Trial · NCT00090103
Benign Prostatic Hyperplasia Trial With Dutasteride And Tamsulosin Combination Treatment
NCT00090103, Phase 3, Completed, GlaxoSmithKline; results first posted 2010-03-16
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Benign Prostatic Hyperplasia Trial With Dutasteride And Tamsulosin Combination Treatment. Trials, record NCT00090103. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00090103
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Benign Prostatic Hyperplasia Trial With Dutasteride And Tamsulosin Combination Treatment
- NCT number
- NCT00090103
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 4,844 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Prostatic Hyperplasia
- Interventions
- dutasteride 0.5mg once daily for 4 years, tamsulosin 0.4mg once daily for 4 years
- First posted
- 2004-08-26
- Last updated
- 2017-02-28
- Results first posted
- 2010-03-16
Source ClinicalTrials.gov
Registered outcomes31
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Events of Acute Urinary Retention (AUR) or Benign Prostatic Hyperplasia (BPH)-Related Prostatic Surgery at the Indicated Time Periods. | Years 1, 2, 3, and 4 | A participant was considered to have AUR when he was unable to urinate and required bladder catheterization. BPH is also known as an enlarged prostate. When symptoms of BPH become bothersome, surgery may be required. When events of AUR and BPH-related surgery were participant-reported or identified, they were recorded in the participants' clinic record. |
| Primary | Number of Participants With AUR or BPH-related Surgery | Baseline (Day 1) through Year 4 | A participant was considered to have AUR when he was unable to urinate and required bladder catheterization. BPH is also known as an enlarged prostate. When symptoms of BPH become bothersome, surgery may be required. When events of AUR and BPH-related surgery were participant reported or identified, they were recorded in the participants' clinic record. |
| Secondary | Number of Events of First BPH Clinical Progression at Years 1, 2, 3 and 4 | Years 1, 2, 3, and 4 | The time when the first symptom/event of BPH clinical progression has occurred (i.e. AUR, incontinence) was measured. Summaries are based on the first occuring event after treatment start. The time period is from treatment start to each participant's last treatment visit. The Year 4 events include all those that occur during the fourth year and beyond. |
| Secondary | The Number of Participants With Each of the Five Components of BPH Clinical Progression | Baseline (Day 1) to Year 4 | The five components measured were symptom deterioration, BPH-related AUR, BPH-related incontinence, recurrent BPH-related Urinary Tract Infection (UTI), and BPH-related renal insufficiency. |
| Secondary | Number of Events of Symptom Deterioration at the Indicated Time Periods | Years 1, 2, 3, and 4 (from treatment start until each participant's last treatment-phase visit) | The number of participants (par.) with symptom deterioration of International Prostate Symptom Score (IPSS) ≥4 points on two consecutive visits post-baseline are presented. Data are based on the first occurrence of an event after treatment start. The year-4 events include all that occured during the 4th year and beyond. The IPSS is a 7-item questionnaire measuring the level of urinary symptoms reported as the total score. Each question has a 6-point response scale (0=none/not at all to 5=almost always), with a total score ranging from 0-35: mild (0-7), moderate (8-19), or severe (20-35). |
| Secondary | Number of Participants With an Event of Post-baseline BPH-related Macroscopic Hematuria | Baseline (Day 1) through Year 4 | A participant was considered to have macroscopic hematuria when there was presence of blood in the urine. The event of macroscopic hematuria was either participant-reported or identified by the investigator during a clinic visit. Overall Crude Rate is the number of participants from the total number analyzed that experience experienced an incident of post-baseline BPH or Non-BPH related macroscopic hematuria. Participants may appear in both categories. |
| Secondary | Number of Participants With an Event of Post-baseline BPH-related Hematospermia | Baseline (Day 1) through Year 4 | A participant was considered to have hematospermia when there was presence of blood in the semen. Hematospermia can occur from prostatitis (prostate infection), from cancer, or after a prostate biopsy. The event of hematospermia was either participant-reported or identified by the investigator during a clinic visit. Overall Crude Rate is the number of participants from the total number analyzed that experience experienced an incident of post-baseline BPH or Non-BPH related hematospermia. Participants may appear in both categories. |
