Trial · NCT00103402

Trial to Compare Alfuzosin Versus Placebo in the Treatment of Chronic Prostatitis/Chronic Pelvic Pain Syndrome

NCT00103402, Phase 3, Completed, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); results first posted 2020-06-12

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Trial to Compare Alfuzosin Versus Placebo in the Treatment of Chronic Prostatitis/Chronic Pelvic Pain Syndrome. Trials, record NCT00103402. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00103402

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Trial

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

Title: Trial to Compare Alfuzosin Versus Placebo in the Treatment of Chronic Prostatitis/Chronic Pelvic Pain Syndrome
NCT number: NCT00103402
Status: Completed
Phases: Phase 3
Enrollment: 272 participants, actual
Lead sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions: Prostatitis
Interventions: Alfuzosin, Placebo
First posted: 2005-02-08
Last updated: 2020-06-12
Results first posted: 2020-06-12

Source ClinicalTrials.gov

Registered outcomes8

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

List	Outcome	Time frame	Description
Primary	Number of Participants With Decline in Total Score ≥4 for the NIH-CPSI Total Score From Baseline to 12 Weeks	Baseline and 12 weeks	For the National Institutes of Health Chronic Prostatitis Symptom Index (NIHCPSI) total score, higher scores indicate more severe symptoms and scores range from 0 to 43. The primary outcome was a decline of at least 4 from baseline to 12 weeks
Secondary	Global Response Assessment (GRA)	12 weeks	The response rate for the global response assessment was based on marked or moderate improvement at 12 weeks using a 7 point scale (marked worsening, moderate worsening, no change, slight improvement, moderate improvement, marked improvement).
Secondary	Change in Subscales of the NIH-CPSI	Baseline and12 weeks	For the National Institutes of Health Chronic Prostatitis Symptom Index (NIHCPSI), higher scores indicate more severe symptoms (for the quality-of-life score, higher scores indicate a more negative effect). Score ranges are as follows: total score, 0 to 43; pain score, 0 to 21; urinary score, 0 to 10, quality-of-life score, 0 to 12; and average pain and urgency scores, 0 to 10.
Secondary	Change in Subscales of the McGill Pain Questionnaire	Baseline and 12 weeks	For the McGill Pain Questionnaire, higher scores indicate greater pain. Score ranges are as follows: total score, 0 to 45; sensory score, 0 to 33; affective score, 0 to 12.
Secondary	Change in Medical Outcomes Study Short Form 12	Baseline and 12 weeks	For the Medical Outcomes Study Short Form Health Survey 12 (SF-12), higher scores indicate better quality of life. Score range for both the physical and mental component summaries is 0 to 100.
Secondary	Change in Hospital Anxiety and Depression Scale	Baseline and 12 weeks	For the Hospital Anxiety and Depression Scale, higher scores indicate greater anxiety and depression; range, 0 to 42.
Secondary	Change in International Index of Erectile Dysfunction (IIEF)	Baseline and 12 weeks	For the International Index of Erectile Function, higher scores indicate better sexual function; range, 0 to 75.
Secondary	Change in Male Sexual Health Questionnaire	Baseline and 12 weeks	For the Male Sexual Health Questionnaire, higher scores indicate better function with respect to erection and ejaculation and greater satisfaction with sexual life; range, 0 to 40.

Source ClinicalTrials.gov

Outcomes8

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Number of Participants With Decline in Total Score ≥4 for the NIH-CPSI Total Score From Baseline to 12 Weeks	Baseline and 12 weeks		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Global Response Assessment (GRA)	12 weeks	The analysis population for this outcome is larger than the number of participants who completed the trial because a few participant answered this question without completing the other questionnaires	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Change in Subscales of the NIH-CPSI	Baseline and12 weeks		units on a scale	MEAN
SECONDARY	Change in Subscales of the McGill Pain Questionnaire	Baseline and 12 weeks		units on a scale	MEAN
SECONDARY	Change in Medical Outcomes Study Short Form 12	Baseline and 12 weeks		units on a scale	MEAN
SECONDARY	Change in Hospital Anxiety and Depression Scale	Baseline and 12 weeks		units on a scale	MEAN
SECONDARY	Change in International Index of Erectile Dysfunction (IIEF)	Baseline and 12 weeks		units on a scale	MEAN
SECONDARY	Change in Male Sexual Health Questionnaire	Baseline and 12 weeks		units on a scale	MEAN

