Effect of growth hormone replacement on cortisol-to-cortisone interconversion in hypopituitary patients with growth hormone deficiency and the influence of different aetiologies of hypopituitarism.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2009-010918-30-IE

Enrollment

Registered

2009-03-11

Start date

2009-08-11

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

20 patients with hypopituitarism including growth hormone deficiency will be evaluated both on growth hormone replacement and when they have been off it for a 2 month period. They will have been prescribed growth hormone replacement in the form of Genotropin/Genotropin Miniquick/Norditropin prior to inclusion in this study as part of their routine clinical care. MedDRA version: 9.1 Level: LLT Classification code 10021067 Term: Hypopituitarism MedDRA version: 9.1 Level: LLT Classification code

Interventions

Trade Name: Genotropin 5.3mg Pharmaceutical Form: Powder and solvent for solution for injection INN or Proposed INN: SOMATROPIN CAS Number: 12629015 Concentration unit: mg milligram(s) Concentration t

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.Age 18 and over 2.Hypopituitary including GHD and ACTH deficiency previously diagnosed on dynamic stimulation testing 3.Underlying diagnosis including non functioning pituitary adenoma, prolactin secreting pituitary adenoma, craniopharyngioma, treated Cushing’s disease (with permanent ACTH/cortisol deficiency 4.Stable dose of GH and hydrocortisone replacement for at least 3 months 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 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: 1.Patients with liver or kidney disease as this affects cortisol metabolism and measurements 2.Females of childbearing potential 3.Terminal or severe acute medical illness 4.Patients receiving steroids for reasons other than pituitary hormone replacement 5.Patients with malignancy, chronic inflammatory conditions or chronic infections

Design outcomes

Primary

Measure	Time frame
Main Objective: To study the local and total cortisol-to-cortisone inter-conversion in hypopituitary patients with growth hormone deficiency while the patient is on and off growth hormone replacement therapy, with particular reference to subgroups with non functioning pituitary adenomas, craniopharyngiomas, treated Cushing's disease and prolactinomas.;Secondary Objective: To delineate differences in cortisol-to-cortisone inter-conversion between groups of patients with different aetiologies for their pituitary disease, namely non functioning pituitary adenomas, craniopharyngiomas, treated Cushing's disease and prolactinomas.;Primary end point(s): The effect of growth hormone deficiency and growth hormone therapy on the activity of 11 beta-hydroxysteroid dehydrogenase type 1, as measured through urinary metabolites and therefore the effect on cortisol metabolism in adipose tissue and liver.	—

Measure

Time frame

Main Objective: To study the local and total cortisol-to-cortisone inter-conversion in hypopituitary patients with growth hormone deficiency while the patient is on and off growth hormone replacement therapy, with particular reference to subgroups with non functioning pituitary adenomas, craniopharyngiomas, treated Cushing's disease and prolactinomas.;Secondary Objective: To delineate differences in cortisol-to-cortisone inter-conversion between groups of patients with different aetiologies for their pituitary disease, namely non functioning pituitary adenomas, craniopharyngiomas, treated Cushing's disease and prolactinomas.;Primary end point(s): The effect of growth hormone deficiency and growth hormone therapy on the activity of 11 beta-hydroxysteroid dehydrogenase type 1, as measured through urinary metabolites and therefore the effect on cortisol metabolism in adipose tissue and liver.

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Countries

Ireland

Outcome results

None listed

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