Adrenal InsufficiencyPhase 4REPLACENCT05193396
Hydrocortisone and Placebo in Patients With Symptoms of Adrenal Insufficiency After Cessation of Glucocorticoid Treatment
A Phase 4 study testing Hydrocortisone in people with Adrenal Insufficiency and Polymyalgia Rheumatica (PMR), run by Marianne Andersen at 3 sites in Denmark.
Trial summary
Cortisol, a glucocorticoid (GC) hormone secreted from the adrenal glands, is essential for survival. Cortisol also possesses anti-inflammatory actions and GC formulations (prednisolone) are used to treat many inflammatory diseases and conditions. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Adrenal Insufficiency, Polymyalgia Rheumatica (PMR), Giant Cell Arteritis (GCA)
- What is being tested?
- Hydrocortisone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 3 sitesDenmark
- Study dates
- 1 Feb 2022to Jan 2026
- Phase
- Phase 4
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 50 years
- A diagnosis of PMR or GCA in GC free remission for >2 week and <12 weeks after treatment with prednisolone (any dosage) for ≥12 weeks
Who cannot join
- Known primary or secondary adrenal insufficiency
- Known Cushing´s syndrome
- Heart failure (New York Heart Association class IV)
- Kidney failure with an estimated glomerular filtration rate <30 mL/min
- Liver cirrhosis
- Active cancer
Show all 16Show fewer
- Known severe immune deficiency
- A history of psychiatric disease requiring treatment by a psychiatric department (for affective disorders only if within the last year before study entry)
- Alcohol consumption >21 units per week
- Planned major surgery during the study period at study entry
- Use of drugs that interfere with cortisol metabolism/measurements:
- Systemic oestrogen treatment within 1 month before study inclusion
- Strong CYP3A4 inhibitors or inducers
- Use of other glucocorticoid formulations: inhaled, intra-articular or intramuscular injections, creams European steroid group IV applied in genital area
- Permitted glucocorticoid formulations: eye-drops, nasal spray, creams European group I-III, and European group IV applied in non-genital area
- Inability to provide written informed consent
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark3 sites, 3 recruiting
- Recruiting
Department of Endocrinology and Internal Medicine, Aarhus University Hospital
Aarhus
Jens Otto L Jørgensen, Professor, +45 20727383, joj@clin.au.dk
- Recruiting
Department of Nephrology and Endocrinology, Rigshospitalet
Copenhagen
Ulla Feldt-Rasmussen, Professor, +45 35451023, Ulla.Feldt-Rasmussen@regionh.dk
- Recruiting
Department of Endocrinology, Odense University Hospital
Odense, 5230
Marianne S Andersen, Professor, +45 65411807, Marianne.Andersen1@rsyd.dk
Marianne Andersen, DMSci
About this study
Official title: A Multi-centre, Randomised, Double-blinded, Placebo Controlled 16-weeks Study to Compare the Effect of Hydrocortisone and Placebo in Patients With Giant Cell Arteritis (GCA)/ Polymyalgia Rheumatica (PMR) With Patient-reported Symptoms of Adrenal Insufficiency After Cessation of Glucocorticoid Treatment.
Cortisol, a glucocorticoid (GC) hormone secreted from the adrenal glands, is essential for survival. Cortisol also possesses anti-inflammatory actions and GC formulations (prednisolone) are used to treat many inflammatory diseases and conditions. Indeed, three percent of the Danish population (≈ 180.000 individuals) redeems at least one prescription of synthetic GC per year and at least 20,000 patients annually discontinue GC treatment. Pharmacological GC therapy suppresses endogenous cortisol production and thereby induce relative adrenal insufficiency (GIA). The risk of GIA as determined by the adrenal corticotrophic hormone (ACTH) stimulation test has previously been reported to ≈ 25 %, but testing after GC treatment is not routinely performed. Indeed, new evidence suggest that the risk of GIA after planned cessation of prednisolone treatment for polymyalgia rheumatic (PMR) or giant cell arteritis (GCA) is substantially lower, probably 2%. The reason for this discrepancy is undoubtedly selection bias in the previous publications and the use of inaccurate cortisol assays. At the same time, however, it was observed that 25% exhibited pronounced symptoms of adrenal insufficiency based on a questionnaire specific for detecting symptoms of adrenal insufficiency, the so-called AddiQoL-30. Concomitantly, the basal cortisol levels in the same group were significantly lower as compared to the group, who exhibited milder or no symptoms attributable to adrenal insufficiency. This observation aligns with the clinical experience that PMR/GCA patients often complain of fatigue after planned cessation of prednisolone treatment. This often occurs in the absence of objective symptoms or signs of residual PMR/GCA disease activity. The scenario has been designated as "the steroid withdrawal syndrome". This may represent a state of relative adrenal insufficiency prompted by long term, high dose prednisolone treatment. The proper way to tackle this clinical conundrum is to perform a proper randomized trial, which so far has not been conducted.