| Secondary | Adjusted Mean Change From Baseline in International Prostate Symptom Score (IPSS) at Months 12, 24, 36, and 48 | Baseline and Months 12, 24, 36, and 48 | The IPSS is a 7-item questionnaire that measures urinary symptoms. It measures the level of urinary symptoms (including incomplete emptying, frequency, intermittency, urgency, weak stream, straining, and nocturia) reported as the total IPSS score. Each of the 7 questions has a 6-point response scale (0=none/not at all to 5=almost always) with a total score that can range from 0-35: mild (0-7), moderate (8-19), or severe (20-35). Estimates are based on adjusted (least squares) means from the general linear model: change from baseline IPSS = Treatment + Cluster + Baseline IPSS. |
| Secondary | Adjusted Mean Change From Baseline in Urinary Flow Rate (Qmax) at Months 12, 24, 36, and 48 | Baseline and Months 12, 24, 36, and 48 | Peak maximum urinary flow (Qmax) of urinary flow using a Medtronic (formerly Dantec) Uroflow Meter (Urodyn 1000 or Duet models) with a Thompson filter was measured. Estimates are based on adjusted (least squares) means from the general linear model: Change from baseline Qmax = treatment + cluster + baseline Qmax. |
| Secondary | Adjusted Mean Percent Change From Baseline in Prostate Volume at Months 12, 24, 36, and 48 | Baseline and Months 12, 24, 36, and 48 | Prostate volume measurements were conducted annually using Transurethral ultrasound (TRUS). The anteroposterior, cephalocaudal, and transverse diameters of the prostate obtained by TRUS calculate the total prostate volume centimeters (cc). Percent change from baseline = \[(post-baseline - baseline)/baseline value\] x 100. Estimates were based on the adjusted (least squares) means from the general linear model: log(post-baseline/baseline value) + treatment + cluster + log(baseline value) and are reported as percent change from baseline. |
1 to 10 of 31Source ClinicalTrials.gov
See all 31 registered outcomesOutcomes31
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Events of Acute Urinary Retention (AUR) or Benign Prostatic Hyperplasia (BPH)-Related Prostatic Surgery at the Indicated Time Periods. | Years 1, 2, 3, and 4 | Intent-to-Treat (ITT) Population: all participants randomized to the double-blind treatment period. As the study progressed, participants dropped out of the study. | events | NUMBER |
| SECONDARY | Number of Events of First BPH Clinical Progression at Years 1, 2, 3 and 4 | Years 1, 2, 3, and 4 | ITT Population. As the study progressed, participants dropped out of the study. | events | NUMBER |
| PRIMARY | Number of Participants With AUR or BPH-related Surgery | Baseline (Day 1) through Year 4 | ITT Population | participants | NUMBER |
| SECONDARY | The Number of Participants With Each of the Five Components of BPH Clinical Progression | Baseline (Day 1) to Year 4 | ITT Population | participants | NUMBER |
| SECONDARY | Number of Events of Symptom Deterioration at the Indicated Time Periods | Years 1, 2, 3, and 4 (from treatment start until each participant's last treatment-phase visit) | Intent-to-Treat (ITT) Population: all participants randomized to the double-blind treatment period. As the study progressed, participants dropped out of the study. | events | NUMBER |
| SECONDARY | Number of Participants With an Event of Post-baseline BPH-related Macroscopic Hematuria | Baseline (Day 1) through Year 4 | ITT Population | participants | NUMBER |
| SECONDARY | Number of Participants With an Event of Post-baseline BPH-related Hematospermia | Baseline (Day 1) through Year 4 | ITT Population | participants | NUMBER |
| SECONDARY | Adjusted Mean Change From Baseline in International Prostate Symptom Score (IPSS) at Months 12, 24, 36, and 48 | Baseline and Months 12, 24, 36, and 48 | ITT Population. As the study progressed, participants dropped out of the study. | points on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Adjusted Mean Change From Baseline in Urinary Flow Rate (Qmax) at Months 12, 24, 36, and 48 | Baseline and Months 12, 24, 36, and 48 | ITT Population. As the study progressed, participants dropped out of the study. Also, assessments with voided volumes \<125 ml were not included in the analysis. | milliliters (mL)/second (sec) | LEAST_SQUARES_MEAN |
| SECONDARY | Adjusted Mean Percent Change From Baseline in Prostate Volume at Months 12, 24, 36, and 48 | Baseline and Months 12, 24, 36, and 48 | ITT Population. As the study progressed, participants dropped out of the study. Also, prostate measurements were either not performed or missing for some participants at various timepoints. | percent change | LEAST_SQUARES_MEAN |
1 to 10 of 31Source ClinicalTrials.gov
See all 31 outcomesResults by group795
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Events of Acute Urinary Retention (AUR) or Benign Prostatic Hyperplasia (BPH)-Related Prostatic Surgery at the Indicated Time Periods. | Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Year 1, n=1610, 1623, 1611 | 29 | events | |
| Number of Events of Acute Urinary Retention (AUR) or Benign Prostatic Hyperplasia (BPH)-Related Prostatic Surgery at the Indicated Time Periods. | Dutasteride 0.5 mg | Year 1, n=1610, 1623, 1611 | 27 | events | |
