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

This study has been completed.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp. Identifier:
First received: November 2, 2006
Last updated: September 25, 2014
Last verified: September 2014
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
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

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)

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

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

Responsible Party: Merck Sharp & Dohme Corp. Identifier: NCT00396175     History of Changes
Other Study ID Numbers: 0906-111
Study First Received: November 2, 2006
Last Updated: September 25, 2014

Additional relevant MeSH terms:
Alopecia Areata
Hair Diseases
Skin Diseases
Pathological Conditions, Anatomical
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 processed this record on September 20, 2017