AgingPhase 1NCT00309855
Testosterone-Driven Growth-Hormone (GH) Secretion in Aging Men
A Phase 1 study testing Testosterone, Anastrazole and Dutasteride in people with Aging, run by Mayo Clinic at 1 site in United States.
Trial summary
This study is being done to understand how testosterone, the major male sex hormone, controls the pituitary gland's secretion of growth hormone (GH). GH is an important metabolic hormone, which controls sugar; fat and protein use in the body and maintains muscle strength and bone calcium content. Read more about this study
- Who is it for?
- Ages 50 to 80 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Aging
- What is being tested?
- Testosterone, Anastrazole and Dutasteride
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2005to Aug 2008
- Phase
- Phase 1
- 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 80 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- healthy men between the ages of 50 and 80;
- normal weight (within 30% of ideal body weight defined by New York Metropolitan Life tables); and
- normal hematocrit (greater than 38%);
- community dwelling; and
- voluntarily consenting
Who cannot join
- recent use of psychotropic or neuroactive drugs (within five biological half-live);
- obesity (outside weight range above);
- anemia (hematocrit < 38%);
- drug or alcohol abuse, psychosis, depression, mania or severe anxiety;
- acute or chronic organ-system disease;
- endocrinopathy, other than primary thyroidal failure receiving replacement;
Show all 10Show fewer
- nightshift work or recent transmeridian travel (exceeding 3 time zones within 7 days of admission);
- acute weight change (loss or gain of > 2 kg in 6 weeks);
- allergy to administered compounds; and
- unwillingness to provide written informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Mechanisms of Testosterone-Driven Growth-Hormone (GH) Secretion in Aging Men: Modulation of GHRH, GHRP and Somatostatin Action by Estrogenic Versus Androgenic Steroids
This study is being done to understand how testosterone, the major male sex hormone, controls the pituitary gland's secretion of growth hormone (GH). GH is an important metabolic hormone, which controls sugar; fat and protein use in the body and maintains muscle strength and bone calcium content. Both testosterone and GH decline in older men. The age-related fall in these hormones probably contributes to relative frailty, reduced quality of life, bone loss, muscle wasting and impaired sexual function.
Read the detailed description
Repletion of testosterone in older men drives pulsatile GH secretion via conjoint facilitation of feedforward by the primary secretagogues GHRH and GHRP and repression of feedback by the dominant inhibitor, somatostatin; and, in corollary, testosterone acts via aromatization to estradiol and/or reduction to 5 alpha-dihydrotestosterone
- Conditions
- Aging
- Being tested
- Placebo, Testosterone, Anastrazole, Dutasteride
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
im and orally
TestosteroneDrug
injections
AnastrazoleDrug
orally x 21 days
DutasterideDrug
orally x 21 days
| Study group | Role | What they receive |
|---|---|---|
| Double Placebo | Placebo comparator | (i.m. vehicle 0.5 mL weekly x three injections and oral placebo once daily x 21 days) Receives: Drug: Placebo |
| Testosterone IM and oral placebo | Other | IM injections weekly x three injections and oral placebo once daily x 21 days Receives: Drug: Testosterone |
| Testosterone and Oral Anastrozole | Other | IM injections weekly x 3 injections and oral daily x 21 days Receives: Drug: Testosterone; Drug: Anastrazole |
| Testosterone and Dutasteride | Other | IM injections weekly x 3 injections and oral once daily x 21 days Receives: Drug: Testosterone; Drug: Dutasteride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Growth Hormone concentration after injections
GH will be measured 4 different times mornings within 16-21 days following the first testosterone injection (day 1).
