Cushing SyndromePhase 2NCT06635629
Desmopressin Stimulation Test Performance in ACTH-Dependent Cushing Syndrome
A Phase 2 study testing Desmopressin and Dexamethasone in people with Cushing Syndrome, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 1 site in United States.
Trial summary
Background: Cushing syndrome (CS) is a set of diseases that develop when the body produces too much adrenocorticotropic hormone (ACTH). ACTH stimulates the production of a hormone called cortisol. Excess cortisol can cause serious issues, such as diabetes, high blood pressure, weight gain, and mood changes. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Cushing Syndrome
- What is being tested?
- Desmopressin and Dexamethasone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Dec 2024to 1 Jan 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- To be eligible to participate in this study, an individual must meet all of the following criteria:
- Aged 18-70 years
- Agreement to adhere to Lifestyle Considerations throughout the study.
- Evidence of acceptable laboratory testing results within four weeks of the first test day, as shown by medical record review:
- Hematocrit at entry >=33 %
- Plasma sodium 136-145 mmol/L (unless taking a drug that can cause hyponatremia, see below) eGFR >=60 ml/min/1.73 sq.m, calculated based on serum creatinine
Show all 15Show fewer
- For subjects taking any drug that could worsen hyponatremia, a normal plasma sodium (136-145 mmol/L) must have been obtained within seven days of the first test day.
- In addition, an individual must meet all the criteria listed for their diagnostic group below, based on medical record review:
- Patients with possible ACTH-dependent Cushing Syndrome (where the results of further work up will classify the patient as having CD, EAS or pseudo-CS):
- A. Hypercortisolemia as evidenced by physician note or laboratory report: at least one screening modality (1 mg dexamethasone suppression test, 24-hour urinary free cortisol (UFC), bedtime or late night (2200h - 2359h) salivary or serum cortisol) within 4 weeks of screening. In patients suspected to have cyclic CS any previous abnormal result will suffice.
- A. Normal or increased plasma ACTH (>20 pg/mL) as evidenced by physician note or laboratory report.
- Patients with recurrent ACTH-dependent Cushing Syndrome (previous CD or EAS):
- 1B. Evidence of previous remission of CD or EAS after resection of a causative pituitary or ectopic tumor, evidence of current ACTH-dependent hypercortisolism, and willingness to undergo repeat surgery.
- Healthy volunteers:
- C1. In good general health as evidenced by medical history and physical examination; and in a stable state of health without ongoing acute/temporary illness per the clinical judgement of the investigator.
Who cannot join
- An individual who meets any of the following criteria will be excluded from participation in this study, based on medical record review (possible Cushing syndrome patients) or a screening visit (healthy volunteers).
- Inability to comply with all study procedures and visits
- Inability of subject to understand or to sign a written informed consent document.
- Known allergy/hypersensitivity to desmopressin.
- Pregnancy or lactation, due to alterations in measured serum cortisol and lack of data on desmopressin safety.
- A history of angina, significant coronary artery disease, congestive heart failure, or syndrome of inappropriate antidiuretic hormone secretion (SIADH), due to risk of fluid overload and/or hyponatremia.
Show all 30Show fewer
- Uncontrolled hypertension (blood pressure >150/95 mmHg) at screening and before desmopressin administration, due to risk of further increase if fluid overload occurs
- Any condition that in the opinion of the Investigator would jeopardize the participant s appropriate participation in this study.
- Current daily use of any of the following medications:
- Drug used for the stimulation tests: Desmopressin.
- Drugs that can suppress ACTH and cortisol test responses: Systemic glucocorticoids, including inhaled or topical formulations.
- Vasopressors: phenylephrine, dopamine and vasopressin.
- Drugs that interfere with desmopressin duration of action or potency: carbamazepine, lamotrigine, tolvaptan
- Strong inducers of CYP3A4 (e.g. barbiturates, phenytoin, rifampin, rifabutin, rifapentine, carbamazepine, eslicarbazepine, primidone, cenobamate, Modafinil). Use of St John's wort or nafcillin within 14 days.
