Actual Use Study of Tamsulosin in Men

April 6, 2020 updated by: Boehringer Ingelheim

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

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.

Study Overview

Status

Completed

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1117

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Alabama
      • Birmingham, Alabama, United States, 35215
        • Parkway Discount Drugs
      • Homewood, Alabama, United States, 35209
        • Homewood Pharmacy
      • Hoover, Alabama, United States, 35226
        • Robert's Discount Pharmacy
      • McCalla, Alabama, United States, 35111
        • Pharmacy at the Pig
      • Pinson, Alabama, United States, 35126
        • Pinson Discount Drugs
    • Arizona
      • Tucson, Arizona, United States, 85704
        • ACACIA Apothecary and Wellness
    • California
      • Rancho Cucamonga, California, United States, 91730
        • Parkview Compounding Pharmacy
    • Florida
      • Fort Lauderdale, Florida, United States, 33309
        • Garden Drug
      • Pembroke Pines, Florida, United States, 33026
        • Pill Box Pharmacy
    • Georgia
      • Dalton, Georgia, United States, 30721
        • Sutton Family Pharmacy
      • Ellijay, Georgia, United States, 30540
        • Huff's Drug Store
      • Griffin, Georgia, United States, 30224
        • Wynn's Pharmacy Incorporated
    • Illinois
      • Highland, Illinois, United States, 62249
        • Family Care Pharmacy
    • Minnesota
      • Andover, Minnesota, United States, 55304
        • Goodrich Pharmacy
      • Blaine, Minnesota, United States, 55434
        • Goodrich Pharmacy
      • Elk River, Minnesota, United States, 55330
        • Goodrich Pharmacy
      • Northfield, Minnesota, United States, 55057
        • Northfield Pharmacy
      • Saint Louis Park, Minnesota, United States, 55426
        • Cub Pharmacy #1924
    • Missouri
      • Elsberry, Missouri, United States, 63343
        • The Medicine Shoppe and Elsberry Pharmacy
      • Kansas City, Missouri, United States, 64111
        • Albers' Specialty Pharmacy
      • Riverside, Missouri, United States, 64150
        • Apex Specialty Pharmacy
      • Saint Joseph, Missouri, United States, 64504
        • Stevenson Family Pharmacy
      • Savannah, Missouri, United States, 64485
        • Countryside Pharmacy
    • New Jersey
      • Monroe, New Jersey, United States, 08831
        • Texas Road Pharmacy
    • New Mexico
      • Albuquerque, New Mexico, United States, 87104
        • Duran Central Pharmacy
      • Albuquerque, New Mexico, United States, 87109
        • Sam's Regent Pharmacy
    • North Carolina
      • Burlington, North Carolina, United States, 27215
        • Total Care Pharmacy
      • Cary, North Carolina, United States, 27513
        • Kroger Pharmacy #342
    • Ohio
      • South Charleston, Ohio, United States, 45368
        • Charleston Pharmacy, South Charleston
    • Tennessee
      • Cleveland, Tennessee, United States, 37311
        • Med Center Compounding Pharmacy & Health Center
    • Texas
      • Hillsboro, Texas, United States, 76645
        • T.B. Bond Pharmacy
      • Houston, Texas, United States, 77099
        • Eagle Pharmacy
    • Utah
      • Bountiful, Utah, United States, 84010
        • Mountain West Apothecary
      • Mapleton, Utah, United States, 84664
        • Maple Mountain Pharmacy
      • Ogden, Utah, United States, 84401
        • The Medicine Shoppe
      • West Jordan, Utah, United States, 84088
        • Family Plaza Pharmacy
    • Washington
      • Enumclaw, Washington, United States, 98022
        • Foothills Compounding Pharmacy
      • Seattle, Washington, United States, 98104
        • Kelley-Ross Compounding Pharmacy
      • Seattle, Washington, United States, 98115
        • Rxtra Care
      • Snohomish, Washington, United States, 98290
        • Kusler's Compounding Pharmacy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: men

What is the study measuring?

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
Time Frame: 12 weeks
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
Time Frame: 24 weeks
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
Time Frame: Week 12
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
Time Frame: Week 24
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
Time Frame: 12 weeks
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
Time Frame: 24 weeks
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
Time Frame: 24 weeks
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
Time Frame: Week 12 and Week 24
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
Time Frame: 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 of men in Cohort 1 is presented along with 95% exact two sided Clopper-Pearson confidence interval
Week 12 and Week 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 23, 2015

Primary Completion (Actual)

August 1, 2016

Study Completion (Actual)

August 1, 2016

Study Registration Dates

First Submitted

October 1, 2015

First Submitted That Met QC Criteria

October 8, 2015

First Posted (Estimate)

October 9, 2015

Study Record Updates

Last Update Posted (Actual)

April 8, 2020

Last Update Submitted That Met QC Criteria

April 6, 2020

Last Verified

April 1, 2020

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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