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

• Sponsor: Organon and Co (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00396175
• Collaborator: (none)
• Enrollment: 355

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Androgenetic Alopecia	Drug: MK0906, finasteride / Duration of Treatment : 48 Weeks; Drug: Comparator : placebo (unspecified) / Duration of Treatment : 48 Weeks	Phase 3

Study Design

• Study Type: Interventional
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• 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 Start Date: Mar 1, 1998
• Actual Primary Completion Date: Jan 1, 2000

Outcome Measures

Primary Outcome Measures

1. Serum Prostatic Specific Antigen (PSA) after 48 weeks of treatment []

Secondary Outcome Measures

1. Reversibility of effects on Serum Prostatic Specific Antigen (PSA) after 24 weeks off drug []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years to 60 Years
• Sexes Eligible for Study: Male
• Accepts 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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Organon and Co

Investigators

• Study Director: Medical Monitor, Merck Sharp & Dohme LLC

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Organon and Co
• ClinicalTrials.gov Identifier: NCT00396175
• Other Study ID Numbers: 0906-111; 2006_556
• First Posted: Nov 6, 2006
• Last Update Posted: Feb 17, 2022
• Last Verified: Feb 1, 2022

• Additional relevant MeSH terms: Alopecia; Alopecia Areata; Finasteride

Study Results

No Results Posted as of Feb 17, 2022