Phase 3
Completed N=2,101
Actual Use Study of Tamsulosin in Men
Urological Manifestations
Source: ClinicalTrials.gov NCT02573311 ↗
Enrolled (actual)
2,101
Serious AEs
6.1%
Results posted
Apr 2020
Primary outcomePrimary: 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 — 0.2 Percentage of participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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 |
0.2 | — |
| SECONDARY 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 |
0.2 | — |
| SECONDARY 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 |
1.0 | — |
| SECONDARY 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 |
0.9 | — |
| SECONDARY 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 |
22.4 | — |
| SECONDARY 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 |
20.3 | — |
| SECONDARY 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 |
84.3 | — |
| SECONDARY 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 |
43.1; 56.4 | — |
| SECONDARY 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 |
7.6; 9.5 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02573311). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.