An 8-week, Open-label, Uncontrolled Study of Tamsulosin 0.4mg in Men With Bothersome Urinary Symptoms

Study Overview
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Brief Summary
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Multicenter trial conducted in Pharmacy retail centers

Official Title
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A 8-week, Open-label, Uncontrolled, Exploratory Actual Use Study of Tamsulosin 0.4mg in Men With Prostate Urinary Symptoms in a Simulated Over-the-Counter Environment

Conditions
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Lower Urinary Tract Symptoms

Intervention / Treatment
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* Drug: tamsulosin


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Men 18 years of age and older. Able to speak, read and understand English. Willing to participate in the study and voluntarily sign an informed consent document. Exclusion criteria: 1. Subject or anyone in their household is currently employed by a marketing or marketing research company, and advertising agency or public relations firm, a pharmacy or pharmaceutical company, a manufacturer of medicines, a managed care or health insurance company as a healthcare professional or healthcare practice.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 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: tamsulosin hydrochloride<br>patients will take drug for 8 weeks in this exploratory study | Drug: tamsulosin<br>* 0.4 mg<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Who Appropriately Followed the Label Instructions | Includes subjects who reported: No improvement in urinary symptoms and stopped taking product, Reported worsening of urinary symptoms and stopped taking the product, Reported a new urinary symptom and stopped taking the product, Reported no Stop Use condition and never took more than 1 capsule on any given day, Reported a Stop Use condition and contacted a provider. | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Who Took no More Than One Capsule Per Day | Percentage of participants who took no more than one capsule per day | 8 weeks | 
| Percentage of Use-Days for All Participants Who Took no More Than One Capsule Per Day | Use-day was defind as a calendar day for which data were available regarding use or non-use. | 8 weeks | 
| Percentage of Participants < 45 Years of Age Who Spoke to a Doctor During the Actual Use Phase | Includes participants who: were less than 45 years of age at enrollment, and spoke to a doctor during the actual use phase. | 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 | 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 Have a Correct Self-selection Response Out of the Total Study Population | 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. | 8 weeks |