Trial · NCT00527605
Dutasteride 0.5mg For The Treatment Of Chinese Patients With Benign Prostatic Hyperplasia (BPH)
NCT00527605, Phase 3, Completed, GlaxoSmithKline; results first posted 2010-03-11
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Dutasteride 0.5mg For The Treatment Of Chinese Patients With Benign Prostatic Hyperplasia (BPH). Trials, record NCT00527605. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00527605
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Dutasteride 0.5mg For The Treatment Of Chinese Patients With Benign Prostatic Hyperplasia (BPH)
- NCT number
- NCT00527605
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 253 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Benign Prostatic Hyperplasia, Prostatic Hyperplasia
- Interventions
- Dutasteride 0.5mg capsule, Dutasteride matched placebo
- First posted
- 2007-09-11
- Last updated
- 2012-03-21
- Results first posted
- 2010-03-11
Source ClinicalTrials.gov
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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 | 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. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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. |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 registered outcomesOutcomes16
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percent Change From Baseline in the Prostate Volume at Month 6 | Baseline and Month 6 | 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. | percent change in volume | MEAN |
| SECONDARY | Percent Change From Baseline in the Prostate Volume at Month 3 | Baseline and Month 3 | ITT Population. Some participants were missing Month 3 measurements. | percent change in volume | MEAN |
| SECONDARY | Change From Baseline in the Prostate Volume at Month 6 | Baseline and Month 6 | ITT Population. Some participants were missing Month 6 measurements. | cubic centimeters | MEAN |
| SECONDARY | Change From Baseline in the Prostate Volume at Month 3 | Baseline and Month 3 | ITT Population. Some participants were missing Month 3 measurements. | cubic centimeters | MEAN |
| SECONDARY | Percent Change From Baseline in the Serum Dihydrotestosterone (DHT) at Month 6 | Baseline and Month 6 | ITT Population. Some participants were missing Month 6 measurements. | percent change | MEAN |
| SECONDARY | Percent Change From Baseline in the Serum DHT at Month 3 | Baseline and Month 3 | ITT Population. Some participants were missing Month 3 measurements. | percent change | MEAN |
| SECONDARY | Change From Baseline in the Serum DHT at Month 6 | Baseline and Month 6 | ITT Population. Some participants were missing Month 6 measurements. | picograms/milliliter (pg/ml) | MEAN |
| SECONDARY | Change From Baseline in the Serum DHT at Month 3 | Baseline and Month 3 | ITT Population. Some participants were missing Month 3 measurements. | pg/ml | MEAN |
| SECONDARY | Percent Change From Baseline in the American Urological Association Symptom Index (AUA-SI) Score at Month 6 | Baseline and Month 6 | ITT Population. Some participants were missing Month 6 measurements. | percent change | MEAN |
| SECONDARY | Percent Change From Baseline in the AUA-SI Score at Month 3 | Baseline and Month 3 | ITT Population. Some participants were missing Month 3 measurements. | percent change | MEAN |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 outcomesResults by group32
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percent Change From Baseline in the Prostate Volume at Month 6 | Dutasteride 0.5 mg | -17.00 | Standard Deviation 21.41 | percent change in volume | |
| Percent Change From Baseline in the Prostate Volume at Month 6 | Placebo | -2.77 | Standard Deviation 24.96 | percent change in volume | |
| Percent Change From Baseline in the Prostate Volume at Month 3 | Dutasteride 0.5 mg | -12.02 | Standard Deviation 23.22 | percent change in volume | |
| Percent Change From Baseline in the Prostate Volume at Month 3 | Placebo | -1.02 | Standard Deviation 25.79 | percent change in volume | |
| Change From Baseline in the Prostate Volume at Month 6 | Dutasteride 0.5 mg | -9.16 | Standard Deviation 12.74 | cubic centimeters | |
| Change From Baseline in the Prostate Volume at Month 6 | Placebo | -1.20 | Standard Deviation 12.77 | cubic centimeters | |
| Change From Baseline in the Prostate Volume at Month 3 | Dutasteride 0.5 mg | -7.11 | Standard Deviation 13.02 | cubic centimeters | |
| Change From Baseline in the Prostate Volume at Month 3 | Placebo | -1.06 | Standard Deviation 11.48 | cubic centimeters | |
| Percent Change From Baseline in the Serum Dihydrotestosterone (DHT) at Month 6 | Dutasteride 0.5 mg | -52.53 | Standard Deviation 44.42 | percent change | |
| Percent Change From Baseline in the Serum Dihydrotestosterone (DHT) at Month 6 | Placebo | 26.78 | Standard Deviation 149.07 | percent change |
1 to 10 of 32Source ClinicalTrials.gov
See all 32 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Dutasteride 0.5 mg | 126 | |
| Overall Study | STARTED | Placebo | 127 | |
| Overall Study | COMPLETED | Dutasteride 0.5 mg | 113 | |
| Overall Study | COMPLETED | Placebo | 116 | |
| Overall Study | NOT COMPLETED | Dutasteride 0.5 mg | 13 | |
| Overall Study | NOT COMPLETED | Placebo | 11 |
Source ClinicalTrials.gov
Adverse events94
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 | Palpitations | Cardiac disorders | Dutasteride 0.5 mg | 0 | 126 | |
| other | Palpitations | Cardiac disorders | Placebo | 1 | 127 | |
| other | Dry eye | Eye disorders | Dutasteride 0.5 mg | 1 | 126 | |
| other | Dry eye | Eye disorders | Placebo | 0 | 127 | |
| other | Keratitis | Eye disorders | Dutasteride 0.5 mg | 1 | 126 | |
| other | Keratitis | Eye disorders | Placebo | 0 | 127 | |
| other | Abdominal distension | Gastrointestinal disorders | Dutasteride 0.5 mg | 1 | 126 | |
| other | Abdominal distension | Gastrointestinal disorders | Placebo | 0 | 127 | |
| other | Abdominal pain | Gastrointestinal disorders | Dutasteride 0.5 mg | 1 | 126 | |
| other | Abdominal pain | Gastrointestinal disorders | Placebo | 0 | 127 |
1 to 10 of 94Source ClinicalTrials.gov
See all 94 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Dutasteride 0.5 mg | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Dutasteride 0.5 mg | 27 | 126 |
| Total, other adverse events | Placebo | 25 | 127 |
| Total, serious adverse events | Dutasteride 0.5 mg | 0 | 126 |
| Total, serious adverse events | Placebo | 1 | 127 |
Source ClinicalTrials.gov
Papers2
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Dutasteride 0.5 mg 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.
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/NCT00527605
GET https://conductscience.org/api/trials/v1/NCT00527605/results?page=2