Impact of Exogenous Estrogens on Cotisol Levels During Synacthen Stimulation

Not Applicable

• Conditions: Hypogonadism Female; Adrenal Insufficiency
• Interventions: Drug: Estrogen

• Registration Number: NCT05302726
• Lead Sponsor: Rigshospitalet, Denmark

Brief 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

Detailed 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

Study Timeline

• Study Start: 2022-01-01
• Status Verified: 2022-03
• Study First Submitted: 2022-03-18
• Study First Submitted QC: 2022-03-29
• Last Update Submitted: 2022-03-29
• Study First Posted: 2022-03-31
• Last Update Posted: 2022-03-31
• Primary Completion: 2022-12-31
• Study Completion: 2023-06-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 20

Inclusion Criteria

• Hypogonadism
• Treatment with estrogen substitution

Exclusion Criteria

• Other formulations of glucocorticoid than oral hydrocortisone
• Pregnancy
• BMI > 35

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Oral estrogen	Estrogen	oral estrogen (2 mg/24 hours)
Transdermal estrogen	Estrogen	Transdermal estrogen (100ug/24 hours)

Primary Outcome Measures

Name	Time	Method
Change in serum cortisol oral estrogen	Assessment will take place before and 3 months after introduction of the intervention	Change in serum cortisol 30 minutes after stimulation with synacthen in patients on oral estrogen vs no estrogen substitution
Change in serum cortisol transdermal estrogen	Assessment will take place before and 3 months after introduction of the intervention	Change in serum cortisol 30 minutes after stimulation with synacthen in patients on transdermal estrogen vs no estrogen substitution

Trial Locations

Locations (1)

Mikkel Mr Andreassen; 🇩🇰 Copenhagen, Denmark