Impact of Exogenous Estrogens on Cotisol Levels During Synacthen Stimulation

March 29, 2022 updated by: Mikkel Andreassen, Rigshospitalet, Denmark

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

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

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Copenhagen, Denmark, 2100
        • Mikkel Mr Andreassen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Hypogonadism
  • Treatment with estrogen substitution

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in serum cortisol oral estrogen
Time Frame: 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
Assessment will take place before and 3 months after introduction of the intervention
Change in serum cortisol transdermal estrogen
Time Frame: 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
Assessment will take place before and 3 months after introduction of the intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rigshospitalet, Denmark

Investigators

  • Principal Investigator: Mikkel M Andreassen, Department of Endocrinology and Metabolism

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2022

Primary Completion (Anticipated)

December 31, 2022

Study Completion (Anticipated)

June 1, 2023

Study Registration Dates

First Submitted

March 18, 2022

First Submitted That Met QC Criteria

March 29, 2022

First Posted (Actual)

March 31, 2022

Study Record Updates

Last Update Posted (Actual)

March 31, 2022

Last Update Submitted That Met QC Criteria

March 29, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-20048992

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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