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

Phase 1

• Conditions: ormal, 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

• Registration Number: EUCTR2007-000056-14-GB
• Lead Sponsor: Cardiff University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-01-04
• Study Completion: 2013-01-31
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 240

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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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;<br> Secondary Objective: To compare cortisol results against the gold standard method gas chromatography - mass spectrometry<br> To investigate the effect of oral contraceptives containing ethinyloestradiol on the cortisol cut-off in response to Synacthen<br> To define the salivary cortisol response to Synacthen in normal volunteers<br> To define the 17OHP response to Synacthen in normal female volunteers<br> ;Primary end point(s): To establish method-dependent cortisol cut-offs for the normal response to Synacthen using the 5th percentile