Trial · NCT00224120

A New Drug for Benign Prostatic Hyperplasia (BPH) Compared With Placebo

NCT00224120, Phase 3, Completed, Watson Pharmaceuticals; results first posted 2009-12-03

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A New Drug for Benign Prostatic Hyperplasia (BPH) Compared With Placebo. Trials, record NCT00224120. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00224120

On this page

Trial

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

Title: A New Drug for Benign Prostatic Hyperplasia (BPH) Compared With Placebo
NCT number: NCT00224120
Status: Completed
Phases: Phase 3
Enrollment: 462 participants, actual
Lead sponsor: Watson Pharmaceuticals
Conditions: Benign Prostatic Hyperplasia
Interventions: Silodosin, Placebo
First posted: 2005-09-22
Last updated: 2009-12-15
Results first posted: 2009-12-03

Source ClinicalTrials.gov

Registered outcomes2

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

List	Outcome	Time frame	Description
Primary	Measuring Change From Baseline in International Prostate Symptom Score (IPSS) at 12 Weeks	Baseline and 12 weeks	International prostate symptom score: Measuring prostate signs and symptoms asociated with benign prostatic hyperplasia on a 0 to 35 scale; 0 best, 35 worst symptoms
Secondary	Change From Baseline in Maximum Urine Flow Rate (Qmax) at 12 Weeks	Baseline and 12 weeks

Source ClinicalTrials.gov

Outcomes2

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Measuring Change From Baseline in International Prostate Symptom Score (IPSS) at 12 Weeks	Baseline and 12 weeks	The number of participants for analysis is determined by Last Observation Carried Forward (LOCF).	Units on a scale	MEAN
SECONDARY	Change From Baseline in Maximum Urine Flow Rate (Qmax) at 12 Weeks	Baseline and 12 weeks		mL/min	MEAN

Source ClinicalTrials.gov

Results by group8

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

Outcome	Group	Category	Value	Spread	Units
Measuring Change From Baseline in International Prostate Symptom Score (IPSS) at 12 Weeks	Silodosin	Baseline IPSS	21.2	Standard Deviation 4.88	Units on a scale
Measuring Change From Baseline in International Prostate Symptom Score (IPSS) at 12 Weeks	Placebo	Baseline IPSS	21.2	Standard Deviation 4.92	Units on a scale
Measuring Change From Baseline in International Prostate Symptom Score (IPSS) at 12 Weeks	Silodosin	Change from baseline in IPSS at Week 12	-6.3	Standard Deviation 6.54	Units on a scale
Measuring Change From Baseline in International Prostate Symptom Score (IPSS) at 12 Weeks	Placebo	Change from baseline in IPSS at Week 12	-3.4	Standard Deviation 5.83	Units on a scale
Change From Baseline in Maximum Urine Flow Rate (Qmax) at 12 Weeks	Silodosin	Baseline Qmax	8.4	Standard Deviation 2.48	mL/min
Change From Baseline in Maximum Urine Flow Rate (Qmax) at 12 Weeks	Placebo	Baseline Qmax	8.7	Standard Deviation 2.67	mL/min
Change From Baseline in Maximum Urine Flow Rate (Qmax) at 12 Weeks	Silodosin	Change from baseline in Qmax at Week 12	2.9	Standard Deviation 4.53	mL/min
Change From Baseline in Maximum Urine Flow Rate (Qmax) at 12 Weeks	Placebo	Change from baseline in Qmax at Week 12	1.9	Standard Deviation 4.82	mL/min

Source ClinicalTrials.gov

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Silodosin	233
Overall Study	STARTED	Placebo	229
Overall Study	COMPLETED	Silodosin	211
Overall Study	COMPLETED	Placebo	205
Overall Study	NOT COMPLETED	Silodosin	22
Overall Study	NOT COMPLETED	Placebo	24

Source ClinicalTrials.gov

Adverse events30

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	Retrograde ejaculation	Reproductive system and breast disorders	Silodosin	63	233	64
other	Retrograde ejaculation	Reproductive system and breast disorders	Placebo	2	229	2
other	Dizziness	Nervous system disorders	Silodosin	9	233	9
other	Dizziness	Nervous system disorders	Placebo	1	229	2
other	Nasopharyngitis	Infections and infestations	Silodosin	6	233	6
other	Nasopharyngitis	Infections and infestations	Placebo	3	229	3
other	Orthostatic hypotension	Vascular disorders	Silodosin	6	233	6
other	Orthostatic hypotension	Vascular disorders	Placebo	2	229	2
other	Abdominal pain	Gastrointestinal disorders	Silodosin	5	233	5
other	Abdominal pain	Gastrointestinal disorders	Placebo	0	229	0

1 to 10 of 30Source ClinicalTrials.gov

See all 30 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Silodosin
Total, all-cause mortality	Placebo
Total, other adverse events	Silodosin	99	233
Total, other adverse events	Placebo	15	229
Total, serious adverse events	Silodosin	3	233
Total, serious adverse events	Placebo	4	229

Source ClinicalTrials.gov

Papers3

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
19371887	BACKGROUND	PubMed
21135869	DERIVED	PubMed
23234617	DERIVED	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
Silodosin 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.

GET https://conductscience.org/api/trials/v1/NCT00224120

GET https://conductscience.org/api/trials/v1/NCT00224120/events?page=2

API reference For AI assistants