- Initiation or dose increase within the past 14 days of drugs that can worsen hyponatremia: non-steroidal anti-inflammatory drugs (NSAIDs), loop diuretics (bumetanide, ethacrynic acid, furosemide, torsemide), chlorpromazine, chlorpropamide, cisplatin, monoamine oxidase inhibitors (MAOI), opiate agonists, oxybutynin, selective serotonin reuptake inhibitors (SSRI), vincristine, tricyclic antidepressants (TCAs)
- Chronic enhanced hydration (estimated as >4 liters) to supplement mealtime fluid intake.
- Any contraindication to intravenous catheter use.
- Previous participation in this protocol.
- History of hemophilia of any type.
- Any hematology or chemistry screening laboratory value drawn at screening that the Investigator determines is clinically significant for exclusion.
- Condition-specific exclusions will also apply to each subject group as follows:
- A.Patients with possible ACTH-dependent Cushing Syndrome:
- A. Use of medications that block glucocorticoid production (ketoconazole, levoketoconazole, metyrapone, osilodrostat) within the past two weeks, if normal cortisol is achieved. If hypercortisolism persists despite the use of these medications, as evidenced by an elevated 24-hour urinary free cortisol (UFC) or late night (2200h - 2359h) salivary or serum cortisol within two weeks of the first desmopressin test, the medication(s) may be continued until 48 hours before the first desmopressin test.
- A. Use of the adrenolytic mitotane at any point, due to its prolonged half-life.
- A. Use of medications that block glucocorticoid action or ACTH release within the past two weeks - mifepristone, cabergoline, octreotide (subcutaneous), pasireotide (subcutaneous), megestrol acetate, other synthetic glucocorticoids (except for topical or inhaled agents and single doses of oral dexamethasone for diagnostic testing within the past 48 hours)
- A. Use of intramuscular long-acting forms of octreotide or pasireotide within the past 4 months.
- A. Treatment of diabetes insipidus.
- Healthy volunteers:
- B. Use of oral, injectable, or inhaled glucocorticoids (unless intermittent, for symptomatic asthma) within the last year. Use of topical non-hydrocortisone containing potent glucocorticoids on more than 36 square inches in the last six months.
- B. Hemoglobin A1c >= 6.5% on screening labs.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
NIH Clinical Center Office of Patient Recruitment (OPR), 800-411-1222 ext. TTY dial 711, ccopr@nih.gov
About this study
Official title: Phase II Prospective Evaluation of Desmopressin Stimulation Test Performance in ACTH-dependent Cushing s Syndrome
Background:
Cushing syndrome (CS) is a set of diseases that develop when the body produces too much adrenocorticotropic hormone (ACTH). ACTH stimulates the production of a hormone called cortisol. Excess cortisol can cause serious issues, such as diabetes, high blood pressure, weight gain, and mood changes. Diagnosing CS early can be difficult. One test used to diagnose CS, the desmopressin (Desmo) stimulation test (DesmoST), has not been studied in enough people to know how accurate it is.
Read more
Objective:
To find ways to improve the DesmoST. Researchers especially want to learn more about how well the DesmoST identifies people with specific ACTH CSs: Cushing disease (CD) and ectopic ACTH syndrome (EAS).
Eligibility:
People aged 18 to 70 years who have or may have CS, especially CD or EAS. Healthy volunteers are also needed.
Design:
Participants with CS will have 3 DesmoSTs at least 48 hours apart. The procedure for each is as follows:
They will limit their fluid intake the day before each test. They will have nothing to eat or drink for 12 hours before the test.
For 1 of the tests, they will take a pill that contains a hormone (dexamethasone). They will take it around 11 pm the day before the test.
Desmo is given through a tube attached to a needle inserted into a vein.
Blood will be drawn a total of 6 times before and after the desmo is given.
Healthy volunteers will have 4 DesmoSTs. These will be 2 to 14 days apart.
All participants will have follow-up visits 3 to 5 days after each test. These visits may be by phone.
