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NCT00396175 Clinical Trial

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

Androgenetic Alopecia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00396175
Other study ID # 0906-111
Secondary ID 2006_556
Status Completed
Phase Phase 3
First received
Last updated
Start date March 1998

Study information
Verified date February 2022
Source Organon and Co
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 355
Est. completion date
Est. primary completion date January 2000
Accepts healthy volunteers No
Gender Male
Age group 40 Years to 60 Years
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• MK0906, finasteride / Duration of Treatment : 48 Weeks

• Comparator : placebo (unspecified) / Duration of Treatment : 48 Weeks

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Organon and Co

References & Publications (1)

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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Serum Prostatic Specific Antigen (PSA) after 48 weeks of treatment
Secondary Reversibility of effects on Serum Prostatic Specific Antigen (PSA) after 24 weeks off drug
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