| Number of Events of Acute Urinary Retention (AUR) or Benign Prostatic Hyperplasia (BPH)-Related Prostatic Surgery at the Indicated Time Periods. | Tamsulosin 0.4 mg | Year 1, n=1610, 1623, 1611 | 40 | events | |
| Number of Events of Acute Urinary Retention (AUR) or Benign Prostatic Hyperplasia (BPH)-Related Prostatic Surgery at the Indicated Time Periods. | Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Year 2, n=1457, 1484, 1464 | 14 | events | |
| Number of Events of Acute Urinary Retention (AUR) or Benign Prostatic Hyperplasia (BPH)-Related Prostatic Surgery at the Indicated Time Periods. | Dutasteride 0.5 mg | Year 2, n=1457, 1484, 1464 | 22 | events | |
| Number of Events of Acute Urinary Retention (AUR) or Benign Prostatic Hyperplasia (BPH)-Related Prostatic Surgery at the Indicated Time Periods. | Tamsulosin 0.4 mg | Year 2, n=1457, 1484, 1464 | 62 | events | |
| Number of Events of Acute Urinary Retention (AUR) or Benign Prostatic Hyperplasia (BPH)-Related Prostatic Surgery at the Indicated Time Periods. | Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Year 3, n=1347, 1365, 1307 | 15 | events | |
| Number of Events of Acute Urinary Retention (AUR) or Benign Prostatic Hyperplasia (BPH)-Related Prostatic Surgery at the Indicated Time Periods. | Dutasteride 0.5 mg | Year 3, n=1347, 1365, 1307 | 16 | events | |
| Number of Events of Acute Urinary Retention (AUR) or Benign Prostatic Hyperplasia (BPH)-Related Prostatic Surgery at the Indicated Time Periods. | Tamsulosin 0.4 mg | Year 3, n=1347, 1365, 1307 | 44 | events | |
| Number of Events of Acute Urinary Retention (AUR) or Benign Prostatic Hyperplasia (BPH)-Related Prostatic Surgery at the Indicated Time Periods. | Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | Year 4, n=1274, 1277, 1176 | 9 | events |
1 to 10 of 795Source ClinicalTrials.gov
See all 795 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Four-Year Double-Blind Treatment Period | STARTED | Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | 1,610 | |
| Four-Year Double-Blind Treatment Period | STARTED | Dutasteride 0.5 mg | 1,623 | |
| Four-Year Double-Blind Treatment Period | STARTED | Tamsulosin 0.4 mg | 1,611 | |
| Four-Year Double-Blind Treatment Period | COMPLETED | Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | 1,113 | |
| Four-Year Double-Blind Treatment Period | COMPLETED | Dutasteride 0.5 mg | 1,093 | |
| Four-Year Double-Blind Treatment Period | COMPLETED | Tamsulosin 0.4 mg | 989 | |
| Four-Year Double-Blind Treatment Period | NOT COMPLETED | Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | 497 | |
| Four-Year Double-Blind Treatment Period | NOT COMPLETED | Dutasteride 0.5 mg | 530 | |
| Four-Year Double-Blind Treatment Period | NOT COMPLETED | Tamsulosin 0.4 mg | 622 | |
| 16-Week Safety Follow-up Period | STARTED | Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg | 1,598 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events1,539
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 | Events |
|---|---|---|---|---|---|---|
| other | Erectile dysfunction | Reproductive system and breast disorders | Combination | 167 | 1,610 | |
| other | Erectile dysfunction | Reproductive system and breast disorders | Dutasteride 0.5 mg | 147 | 1,623 | |
| other | Erectile dysfunction | Reproductive system and breast disorders | Tamsulosin 0.4 mg | 109 | 1,611 | |
| other | Hypertension | Vascular disorders | Combination | 133 | 1,610 | |
| other | Hypertension | Vascular disorders | Dutasteride 0.5 mg | 147 | 1,623 | |
| other | Hypertension | Vascular disorders | Tamsulosin 0.4 mg | 136 | 1,611 | |
| other | Nasopharyngitis | Infections and infestations | Combination | 134 | 1,610 | |
| other | Nasopharyngitis | Infections and infestations | Dutasteride 0.5 mg | 129 | 1,623 | |
| other | Nasopharyngitis | Infections and infestations | Tamsulosin 0.4 mg | 149 | 1,611 | |
| other | Back pain | Musculoskeletal and connective tissue disorders | Combination | 107 | 1,610 |
1 to 10 of 1,539Source ClinicalTrials.gov
See all 1,539 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Combination | ||
| Total, all-cause mortality | Dutasteride 0.5 mg | ||
| Total, all-cause mortality | Tamsulosin 0.4 mg | ||
| Total, other adverse events | Combination | 618 | 1,610 |
| Total, other adverse events | Dutasteride 0.5 mg | 586 | 1,623 |
| Total, other adverse events | Tamsulosin 0.4 mg | 590 | 1,611 |
| Total, serious adverse events | Combination | 303 | 1,610 |
| Total, serious adverse events | Dutasteride 0.5 mg | 339 | 1,623 |
| Total, serious adverse events | Tamsulosin 0.4 mg | 348 | 1,611 |
Source ClinicalTrials.gov
Papers14
The papers the trial lists on ClinicalTrials.gov.
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.
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.
GET https://conductscience.org/api/trials/v1/NCT00090103
GET https://conductscience.org/api/trials/v1/NCT00090103/registered?page=2