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”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety Study

Intervention(s) in this Clinical Trial

• Drug: MK0906, finasteride / Duration of Treatment : 48 Weeks
• Drug: Comparator : placebo (unspecified) / Duration of Treatment : 48 Weeks

Primary Measures

• Serum Prostatic Specific Antigen (PSA) after 48 weeks of treatment

Secondary Measures

• Reversibility of effects on Serum Prostatic Specific Antigen (PSA) after 24 weeks off drug

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.

Gender Eligibility for this Clinical Trial: Male

Minimum Age for this Clinical Trial: 40 Years

Maximum Age for this Clinical Trial: 60 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Merck

Overall Clinical Trial Officials and Contacts

Medical Monitor Study Director Merck  

Information obtained from ClinicalTrials.gov on November 20, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00396175

Study ID Number: 2006_556

ClinicalTrials.gov Identifier: NCT00396175

Health Authority: United States: Food and Drug Administration