CClinicalTrials.gg
Status unknownNCT05302726Updated Mar 31, 2022

Impact of Exogenous Estrogens on Cotisol Levels During Synacthen Stimulation

An interventional study of Estrogen in Adrenal Insufficiency and Hypogonadism Female, sponsored by Rigshospitalet, Denmark. Status unknown at 1 site in Denmark. Open to female participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2022-03-31.

Sponsored by Rigshospitalet, Denmark · Not applicable, Interventional, and Diagnostic

The sponsor has not verified this record recently (last verified Mar 2022), so the status shown — last known as Enrolling by invitation — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Non-randomized
Ages
18 Years to 50 Years
Sex
Female
01

Study 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

Read the 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

02

Conditions studied

  • Adrenal Insufficiency
  • Hypogonadism Female
03

In context

Hypogonadism

345 studies on the registry are indexed under Hypogonadism; 43 are open to participants now.

This study's planned enrollment of 20 is below the median of 56 across 260 interventional studies indexed under Hypogonadism.

Browse Hypogonadism studies →

Lead sponsor

Rigshospitalet, Denmark is the lead sponsor of 1,017 studies on the registry; 183 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • Hypogonadism
  • Treatment with estrogen substitution

Exclusion criteria

Exclusion Criteria:

  • Other formulations of glucocorticoid than oral hydrocortisone
  • Pregnancy
  • BMI > 35
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Non-randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • Active comparator
    Oral estrogen

    oral estrogen (2 mg/24 hours)

    Drug: Estrogen

  • Active comparator
    Transdermal estrogen

    Transdermal estrogen (100ug/24 hours)

    Drug: Estrogen

  • No intervention
    No treatment

    Estrogen pause

Interventions

  • DrugEstrogen

    Transdermal and oral estrogen both as substitution therapy

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: Assessment will take place before and 3 months after introduction of the intervention

  2. 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

    Time frame: Assessment will take place before and 3 months after introduction of the intervention

07

Study locations

1 site
  • Mikkel Mr Andreassen
    Copenhagen, 2100, Denmark
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 31, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05302726
Lead sponsor
Rigshospitalet, Denmark
Responsible party
Mikkel Andreassen (Consultant, PhD associate professor, Rigshospitalet, Denmark) — Principal investigator
First posted
Mar 31, 2022
Start date
Jan 1, 2022
Primary completion
Dec 31, 2022 (estimated)
Completion
Jun 1, 2023 (estimated)
Last update
Mar 31, 2022

Study contacts

Mikkel M Andreassen
principal investigator · Department of endocrinology and metabolism

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.

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