NCT04572139

Brief Summary

The purpose of this study to age-related differences to the response of a combined pituitary stimulation test with TRH, LHRH and ACTH.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 23, 2020

Completed
Same day until next milestone

Study Start

First participant enrolled

September 23, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 1, 2020

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

July 16, 2025

Status Verified

August 1, 2023

Enrollment Period

2.3 years

First QC Date

September 23, 2020

Last Update Submit

July 14, 2025

Conditions

PituitaryAging

Outcome Measures

Primary Outcomes (5)

  • 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.

    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.

    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.

    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.

    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.

    Immediately after procedure.

Other Outcomes (10)

  • Differences in peak values in TSH

    Immediately after procedure.

  • Differences in peak values in Prolactin

    Immediately after procedure.

  • Differences in peak values in LH

    Immediately after procedure.

  • +7 more other outcomes

Study Arms (3)

Young participants

18-45 years old

Diagnostic Test: Pituitary stimulation test

Old participants

55-80 years old

Diagnostic Test: Pituitary stimulation test

Oldest old participants

over 80 years old

Diagnostic Test: Pituitary stimulation test

Interventions

Pituitary stimulation testDIAGNOSTIC_TEST

Pituitary stimulation with 0.1 mg LHRH, 0.2 mg TRH and 0.25 mg ACTH

Old participantsOldest old participantsYoung participants

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • Ages between 18-45 or above 55.
  • Healthy Volunteers

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Geriatric Medicine, Aalborg University Hospital

Aalborg, Northen Jutland, 9000, Denmark

Location

Biospecimen

Retention: SAMPLES WITH DNA

Serum and urine samples

MeSH Terms

Conditions

Pituitary Diseases

Condition Hierarchy (Ancestors)

Hypothalamic DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesEndocrine System Diseases

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

September 23, 2020

First Posted

October 1, 2020

Study Start

September 23, 2020

Primary Completion

December 31, 2022

Study Completion

December 31, 2024

Last Updated

July 16, 2025

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)