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The Effects of Two Brands of Hydrocortisone Injected Intramuscularly Into Deltoid and Thigh Muscles

NCT05350020 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2022-04-27

No results posted yet for this study

Summary

The study will be looking at the cortisol profiles of hypocortisolaemic patients following 100mg injections of two hydrocortisone preparations (Solu-Cortef® \& Hydrocortisone 100mg/ml). The investigators plan to use two methods of intramuscular injection to administer the preparations, one using a 1inch orange needle into the deltoid muscle and the other using a 1.25inch blue needle into the thigh muscle.

Conditions

  • Addison's Disease

Interventions

DRUG

Solu-Cortef 100 MG Injection

Licensed medicine used in clinical practice. Preparations will be used unmodified in this trial withinmarketing authorisations.

DRUG

Hydrocortisone 100mg/ml

Licensed medicine used in clinical practice. Preparations will be used unmodified in this trial within marketing authorisations.

Sponsors & Collaborators

  • The London Clinic

    lead OTHER

Principal Investigators

  • Pierre Bouloux · Endocrinology Consultant

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-14
Primary Completion
2023-03-31
Completion
2023-08-31

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05350020 on ClinicalTrials.gov