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Trial · Interventional

CompletedPhase 4Registry data

Standardized 1µg Adrenocorticotropic Hormone Stimulation Test, and Salivary Cortisol Concentration During the Test

NCTNCT02413944 (opens ClinicalTrials.gov in a new tab)Other idBnaiZionMC
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 4
Enrollment
20 participants (actual)
Sponsor
Bnai Zion Medical Center · Other gov
Design
Allocation not applicable · Open label (no masking)
Countries
1 country

Israel

Start
Apr 2015
Primary completion
Oct 2016
Completion
Oct 2016
First posted
10 Apr 2015 (estimated)
Last update posted
27 Oct 2016 (estimated)
Conditions
Healthy

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
201520162017
  1. Ph 4

    Standardized 1µg Adrenocorticotropic Hormone Stimulation Test, and Salivary Cortisol Concentration During the Test

    NCT02413944

    Apr 2015 to Oct 2016

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

Study objectives: First, to determine whether intravenous injection of 1 mcg adrenocorticotropic hormone (ACTH) through short cannula, in healthy participants, provides reliable results of cortisol response, and whether this method would replace the conventional technique of injecting ACTH by a needle directly into a peripheral vein. Secondly, to determine salivary free cortisol concentration during the test in healthy controls. Rationale of study: Intravenous injection of synthetic ACTH1-24 concentration through venous short cannula appears to be feasible and simple method. On the other hand, injection of ACTH1-24 by a needle directly into peripheral vein, is not infrequently complicated by technical problems in subjects with challenging veins. The investigators suppose that, both methods would have the same yield in predicting cortisol response. Salivary free cortisol test has an evolving importance in assessing the adrenal function. This test would be reliable for use in low dose ACTH stimulation (1 mcg) test. The investigators will examine the concentration of salivary free cortisol during ACTH stimulation test, in order to determine level range in normal controls.

Interventions

  • ACTH stimulation testProcedure

Arms1

  • Experimental

    healthy volunteers

    ACTH stimulation test

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Serum cortisol concentrations during intravenous injection of 1 mcg adrenocorticotropic hormone through short cannula and during direct intravenous injection, in healthy participants.

    Time frame · 1 year

Secondary outcomes(1)

  1. Salivary free cortisol concentrations during intravenous injection of 1 mcg adrenocorticotropic hormone through short cannula and during direct intravenous injection, in healthy participants.

    Time frame · 1 year

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 70 Years
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * healthy participants of both sexes * aged 18-70 year Exclusion Criteria: * any clinical suspicion of hypoadrenalism, or any active medical condition or treatment that might alter blood cortisol levels * pregnant women and patients whose medical or mental condition precludes obtaining informed consent

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