Phase 2
Completed N=689
An 8-week, Open-label, Uncontrolled Study of Tamsulosin 0.4mg in Men With Bothersome Urinary Symptoms
Source: ClinicalTrials.gov NCT01726270 ↗Enrolled (actual)
689
Serious AEs
2.2%
Results posted
Mar 2020
Primary outcomePrimary: Percentage of Participants Who Appropriately Followed the Label Instructions — 85.4 Percentage of participants
Summary
Multicenter trial conducted in Pharmacy retail centers
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Who Appropriately Followed the Label Instructions |
85.4 | — |
| SECONDARY Percentage of Participants Who Took no More Than One Capsule Per Day |
93.7 | — |
| SECONDARY Percentage of "Use-Days" for All Participants Who Took no More Than One Capsule Per Day |
94.1 | — |
| SECONDARY Percentage of Participants < 45 Years of Age Who Spoke to a Doctor During the Actual Use Phase |
30.4 | — |
| SECONDARY Percentage of Participants Who Are Potentially at Risk of Harm by Incorrectly Selecting to Use the Study Product Out of the Total Study Population |
20.9 | — |
| SECONDARY Percentage of Participants Who Have a Correct Self-selection Response Out of the Total Study Population |
73.9 | — |
Eligibility Criteria
Inclusion criteria
- Men 18 years of age and older.
- Able to speak, read and understand English.
- Willing to participate in the study and voluntarily sign an informed consent document.
Exclusion criteria
- Subject or anyone in their household is currently employed by a marketing or marketing research company, and advertising agency or public relations firm, a pharmacy or pharmaceutical company, a manufacturer of medicines, a managed care or health insurance company as a healthcare professional or healthcare practice.
Data sourced from ClinicalTrials.gov (NCT01726270). 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.