Adrenal InsufficiencyNCT05302726
Impact of Exogenous Estrogens on Cotisol Levels During Synacthen Stimulation
A study testing Estrogen in people with Adrenal Insufficiency and Hypogonadism Female, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Adrenal Insufficiency, Hypogonadism Female
- What is being tested?
- Estrogen
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Jan 2022to 1 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Hypogonadism
- Treatment with estrogen substitution
Who cannot join
- Other formulations of glucocorticoid than oral hydrocortisone
- Pregnancy
- BMI > 35
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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
- Conditions
- Adrenal Insufficiency, Hypogonadism Female
- Being tested
- Estrogen
- Medical subject headings
- Adrenal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EstrogenDrug
Transdermal and oral estrogen both as substitution therapy
| Study group | Role | What they receive |
|---|---|---|
| Oral estrogen | Active comparator | oral estrogen (2 mg/24 hours) Receives: Drug: Estrogen |
| Transdermal estrogen | Active comparator | Transdermal estrogen (100ug/24 hours) Receives: Drug: Estrogen |
| No treatment | No intervention | Estrogen pause |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: Assessment will take place before and 3 months after introduction of the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2022
- Study start1 Jan 2022
- Primary completion31 Dec 2022 (estimated)
- Study completion1 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adrenal InsufficiencyStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Crossover
- 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)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mikkel Andreassen, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Mikkel M Andreassen, Principal investigator, Department of endocrinology and metabolism
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05302726
- Sponsor's protocol ID
- H-20048992
- Status last verified
- Mar 2022
- First submitted
- 18 Mar 2022
- Last updated
- 31 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Betydning af Eksogent østrogen på Serum Kortisol Under Synacthen-stimulering Hos Hypogonade Kvinder Med Binyrebarkinsufficiens
- ClinicalTrials.gov ID
- NCT05302726
- Acronym / sponsor ID
- H-20048992
- Conditions
- Adrenal Insufficiency, Hypogonadism Female
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 1 Jun 2023 (estimated)
- First posted
- 31 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- 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
| Arm | Type | Receives |
|---|---|---|
| Oral estrogen | Active comparator | Drug: Estrogenoral estrogen (2 mg/24 hours) |
| Transdermal estrogen | Active comparator | Drug: EstrogenTransdermal estrogen (100ug/24 hours) |
| No treatment | No intervention | –Estrogen pause |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Hypogonadism
- Treatment with estrogen substitution
Key exclusion criteria (3 listed)
- Other formulations of glucocorticoid than oral hydrocortisone
- Pregnancy
- BMI > 35
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EstrogenTransdermal and oral estrogen both as substitution therapy | Drug | Oral estrogen, Transdermal estrogen |
Primary outcome
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mikkel M Andreassen principal investigator
Department of endocrinology and metabolism
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Estrogen in people with Adrenal Insufficiency and Hypogonadism Female, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in serum cortisol oral estrogen (time frame: Assessment will take place before and 3 months after introduction of the intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2022.