Impact of Exogenous Estrogens on Cotisol Levels During Synacthen Stimulation

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Adrenal Insufficiency, Hypogonadism Female

Intervention / Treatment
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* Drug: Estrogen


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Hypogonadism Treatment with estrogen substitution Exclusion Criteria: Other formulations of glucocorticoid than oral hydrocortisone Pregnancy BMI > 35

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: All patients will be examinated after 3 months on oral estrogen, 3 months on transdermal estrogen and after 3 months without estrogen substitution
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Oral estrogen<br>oral estrogen (2 mg/24 hours) | Drug: Estrogen<br>* Transdermal and oral estrogen both as substitution therapy<br>|
| Active Comparator: Transdermal estrogen<br>Transdermal estrogen (100ug/24 hours) | Drug: Estrogen<br>* Transdermal and oral estrogen both as substitution therapy<br>|
| No Intervention: No treatment<br>Estrogen pause | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 |