Benign Prostatic HyperplasiaPhase 3NCT00127179
A Study of an Investigational Study Drug for Benign Prostatic Hyperplasia (0906-140)
A Phase 3 study testing MK0906, finasteride / Duration of Treatment: 48 weeks in people with Benign Prostatic Hyperplasia, run by Organon and Co.
Trial summary
The purpose of this trial is to determine the efficacy and safety of an investigational drug in patients with benign prostatic hyperplasia. Read more about this study
- Who is it for?
- Ages 50 to 79 years, men only
- Conditions the study is for
- Benign Prostatic Hyperplasia
- 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
- 600 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2004to 25 Jul 2005
- 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 50 to 79 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with benign prostatic hyperplasia
Who cannot join
- Patients who are suspected to be suffering from prostatic cancer
About this study
Official title: MK0906 Phase III Double-Blind Comparative Study - Benign Prostate Hyperplasia
The purpose of this trial is to determine the efficacy and safety of an investigational drug in patients with benign prostatic hyperplasia.
- Conditions
- Benign Prostatic Hyperplasia
- Being tested
- MK0906, finasteride / Duration of Treatment: 48 weeks, Comparator: placebo / Duration of Treatment: 48 weeks
- Medical subject headings
- Prostatic Hyperplasia
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 / Duration of Treatment: 48 weeksDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in the International Prostate Symptom Score
Secondary outcomes (3)
Change from baseline in QOL - index
Change from baseline in maximum urinary flow rate, %
Change from baseline in Prostate volume
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2005 (estimated)
- Study start1 Jan 2004
- Primary completion1 Jul 2005
- Study completion25 Jul 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Benign Prostatic HyperplasiaStudies 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
- 600 participants (actual)
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
- NCT00127179
- Sponsor's protocol ID
- 0906-140
- Other IDs
- MK0906-140, 2005_042
- Status last verified
- Feb 2022
- First submitted
- 3 Aug 2005
- Last updated
- 15 Aug 2024
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MK0906 Phase III Double-Blind Comparative Study - Benign Prostate Hyperplasia
- ClinicalTrials.gov ID
- NCT00127179
- Acronym / sponsor ID
- 0906-140
- Conditions
- Benign Prostatic Hyperplasia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 600 participants (actual)
- Lead sponsor
- Organon and CoIndustry (pharma, biotech, devices)
- Study start
- 1 Jan 2004 (actual)
- Primary completion
- 1 Jul 2005 (actual)
- Study completion
- 25 Jul 2005 (actual)
- First posted
- 5 Aug 2005 (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.
The purpose of this trial is to determine the efficacy and safety of an investigational drug in patients with benign prostatic hyperplasia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
Who may qualify
- Ages
- 50 to 79 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with benign prostatic hyperplasia
Key exclusion criteria (1 listed)
- Patients who are suspected to be suffering from prostatic cancer
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 / Duration of Treatment: 48 weeks | Drug | – |
Primary outcome
Change from baseline in the International Prostate Symptom Score
3 secondary outcomes
Change from baseline in QOL - index
Change from baseline in maximum urinary flow rate, %
Change from baseline in Prostate volume
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 15 Aug 2024.
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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 Benign Prostatic Hyperplasia, 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 1 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 15 Aug 2024. 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?
Change from baseline in the International Prostate Symptom Score. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Aug 2024.