Effects of Finasteride on Serum Prostate-Specific Antigen... | NCT00396175

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

NCT00396175

Sponsor

Organon and Co

Status

Completed

Last Update Posted

Feb 17, 2022Actual

Enrollment

355

Phase

Phase 3

Conditions

Androgenetic Alopecia

Interventions

MK0906, finasteride / Duration of Treatment : 48 Weeks
Comparator : placebo (unspecified) / Duration of Treatment : 48 Weeks

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2006_556

Status Module

Record Verification Date

Feb 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 1998

Primary Completion Date

Jan 2000Actual

Completion Date

Not provided

First Submitted Date

Nov 2, 2006

First Submission Date that Met QC Criteria

Nov 2, 2006

First Posted Date

Nov 6, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 7, 2022

Last Update Posted Date

Feb 17, 2022Actual

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

355

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
MK0906, finasteride / Duration of Treatment : 48 Weeks	Drug
Comparator : placebo (unspecified) / Duration of Treatment : 48 Weeks	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Serum Prostatic Specific Antigen (PSA) after 48 weeks of treatment

Secondary Outcomes

Measure	Description	Time Frame
Reversibility of effects on Serum Prostatic Specific Antigen (PSA) after 24 weeks off drug

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Medical Monitor	Merck Sharp & Dohme LLC	Study Director

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
17196507	Result	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.

ID	Term
D007039	Hypotrichosis
D006201	Hair Diseases
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases

ID	Term
D018120	Finasteride
D000081206	Duration of Therapy

ID	Term
D000736	Androstenes
D000731	Androstanes
D013256	Steroids
D000072473	Fused-Ring Compounds