Optimal glucocorticoid replacement therapy in adrenocorticotropin (ACTH) deficient hypopituitary patients - Optimal glucocorticoid replacement

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2007-005018-37-IE

Enrollment

Registered

2007-09-07

Start date

2008-01-18

Completion date

Unknown

Last updated

2025-04-14

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

Conditions

10 male patients with hypopituitarism resulting in ACTH (adrenocorticotropin) deficiency (ICD E23.0) will be studied on varying doses of hydrocortisone replacement therapy. THis is not a new medication for these patients. 10 healthy male volunteers will be studied as control subjects. They will NOT receive hydrocortisone. MedDRA version: 9.1 Level: LLT Classification code 10021067 Term: Hypopituitarism MedDRA version: 9.1 Level: LLT Classification code 10033662 Term: Panhypopituitarism MedDR

Interventions

Trade Name: Hydrocortone Pharmaceutical Form: Tablet INN or Proposed INN: Hydrocortisone CAS Number: 50-23-7 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 10- INN

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: Male, Age >18 years Hypopituitarism Known severe ACTH deficiency as defined by a basal serum cortisol =65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Female Age <18 years Patients with acute medical or surgical illness Advanced cardiac or pulmonary disease Unstable Angina/MI in the preceeding 3 months Patients with a terminal illness Patients on steroids for reasons other than ACTH deficiency Patients on phenytoin or other agents that interfere with corticosteroid metabolism.

Design outcomes

Primary

Measure	Time frame
Main Objective: We aim to define the most appropriate physiological dose of glucocorticoid replacement in ACTH deficienct hypopituitary patients by studying different commonly used dose regimes of hydrocortisone replacement. The regimes range from 10mg to 30mg daily and we will assess the integrated serum cortisol levels, tissue cortisol exposure, metabolic and vascular sequelae of each regimen. We seek that whic most closely resembles the metabolic profile of our healthy control subjects.;Secondary Objective: To assess the side effects of over or under replacement of hydrocortisone in the hypopituitary patient.;Primary end point(s): The identification of a dose of hydrocortisone which results in a metabolic profile that most closely resembles that of the healthy control subjects.	—

Measure

Time frame

Main Objective: We aim to define the most appropriate physiological dose of glucocorticoid replacement in ACTH deficienct hypopituitary patients by studying different commonly used dose regimes of hydrocortisone replacement. The regimes range from 10mg to 30mg daily and we will assess the integrated serum cortisol levels, tissue cortisol exposure, metabolic and vascular sequelae of each regimen. We seek that whic most closely resembles the metabolic profile of our healthy control subjects.;Secondary Objective: To assess the side effects of over or under replacement of hydrocortisone in the hypopituitary patient.;Primary end point(s): The identification of a dose of hydrocortisone which results in a metabolic profile that most closely resembles that of the healthy control subjects.

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Countries

Ireland

Outcome results

None listed

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