An intervention study of the effects of a low dose and high dose hydrocortisone replacement therapy on brain functions, quality of life, risk factors for cardiovascular diseases and sensitivity in patients with adrenal insufficiency due to a previous pituitary tumor.

A randomized double blind cross-over study of the effects of low dose and high dose hydrocortisone replacement therapy on cognition, quality of life, metabolic profile and somatosensation in patients with secondary adrenal insufficiency - Hydrocortisone replacement in patients with secondary adrenal insufficiency

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-000864-82-NL

Enrollment

Registered

2011-11-23

Start date

2011-12-22

Completion date

Unknown

Last updated

2022-04-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Secondary adrenal insufficiency MedDRA version: 14.0 Level: LLT Classification code 10020518 Term: Hydrocortisone System Organ Class: 10022891 - Investigations

Interventions

Trade Name: Hydrocortisone Product Name: hydrocortisone Product Code: CAS 50237 Pharmaceutical Form: Tablet CAS Number: 50-23-7 Other descriptive name: HYDROCORTISONE Concentration unit: mg milligram(

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients with secondary adrenal insufficiency without prior evidence of hormonal overproduction (e.g. acromegaly, Cushing disease and prolactinoma). Age = 18 – 70 years = One year after tumor treatment with surgery and/or radiotherapy On stable concomitant medications for at least six months prior to entry of study Body weight 50-100 kg Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 33 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 33

Exclusion criteria

Exclusion criteria: Inability of legal consent Documented cognitive impairment Drug abuse/dependence History of or current psychiatric disorders Drugs that interact with hydrocortisone Use of anti-epileptics (e.g. carbamezapine) Premenopausal women (because of effects of estrogens on cortisol binding globulin and because differences in HPA axis functioning in the luteal or follicular phase) Type 1 or Type 2 diabetes Current treatment for second malignancy Have a significant medical condition (e.g. hepatic, respiratory, or cardiovascular) which, in the opinion of the investigator, may interfere with the interpretation of results and safety or efficacy evaluations. A history of frequent hypocortisolism Hospitalization during study Work in shifts

Design outcomes

Primary

Measure	Time frame
Timepoint(s) of evaluation of this end point: First evaluation after 4 weeks run-in phase to assess baseline functioning in patients with secundairy insufficiency.Second evaluation at the end of the study. That is after 24 weeks after initiation of the study (4 weeks run-in phase and two intervention periods of 10 weeks) ;Main Objective: The aim of this study is to investigate whether a physiologically low HC dose is better for cognition as compared to a high HC dose. ;Secondary Objective: In addition, quality of life, metabolic profile and somatosensation will be described in relation to HC dose. ;Primary end point(s): Cognitive performance. If the significance value is less than .05, there is a significant difference. This will be calculated with a paired samples t-test.	—

Measure

Time frame

Timepoint(s) of evaluation of this end point: First evaluation after 4 weeks run-in phase to assess baseline functioning in patients with secundairy insufficiency.Second evaluation at the end of the study. That is after 24 weeks after initiation of the study (4 weeks run-in phase and two intervention periods of 10 weeks) ;Main Objective: The aim of this study is to investigate whether a physiologically low HC dose is better for cognition as compared to a high HC dose. ;Secondary Objective: In addition, quality of life, metabolic profile and somatosensation will be described in relation to HC dose. ;Primary end point(s): Cognitive performance. If the significance value is less than .05, there is a significant difference. This will be calculated with a paired samples t-test.

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Secondary

Measure	Time frame
Secondary end point(s): Quality of Life (QoL), Metabolic profile Somatosensation ;Timepoint(s) of evaluation of this end point: First evaluation after 4 weeks run-in phase to assess baseline functioning in patients with secundairy insufficiency. Second evaluation at the end of the study. That is after 24 weeks after initiation of the study (4 weeks run-in phase and two intervention periods of 10 weeks)	—

Measure

Time frame

Secondary end point(s): Quality of Life (QoL), Metabolic profile Somatosensation ;Timepoint(s) of evaluation of this end point: First evaluation after 4 weeks run-in phase to assess baseline functioning in patients with secundairy insufficiency. Second evaluation at the end of the study. That is after 24 weeks after initiation of the study (4 weeks run-in phase and two intervention periods of 10 weeks)

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Countries

Netherlands

Contacts

Public ContactDepartment of Endocrinology

University Medical Center Groningen

n.alma@umcg.nl+31503613962

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026