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

NCT ID: NCT00396175

Last Updated: 2022-02-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

355 participants

Study Classification

INTERVENTIONAL

Study Start Date

1998-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Androgenetic Alopecia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Interventions

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MK0906, finasteride / Duration of Treatment : 48 Weeks

Intervention Type DRUG

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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

40 Years

Maximum Eligible Age

60 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Organon and Co

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Monitor

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

References

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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.

Reference Type RESULT
PMID: 17196507 (View on PubMed)

Other Identifiers

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2006_556

Identifier Type: -

Identifier Source: secondary_id

0906-111

Identifier Type: -

Identifier Source: org_study_id

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