dutasteride plus tamsulosin or (escalated to) tamsulosin, as indicated by a nonmissing electronic Case Report Form treatment start date	days	MEAN

1 to 10 of 11Source ClinicalTrials.gov

See all 11 outcomes

Results by group232

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 the Total International Prostate Symptom Score (IPSS) at Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the Last Observation Carried Forward (LOCF) Approach	Dutasteride Plus Tamsulosin	Month 1, n=358, 367	-3.2	Standard Error 0.21	Scores on a scale
Change From Baseline in the Total International Prostate Symptom Score (IPSS) at Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the Last Observation Carried Forward (LOCF) Approach	Watchful Waiting All: Escalated Yes and No	Month 1, n=358, 367	-0.9	Standard Error 0.20	Scores on a scale
Change From Baseline in the Total International Prostate Symptom Score (IPSS) at Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the Last Observation Carried Forward (LOCF) Approach	Dutasteride Plus Tamsulosin	Month 3, n=359, 368	-4.5	Standard Error 0.22	Scores on a scale
Change From Baseline in the Total International Prostate Symptom Score (IPSS) at Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the Last Observation Carried Forward (LOCF) Approach	Watchful Waiting All: Escalated Yes and No	Month 3, n=359, 368	-2.4	Standard Error 0.22	Scores on a scale
Change From Baseline in the Total International Prostate Symptom Score (IPSS) at Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the Last Observation Carried Forward (LOCF) Approach	Dutasteride Plus Tamsulosin	Month 6, n=359, 368	-4.6	Standard Error 0.23	Scores on a scale
Change From Baseline in the Total International Prostate Symptom Score (IPSS) at Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the Last Observation Carried Forward (LOCF) Approach	Watchful Waiting All: Escalated Yes and No	Month 6, n=359, 368	-3.2	Standard Error 0.22	Scores on a scale
Change From Baseline in the Total International Prostate Symptom Score (IPSS) at Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the Last Observation Carried Forward (LOCF) Approach	Dutasteride Plus Tamsulosin	Month 9, n=359, 368	-5.1	Standard Error 0.22	Scores on a scale
Change From Baseline in the Total International Prostate Symptom Score (IPSS) at Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the Last Observation Carried Forward (LOCF) Approach	Watchful Waiting All: Escalated Yes and No	Month 9, n=359, 368	-3.6	Standard Error 0.22	Scores on a scale
Change From Baseline in the Total International Prostate Symptom Score (IPSS) at Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the Last Observation Carried Forward (LOCF) Approach	Dutasteride Plus Tamsulosin	Month 12, n=359, 368	-5.2	Standard Error 0.23	Scores on a scale
Change From Baseline in the Total International Prostate Symptom Score (IPSS) at Months 1, 3, 6, 9, 12, 15, 18, 21, and 24 Using the Last Observation Carried Forward (LOCF) Approach	Watchful Waiting All: Escalated Yes and No	Month 12, n=359, 368	-3.6	Standard Error 0.23	Scores on a scale

1 to 10 of 232Source ClinicalTrials.gov

See all 232 results by group

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Dutasteride Plus Tamsulosin	369
Overall Study	STARTED	Watchful Waiting All: Escalated Yes and No	373
Overall Study	COMPLETED	Dutasteride Plus Tamsulosin	292
Overall Study	COMPLETED	Watchful Waiting All: Escalated Yes and No	300
Overall Study	NOT COMPLETED	Dutasteride Plus Tamsulosin	77
Overall Study	NOT COMPLETED	Watchful Waiting All: Escalated Yes and No	73

Source ClinicalTrials.gov

Adverse events240

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	Erectile dysfunction	Reproductive system and breast disorders	Dutasteride Plus Tamsulosin	31	369
other	Erectile dysfunction	Reproductive system and breast disorders	Watchful Waiting All: Escalated Yes and No	4	373
other	Erectile dysfunction	Reproductive system and breast disorders	Watchful Waiting Escalated=Yes	3	229
other	Retrograde ejaculation	Reproductive system and breast disorders	Dutasteride Plus Tamsulosin	19	369
other	Retrograde ejaculation	Reproductive system and breast disorders	Watchful Waiting All: Escalated Yes and No	10	373
other	Retrograde ejaculation	Reproductive system and breast disorders	Watchful Waiting Escalated=Yes	10	229
serious	Atrial fibrillation	Cardiac disorders	Dutasteride Plus Tamsulosin	4	369
serious	Atrial fibrillation	Cardiac disorders	Watchful Waiting All: Escalated Yes and No	2	373
serious	Atrial fibrillation	Cardiac disorders	Watchful Waiting Escalated=Yes	2	229
serious	Cardiac failure	Cardiac disorders	Dutasteride Plus Tamsulosin	1	369

1 to 10 of 240Source ClinicalTrials.gov

See all 240 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Dutasteride Plus Tamsulosin
Total, all-cause mortality	Watchful Waiting All: Escalated Yes and No
Total, all-cause mortality	Watchful Waiting Escalated=Yes
Total, other adverse events	Dutasteride Plus Tamsulosin	43	369
Total, other adverse events	Watchful Waiting All: Escalated Yes and No	13	373
Total, other adverse events	Watchful Waiting Escalated=Yes	12	229
Total, serious adverse events	Dutasteride Plus Tamsulosin	38	369
Total, serious adverse events	Watchful Waiting All: Escalated Yes and No	25	373
Total, serious adverse events	Watchful Waiting Escalated=Yes	19	229

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

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 comparisons0

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

None in this release.

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.

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