Effects of Finasteride on Serum Prostate-Specific Antigen - Full Text View

Sponsor:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00396175

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 III

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

Genetics Home Reference related topics: androgenetic alopecia

MedlinePlus related topics: Hair Problems

Drug Information available for: Finasteride

U.S. FDA Resources

Further study details as provided by Merck:

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

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

Investigators

Study Director:

Medical Monitor

Merck

More Information

No publications provided

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

Additional relevant MeSH terms:

Finasteride
Pathological Conditions, Anatomical
Hair Diseases
Hypotrichosis
Molecular Mechanisms of Pharmacological Action

Skin Diseases
Alopecia
Enzyme Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 08, 2010