Impact of Exogenous Estrogens on Cotisol Levels During Synacthen Stimulation

NCT ID: NCT05302726

Last Updated: 2022-03-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-01

Study Completion Date

2023-06-01

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

Conditions

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Adrenal Insufficiency Hypogonadism Female

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

All patients will be examinated after 3 months on oral estrogen, 3 months on transdermal estrogen and after 3 months without estrogen substitution
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Oral estrogen

oral estrogen (2 mg/24 hours)

Group Type ACTIVE_COMPARATOR

Estrogen

Intervention Type DRUG

Transdermal and oral estrogen both as substitution therapy

Transdermal estrogen

Transdermal estrogen (100ug/24 hours)

Group Type ACTIVE_COMPARATOR

Estrogen

Intervention Type DRUG

Transdermal and oral estrogen both as substitution therapy

No treatment

Estrogen pause

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Estrogen

Transdermal and oral estrogen both as substitution therapy

Intervention Type DRUG

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Rigshospitalet, Denmark

OTHER

Sponsor Role lead

Responsible Party

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Mikkel Andreassen

Consultant, PhD associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mikkel M Andreassen

Role: PRINCIPAL_INVESTIGATOR

Department of endocrinology and metabolism

Locations

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Mikkel Mr Andreassen

Copenhagen, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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H-20048992

Identifier Type: -

Identifier Source: org_study_id

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