A Study of an Investigational Study Drug for Benign Prostatic Hyperplasia (0906-140)

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. Identifier: NCT00127179
Recruitment Status : Completed
First Posted : August 5, 2005
Last Update Posted : April 7, 2017
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Brief Summary:
The purpose of this trial is to determine the efficacy and safety of an investigational drug in patients with benign prostatic hyperplasia.

Condition or disease Intervention/treatment Phase
Benign Prostatic Hyperplasia Drug: MK0906, finasteride / Duration of Treatment: 48 weeks Drug: Comparator: placebo / Duration of Treatment: 48 weeks Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: MK0906 Phase III Double-Blind Comparative Study - Benign Prostate Hyperplasia
Actual Study Start Date : January 1, 2004
Actual Primary Completion Date : July 1, 2005
Actual Study Completion Date : July 25, 2005

Resource links provided by the National Library of Medicine

Drug Information available for: Finasteride
U.S. FDA Resources

Primary Outcome Measures :
  1. Change from baseline in the International Prostate Symptom Score

Secondary Outcome Measures :
  1. Change from baseline in QOL - index
  2. Change from baseline in maximum urinary flow rate, %
  3. Change from baseline in Prostate volume

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 79 Years   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients with benign prostatic hyperplasia

Exclusion Criteria:

  • Patients who are suspected to be suffering from prostatic cancer

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00127179

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Study Director: Medical Monitor Merck Sharp & Dohme Corp.

Study Data/Documents: CSR Synopsis  This link exits the site

Responsible Party: Merck Sharp & Dohme Corp. Identifier: NCT00127179     History of Changes
Other Study ID Numbers: 0906-140
First Posted: August 5, 2005    Key Record Dates
Last Update Posted: April 7, 2017
Last Verified: April 2017

Additional relevant MeSH terms:
Prostatic Hyperplasia
Pathologic Processes
Prostatic Diseases
Genital Diseases, Male
5-alpha Reductase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Urological Agents