Therefore, investigators of this study will perform the first placebo-controlled randomised controlled trial (RCT) in patients with PMR and GCA after planned cessation of GC treatment. Investigators argue that neither watchful waiting nor routine hydrocortisone replacement are infallible. The study will be the first evidence-based guidance and aid to GIA patients and thus meet an important need for many thousand patients.
- Being tested
- Hydrocortisone, Placebo
- Keywords
- tertiary adrenal insufficiency
- Medical subject headings
- Adrenal Insufficiency, Polymyalgia Rheumatica, Giant Cell Arteritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HydrocortisoneDrug
Patients are randomized to oral hydrocortisone (10 mg twice daily) or placebo for 16 weeks.
PlaceboDrug
Patients are randomized to oral hydrocortisone (10 mg twice daily) or placebo for 16 weeks.
| Study group | Role | What they receive |
|---|---|---|
| RCT group - Placebo | Placebo comparator | Included patients with an AddiQoL-30 score < 85 and/or short Synacthen test stimulated plasma cortisol levels > 100 and < 420 nmol/L that are radomized to recieve placebo tablets. Receives: Drug: Placebo |
| RCT group - Hydrocortisone | Active comparator | Included patients with an AddiQoL-30 score < 85 and/or short Synacthen test stimulated plasma cortisol levels > 100 and < 420 nmol/L that are radomized to recieve hydrocortisone tablets. Receives: Drug: Hydrocortisone |
| Comparator group 1 | No intervention | Patients with an AddiQoL-30 score > 85 and short Synacthen test stimulated plasma cortisol level > 420 nmol/L. Patients undergo baseline examination only. |
| Comparator group 2 | No intervention | Patients with pronounced adrenal insufficiency (short Synacthen test stimulated plasma cortisol levels < 100 nmol/L) - regardless of AddiQoL-30 score. These patients undergo baseline examination and commence open hydrocortisone replacement according to standard clinical practice. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adrenal insufficiency symptoms
Symptoms measured by the Addison's disease-specific quality of life questionnaire (AddiQoL-30), which consists of 30 questions focusing on common symptoms of adrenal insufficiency related to quality of life. Each item belongs to one of following subthemes: fatigue, symptoms, emotions and miscellaneous. Each question can be scored from 1 (none of the time/strongly disagree) to 6 (all of the time/strongly agree) and yields a score between 1 - 4 arbitrary units. This adds up to a total score ranging from 30 (worst quality of life) to 120 (best quality of life).
Measured: Screening and 16 weeks
Secondary outcomes (19)
Patient-reported symptoms via mobile phone app - PRO-CTCAETM
Symptoms of fatigue, nausea, dizziness, and "feeling generally unwell" assessed by the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAETM). Each symptom is evaluated in terms of frequency and severity with a score from 1 (never/nothing) to 5 (almost constant/very strong).
Measured: Patients are asked daily throughout the study period.
Patient-reported symptoms via mobile phone app - EMA-MFI
Four statements regarding diurnal fatigue based on the validated General Fatigue Scale from the Multidimensional Fatigue Inventory (MFI-20) adapted for Ecological Momentary Assessments (EMA). Each statement is answered by a visuel scale from left (yes, that is correct) to right (no, that is not correct).
Measured: In situations of stress, participants are asked to answer the EMA items 5 times daily at semi-randomised time points, for 3 days.
Cushing quality of life (CushingQoL)
Cushing quality of life (CushingQoL) is a disease-specific questionnaire for patients with endogenous cortisol excess. It consists of 12 items about mental and physical adverse effects of cortisol excess. The total score os normalised to a scale ranging from 0 (lowest quality of lige) to 100 (highest quality of life).
Measured: Baseline and 16 weeks
The short form 36 (SF-36)
SF-36 is a genereic qeustionnaire evaluating general health perception with 36 items related to 8 dimensions: physical functioning for the limitation in performing all physical activities; role physical for problems with work or other daily activities; bodily pain; general health; vitality; social functioning; role emotional; and mental health.
Measured: Baseline and 16 weeks
Sleep Quality Scale (SQS)
SQS is a single item questionnaire consisting of a numerical rating scale to evaluate the overall sleep quality over the last 7 nights. The scale is ranging from 0 (terrible sleep) to 10 (excellent sleep).
