Androgenetic AlopeciaPhase 3NCT00396175
Effects of Finasteride on Serum Prostate-Specific Antigen (0906-111)
A Phase 3 study testing MK0906, finasteride / Duration of Treatment : 48 Weeks in people with Androgenetic Alopecia, run by Organon and Co.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 60 years, men only
- Conditions the study is for
- Androgenetic Alopecia
- What is being tested?
- MK0906, finasteride / Duration of Treatment : 48 Weeks
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 355 participants
- Where
- No sites listed yet
- Study dates
- Mar 1998to Jan 2000
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 60 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Men 40 to 60 years of age, and in good general physical and mental health, with androgenetic alopecia
Who cannot join
- 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.
About this study
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
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.
- Conditions
- Androgenetic Alopecia
- Being tested
- MK0906, finasteride / Duration of Treatment : 48 Weeks, Comparator : placebo (unspecified) / Duration of Treatment : 48 Weeks
- Medical subject headings
- Alopecia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MK0906, finasteride / Duration of Treatment : 48 WeeksDrug
Comparator : placebo (unspecified) / Duration of Treatment : 48 WeeksDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum Prostatic Specific Antigen (PSA) after 48 weeks of treatment
Secondary outcomes (1)
Reversibility of effects on Serum Prostatic Specific Antigen (PSA) after 24 weeks off drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2006 (estimated)
- Study startMar 1998
- Primary completionJan 2000
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Androgenetic AlopeciaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 355 participants
Sponsor and investigators
- Lead sponsor
- Organon and Co
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Monitor, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00396175
- Sponsor's protocol ID
- 0906-111
- Other IDs
- 2006_556
- Status last verified
- Feb 2022
- First submitted
- 2 Nov 2006
- Last updated
- 17 Feb 2022
- Results posted
- No
Publications
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.
PubMed 17196507
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00396175
- Acronym / sponsor ID
- 0906-111
- Conditions
- Androgenetic Alopecia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 355 participants
- Lead sponsor
- Organon and CoIndustry (pharma, biotech, devices)
- Study start
- Mar 1998
- Primary completion
- Jan 2000 (actual)
- First posted
- 6 Nov 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
Who may qualify
- Ages
- 40 to 60 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Men 40 to 60 years of age, and in good general physical and mental health, with androgenetic alopecia
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MK0906, finasteride / Duration of Treatment : 48 Weeks | Drug | – |
| Comparator : placebo (unspecified) / Duration of Treatment : 48 Weeks | Drug | – |
Primary outcome
Serum Prostatic Specific Antigen (PSA) after 48 weeks of treatment
1 secondary outcome
Reversibility of effects on Serum Prostatic Specific Antigen (PSA) after 24 weeks off drug
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2022.
- Results publication: PubMed 17196507D'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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Monitor study director
Merck Sharp & Dohme LLC
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing MK0906, finasteride / Duration of Treatment : 48 Weeks in people with Androgenetic Alopecia, run by Organon and Co.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum Prostatic Specific Antigen (PSA) after 48 weeks of treatment. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00396175, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2022.