Actual Use Study of Tamsulosin in Men

• Status: Completed
• Trial end date: 2016-08-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Boehringer Ingelheim
• Treatments: Tamsulosin

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