Men With Low Testosterone LevelsPhase 2/3NCT00161304
Study to Determine the Effects of Testosterone Replacement Therapy in Aging Men With Androgen Deficiency
A Phase 2/3 study testing Testosterone Enanthate in people with Men With Low Testosterone Levels, run by Leonard S. Marks, M.D. at 1 site in United States.
Trial summary
The T-001 study is a placebo-controlled investigation of the effects of injectable testosterone replacement therapy on prostate tissues of aging men with low testosterone levels. Read more about this study
- Who is it for?
- Ages 50 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Men With Low Testosterone Levels
- What is being tested?
- Testosterone Enanthate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2003to Nov 2004
- Phase
- Phase 2/3
- 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 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- use in the past 6 months of any drug potentially affecting the pituitary-gonadal axis
- serum PSA level greater than 10.0 ng/mL
- refusal or inability to undergo prostate biopsies
- presence of prostate cancer on initial biopsy results.
Trial locations and contacts
1 site in 1 country.
United States1 site
Urological Sciences Research Foundation
Culver City, California, 90232
About this study
Official title: Effects of Testosterone Administration on Tissues of Men With A.D.A.M. (Androgen Deficiency of Aging Men)
The T-001 study is a placebo-controlled investigation of the effects of injectable testosterone replacement therapy on prostate tissues of aging men with low testosterone levels.
Read the detailed description
The T-001 study is a placebo-controlled investigation of the effects of injectable testosterone replacement therapy on prostate tissues of aging men with low testosterone levels. The primary objectives of the study are to measure the changes in tissue hormones and other biomarkers in the prostate tissue specimens.
- Conditions
- Men With Low Testosterone Levels
- Being tested
- Testosterone Enanthate, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Testosterone EnanthateDrug
Also called testosterone
Testosterone Enanthate
PlaceboOther
placebo
| Study group | Role | What they receive |
|---|---|---|
| Testosterone Enanthate | Active comparator | Testosterone Receives: Drug: Testosterone Enanthate |
| Placebo | Placebo comparator | Placebo Receives: Other: Placebo |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2005 (estimated)
- Study startApr 2003
- Primary completionAug 2004
- Study completionNov 2004
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 Men With Low Testosterone LevelsStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Leonard S. Marks, M.D.
- Sponsor type
- University, hospital or other
- Collaborators
- Solvay Pharmaceuticals, Watson Pharmaceuticals
- Responsible party
- Sponsor-investigator, Leonard S. Marks, M.D., Urological Sciences Research Foundation
- Investigators
- Leonard S Marks, M.D., Principal investigator, Urological Sciences Research Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00161304
- Sponsor's protocol ID
- T-001
- Status last verified
- Apr 2021
- First submitted
- 8 Sep 2005
- Last updated
- 28 Apr 2021
- Results posted
- No
Publications
Marks LS, Mazer NA, Mostaghel E, Hess DL, Dorey FJ, Epstein JI, Veltri RW, Makarov DV, Partin AW, Bostwick DG, Macairan ML, Nelson PS. Effect of testosterone replacement therapy on prostate tissue in men with late-onset hypogonadism: a randomized controlled trial. JAMA. 2006 Nov 15;296(19):2351-61. doi: 10.1001/jama.296.19.2351.
PubMed 17105798
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Testosterone Administration on Tissues of Men With A.D.A.M. (Androgen Deficiency of Aging Men)
- ClinicalTrials.gov ID
- NCT00161304
- Acronym / sponsor ID
- T-001
- Conditions
- Men With Low Testosterone Levels
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Leonard S. Marks, M.D.University, hospital or other
- Collaborators
- Solvay Pharmaceuticals, Watson Pharmaceuticals
- Study start
- Apr 2003 (actual)
- Primary completion
- Aug 2004 (actual)
- Study completion
- Nov 2004 (actual)
- First posted
- 12 Sep 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 T-001 study is a placebo-controlled investigation of the effects of injectable testosterone replacement therapy on prostate tissues of aging men with low testosterone levels.
Detailed description
The T-001 study is a placebo-controlled investigation of the effects of injectable testosterone replacement therapy on prostate tissues of aging men with low testosterone levels. The primary objectives of the study are to measure the changes in tissue hormones and other biomarkers in the prostate tissue specimens.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Testosterone Enanthate | Active comparator | Drug: Testosterone EnanthateTestosterone |
| Placebo | Placebo comparator | Other: PlaceboPlacebo |
Who may qualify
- Ages
- 50 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (4 listed)
- use in the past 6 months of any drug potentially affecting the pituitary-gonadal axis
- serum PSA level greater than 10.0 ng/mL
- refusal or inability to undergo prostate biopsies
- presence of prostate cancer on initial biopsy results.
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 |
|---|---|---|
| Testosterone EnanthateAlso: testosteroneTestosterone Enanthate | Drug | Testosterone Enanthate |
| Placeboplacebo | Other | Placebo |
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 Apr 2021.
- Derived from this study: PubMed 17105798Marks LS, Mazer NA, Mostaghel E, Hess DL, Dorey FJ, Epstein JI, Veltri RW, Makarov DV, Partin AW, Bostwick DG, Macairan ML, Nelson PS. Effect of testosterone replacement therapy on prostate tissue in men with late-onset hypogonadism: a randomized controlled trial. JAMA. 2006 Nov 15;296(19):2351-61. doi: 10.1001/jama.296.19.2351.
- Urological Sciences Research FoundationLink provided by the sponsor.
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.
Leonard S Marks, M.D. principal investigator
Urological Sciences Research Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Testosterone Enanthate in people with Men With Low Testosterone Levels, run by Leonard S. Marks, M.D. at 1 site in United States.
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 0 inclusion and 4 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 28 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
On the ClinicalTrials.gov record for NCT00161304, 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 28 Apr 2021.