Impact of Exogenous Estrogens on Cotisol Levels During Synacthen Stimulation

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05302726

Enrollment

Registered

2022-03-31

Start date

2022-01-01

Completion date

2023-06-01

Last updated

2022-03-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adrenal Insufficiency, Hypogonadism Female

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

Interventions

DRUGEstrogen

Transdermal and oral estrogen both as substitution therapy

Study design

Allocation

NON_RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

DIAGNOSTIC

Masking

NONE

Intervention 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

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 50 Years

Healthy volunteers

Inclusion criteria

* Hypogonadism * Treatment with estrogen substitution

Exclusion criteria

* Other formulations of glucocorticoid than oral hydrocortisone * Pregnancy * BMI \> 35

Design outcomes

Primary

Measure	Time frame	Description
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

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026