Measured: Baseline and 16 weeks
International Physical Activity Questionnaire, short form, 7 days (IPAQ-7s)
The IPAQ-7s records types and intensity of physical activity. The questionnaire consists of seven open items covering 4 types of activity (energetic activity, moderate activity, walk, and sitting). The first three is measured in "number of days per week", "hours per day", and "minutes per day". The last activity (sitting) is measured in "hours per day" and "minutes per day".
Measured: Baseline and 16 weeks
Incidence of adrenal crises
Incidence of adrenal crises, including information on hospitalizations, number of sick days, diagnoses and therapy.
Measured: 16 weeks
Cardiovascular health - Blood pressure
Office blood pressure (OBP) and automated blood pressure (AOBP). Blood pressure measurements will be performed with (OBP) and without (AOBP) the presence of investigator. Unit is mmHg.
Measured: Baseline and 16 weeks
Cardiovascular health - PWV
Arterial stiffness and pulse wave velocity (PWV). PVW is measured three times, unit is m/s.
Measured: Baseline and 16 weeks
Body composition - DXA scan
Body composition by dual X-ray absorptiometry (DXA) scan. Body composition is measured in the distribution of fat and lean mass in grams (g).
Measured: Only performed at baseline visit
Bone quality - DXA scan
Bone quality by dual X-ray absorptiometry (DXA) scan. Bone mineral density (g/cm^2) and T-score of the lumbal spine and hip.
Measured: Only performed at baseline visit
HR-pQCT
High-resolution peripheral quantitative computed tomography (HR-pQCT) in order to obtain three-dimensional BMD.
Measured: Only performed at baseline visit
Muscle function and physical activity - Handgrip strength.
Handgrip strength is measured in kg using a hydraulic hand dynamometer.
Measured: Baseline and 16 weeks.
Muscle function and physical activity - TUG
Timed Up and Go (TUG) test measures the time taken to stand up, walk three meters in a straight line, and immediately return to the chair.
Measured: Baseline and 16 weeks.
Muscle function and physical activity - SPPB
The Short Physical Performance Battery including Chair Rising Test (SPPB) evaluates the lower extremity function of the patient.
Measured: Baseline and 16 weeks.
Muscle function and physical activity - Actigraph
Patients are asked to wear an accelerometer device on their non-dominant wrist to measure physical activity and sleep. Time of physical activity and sleep will be measured in minutes.
Measured: Baseline and 16 weeks, duration: 7 days
Muscle function and physical activity - Muscle power
The muscle power of the dominant arm and upper back, as well as elbow, hip, and knee extension and flexion, are evaluated by use of a exercise machine. Power is measured in watt.
Measured: Baseline and 16 weeks.
Muscle function and physical activity - Isometric muscle strength
The isometric muscle strength of the dominant arm and upper back, as well as elbow, hip, and knee extension and flexion, are evaluated by use of a exercise machine. Strength is measured in kg.
Measured: Baseline and 16 weeks.
Normalization of adrenal function evaluated by SST
Short Synacthen® test. Cortisol is measured in nmol/L before (0 min) and after (30 min) administration of 1 ml Synacthen (0.25 mg/ml).
Measured: Screening/Baseline and 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2022
- Study start1 Feb 2022
- Primary completionJan 2026 (estimated)
- Study completionJan 2026 (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 Adrenal InsufficiencyStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double-blinded randomised placebo-controlled clinical trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Marianne Andersen
- Sponsor type
- University, hospital or other
- Collaborators
- Aarhus University Hospital, Copenhagen University Hospital, Denmark
- Responsible party
- Sponsor-investigator, Marianne Andersen, Odense University Hospital
- Investigators
- Marianne S Andersen, Principal investigator, Odense University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05193396
- Sponsor's protocol ID
- REPLACE
- Other IDs
- 2024-513822-53-00, 2020-006121-65, journal no. 21/27119, project-ID: S-20210076
- Acronym
- REPLACE
- Status last verified
- Mar 2025
- First submitted
- 2 Jan 2022
- Last updated
- 22 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Deidentified participant data will be made available after completion of the study and publication of the main results, upon reasonable request. Data sharing will comply with GDPR and national data protection regulations.
