Determination of method-specific normal cortisol and adrenal hormone responses to the short Synacthen test - Short Synacthen test Study

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2007-000056-14-GB

Enrollment

240

Registered

2008-01-04

Start date

2008-03-03

Completion date

Unknown

Last updated

2019-06-30

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

Conditions

Normal, healthy volunteers to establish a reference range for the synacthen test, plus patients with hypoadrenalism/hypopituitarism MedDRA version: 9.1 Level: LLT Classification code 10020936 Term: Hypoadrenalism MedDRA version: 9.1 Level: LLT Classification code 10021067 Term: Hypopituitarism

Interventions

Trade Name: Synacthen Pharmaceutical Form: Solution for injection

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: In self-proclaimed good health Free of illness on the day of testing Not taking drug therapy (other than females under the age of 40 years who are permitted to be taking an ethinyloestradiol-containing oral contraceptive) 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) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Pregnancy. Females of childbearing potential must have a negative pregnancy test before enrolment Lactation/breastfeeding Taking corticosteroids currently Significant intercurrent illness History of thyroid or other autoimmune disease Previous history of hypersensitivity to Synacthen Previous history of asthma Any mental condition rendering the patient unable to understand the nature or possible consequences of the study, and/or evidence of an uncooperative attitude

Design outcomes

Primary

Measure	Time frame
Main Objective: To define the cortisol response to Synacthen in normal volunteers using commercially available cortisol immunoassays in use in clinical laboratories in the UK; Secondary Objective: To compare cortisol results against the gold standard method gas chromatography - mass spectrometry To investigate the effect of oral contraceptives containing ethinyloestradiol on the cortisol cut-off in response to Synacthen To define the salivary cortisol response to Synacthen in normal volunteers To define the 17OHP response to Synacthen in normal female volunteers ;Primary end point(s): To establish method-dependent cortisol cut-offs for the normal response to Synacthen using the 5th percentile	—

Measure

Time frame

Main Objective: To define the cortisol response to Synacthen in normal volunteers using commercially available cortisol immunoassays in use in clinical laboratories in the UK; Secondary Objective: To compare cortisol results against the gold standard method gas chromatography - mass spectrometry To investigate the effect of oral contraceptives containing ethinyloestradiol on the cortisol cut-off in response to Synacthen To define the salivary cortisol response to Synacthen in normal volunteers To define the 17OHP response to Synacthen in normal female volunteers ;Primary end point(s): To establish method-dependent cortisol cut-offs for the normal response to Synacthen using the 5th percentile

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Countries

United Kingdom

Outcome results

None listed

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