PituitaryNCT04572139
Age-related Differences in Response to Pituitary Stimulation Tests
An observational study of Pituitary and Aging, run by Aalborg University Hospital at 1 site in Denmark.
Trial summary
The purpose of this study to age-related differences to the response of a combined pituitary stimulation test with TRH, LHRH and ACTH. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- What is being tested?
- Pituitary stimulation test
- How many people
- 25 participants
- Where
- 1 siteDenmark
- Study dates
- 23 Sep 2020to 31 Dec 2024
- Phase
- Observational
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adults across different age groups without conditions affecting pituitary function. Minimum sample size has been determined by power calculation to be 15 participants. The study aims to include up 24 particpants to increase power in the primary analysis.
Who may be able to join
- Ages between 18-45 or above 55.
- Healthy Volunteers
Who cannot join
- Medication or conditions affecting pituitary response (such as hormonal birth control, steriod use, thyroid disorders)
- Pregnancy or birth within the last year
- inability to give informed consent
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Geriatric Medicine, Aalborg University Hospital
Aalborg, Northen Jutland, 9000
About this study
Official title: Age-related Differences in the Response to a Combined Pituitary Stimulation Test With TRH, LHRH and ACTH
The purpose of this study to age-related differences to the response of a combined pituitary stimulation test with TRH, LHRH and ACTH.
Read the detailed description
Participants will be recruited in three different age intervals: 18-45 years, 55-80 years and 80+ years. These participants will all undergo the same stimulation test with 0.1 mg LHRH, 0.2 mg TRH, and 0.25 mg ACTH (Synachten). The tests will be perfomed at the same time of day for all particpants (between 08:15 and 08:45) and participants will be fasting for the test. Blood samples will be taken just before and at 10, 20, 30, 45, 60, 90 and 120 minutes following the stimulation test. Serum from blood samples will be stored at -20 degrees until analysis.
- Being tested
- Pituitary stimulation test
- Medical subject headings
- Pituitary Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pituitary stimulation testDiagnostic test
Pituitary stimulation with 0.1 mg LHRH, 0.2 mg TRH and 0.25 mg ACTH
| Study group | Role | What they receive |
|---|---|---|
| Young participants | 18-45 years old Receives: Diagnostic Test: Pituitary stimulation test | |
| Old participants | 55-80 years old Receives: Diagnostic Test: Pituitary stimulation test | |
| Oldest old participants | over 80 years old Receives: Diagnostic Test: Pituitary stimulation test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences in area under the curve in TSH.
Differences will be measured by calculating the area under the curve adjusted for the basal level for the time of the test period.
Measured: Immediately after procedure.
Differences in area under the curve in Prolactin.
Differences will be measured by calculating the area under the curve adjusted for the basal level for the time of the test period.
Measured: Immediately after procedure.
Differences in area under the curve in LH.
Differences will be measured by calculating the area under the curve adjusted for the basal level for the time of the test period.
Measured: Immediately after procedure.
Differences in area under the curve in FSH.
Differences will be measured by calculating the area under the curve adjusted for the basal level for the time of the test period.
Measured: Immediately after procedure.
Differences in area under the curve in Cortisol.
Differences will be measured by calculating the area under the curve adjusted for the basal level for the time of the test period.
Measured: Immediately after procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2020
- Study start23 Sep 2020
- Primary completion31 Dec 2022
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PituitaryStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aalborg University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Johannes Riis, Aalborg University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04572139
- Sponsor's protocol ID
- N-20200008
- Status last verified
- Aug 2023
- First submitted
- 23 Sep 2020
- Last updated
- 16 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Age-related Differences in the Response to a Combined Pituitary Stimulation Test With TRH, LHRH and ACTH
- ClinicalTrials.gov ID
- NCT04572139
- Acronym / sponsor ID
- N-20200008
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Aalborg University HospitalUniversity, hospital or other
- Study start
- 23 Sep 2020 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 1 Oct 2020 (actual)
- 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 study to age-related differences to the response of a combined pituitary stimulation test with TRH, LHRH and ACTH.
Detailed description
Participants will be recruited in three different age intervals: 18-45 years, 55-80 years and 80+ years. These participants will all undergo the same stimulation test with 0.1 mg LHRH, 0.2 mg TRH, and 0.25 mg ACTH (Synachten). The tests will be perfomed at the same time of day for all particpants (between 08:15 and 08:45) and participants will be fasting for the test. Blood samples will be taken just before and at 10, 20, 30, 45, 60, 90 and 120 minutes following the stimulation test. Serum from blood samples will be stored at -20 degrees until analysis.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Young participants | – | Diagnostic Test: Pituitary stimulation test18-45 years old |
| Old participants | – | Diagnostic Test: Pituitary stimulation test55-80 years old |
| Oldest old participants | – | Diagnostic Test: Pituitary stimulation testover 80 years old |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adults across different age groups without conditions affecting pituitary function. Minimum sample size has been determined by power calculation to be 15 participants. The study aims to include up 24 particpants to increase power in the primary analysis.
Key inclusion criteria (2 listed)
- Ages between 18-45 or above 55.
- Healthy Volunteers
Key exclusion criteria (3 listed)
- Medication or conditions affecting pituitary response (such as hormonal birth control, steriod use, thyroid disorders)
- Pregnancy or birth within the last year
- inability to give informed consent
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 |
|---|---|---|
| Pituitary stimulation testPituitary stimulation with 0.1 mg LHRH, 0.2 mg TRH and 0.25 mg ACTH | Diagnostic test | Old participants, Oldest old participants, Young participants |
Primary outcome
Differences in area under the curve in TSH.
Time frame: Immediately after procedure.
Differences will be measured by calculating the area under the curve adjusted for the basal level for the time of the test period.
Differences in area under the curve in Prolactin.
Time frame: Immediately after procedure.
Differences will be measured by calculating the area under the curve adjusted for the basal level for the time of the test period.
Differences in area under the curve in LH.
Time frame: Immediately after procedure.
Differences will be measured by calculating the area under the curve adjusted for the basal level for the time of the test period.
Differences in area under the curve in FSH.
Time frame: Immediately after procedure.
Differences will be measured by calculating the area under the curve adjusted for the basal level for the time of the test period.
Differences in area under the curve in Cortisol.
Time frame: Immediately after procedure.
Differences will be measured by calculating the area under the curve adjusted for the basal level for the time of the test period.
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 16 Jul 2025.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pituitary and Aging, run by Aalborg University Hospital at 1 site in Denmark.
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 2 inclusion and 3 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 16 Jul 2025. 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 Denmark. 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.
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?
Differences in area under the curve in TSH. (time frame: Immediately after procedure.). The study lists 5 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 16 Jul 2025; AzTrials last refreshed its copy on 26 Oct 2026.