Publications
Dreyer AF, Hansen SB, Borresen SW, Al-Jorani H, Bislev LS, Boesen VB, Christensen LL, Glintborg D, Jensen RC, Jorgensen NT, Klose MC, Lund ML, Frederiksen JSS, Tei R, Feldt-Rasmussen U, Jorgensen JOL, Andersen MS. Hydrocortisone replacement therapy in patients with glucocorticoid withdrawal syndrome after cessation of glucocorticoid treatment: REPLACE, a multicentre, randomised, double-blinded, placebo-controlled, 16-week study protocol. BMJ Open. 2026 Feb 4;16(2):e111334. doi: 10.1136/bmjopen-2025-111334.
PubMed 41638742
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-centre, Randomised, Double-blinded, Placebo Controlled 16-weeks Study to Compare the Effect of Hydrocortisone and Placebo in Patients With Giant Cell Arteritis (GCA)/ Polymyalgia Rheumatica (PMR) With Patient-reported Symptoms of Adrenal Insufficiency After Cessation of Glucocorticoid Treatment.
- ClinicalTrials.gov ID
- NCT05193396
- Acronym / sponsor ID
- REPLACE / REPLACE
- Keywords
- tertiary adrenal insufficiency
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Marianne AndersenUniversity, hospital or other
- Collaborators
- Aarhus University Hospital, Copenhagen University Hospital, Denmark
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- Jan 2026 (estimated)
- Study completion
- Jan 2026 (estimated)
- First posted
- 14 Jan 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.
Cortisol, a glucocorticoid (GC) hormone secreted from the adrenal glands, is essential for survival. Cortisol also possesses anti-inflammatory actions and GC formulations (prednisolone) are used to treat many inflammatory diseases and conditions. Indeed, three percent of the Danish population (≈ 180.000 individuals) redeems at least one prescription of synthetic GC per year and at least 20,000 patients annually discontinue GC treatment. Pharmacological GC therapy suppresses endogenous cortisol production and thereby induce relative adrenal insufficiency (GIA). The risk of GIA as determined by the adrenal corticotrophic hormone (ACTH) stimulation test has previously been reported to ≈ 25 %, but testing after GC treatment is not routinely performed. Indeed, new evidence suggest that the risk of GIA after planned cessation of prednisolone treatment for polymyalgia rheumatic (PMR) or giant cell arteritis (GCA) is substantially lower, probably 2%. The reason for this discrepancy is undoubtedly selection bias in the previous publications and the use of inaccurate cortisol assays. At the same time, however, it was observed that 25% exhibited pronounced symptoms of adrenal insufficiency based on a questionnaire specific for detecting symptoms of adrenal insufficiency, the so-called AddiQoL-30. Concomitantly, the basal cortisol levels in the same group were significantly lower as compared to the group, who exhibited milder or no symptoms attributable to adrenal insufficiency. This observation aligns with the clinical experience that PMR/GCA patients often complain of fatigue after planned cessation of prednisolone treatment. This often occurs in the absence of objective symptoms or signs of residual PMR/GCA disease activity. The scenario has been designated as "the steroid withdrawal syndrome". This may represent a state of relative adrenal insufficiency prompted by long term, high dose prednisolone treatment. The proper way to tackle this clinical conundrum is to perform a proper randomized trial, which so far has not been conducted.
Therefore, investigators of this study will perform the first placebo-controlled randomised controlled trial (RCT) in patients with PMR and GCA after planned cessation of GC treatment. Investigators argue that neither watchful waiting nor routine hydrocortisone replacement are infallible. The study will be the first evidence-based guidance and aid to GIA patients and thus meet an important need for many thousand patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- Double-blinded randomised placebo-controlled clinical trial
| Arm | Type | Receives |
|---|---|---|
| RCT group - Placebo | Placebo comparator | Drug: PlaceboIncluded patients with an AddiQoL-30 score < 85 and/or short Synacthen test stimulated plasma cortisol levels > 100 and < 420 nmol/L that are radomized to recieve placebo tablets. |
| RCT group - Hydrocortisone | Active comparator | Drug: HydrocortisoneIncluded patients with an AddiQoL-30 score < 85 and/or short Synacthen test stimulated plasma cortisol levels > 100 and < 420 nmol/L that are radomized to recieve hydrocortisone tablets. |
| Comparator group 1 | No intervention | –Patients with an AddiQoL-30 score > 85 and short Synacthen test stimulated plasma cortisol level > 420 nmol/L. Patients undergo baseline examination only. |
| Comparator group 2 | No intervention | –Patients with pronounced adrenal insufficiency (short Synacthen test stimulated plasma cortisol levels < 100 nmol/L) - regardless of AddiQoL-30 score. These patients undergo baseline examination and commence open hydrocortisone replacement according to standard clinical practice. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age ≥ 50 years
