Back to resultsEffects of Finasteride on Serum Prostate-Specific Antigen (0906-111)
Primary Purpose
Androgenetic Alopecia
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
MK0906, finasteride / Duration of Treatment : 48 Weeks
Comparator : placebo (unspecified) / Duration of Treatment : 48 Weeks
Sponsored by
About this trial
This is an interventional treatment trial for Androgenetic Alopecia
Eligibility 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.
Sites / Locations
Outcomes
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00396175
Brief Title
Effects of Finasteride on Serum Prostate-Specific Antigen (0906-111)
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 Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
March 1998 (undefined)
Primary Completion Date
January 2000 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Organon and Co
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Androgenetic Alopecia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
355 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
MK0906, finasteride / Duration of Treatment : 48 Weeks
Intervention Type
Drug
Intervention Name(s)
Comparator : placebo (unspecified) / Duration of Treatment : 48 Weeks
Primary Outcome Measure Information:
Title
Serum Prostatic Specific Antigen (PSA) after 48 weeks of treatment
Secondary Outcome Measure Information:
Title
Reversibility of effects on Serum Prostatic Specific Antigen (PSA) after 24 weeks off drug
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
12. IPD Sharing Statement
Citations:
PubMed Identifier
17196507
Citation
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. doi: 10.1016/S1470-2045(06)70981-0.
Results Reference
result
Learn more about this trial
Effects of Finasteride on Serum Prostate-Specific Antigen (0906-111)
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