Actual Use Study of Tamsulosin in Men
- Registration Number
- NCT02573311
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 1117
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description men tamsulosin hydrochloride -
- Primary Outcome Measures
Name Time Method 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 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.
- Secondary Outcome Measures
Name Time Method 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 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.
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 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.
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 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
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 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.
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 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
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 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
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 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.
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 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.
Trial Locations
- Locations (38)
Kroger Pharmacy #342
🇺🇸Cary, North Carolina, United States
Garden Drug
🇺🇸Fort Lauderdale, Florida, United States
Eagle Pharmacy
🇺🇸Houston, Texas, United States
Family Plaza Pharmacy
🇺🇸West Jordan, Utah, United States
Kusler's Compounding Pharmacy
🇺🇸Snohomish, Washington, United States
Parkway Discount Drugs
🇺🇸Birmingham, Alabama, United States
Homewood Pharmacy
🇺🇸Homewood, Alabama, United States
Robert's Discount Pharmacy
🇺🇸Hoover, Alabama, United States
ACACIA Apothecary and Wellness
🇺🇸Tucson, Arizona, United States
Pharmacy at the Pig
🇺🇸McCalla, Alabama, United States
Pinson Discount Drugs
🇺🇸Pinson, Alabama, United States
Pill Box Pharmacy
🇺🇸Pembroke Pines, Florida, United States
Parkview Compounding Pharmacy
🇺🇸Rancho Cucamonga, California, United States
Family Care Pharmacy
🇺🇸Highland, Illinois, United States
Wynn's Pharmacy Incorporated
🇺🇸Griffin, Georgia, United States
Goodrich Pharmacy
🇺🇸Elk River, Minnesota, United States
Cub Pharmacy #1924
🇺🇸Saint Louis Park, Minnesota, United States
Northfield Pharmacy
🇺🇸Northfield, Minnesota, United States
Texas Road Pharmacy
🇺🇸Monroe, New Jersey, United States
Apex Specialty Pharmacy
🇺🇸Riverside, Missouri, United States
Albers' Specialty Pharmacy
🇺🇸Kansas City, Missouri, United States
Stevenson Family Pharmacy
🇺🇸Saint Joseph, Missouri, United States
Countryside Pharmacy
🇺🇸Savannah, Missouri, United States
Duran Central Pharmacy
🇺🇸Albuquerque, New Mexico, United States
Charleston Pharmacy, South Charleston
🇺🇸South Charleston, Ohio, United States
Mountain West Apothecary
🇺🇸Bountiful, Utah, United States
Maple Mountain Pharmacy
🇺🇸Mapleton, Utah, United States
T.B. Bond Pharmacy
🇺🇸Hillsboro, Texas, United States
The Medicine Shoppe
🇺🇸Ogden, Utah, United States
Rxtra Care
🇺🇸Seattle, Washington, United States
Kelley-Ross Compounding Pharmacy
🇺🇸Seattle, Washington, United States
Huff's Drug Store
🇺🇸Ellijay, Georgia, United States
The Medicine Shoppe and Elsberry Pharmacy
🇺🇸Elsberry, Missouri, United States
Sam's Regent Pharmacy
🇺🇸Albuquerque, New Mexico, United States
Sutton Family Pharmacy
🇺🇸Dalton, Georgia, United States
Total Care Pharmacy
🇺🇸Burlington, North Carolina, United States
Med Center Compounding Pharmacy & Health Center
🇺🇸Cleveland, Tennessee, United States
Foothills Compounding Pharmacy
🇺🇸Enumclaw, Washington, United States