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NCT05302726 Clinical Trial

Impact of Exogenous Estrogens on Cotisol Levels During Synacthen Stimulation

Adrenal Insufficiency Clinical Trial

Official title:
Betydning af Eksogent østrogen på Serum Kortisol Under Synacthen-stimulering Hos Hypogonade Kvinder Med Binyrebarkinsufficiens

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT05302726
Other study ID # H-20048992
Secondary ID
Status Enrolling by invitation
Phase N/A
First received
Last updated
Start date January 1, 2022
Est. completion date June 1, 2023

Study information
Verified date March 2022
Source Rigshospitalet, Denmark
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aim is to investigate impact of exogenous estrogens on cotisol Levels during synacthen stimulation in female hypogonal patients on estrogen substitution. Both patients with and withour adrenal insufficiency will be studied

Description:

The aim is to investigate impact of exogenous estrogens on cotisol levels during synacthen stimulation in female hypogonal patients on estrogen substitution. Both patients with and without adrenal insufficiency will be studied . All patients (inclusion criteria age 18-50 years, BMI <35) will be followed for 6 months and have 3 synacthentests performed: One on transdermal estrogen (minimum 3 months), one on oral estrogens (min 3 months) and one without estrogen substitution for at least 3 months. Primary endpoint is change in serum cortisol 30 minutes after synacthen stimulation

Recruitment information / eligibility
Status Enrolling by invitation
Enrollment 20
Est. completion date June 1, 2023
Est. primary completion date December 31, 2022
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 50 Years
Eligibility Inclusion Criteria: - Hypogonadism - Treatment with estrogen substitution Exclusion Criteria: - Other formulations of glucocorticoid than oral hydrocortisone - Pregnancy - BMI > 35

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Estrogen
Transdermal and oral estrogen both as substitution therapy

Locations
Country Name City State
Denmark Mikkel Mr Andreassen Copenhagen

Sponsors (1)
Lead Sponsor Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change in serum cortisol oral estrogen Change in serum cortisol 30 minutes after stimulation with synacthen in patients on oral estrogen vs no estrogen substitution Assessment will take place before and 3 months after introduction of the intervention
Primary Change in serum cortisol transdermal estrogen Change in serum cortisol 30 minutes after stimulation with synacthen in patients on transdermal estrogen vs no estrogen substitution Assessment will take place before and 3 months after introduction of the intervention
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