Source ClinicalTrials.gov

Results by group40

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

Outcome	Group	Category	Value	Units
Number of Participants With Decline in Total Score ≥4 for the NIH-CPSI Total Score From Baseline to 12 Weeks	Alfuzosin		68	Participants
Number of Participants With Decline in Total Score ≥4 for the NIH-CPSI Total Score From Baseline to 12 Weeks	Placebo		66	Participants
Global Response Assessment (GRA)	Alfuzosin	Marked improvement	23	Participants
Global Response Assessment (GRA)	Placebo	Marked improvement	16	Participants
Global Response Assessment (GRA)	Alfuzosin	Moderate improvement	25	Participants
Global Response Assessment (GRA)	Placebo	Moderate improvement	29	Participants
Global Response Assessment (GRA)	Alfuzosin	Slight improvement	26	Participants
Global Response Assessment (GRA)	Placebo	Slight improvement	32	Participants
Global Response Assessment (GRA)	Alfuzosin	No change	36	Participants
Global Response Assessment (GRA)	Placebo	No change	36	Participants

1 to 10 of 40Source ClinicalTrials.gov

See all 40 results by group

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Alfuzosin	138
Overall Study	STARTED	Placebo	134
Overall Study	COMPLETED	Alfuzosin	116
Overall Study	COMPLETED	Placebo	117
Overall Study	NOT COMPLETED	Alfuzosin	22
Overall Study	NOT COMPLETED	Placebo	17

Source ClinicalTrials.gov

Adverse events14

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	Constitutional events	General disorders	Alfuzosin	4	138	4
other	Constitutional events	General disorders	Placebo	7	134	7
other	Gastrointestinal events	Gastrointestinal disorders	Alfuzosin	10	138	10
other	Gastrointestinal events	Gastrointestinal disorders	Placebo	13	134	13
other	Neurologic events	Nervous system disorders	Alfuzosin	11	138	11
other	Neurologic events	Nervous system disorders	Placebo	6	134	6
other	Pain in any body system	General disorders	Alfuzosin	15	138	15
other	Pain in any body system	General disorders	Placebo	20	134	20
serious	Spontaneous pneumothorax	Respiratory, thoracic and mediastinal disorders	Alfuzosin	1	138	1
serious	Spontaneous pneumothorax	Respiratory, thoracic and mediastinal disorders	Placebo	0	134	0

1 to 10 of 14Source ClinicalTrials.gov

See all 14 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Alfuzosin	0	138
Total, all-cause mortality	Placebo	0	134
Total, other adverse events	Alfuzosin	40	138
Total, other adverse events	Placebo	46	134
Total, serious adverse events	Alfuzosin	1	138
Total, serious adverse events	Placebo	2	134

Source ClinicalTrials.gov

Papers7

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
12031372	BACKGROUND	PubMed
12131316	BACKGROUND	PubMed
12521576	BACKGROUND	PubMed
12521581	BACKGROUND	PubMed
15364307	BACKGROUND	PubMed
15492337	BACKGROUND	PubMed
19092152	RESULT	PubMed

Grants1

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.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
U01DK065209	Data Coordinating Center for CPCRN and ICCRN	LANDIS, J RICHARD	UNIVERSITY OF PENNSYLVANIA	NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES	2003 to 2007

Source NIH RePORTER

Trial comparisons3

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

Comparison	Source
Alfuzosin vs Placebo: Number of Participants With Decline in Total Score ≥4 for the NIH-CPSI Total Score From Baseline to 12 Weeks	Trial comparisons
Alfuzosin vs Placebo: deaths from any cause	Trial comparisons
Alfuzosin vs Placebo: serious adverse events	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.

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