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

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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00396175
Enrollment
355
Registered
2006-11-06
Start date
1998-03-31
Completion date
Unknown
Last updated
2022-02-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Androgenetic Alopecia

Brief 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.

Interventions

DRUGMK0906, finasteride / Duration of Treatment : 48 Weeks
DRUGComparator : placebo (unspecified) / Duration of Treatment : 48 Weeks

Sponsors

Organon and Co
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
MALE
Age
40 Years to 60 Years
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.

Design outcomes

Primary

MeasureTime frame
Serum Prostatic Specific Antigen (PSA) after 48 weeks of treatment

Secondary

MeasureTime frame
Reversibility of effects on Serum Prostatic Specific Antigen (PSA) after 24 weeks off drug

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026