Trial · NCT01726270
An 8-week, Open-label, Uncontrolled Study of Tamsulosin 0.4mg in Men With Bothersome Urinary Symptoms
NCT01726270, Phase 2, Completed, Boehringer Ingelheim; results first posted 2020-03-27
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. An 8-week, Open-label, Uncontrolled Study of Tamsulosin 0.4mg in Men With Bothersome Urinary Symptoms. Trials, record NCT01726270. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01726270
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- An 8-week, Open-label, Uncontrolled Study of Tamsulosin 0.4mg in Men With Bothersome Urinary Symptoms
- NCT number
- NCT01726270
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 689 participants, actual
- Lead sponsor
- Boehringer Ingelheim
- Conditions
- Lower Urinary Tract Symptoms
- Interventions
- tamsulosin
- First posted
- 2012-11-14
- Last updated
- 2020-03-27
- Results first posted
- 2020-03-27
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants Who Appropriately Followed the Label Instructions | 8 weeks | Includes subjects who reported: 1. No improvement in urinary symptoms and stopped taking product, 2. Reported worsening of urinary symptoms and stopped taking the product, 3. Reported a new urinary symptom and stopped taking the product, 4. Reported no "Stop Use" condition and never took more than 1 capsule on any given day, 5. Reported a "Stop Use" condition and contacted a provider. |
| Secondary | Percentage of Participants Who Took no More Than One Capsule Per Day | 8 weeks | Percentage of participants who took no more than one capsule per day |
| Secondary | Percentage of "Use-Days" for All Participants Who Took no More Than One Capsule Per Day | 8 weeks | "Use-day" was defind as a calendar day for which data were available regarding use or non-use. |
| Secondary | Percentage of Participants < 45 Years of Age Who Spoke to a Doctor During the Actual Use Phase | 8 weeks | Includes participants who: 1. were less than 45 years of age at enrollment, and 2. spoke to a doctor during the actual use phase. |
| Secondary | Percentage of Participants Who Are Potentially at Risk of Harm by Incorrectly Selecting to Use the Study Product Out of the Total Study Population | 8 weeks | Percentage of participants who are potentially at risk of harm by incorrectly selecting to use the study product out of the total study population |
| Secondary | Percentage of Participants Who Have a Correct Self-selection Response Out of the Total Study Population | 8 weeks | Percentage of participants who have a correct self-selection response as defined by the "Uses", "Allergy alert", and "Do Not Use" sections of the Drug Facts Label. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants Who Appropriately Followed the Label Instructions | 8 weeks | Full Analysis Set for Actual Use Study (FAS-AUS), all subjects who self-selected to use the product, purchased the product, took at least one dose of the product and participated in at least one phone interview. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Who Took no More Than One Capsule Per Day | 8 weeks | Subjects who completed all three telephone follow-up interviews out of the FAS population | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Use-Days for All Participants Who Took no More Than One Capsule Per Day | 8 weeks | Full Analysis Set for Actual Use Study (FAS-AUS), all subjects who self-selected to use the product, purchased the product, took at least one dose of the product and participated in at least one phone interview | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants < 45 Years of Age Who Spoke to a Doctor During the Actual Use Phase | 8 weeks | Full Analysis Set for Actual Use Study- Under 45 years (FAS-AUS45), all subjects less than 45 years of age who self-selected to use the product, purchased the product, took at least one dose of the product and participated in at least one phone interview | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Who Are Potentially at Risk of Harm by Incorrectly Selecting to Use the Study Product Out of the Total Study Population | 8 weeks | Evaluable Analysis Set for Self-Selection (EVAL-SS), all subjects who answered the self-selection question, probing question and followup questions. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Who Have a Correct Self-selection Response Out of the Total Study Population | 8 weeks | Evaluable Analysis Set for Self-Selection (EVAL-SS), all subjects who answered the self-selection question, probing question and followup questions. | Percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants Who Appropriately Followed the Label Instructions | Tamsulosin Hydrochloride | 85.4 | Percentage of participants | ||
| Percentage of Participants Who Took no More Than One Capsule Per Day | Tamsulosin Hydrochloride | 93.7 | 95% Confidence Interval 90.3 to 96.1 | Percentage of participants | |
| Percentage of Use-Days for All Participants Who Took no More Than One Capsule Per Day | Tamsulosin Hydrochloride | 94.1 | 95% Confidence Interval 90.9 to 96.2 | Percentage of participants | |
| Percentage of Participants < 45 Years of Age Who Spoke to a Doctor During the Actual Use Phase | Tamsulosin Hydrochloride | 30.4 | Percentage of participants | ||
| Percentage of Participants Who Are Potentially at Risk of Harm by Incorrectly Selecting to Use the Study Product Out of the Total Study Population | Tamsulosin Hydrochloride | 20.9 | 95% Confidence Interval 17.9 to 24.2 | Percentage of participants | |
| Percentage of Participants Who Have a Correct Self-selection Response Out of the Total Study Population | Tamsulosin Hydrochloride | 73.9 | 95% Confidence Interval 70.5 to 77.2 | Percentage of participants |
Source ClinicalTrials.gov
Participant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Part 1, Self-Selection Phase | STARTED | All Subjects | 689 | |
| Part 1, Self-Selection Phase | COMPLETED | All Subjects | 679 | |
| Part 1, Self-Selection Phase | NOT COMPLETED | All Subjects | 10 | |
| Eligibility for Part 2 | STARTED | All Subjects | 389 | |
| Eligibility for Part 2 | COMPLETED | All Subjects | 369 | |
| Eligibility for Part 2 | NOT COMPLETED | All Subjects | 20 | |
| Part 2, Actual-Use Phase | STARTED | All Subjects | 369 | |
| Part 2, Actual-Use Phase | COMPLETED | All Subjects | 330 | |
| Part 2, Actual-Use Phase | NOT COMPLETED | All Subjects | 39 |
Source ClinicalTrials.gov
Adverse events33
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 | Nasopharyngitis | Infections and infestations | EVAL-SS | 26 | 679 | |
| other | Nasopharyngitis | Infections and infestations | Treated Set | 26 | 351 | |
| other | Nasopharyngitis | Infections and infestations | FAS-AUS | 22 | 321 | |
| serious | Abscess | Infections and infestations | EVAL-SS | 1 | 679 | |
| serious | Abscess | Infections and infestations | Treated Set | 1 | 351 | |
| serious | Abscess | Infections and infestations | FAS-AUS | 1 | 321 | |
| serious | Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | EVAL-SS | 1 | 679 | |
| serious | Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Treated Set | 1 | 351 | |
| serious | Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | FAS-AUS | 1 | 321 | |
| serious | Malignant melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | EVAL-SS | 1 | 679 |
1 to 10 of 33Source ClinicalTrials.gov
See all 33 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | EVAL-SS | ||
| Total, all-cause mortality | Treated Set | ||
| Total, all-cause mortality | FAS-AUS | ||
| Total, other adverse events | EVAL-SS | 26 | 679 |
| Total, other adverse events | Treated Set | 26 | 351 |
| Total, other adverse events | FAS-AUS | 22 | 321 |
| Total, serious adverse events | EVAL-SS | 10 | 679 |
| Total, serious adverse events | Treated Set | 10 | 351 |
| Total, serious adverse events | FAS-AUS | 9 | 321 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 30607798 | DERIVED |
Source 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 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/NCT01726270
GET https://conductscience.org/api/trials/v1/NCT01726270/events?page=2