Urological Manifestations
Conditions
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.
Interventions
Sponsors
Boehringer Ingelheim
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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 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 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. |
| 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 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 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. |
Countries
United States
Participant flow
Pre-assignment details
The trial consisted of 2 parts. One was the product review phase (Part 1) and another was the actual use phase (Part 2). The number of enrolled patients in the protocol represent the number of participants (1117) who intended to purchase study product and enter part 2 of the study. All endpoints are based on part 2 of the study.
Participants by arm
| Arm | Count |
|---|---|
| Cohort 1 Cohort 1 included all men who were not currently using a prescription medicine for Benign Prostatic Hyperplasia (BPH) and answered the purchase question for the study product (FLOMAX® (tamsulosin hydrochloride) 0.4 milligram (mg) capsules for self-directed use orally for a period of 24 weeks). | 1,731 |
| Cohort 2 Cohort 2 included all men who were currently using a prescription medicine for Benign Prostatic Hyperplasia (BPH) and answered the purchase question for the study product (FLOMAX® (tamsulosin hydrochloride) 0.4 milligram (mg) capsules for self-directed use orally for a period of 24 weeks). | 362 |
| Total | 2,093 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Disposition for Part 1 | Withdrawal by Subject | 7 | 3 |
| Disposition for Part 2 | Adverse Event | 36 | 5 |
| Disposition for Part 2 | Investigator decision | 0 | 1 |
| Disposition for Part 2 | Lost to Follow-up | 76 | 7 |
| Disposition for Part 2 | Other than specified above | 13 | 3 |
| Disposition for Part 2 | Physician Decision | 25 | 7 |
| Disposition for Part 2 | Withdrawal by Subject | 60 | 3 |
Baseline characteristics
| Characteristic | Cohort 1 | Cohort 2 | Total |
|---|---|---|---|
| Age, Continuous | 61.8 Years STANDARD_DEVIATION 11.67 | 68.3 Years STANDARD_DEVIATION 9.1 | 63.0 Years STANDARD_DEVIATION 11.53 |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 1731 Participants | 362 Participants | 2093 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 61 / 927 | 25 / 150 | 86 / 1,077 |
| serious Total, serious adverse events | 54 / 927 | 12 / 150 | 66 / 1,077 |
Outcome results
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
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.
Time frame: 12 weeks
Population: Full Analysis Set for Actual Use (FAS-AU1) included all men who were currently not using a prescription medicine for BPH, purchased the study product, took at least one dose of study drug within the first 12 weeks of purchase and participated in at least 1 phone interview within the first 12 weeks of using the study product.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort 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 | 0.2 Percentage of participants |
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
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.
Time frame: 24 weeks
Population: FAS AU1
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort 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 | 0.2 Percentage of participants |
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
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
Time frame: 12 weeks
Population: FAS AU1
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort 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 Out of the Total Population in Cohort 1 | 22.4 Percentage of participants |
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
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.
Time frame: 24 weeks
Population: FAS AU1
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort 1 | 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 Percentage of participants |
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
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.
Time frame: 24 weeks
Population: Full Analysis Set for Actual Use and Ask a Doctor Before Use (FAS-AU1-ASK) is a subset of the FAS-AU1 population which included all men who reported a symptom or condition listed under the Ask a doctor before use section of the DFL.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort 1 | 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 Percentage of participants |
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
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.
Time frame: Week 12
Population: Full Analysis Set for Actual Use and Stop Use and Ask If - Condition Within the First 12 Weeks: (FAS-AU1-COND12): These populations are subsets of the FAS-AU1 population which will include all men who report a condition listed under the Stop use and ask a doctor if section of DFL within the first 12 weeks of using the study product.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort 1 | 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 Percentage of participants |
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
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.
Time frame: Week 24
Population: Full Analysis Set for Actual Use and Stop Use and Ask If - Condition Within the First 24 Weeks: (FAS-AU1-COND24): These populations are subsets of the FAS-AU1 population which will include all men who report a condition listed under the Stop use and ask a doctor if section of DFL within the first 24 weeks of using the study product.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort 1 | 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 Percentage of participants |
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
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
Time frame: Week 12 and Week 24
Population: FAS AU1
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort 1 | 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 (N=924) | 43.1 Percentage of participants |
| Cohort 1 | 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 24 (N=924) | 56.4 Percentage of participants |
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
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
Time frame: Week 12 and Week 24
Population: FAS AU1
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort 1 | 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 (N=924) | 7.6 Percentage of participants |
| Cohort 1 | 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 24 (N=924) | 9.5 Percentage of participants |