At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 1,117 enrolled
Drug / intervention
tamsulosin hydrochloridedrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A 6-month OTC-simulated, Open Label, Uncontrolled Study of Tamsulosin 0.4 mg in Men
In Brief
A Phase 3 clinical trial evaluating tamsulosin hydrochloride for Urological Manifestations. Completed, enrolled 1,117 participants across 40 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsUrological Manifestations
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
20162017201820192020202120222023202420252026
Enrollment StartSep 2015
First PostedOct 2015
Primary CompletionAug 2016
TodayJul 2026
First PostedOct 9, 2015
Enrollment StartSep 23, 2015
Primary CompletionAug 1, 2016
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 10.7 years ago
Interventions
tamsulosin hydrochloridedrug