Read the detailed description
Study Description:
The goal of this study is to improve the diagnostic accuracy of the Desmopressin stimulation test (DesmoST) for three indications: to identify the etiology of ACTH-dependent Cushing syndrome (CS) as either Cushing Disease (CD) or Ectopic ACTH Syndrome (EAS), to discriminate between non-CS subjects (healthy controls and patients with pseudo-CS) and CD, and to identify CD in patients with cyclic hypercortisolism or recurrence. Test conditions include ad libitum water intake vs fluid restriction; increased glucocorticoid negative feedback (1 mg dexamethasone); and variable doses of desmopressin (4 mcg vs 10 mcg). We hypothesize that fluid restriction (via increased endogenous vasopressin levels), increased glucocorticoid negative feedback, and a lower dose of desmopressin improve specificity.
Objectives:
-Primary Objective:
To evaluate the hormonal response to desmopressin in subjects with ACTH-dependent Cushing syndrome (CD and EAS) and non-CS subjects (healthy controls, pseudo-CS) under different conditions.
-Secondary Objective:
To evaluate the DesmoST performance (sensitivity, specificity, diagnostic accuracy) in identifying subjects with CD and distinguishing these from subjects with EAS and non-CS subjects (healthy controls, pseudo-CS) under different conditions.
-Exploratory Objectives:
To evaluate the ability of the DesmoST to identify CD in patients with cyclic hypercortisolism or postoperative recurrence; to evaluate whether Factor VIII is a biomarker for desmopressin action; and to explore the relationship between fluid status and response to desmopressin
Endpoints:
-Primary Endpoints:
Percentage change of peak ACTH and cortisol from baseline levels during the DesmoST under different conditions.
-Secondary Endpoints:
Cut-off points of relative ACTH and cortisol increase during the DesmoST that produce optimal diagnostic accuracy, once diagnostic information from other tests/imaging has been used to categorize subjects with suspected CS as having CD, EAS, or pseudo-CS.
-Exploratory Endpoints:
Percent change of peak ACTH and cortisol from baseline during the DesmoST in patients categorized as having cyclic hypercortisolism, postoperative recurrence, and fluid replete or restricted; the change in factor VIII levels after desmopressin administration.
- Conditions
- Cushing Syndrome
- Being tested
- Desmopressin, Dexamethasone
- Keywords
- desmopressin, Cushing syndrome, diagnosis
- Medical subject headings
- Cushing Syndrome, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DesmopressinDrug
Stimulates ACTH release in Cushing disease
DexamethasoneDrug
Inhibits ACTH release in Cushing disease and healthy volunteers
| Study group | Role | What they receive |
|---|---|---|
| Desmopressin 10 mcg Ad-lib fluid | Other | Desmopressin 10 mcg Ad-lib fluidHealthy volunteers only Receives: Drug: Desmopressin |
| Desmopressin 10 mcg NPO | Active comparator | Desmopressin 10 mcg Receives: Drug: Desmopressin |
| Desmopressin NPO 4 mcg | Active comparator | Desmopressin 4 mcg Receives: Drug: Desmopressin |
| Dexmopressin 10 mcg NPO + Dexamethasone | Active comparator | Desmopressin 10 mcgDexamethasone 1 mg pretreatment Receives: Drug: Desmopressin; Drug: Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
ACTH and cortisol responses
Percent change from mean baseline values (-5, 0 minutes) at all combinations of dose dose timepoints
Measured: -5, 0, 15, 30, 45 and 60 minutes
Secondary outcomes (1)
Diagnostic accuracy, specificity, sensitivity of cortisol and ACTH measurements in response to desmopressin
ROC curve % +/- 95% Confidence interval
Measured: -5, 0, 15, 30, 45 and 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2024
- Study start12 Dec 2024
- Primary completion1 Oct 2028 (estimated)
- Study completion1 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cushing SyndromeStudies of the same condition, open and under way.
- More trials run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)The 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 2
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Lynnette K Nieman, M.D., Principal investigator, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06635629
- Sponsor's protocol ID
- 10001822
- Other IDs
- 001822-DK
- Status last verified
- 27 Aug 2026
- First submitted
- 3 Oct 2024
- Last updated
- 31 Aug 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data appearing in publications will be shared.
Publications
Elenius H, Brown BM, McGlotten R, Moore C, Nieman LK. Evaluation of desmopressin stimulation test specificity in healthy volunteers. Endocr Connect. 2026 Aug 1;15(8):e260270. doi: 10.1530/EC-26-0270.