- A diagnosis of PMR or GCA in GC free remission for >2 week and <12 weeks after treatment with prednisolone (any dosage) for ≥12 weeks
Key exclusion criteria (16 listed)
- Known primary or secondary adrenal insufficiency
- Known Cushing´s syndrome
- Heart failure (New York Heart Association class IV)
- Kidney failure with an estimated glomerular filtration rate <30 mL/min
- Liver cirrhosis
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 |
|---|---|---|
| HydrocortisonePatients are randomized to oral hydrocortisone (10 mg twice daily) or placebo for 16 weeks. | Drug | RCT group - Hydrocortisone |
| PlaceboPatients are randomized to oral hydrocortisone (10 mg twice daily) or placebo for 16 weeks. | Drug | RCT group - Placebo |
Primary outcome
Adrenal insufficiency symptoms
Time frame: Screening and 16 weeks
Symptoms measured by the Addison's disease-specific quality of life questionnaire (AddiQoL-30), which consists of 30 questions focusing on common symptoms of adrenal insufficiency related to quality of life. Each item belongs to one of following subthemes: fatigue, symptoms, emotions and miscellaneous. Each question can be scored from 1 (none of the time/strongly disagree) to 6 (all of the time/strongly agree) and yields a score between 1 - 4 arbitrary units. This adds up to a total score ranging from 30 (worst quality of life) to 120 (best quality of life).
19 secondary outcomes
Patient-reported symptoms via mobile phone app - PRO-CTCAETM
Time frame: Patients are asked daily throughout the study period.
Patient-reported symptoms via mobile phone app - EMA-MFI
Time frame: In situations of stress, participants are asked to answer the EMA items 5 times daily at semi-randomised time points, for 3 days.
Cushing quality of life (CushingQoL)
Time frame: Baseline and 16 weeks
The short form 36 (SF-36)
Time frame: Baseline and 16 weeks
Sleep Quality Scale (SQS)
Time frame: Baseline and 16 weeks
International Physical Activity Questionnaire, short form, 7 days (IPAQ-7s)
Time frame: Baseline and 16 weeks
Incidence of adrenal crises
Time frame: 16 weeks
Cardiovascular health - Blood pressure
Time frame: Baseline and 16 weeks
Cardiovascular health - PWV
Time frame: Baseline and 16 weeks
Body composition - DXA scan
Time frame: Only performed at baseline visit
Bone quality - DXA scan
Time frame: Only performed at baseline visit
HR-pQCT
Time frame: Only performed at baseline visit
Muscle function and physical activity - Handgrip strength.
Time frame: Baseline and 16 weeks.
Muscle function and physical activity - TUG
Time frame: Baseline and 16 weeks.
Muscle function and physical activity - SPPB
Time frame: Baseline and 16 weeks.
Muscle function and physical activity - Actigraph
Time frame: Baseline and 16 weeks, duration: 7 days
Muscle function and physical activity - Muscle power
Time frame: Baseline and 16 weeks.
Muscle function and physical activity - Isometric muscle strength
Time frame: Baseline and 16 weeks.
Normalization of adrenal function evaluated by SST
Time frame: Screening/Baseline and 16 weeks
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 22 Dec 2025.
- Derived from this study: PubMed 41638742Dreyer AF, Hansen SB, Borresen SW, Al-Jorani H, Bislev LS, Boesen VB, Christensen LL, Glintborg D, Jensen RC, Jorgensen NT, Klose MC, Lund ML, Frederiksen JSS, Tei R, Feldt-Rasmussen U, Jorgensen JOL, Andersen MS. Hydrocortisone replacement therapy in patients with glucocorticoid withdrawal syndrome after cessation of glucocorticoid treatment: REPLACE, a multicentre, randomised, double-blinded, placebo-controlled, 16-week study protocol. BMJ Open. 2026 Feb 4;16(2):e111334. doi: 10.1136/bmjopen-2025-111334.
- Individual participant dataSharing planned: No. Deidentified participant data will be made available after completion of the study and publication of the main results, upon reasonable request. Data sharing will comply with GDPR and national data protection regulations.
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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.
Marianne S Andersen principal investigator
Odense University Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Hydrocortisone in people with Adrenal Insufficiency and Polymyalgia Rheumatica (PMR), run by Marianne Andersen at 3 sites 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 16 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 22 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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. Some participants in this study may receive a placebo. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 Marianne S Andersen (+4565411807, marianne.andersen1@rsyd.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adrenal insufficiency symptoms (time frame: Screening and 16 weeks). 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 NCT05193396, 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 22 Dec 2025.