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

This study has been completed.
Sponsor:
Information provided by:
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00396175
First received: November 2, 2006
Last updated: May 20, 2013
Last verified: May 2013
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

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

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

Estimated Enrollment: 355
Study Start Date: March 1998
Primary Completion Date: January 2000 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   40 Years to 60 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00396175

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

No publications provided

ClinicalTrials.gov Identifier: NCT00396175     History of Changes
Other Study ID Numbers: 2006_556
Study First Received: November 2, 2006
Last Updated: May 20, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Alopecia
Alopecia Areata
Hypotrichosis
Hair Diseases
Skin Diseases
Pathological Conditions, Anatomical
Finasteride
5-alpha Reductase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 22, 2014