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Effects of Finasteride on Serum Prostate-Specific Antigen (0906-111)

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: NCT00396175
Recruitment Status : Completed
First Posted : November 6, 2006
Last Update Posted : September 26, 2014
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Brief Summary:
A clinical study to collect additional data in order to characterize the reduction in PSA with finasteride 1 mg, and its reversibility in men with androgenetic alopecia between the ages of 40 to 60 years.

Condition or disease Intervention/treatment Phase
Androgenetic Alopecia Drug: MK0906, finasteride / Duration of Treatment : 48 Weeks Drug: Comparator : placebo (unspecified) / Duration of Treatment : 48 Weeks Phase 3

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Study Type : Interventional  (Clinical Trial)
Enrollment : 355 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Double-Blind, Placebo-Controlled, Multicenter Study To Examine the Effects of Finasteride 1 MG on Serum Prostate-Specific Antigen in Men With Androgenetic Alopecia
Study Start Date : March 1998
Actual Primary Completion Date : January 2000

Resource links provided by the National Library of Medicine

Drug Information available for: Finasteride

Primary Outcome Measures :
  1. Serum Prostatic Specific Antigen (PSA) after 48 weeks of treatment

Secondary Outcome Measures :
  1. Reversibility of effects on Serum Prostatic Specific Antigen (PSA) after 24 weeks off drug

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

Inclusion Criteria :

  • Men 40 to 60 years of age, and in good general physical and mental health, with androgenetic alopecia

Exclusion Criteria :

  • History of previous bladder surgery, acute urinary retention, urethral strictures, repeated urethral catheterizations, repeated urinary tract infections, or active urinary tract infections
  • History of treatment with finasteride (PROSCAR or PROPECIA) or hypersensitivity to any component of finasteride.

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): NCT00396175

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

Publications of Results:
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Responsible Party: Merck Sharp & Dohme Corp. Identifier: NCT00396175    
Other Study ID Numbers: 0906-111
First Posted: November 6, 2006    Key Record Dates
Last Update Posted: September 26, 2014
Last Verified: September 2014
Additional relevant MeSH terms:
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Alopecia Areata
Hair Diseases
Skin Diseases
Pathological Conditions, Anatomical
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
5-alpha Reductase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Urological Agents