PubMed 42535456
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Prospective Evaluation of Desmopressin Stimulation Test Performance in ACTH-dependent Cushing s Syndrome
- ClinicalTrials.gov ID
- NCT06635629
- Acronym / sponsor ID
- 10001822
- Conditions
- Cushing Syndrome
- Keywords
- desmopressin, Cushing syndrome, diagnosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)US National Institutes of Health
- Study start
- 12 Dec 2024 (actual)
- Primary completion
- 1 Oct 2028 (estimated)
- Study completion
- 1 Jan 2029 (estimated)
- First posted
- 10 Oct 2024 (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.
Background:
Cushing syndrome (CS) is a set of diseases that develop when the body produces too much adrenocorticotropic hormone (ACTH). ACTH stimulates the production of a hormone called cortisol. Excess cortisol can cause serious issues, such as diabetes, high blood pressure, weight gain, and mood changes. Diagnosing CS early can be difficult. One test used to diagnose CS, the desmopressin (Desmo) stimulation test (DesmoST), has not been studied in enough people to know how accurate it is.
Objective:
To find ways to improve the DesmoST. Researchers especially want to learn more about how well the DesmoST identifies people with specific ACTH CSs: Cushing disease (CD) and ectopic ACTH syndrome (EAS).
Eligibility:
People aged 18 to 70 years who have or may have CS, especially CD or EAS. Healthy volunteers are also needed.
Design:
Participants with CS will have 3 DesmoSTs at least 48 hours apart. The procedure for each is as follows:
They will limit their fluid intake the day before each test. They will have nothing to eat or drink for 12 hours before the test.
For 1 of the tests, they will take a pill that contains a hormone (dexamethasone). They will take it around 11 pm the day before the test.
Desmo is given through a tube attached to a needle inserted into a vein.
Blood will be drawn a total of 6 times before and after the desmo is given.
Healthy volunteers will have 4 DesmoSTs. These will be 2 to 14 days apart.
All participants will have follow-up visits 3 to 5 days after each test. These visits may be by phone.
Detailed description
Study Description:
The goal of this study is to improve the diagnostic accuracy of the Desmopressin stimulation test (DesmoST) for three indications: to identify the etiology of ACTH-dependent Cushing syndrome (CS) as either Cushing Disease (CD) or Ectopic ACTH Syndrome (EAS), to discriminate between non-CS subjects (healthy controls and patients with pseudo-CS) and CD, and to identify CD in patients with cyclic hypercortisolism or recurrence. Test conditions include ad libitum water intake vs fluid restriction; increased glucocorticoid negative feedback (1 mg dexamethasone); and variable doses of desmopressin (4 mcg vs 10 mcg). We hypothesize that fluid restriction (via increased endogenous vasopressin levels), increased glucocorticoid negative feedback, and a lower dose of desmopressin improve specificity.
Objectives:
-Primary Objective:
To evaluate the hormonal response to desmopressin in subjects with ACTH-dependent Cushing syndrome (CD and EAS) and non-CS subjects (healthy controls, pseudo-CS) under different conditions.
-Secondary Objective:
To evaluate the DesmoST performance (sensitivity, specificity, diagnostic accuracy) in identifying subjects with CD and distinguishing these from subjects with EAS and non-CS subjects (healthy controls, pseudo-CS) under different conditions.
-Exploratory Objectives:
To evaluate the ability of the DesmoST to identify CD in patients with cyclic hypercortisolism or postoperative recurrence; to evaluate whether Factor VIII is a biomarker for desmopressin action; and to explore the relationship between fluid status and response to desmopressin
Endpoints:
-Primary Endpoints:
Percentage change of peak ACTH and cortisol from baseline levels during the DesmoST under different conditions.
-Secondary Endpoints:
Cut-off points of relative ACTH and cortisol increase during the DesmoST that produce optimal diagnostic accuracy, once diagnostic information from other tests/imaging has been used to categorize subjects with suspected CS as having CD, EAS, or pseudo-CS.
