Back to resultsImpact of Exogenous Estrogens on Cotisol Levels During Synacthen Stimulation
Primary Purpose
Adrenal Insufficiency, Hypogonadism Female
Status
Enrolling by invitation
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Estrogen
Sponsored by
About this trial
This is an interventional diagnostic trial for Adrenal Insufficiency
Eligibility Criteria
Inclusion Criteria:
- Hypogonadism
- Treatment with estrogen substitution
Exclusion Criteria:
- Other formulations of glucocorticoid than oral hydrocortisone
- Pregnancy
- BMI > 35
Sites / Locations
- Mikkel Mr Andreassen
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
No Intervention
Arm Label
Oral estrogen
Transdermal estrogen
No treatment
Arm Description
oral estrogen (2 mg/24 hours)
Transdermal estrogen (100ug/24 hours)
Estrogen pause
Outcomes
Primary Outcome Measures
Change in serum cortisol oral estrogen
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
Change in serum cortisol 30 minutes after stimulation with synacthen in patients on transdermal estrogen vs no estrogen substitution
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05302726
Brief Title
Impact of Exogenous Estrogens on Cotisol Levels During Synacthen Stimulation
Official Title
Betydning af Eksogent østrogen på Serum Kortisol Under Synacthen-stimulering Hos Hypogonade Kvinder Med Binyrebarkinsufficiens
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Enrolling by invitation
Study Start Date
January 1, 2022 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
June 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rigshospitalet, Denmark
4. Oversight
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
Data Monitoring Committee
No
5. 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
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adrenal Insufficiency, Hypogonadism Female
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Oral estrogen
Arm Type
Active Comparator
Arm Description
oral estrogen (2 mg/24 hours)
Arm Title
Transdermal estrogen
Arm Type
Active Comparator
Arm Description
Transdermal estrogen (100ug/24 hours)
Arm Title
No treatment
Arm Type
No Intervention
Arm Description
Estrogen pause
Intervention Type
Drug
Intervention Name(s)
Estrogen
Intervention Description
Transdermal and oral estrogen both as substitution therapy
Primary Outcome Measure Information:
Title
Change in serum cortisol oral estrogen
Description
Change in serum cortisol 30 minutes after stimulation with synacthen in patients on oral estrogen vs no estrogen substitution
Time Frame
Assessment will take place before and 3 months after introduction of the intervention
Title
Change in serum cortisol transdermal estrogen
Description
Change in serum cortisol 30 minutes after stimulation with synacthen in patients on transdermal estrogen vs no estrogen substitution
Time Frame
Assessment will take place before and 3 months after introduction of the intervention
10. Eligibility
Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Hypogonadism
Treatment with estrogen substitution
Exclusion Criteria:
Other formulations of glucocorticoid than oral hydrocortisone
Pregnancy
BMI > 35
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mikkel M Andreassen
Organizational Affiliation
Department of endocrinology and metabolism
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mikkel Mr Andreassen
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark
12. IPD Sharing Statement
Learn more about this trial
Impact of Exogenous Estrogens on Cotisol Levels During Synacthen Stimulation
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