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An 8-week, Open-label, Uncontrolled Study of Tamsulosin 0.4mg in Men With Bothersome Urinary Symptoms

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01726270
Recruitment Status : Completed
First Posted : November 14, 2012
Last Update Posted : April 21, 2014
Information provided by (Responsible Party):

November 9, 2012
November 14, 2012
April 21, 2014
November 2012
March 2013   (Final data collection date for primary outcome measure)
The primary objective was to collect preliminary self-reported behavioral data on actual use of the product that will inform the design of a pivotal Actual Use study. [ Time Frame: <please enter timeframe> ]
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Complete list of historical versions of study NCT01726270 on ClinicalTrials.gov Archive Site
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An 8-week, Open-label, Uncontrolled Study of Tamsulosin 0.4mg in Men With Bothersome Urinary Symptoms
A 8-week, Open-label, Uncontrolled, Exploratory Actual Use Study of Tamsulosin 0.4mg in Men With Prostate Urinary Symptoms in a Simulated Over-the-Counter Environment
Multicenter trial conducted in Pharmacy retail centers
Not Provided
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Lower Urinary Tract Symptoms
Drug: tamsulosin
0.4 mg
Experimental: tamsulosin hydrochloride
patients will take drug for 8 weeks in this exploratory study
Intervention: Drug: tamsulosin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
March 2013
March 2013   (Final data collection date for primary outcome measure)

Inclusion criteria:

  1. Men 18 years of age and older.
  2. Able to speak, read and understand English.
  3. Willing to participate in the study and voluntarily sign an informed consent document.

Exclusion criteria:

1. 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.

Sexes Eligible for Study: Male
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
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Boehringer Ingelheim
Boehringer Ingelheim
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Study Chair: Boehringer Ingelheim Boehringer Ingelheim
Boehringer Ingelheim
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP