HypogonadismPhase 4NCT00304213
Does Testosterone Improve Function in Hypogonadal Older Men
A Phase 4 study testing Testosterone in people with Hypogonadism, run by North Florida Foundation for Research and Education at 1 site in United States.
Trial summary
This is a randomized controlled trial of testosterone replacement therapy in hypogonadal men age > 60 years. The goal is to assess the safety and efficacy of TRT in men age > 60 years. Read more about this study
- Who is it for?
- Ages 60 to 80 years, men only
- Conditions the study is for
- Hypogonadism
- What is being tested?
- Testosterone
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2006to Apr 2009
- Phase
- Phase 4
- 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 60 to 80 years
- Men only
- Adult, Older adult
Who may be able to join
- age 60-80 yrs serum total testosterone < 300 ng/dL serum bioavailable testosterone < 70 ng/dL
Who cannot join
- unable to provide informed consent history of prostate or breast cancer untreated sleep apnea
Trial locations and contacts
1 site in 1 country.
About this study
This is a randomized controlled trial of testosterone replacement therapy in hypogonadal men age > 60 years. The goal is to assess the safety and efficacy of TRT in men age > 60 years.
- Conditions
- Hypogonadism
- Being tested
- Testosterone
- Keywords
- hypogonadism, testosterone, aging, Total testosterone < 300 ng/dL, Bioavailable testosterone < 70 ng/dL
- Medical subject headings
- Hypogonadism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TestosteroneDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical function
Cognitive function
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2006 (estimated)
- Study startMar 2006
- Study completionApr 2009 (estimated)
Why it stopped: Study never started, PI relocation
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypogonadismStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- North Florida Foundation for Research and Education
- Sponsor type
- University, hospital or other
- Collaborators
- Solvay Pharmaceuticals
- Investigators
- Thomas Mulligan, MD, Principal investigator, Director, GRECC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00304213
- Sponsor's protocol ID
- 79-06
- Status last verified
- Feb 2015
- First submitted
- 16 Mar 2006
- Last updated
- 13 Feb 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Testosterone Improve Function in Hypogonadal Older Men
- ClinicalTrials.gov ID
- NCT00304213
- Acronym / sponsor ID
- 79-06
- Conditions
- Hypogonadism
- Keywords
- hypogonadism, testosterone, aging, Total testosterone < 300 ng/dL, Bioavailable testosterone < 70 ng/dL
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study never started, PI relocation
- Enrolment
- 0 participants (actual)
- Lead sponsor
- North Florida Foundation for Research and EducationUniversity, hospital or other
- Collaborators
- Solvay Pharmaceuticals
- Study start
- Mar 2006
- Study completion
- Apr 2009 (estimated)
- First posted
- 17 Mar 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.
This is a randomized controlled trial of testosterone replacement therapy in hypogonadal men age > 60 years. The goal is to assess the safety and efficacy of TRT in men age > 60 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 60 to 80 years
- Sex
- Male only
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- age 60-80 yrs serum total testosterone < 300 ng/dL serum bioavailable testosterone < 70 ng/dL
Key exclusion criteria (1 listed)
- unable to provide informed consent history of prostate or breast cancer untreated sleep apnea
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 | Drug | – |
Primary outcome
Physical function
Cognitive function
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2015.
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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.
Thomas Mulligan, MD principal investigator
Director, GRECC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Testosterone in people with Hypogonadism, run by North Florida Foundation for Research and Education 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 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: withdrawn, as of the sponsor's last update on 13 Feb 2015. 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 was withdrawn before enrolling participants, so there are no results.
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?
Physical function. The study lists 2 primary outcomes in all. 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 13 Feb 2015.