Actual Use Study of Tamsulosin in Men

Study Overview
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Brief Summary
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An actual use study to assess how men who respond to advertisements about urinary symptoms use tamsulosin in a simulated Over the Counter (OTC) setting including following stop use and ask a doctor if and ask a doctor before use statements and if they take the medication according to the label instructions, also assess any reported adverse events during simulated OTC use.

Official Title
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A 6-month OTC-simulated, Open Label, Uncontrolled Study of Tamsulosin 0.4 mg in Men

Conditions
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Urological Manifestations

Intervention / Treatment
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* Drug: tamsulosin hydrochloride


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Men, 18 years of age and older, with bothersome urinary symptoms Able to speak, read and understand English Subject or anyone in their household is not currently employed by a marketing or marketing research company, advertising agency or public relations firm, a pharmacy or pharmaceutical company, a manufacturer of medicines, a managed care or health insurance company, as a certified or licensed healthcare professional or in a healthcare practice Has not participated in any clinical trial in the last 12 months Willing to sign an informed consent/HIPPA form and willing and able to provide contact information Exclusion criteria: Allergy to tamsulosin hydrochloride or sulpha drugs Report current use of a medication listed on the Do not use section of the Drug Facts Label (DFL) Choose not to purchase the study product Do not provide consent or sign HIPPA form Do not provide contact information

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: men<br> | Drug: tamsulosin hydrochloride<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Men Who Report a Condition Listed Under the Stop Use and Ask a Doctor if Section of the DFL Within the First 12 Weeks of Using Study Product and do Not Stop Use or Initiate Contact With Doctor Out of Total Population in Cohort 1 | Percentage of men who reported a condition listed under the Stop use and ask a doctor if section of the Drug Facts Label (DFL) within the first 12 weeks of using study product and did not stop use or initiated contact with a doctor out of the total population is presented along with 95% exact two sided Clopper-Pearson confidence interval. | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Men Who Report a Condition Listed Under the Stop Use and Ask a Doctor if Section of the DFL During the Study (24 Weeks) and do Not Stop Use or Initiate Contact With a Doctor Out of the Total Population in Cohort 1 | Percentage of men who reported a condition listed under the Stop use and ask a doctor if section of the DFL during the study (i.e., 24 weeks) and did not stop use or initiated contact with a doctor out of the total population of men in Cohort 1 is presented along with 95% exact two sided Clopper-Pearson confidence interval. | 24 weeks | 
| Percentage of Men Who Report Condition Listed Under Stop Use and Ask a Doctor if Section of the DFL and do Not Stop Use or Initiate Contact With Doctor Out of the Total Population in Cohort 1 Who Report the Condition Within 12 Weeks | Percentage of men who reported a condition listed under the Stop use and ask a doctor if section of the DFL within 12 weeks of using study product and did not stop use or initiated contact with a doctor out of the total population of men in Cohort 1 who reported a condition listed under the Stop use and ask a doctor if section of the DFL within 12 weeks of using study product is presented along with 95% exact two sided Clopper-Pearson confidence interval. | Week 12 | 
| Percentage of Men Who Report Condition Listed Under Stop Use and Ask a Doctor if Section of the DFL and do Not Stop Use or Initiate Contact With Doctor Out of the Total Population in Cohort 1 Who Report the Condition Within 24 Weeks | Percentage of men who reported a condition listed under the Stop use and ask a doctor if section of the DFL within 24 weeks of using study product and did not stop use or initiated contact with a doctor out of the total population of men in Cohort 1 who reported a condition listed under the Stop use and ask a doctor if section of the DFL within 24 weeks of using study product is presented along with 95% exact two sided Clopper-Pearson confidence interval. | Week 24 | 
| Percentage of Men Who Report a Condition Listed Under the Stop Use and Ask a Doctor if Section of the DFL Within the First 12 Weeks of Using Study Product Out of the Total Population in Cohort 1 | Percentage of men who reported a condition listed under the Stop use and ask a doctor if section of the DFL within the first 12 weeks of using the study product out of the total population of men in Cohort 1 is presented along with 95% exact two sided Clopper-Pearson confidence interval | 12 weeks | 
| Percentage of Men Who Report at Baseline a Symptom or Condition Under the Ask A Doctor Before Use Section of the DFL and Initiate Contact With a Doctor Out of the Total Population in Cohort 1 | Percentage of men who reported at baseline a symptom or condition under the Ask A Doctor Before Use section of the DFL and initiated contact with a doctor out of the total population of men in Cohort 1 is presented along with 95% exact two sided Clopper-Pearson confidence interval. | 24 weeks | 
| Percentage of Men Who Report at Baseline a Symptom or Condition Under the Ask A Doctor Before Use Section of the DFL and Initiate Contact With a Doctor Out of the Total Population of Cohort 1 Who Report a Symptom or Condition | Percentage of men who reported at baseline a symptom or condition under the Ask A Doctor Before Use section of the DFL and initiated contact with a doctor out of the total population of men in Cohort 1 who reported a symptom or condition is presented along with 95% exact two sided Clopper-Pearson confidence interval. | 24 weeks | 
| Percentage of Men Who Seek the Advice of a Physician Within the First 12/24 Weeks of the Study Out of the Total Population in Cohort 1 | Percentage of men who sought advice of a physician within the first 12/24 weeks of the study out of the total population of men in Cohort 1 is presented along with 95% exact two sided Clopper-Pearson confidence interval | Week 12 and Week 24 | 
| Percentage of Men Who Took Two or More Capsules Per Day Within the First 12/24 Weeks of Using Study Product Out of the Total Population in Cohort 1 | Percentage of men who took two or more capsules per day within the first 12/24 weeks of using study product out of the total population of men in Cohort 1 is presented along with 95% exact two sided Clopper-Pearson confidence interval | Week 12 and Week 24 |