Prostate CancerPhase 3NCT00076531
Clinical Trial for Prostate Cancer
A Phase 3 study testing Leuprolide Acetate for Injectable Suspension 22.5 mg in people with Prostate Cancer, run by Oakwood Laboratories, LLC.
Trial summary
Phase III trial using an injectable for treatment of prostate cancer. Read more about this study
- Who is it for?
- Ages 40 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Leuprolide Acetate for Injectable Suspension 22.5 mg
- Type of treatment
- Injection or infusion
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Dec 2003to Nov 2004
- 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 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
About this study
Phase III trial using an injectable for treatment of prostate cancer.
- Conditions
- Prostate Cancer
- Being tested
- Leuprolide Acetate for Injectable Suspension 22.5 mg
- Keywords
- Prostate, Cancer, PSA, Leuprolide
- Medical subject headings
- Prostatic Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Leuprolide Acetate for Injectable Suspension 22.5 mgDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2004 (estimated)
- Study startDec 2003
- Primary completionNov 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies 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
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- Oakwood Laboratories, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- James A. Page, M.D., Study chair, Oakwood Laboratories, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00076531
- Sponsor's protocol ID
- OL-007
- Status last verified
- Jan 2008
- First submitted
- 26 Jan 2004
- Last updated
- 28 Jan 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial for Prostate Cancer
- ClinicalTrials.gov ID
- NCT00076531
- Acronym / sponsor ID
- OL-007
- Conditions
- Prostate Cancer
- Keywords
- Prostate, Cancer, PSA, Leuprolide
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Oakwood Laboratories, LLCIndustry (pharma, biotech, devices)
- Study start
- Dec 2003
- Primary completion
- Nov 2004 (actual)
- First posted
- 27 Jan 2004 (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.
Phase III trial using an injectable for treatment of prostate cancer.
Study design
- Primary purpose
- Treatment
- Masking
- None (open label)
Who may qualify
- Ages
- 40 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Leuprolide Acetate for Injectable Suspension 22.5 mg | Drug | – |
Primary outcome
Not reported in the source record.
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 28 Jan 2008.
- Oakwood (sponsor) siteLink provided by the sponsor.
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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.
James A. Page, M.D. study chair
Oakwood Laboratories, LLC
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Leuprolide Acetate for Injectable Suspension 22.5 mg in people with Prostate Cancer, run by Oakwood Laboratories, LLC.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 28 Jan 2008. 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.
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 28 Jan 2008.