-Exploratory Endpoints:
Percent change of peak ACTH and cortisol from baseline during the DesmoST in patients categorized as having cyclic hypercortisolism, postoperative recurrence, and fluid replete or restricted; the change in factor VIII levels after desmopressin administration.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Desmopressin 10 mcg Ad-lib fluid | Other | Drug: DesmopressinDesmopressin 10 mcg Ad-lib fluidHealthy volunteers only |
| Desmopressin 10 mcg NPO | Active comparator | Drug: DesmopressinDesmopressin 10 mcg |
| Desmopressin NPO 4 mcg | Active comparator | Drug: DesmopressinDesmopressin 4 mcg |
| Dexmopressin 10 mcg NPO + Dexamethasone | Active comparator | Drug: Desmopressin, Drug: DexamethasoneDesmopressin 10 mcgDexamethasone 1 mg pretreatment |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- To be eligible to participate in this study, an individual must meet all of the following criteria:
- Aged 18-70 years
- Agreement to adhere to Lifestyle Considerations throughout the study.
- Evidence of acceptable laboratory testing results within four weeks of the first test day, as shown by medical record review:
- For subjects taking any drug that could worsen hyponatremia, a normal plasma sodium (136-145 mmol/L) must have been obtained within seven days of the first test day.
Key exclusion criteria (30 listed)
- An individual who meets any of the following criteria will be excluded from participation in this study, based on medical record review (possible Cushing syndrome patients) or a screening visit (healthy volunteers).
- Inability to comply with all study procedures and visits
- Inability of subject to understand or to sign a written informed consent document.
- Known allergy/hypersensitivity to desmopressin.
- Pregnancy or lactation, due to alterations in measured serum cortisol and lack of data on desmopressin safety.
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 |
|---|---|---|
| DesmopressinStimulates ACTH release in Cushing disease | Drug | Desmopressin 10 mcg Ad-lib fluid, Desmopressin 10 mcg NPO, Desmopressin NPO 4 mcg, Dexmopressin 10 mcg NPO + Dexamethasone |
| DexamethasoneInhibits ACTH release in Cushing disease and healthy volunteers | Drug | Dexmopressin 10 mcg NPO + Dexamethasone |
Primary outcome
ACTH and cortisol responses
Time frame: -5, 0, 15, 30, 45 and 60 minutes
Percent change from mean baseline values (-5, 0 minutes) at all combinations of dose dose timepoints
1 secondary outcome
Diagnostic accuracy, specificity, sensitivity of cortisol and ACTH measurements in response to desmopressin
Time frame: -5, 0, 15, 30, 45 and 60 minutes
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2026.
- Derived from this study: PubMed 42535456Elenius H, Brown BM, McGlotten R, Moore C, Nieman LK. Evaluation of desmopressin stimulation test specificity in healthy volunteers. Endocr Connect. 2026 Aug 1;15(8):e260270. doi: 10.1530/EC-26-0270.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Data appearing in publications will be shared.
Related trials for Cushing Syndrome
RecruitingObservational study
Long-Term Follow-Up of Survivors of Pediatric Cushing Disease
Cushing Disease
RecruitingPhase 4
Osilodrostat in Patients With Hypertension Caused by Hypercortisolaemia Due to Cushing's Syndrome
Hypertension, Hypercortisolemia
RecruitingObservational study
Collecting Information About Treatment Results for Patients With Cushing's Syndrome
Cushing's Disease, Cushing Syndrome
RecruitingPhase 4
Isturisa Treatment in Mild Autonomous Cortisol Secretion( MACS)
Mild Autonomous Cortisol Secretion (MACS)
RecruitingPhase 2
Evaluating the Functional Status of the Adrenal Glands With [68Ga]Ga-PentixaFor in Hyperaldosteronism and Hypercortisolism
Hyperaldosteronism, Hypercortisolism
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.
Lynnette K Nieman, M.D. principal investigator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Desmopressin and Dexamethasone in people with Cushing Syndrome, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 1 site in United States.
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 15 inclusion and 30 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: looking for participants now, as of the sponsor's last update on 31 Aug 2026. 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 United States. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Raven N McGlotten, R.N. ((301) 827-0190, mcglottenr@mail.nih.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ACTH and cortisol responses (time frame: -5, 0, 15, 30, 45 and 60 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06635629, which also lists 1 linked publication.
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 Aug 2026.