NCT05302726

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2022

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 18, 2022

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 31, 2022

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2023

Completed
Last Updated

March 31, 2022

Status Verified

March 1, 2022

Enrollment Period

12 months

First QC Date

March 18, 2022

Last Update Submit

March 29, 2022

Conditions

Adrenal InsufficiencyHypogonadism Female

Outcome Measures

Primary Outcomes (2)

  • 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

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

  • 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

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

Study Arms (3)

Oral estrogen

ACTIVE COMPARATOR

oral estrogen (2 mg/24 hours)

Drug: Estrogen

Transdermal estrogen

ACTIVE COMPARATOR

Transdermal estrogen (100ug/24 hours)

Drug: Estrogen

No treatment

NO INTERVENTION

Estrogen pause

Interventions

EstrogenDRUG

Transdermal and oral estrogen both as substitution therapy

Oral estrogenTransdermal estrogen

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Hypogonadism
  • Treatment with estrogen substitution

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mikkel Mr Andreassen

Copenhagen, 2100, Denmark

Location

MeSH Terms

Conditions

Adrenal Insufficiency

Interventions

Estrogens

Condition Hierarchy (Ancestors)

Adrenal Gland DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

HormonesHormones, Hormone Substitutes, and Hormone AntagonistsPhysiological Effects of DrugsPharmacologic ActionsChemical Actions and Uses

Study Officials

  • Mikkel M Andreassen

    Department of endocrinology and metabolism

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
CROSSOVER
Model Details: All patients will be examinated after 3 months on oral estrogen, 3 months on transdermal estrogen and after 3 months without estrogen substitution
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant, PhD associate professor

Study Record Dates

First Submitted

March 18, 2022

First Posted

March 31, 2022

Study Start

January 1, 2022

Primary Completion

December 31, 2022

Study Completion

June 1, 2023

Last Updated

March 31, 2022

Record last verified: 2022-03

Locations

DK(1)