Impact of Exogenous Estrogens on Cotisol Levels During Synacthen Stimulation

Rigshospitalet

Status: Unknown

Conditions: Adrenal Insufficiency; Hypogonadism Female

Treatments: Drug: Estrogen

Study type: Interventional

Funder types: Other

Identifiers

NCT05302726

H-20048992

Details and patient eligibility

About

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

Full 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

Enrollment: 20 estimated patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Hypogonadism
• Treatment with estrogen substitution

Exclusion criteria

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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20 participants in 3 patient groups

Oral estrogen

Active Comparator group

Description:

oral estrogen (2 mg/24 hours)

Treatment:

Drug: Estrogen

Transdermal estrogen

Active Comparator group

Description:

Transdermal estrogen (100ug/24 hours)

Treatment:

Drug: Estrogen

No treatment

No Intervention group

Description:

Estrogen pause