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Effects of Finasteride on Serum Prostate-Specific Antigen

Information source: Merck
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Androgenetic Alopecia

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

Phase: Phase 3

Status: Completed

Sponsored by: Merck

Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Merck

Summary

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.

Clinical Details

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

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

Primary outcome: Serum Prostatic Specific Antigen (PSA) after 48 weeks of treatment

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

Eligibility

Minimum age: 40 Years. Maximum age: 60 Years. Gender(s): Male.

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.

Locations and Contacts

Additional Information

Starting date: March 1998
Last updated: November 2, 2006

Page last updated: June 20, 2008

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