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

Overview

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.

Full Title of Study: “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 Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: January 2000

Interventions

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

Clinical Trial Outcome Measures

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

Participating in This Clinical Trial

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: Male

Minimum Age: 40 Years

Maximum Age: 60 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Merck Sharp & Dohme Corp.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Medical Monitor, Study Director, Merck Sharp & Dohme Corp.

Citations Reporting on Results

D'Amico AV, Roehrborn CG. Effect of 1 mg/day finasteride on concentrations of serum prostate-specific antigen in men with androgenic alopecia: a randomised controlled trial. Lancet Oncol. 2007 Jan;8(1):21-5.

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