Actual Use Study of Tamsulosin in Men
A 6-month OTC-simulated, Open Label, Uncontrolled Study of Tamsulosin 0.4 mg in Men
1 other identifier
interventional
1,117
1 country
40
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Sep 2015
Shorter than P25 for phase_3
40 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 23, 2015
CompletedFirst Submitted
Initial submission to the registry
October 1, 2015
CompletedFirst Posted
Study publicly available on registry
October 9, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2016
CompletedResults Posted
Study results publicly available
April 8, 2020
CompletedApril 8, 2020
April 1, 2020
10 months
October 1, 2015
March 12, 2020
April 6, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (8)
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 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 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 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 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
- +3 more secondary outcomes
Study Arms (1)
men
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (40)
Parkway Discount Drugs
Birmingham, Alabama, 35215, United States
Homewood Pharmacy
Homewood, Alabama, 35209, United States
Robert's Discount Pharmacy
Hoover, Alabama, 35226, United States
Pharmacy at the Pig
McCalla, Alabama, 35111, United States
Pinson Discount Drugs
Pinson, Alabama, 35126, United States
ACACIA Apothecary and Wellness
Tucson, Arizona, 85704, United States
Parkview Compounding Pharmacy
Rancho Cucamonga, California, 91730, United States
Garden Drug
Fort Lauderdale, Florida, 33309, United States
Pill Box Pharmacy
Pembroke Pines, Florida, 33026, United States
Sutton Family Pharmacy
Dalton, Georgia, 30721, United States
Huff's Drug Store
Ellijay, Georgia, 30540, United States
Wynn's Pharmacy Incorporated
Griffin, Georgia, 30224, United States
Family Care Pharmacy
Highland, Illinois, 62249, United States
Goodrich Pharmacy
Andover, Minnesota, 55304, United States
Goodrich Pharmacy
Blaine, Minnesota, 55434, United States
Goodrich Pharmacy
Elk River, Minnesota, 55330, United States
Northfield Pharmacy
Northfield, Minnesota, 55057, United States
Cub Pharmacy #1924
Saint Louis Park, Minnesota, 55426, United States
The Medicine Shoppe and Elsberry Pharmacy
Elsberry, Missouri, 63343, United States
Albers' Specialty Pharmacy
Kansas City, Missouri, 64111, United States
Apex Specialty Pharmacy
Riverside, Missouri, 64150, United States
Stevenson Family Pharmacy
Saint Joseph, Missouri, 64504, United States
Countryside Pharmacy
Savannah, Missouri, 64485, United States
Texas Road Pharmacy
Monroe, New Jersey, 08831, United States
Duran Central Pharmacy
Albuquerque, New Mexico, 87104, United States
Sam's Regent Pharmacy
Albuquerque, New Mexico, 87109, United States
Total Care Pharmacy
Burlington, North Carolina, 27215, United States
Kroger Pharmacy #342
Cary, North Carolina, 27513, United States
Charleston Pharmacy, South Charleston
South Charleston, Ohio, 45368, United States
Med Center Compounding Pharmacy & Health Center
Cleveland, Tennessee, 37311, United States
T.B. Bond Pharmacy
Hillsboro, Texas, 76645, United States
Eagle Pharmacy
Houston, Texas, 77099, United States
Mountain West Apothecary
Bountiful, Utah, 84010, United States
Maple Mountain Pharmacy
Mapleton, Utah, 84664, United States
The Medicine Shoppe
Ogden, Utah, 84401, United States
Family Plaza Pharmacy
West Jordan, Utah, 84088, United States
Foothills Compounding Pharmacy
Enumclaw, Washington, 98022, United States
Kelley-Ross Compounding Pharmacy
Seattle, Washington, 98104, United States
Rxtra Care
Seattle, Washington, 98115, United States
Kusler's Compounding Pharmacy
Snohomish, Washington, 98290, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Boehringer Ingelheim, Call Center
- Organization
- Boehringer Ingelheim
Study Officials
- STUDY CHAIR
Boehringer Ingelheim
Boehringer Ingelheim
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 1, 2015
First Posted
October 9, 2015
Study Start
September 23, 2015
Primary Completion
August 1, 2016
Study Completion
August 1, 2016
Last Updated
April 8, 2020
Results First Posted
April 8, 2020
Record last verified: 2020-04