Skip to main content
OpenTrials
Completed

NCT Number: NCT02573311

Actual Use Study of Tamsulosin 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Urological Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 3

Primary location

Parkway Discount Drugs, Birmingham, Alabama, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tamsulosin Hydrochloride

Drug

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

    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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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

  5. 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.

  6. 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.

  7. 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

  8. 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

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Oct 9, 2015
Registry last updated
Apr 8, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.