Measured: 24 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2006 (estimated)
- Study startDec 2005
- Primary completionAug 2008
- Study completionAug 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- GlaxoSmithKline
- Investigators
- Johannes D. Veldhuis, M.D., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00309855
- Sponsor's protocol ID
- 319-03
- Status last verified
- Jul 2012
- First submitted
- 31 Mar 2006
- Last updated
- 31 Jul 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanisms of Testosterone-Driven Growth-Hormone (GH) Secretion in Aging Men: Modulation of GHRH, GHRP and Somatostatin Action by Estrogenic Versus Androgenic Steroids
- ClinicalTrials.gov ID
- NCT00309855
- Acronym / sponsor ID
- 319-03
- Conditions
- Aging
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- GlaxoSmithKline
- Study start
- Dec 2005
- Primary completion
- Aug 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 3 Apr 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 study is being done to understand how testosterone, the major male sex hormone, controls the pituitary gland's secretion of growth hormone (GH). GH is an important metabolic hormone, which controls sugar; fat and protein use in the body and maintains muscle strength and bone calcium content. Both testosterone and GH decline in older men. The age-related fall in these hormones probably contributes to relative frailty, reduced quality of life, bone loss, muscle wasting and impaired sexual function.
Detailed description
Repletion of testosterone in older men drives pulsatile GH secretion via conjoint facilitation of feedforward by the primary secretagogues GHRH and GHRP and repression of feedback by the dominant inhibitor, somatostatin; and, in corollary, testosterone acts via aromatization to estradiol and/or reduction to 5 alpha-dihydrotestosterone
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Double Placebo | Placebo comparator | Drug: Placebo(i.m. vehicle 0.5 mL weekly x three injections and oral placebo once daily x 21 days) |
| Testosterone IM and oral placebo | Other | Drug: TestosteroneIM injections weekly x three injections and oral placebo once daily x 21 days |
| Testosterone and Oral Anastrozole | Other | Drug: Testosterone, Drug: AnastrazoleIM injections weekly x 3 injections and oral daily x 21 days |
| Testosterone and Dutasteride | Other | Drug: Testosterone, Drug: DutasterideIM injections weekly x 3 injections and oral once daily x 21 days |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- healthy men between the ages of 50 and 80;
- normal weight (within 30% of ideal body weight defined by New York Metropolitan Life tables); and
- normal hematocrit (greater than 38%);
- community dwelling; and
- voluntarily consenting
Key exclusion criteria (10 listed)
- recent use of psychotropic or neuroactive drugs (within five biological half-live);
- obesity (outside weight range above);
- anemia (hematocrit < 38%);
- drug or alcohol abuse, psychosis, depression, mania or severe anxiety;
- acute or chronic organ-system disease;
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 |
|---|---|---|
| Placeboim and orally | Drug | Double Placebo |
| Testosteroneinjections | Drug | Testosterone IM and oral placebo, Testosterone and Dutasteride, Testosterone and Oral Anastrozole |
| Anastrazoleorally x 21 days | Drug | Testosterone and Oral Anastrozole |
| Dutasterideorally x 21 days | Drug | Testosterone and Dutasteride |
Primary outcome
Growth Hormone concentration after injections
Time frame: 24 days
GH will be measured 4 different times mornings within 16-21 days following the first testosterone injection (day 1).
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 31 Jul 2012.
Related trials for Aging
RecruitingObservational study
PET Imaging in the Baltimore Longitudinal Study of Aging (BLSA)
Aging
Not yet recruiting
Effects of Cannabidiol on Memory and Attention in Adults Aged 60-70: A Pilot Study
Healthy Aging, Cognition
RecruitingPhase 2
Neuroplasticity Enhancement From Cognitive Training Reinforced by Psilocybin
Alzheimer's Disease
Active, not recruitingObservational study
MCR Syndrome in Quebec : Results From NuAge Study
Motoric Cognitive Risk Syndrome, Aging Disorder
Active, not recruitingObservational study
Passive Limb Movement: A Tool to Assess Vascular Health and Guide Rehabilitation
Aging, Cardiovascular Disease
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.
Johannes D. Veldhuis, M.D. principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Testosterone, Anastrazole and Dutasteride in people with Aging, run by Mayo Clinic 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 5 inclusion and 10 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 31 Jul 2012. 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 phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Growth Hormone concentration after injections (time frame: 24 days). 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 31 Jul 2012.