Brief Summary

Multicenter trial conducted in Pharmacy retail centers

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

689

participants targeted

Target at P75+ for phase_2

Timeline

Completed

Started Nov 2012

Shorter than P25 for phase_2

Geographic Reach

1 country

18 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

4 months study duration

Study Start

First participant enrolled

November 1, 2012

Completed

8 days until next milestone

First Submitted

Initial submission to the registry

November 9, 2012

Completed

5 days until next milestone

First Posted

Study publicly available on registry

November 14, 2012

Completed

4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed

7.1 years until next milestone

Results Posted

Study results publicly available

March 27, 2020

Completed

Last Updated

March 27, 2020

Status Verified

March 1, 2020

Enrollment Period

4 months

First QC Date

November 9, 2012

Results QC Date

March 12, 2020

Last Update Submit

March 12, 2020

Conditions

Lower Urinary Tract Symptoms

Outcome Measures

Primary Outcomes (1)

Percentage of Participants Who Appropriately Followed the Label Instructions
Includes subjects who reported: 1. No improvement in urinary symptoms and stopped taking product, 2. Reported worsening of urinary symptoms and stopped taking the product, 3. Reported a new urinary symptom and stopped taking the product, 4. Reported no "Stop Use" condition and never took more than 1 capsule on any given day, 5. Reported a "Stop Use" condition and contacted a provider.
8 weeks

Secondary Outcomes (5)

Percentage of Participants Who Took no More Than One Capsule Per Day
8 weeks
Percentage of "Use-Days" for All Participants Who Took no More Than One Capsule Per Day
8 weeks
Percentage of Participants < 45 Years of Age Who Spoke to a Doctor During the Actual Use Phase
8 weeks
Percentage of Participants Who Are Potentially at Risk of Harm by Incorrectly Selecting to Use the Study Product Out of the Total Study Population
8 weeks
Percentage of Participants Who Have a Correct Self-selection Response Out of the Total Study Population
8 weeks

Study Arms (1)

tamsulosin hydrochloride

EXPERIMENTAL

patients will take drug for 8 weeks in this exploratory study

Drug: tamsulosin

Interventions

tamsulosinDRUG

0.4 mg

tamsulosin hydrochloride

Eligibility Criteria

Age18 Years - 100 Years

Sexmale

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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.

You may not qualify if:

\. 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.

Contact the study team to confirm eligibility.