Impact of Exogenous Estrogens on Cotisol Levels During Synacthen Stimulation

Sponsor

Rigshospitalet, Denmark (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT05302726

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

1.2

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Adrenal Insufficiency Hypogonadism Female	Drug: Estrogen	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

Non-Randomized

Intervention Model:

Crossover Assignment

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 substitutionAll 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)

Primary Purpose:

Diagnostic

Official Title:

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

Actual Study Start Date :

Jan 1, 2022

Anticipated Primary Completion Date :

Dec 31, 2022

Anticipated Study Completion Date :

Jun 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Oral estrogen oral estrogen (2 mg/24 hours)	Drug: Estrogen Transdermal and oral estrogen both as substitution therapy
Active Comparator: Transdermal estrogen Transdermal estrogen (100ug/24 hours)	Drug: Estrogen Transdermal and oral estrogen both as substitution therapy
No Intervention: No treatment Estrogen pause

Arm

Intervention/Treatment

Active Comparator: Oral estrogen

oral estrogen (2 mg/24 hours)

Drug: Estrogen

Transdermal and oral estrogen both as substitution therapy

Active Comparator: Transdermal estrogen

Transdermal estrogen (100ug/24 hours)

Drug: Estrogen

Transdermal and oral estrogen both as substitution therapy

No Intervention: No treatment

Estrogen pause

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

Hypogonadism
Treatment with estrogen substitution

Exclusion Criteria:

Other formulations of glucocorticoid than oral hydrocortisone
Pregnancy
BMI > 35

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mikkel Mr Andreassen	Copenhagen		Denmark	2100

Sponsors and Collaborators

Rigshospitalet, Denmark

Investigators

Principal Investigator: Mikkel M Andreassen, Department of endocrinology and metabolism

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Mikkel Andreassen, Consultant, PhD associate professor, Rigshospitalet, Denmark

ClinicalTrials.gov Identifier:

NCT05302726

Other Study ID Numbers:

H-20048992

First Posted:

Mar 31, 2022

Last Update Posted:

Mar 31, 2022

Last Verified:

Mar 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Hypogonadism

Adrenal Insufficiency

Estrogens

Study Results

No Results Posted as of Mar 31, 2022