An observational study in Adrenal Insufficiency, sponsored by Wuerzburg University Hospital. Status unknown at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-10-14.
Sponsored by Wuerzburg University Hospital · Observational
Among 17 studies in Adrenal Insufficiency with a site in Germany — 1 open to participants now, 1 under way, none of them phase 3. Adrenal Insufficiency · Germany.
Among the 17 studies in Adrenal Insufficiency with a site in Germany, this one is one of 2 that started in 2015, is one of 7 observational ones, and was the 14th registered.
136 studies on the registry are indexed under Adrenal Insufficiency; 27 are open to participants now.
Browse Adrenal Insufficiency studies →1 of the 17 studies in Adrenal Insufficiency with a site in Germany is open now. Recruiting first, the newest first:
Alexion Pharmaceuticals, Inc. · Sites in Germany, United States, Italy and 1 more country
Ages 18+
A study can be open while its sites in Germany have not opened yet or have stopped. Only those recruiting at a site in Germany →
Of the 20 Adrenal Insufficiency studies recruiting now, 7 (35%) set no upper age limit and 7 (35%) stop at 75 or younger; 5 take children under 18; 5 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
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17 studies; the count open now beside each. This study's row is marked.
First in 2002; this study’s year is marked. 2 started in 2015.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 71 is below the median of 85 across 59 observational studies indexed under Adrenal Insufficiency.
Median enrollment 47 across the 10 interventional studies, 70 across the 6 observational. Of the 14 that completed or were terminated, 2 (14%) have results posted.
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5 of 17 have an industry lead sponsor. The 9 most frequent:
Wuerzburg University Hospital is the lead sponsor of 98 studies on the registry; 19 are open to participants now.
Wuerzburg University Hospital has 8 studies filed under Adrenal Insufficiency — fewer than ten, so there is no comparison to draw.
1 of the studies in Adrenal Insufficiency with a site in Germany that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07221838Alexion Pharmaceuticals, Inc.A Study to Investigate OCS Tapering in Adult Participants With Generalized Myasthenia Gravis Treated With Ravulizumab | 2027-08-27 |
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Among the 17 studies in Adrenal Insufficiency with a site in Germany, from their registry updates:
Nothing recorded among them since 2026-09-25.
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Within this clinical study patients with chronic adrenal insufficiency will be investigated by clinical and biochemical examination as well as questionnaire to identify predisposing factors for adrenal crisis.
Patients with chronic adrenal insufficiency (AI) are at risk of suffering from life-threatening adrenal crisis (AC), despite established hormone replacement therapies and patient education. Recent retrospective analyses observed different risk factors for AC, e.g. primary AI and comorbidities. Furthermore, patients that already experienced an AC seem to have an increased risk to develop further AC. The aim of the study is to evaluate potential risk factors/predisposing factors for AC in patients with chronic primary and secondary AI (PAI/SAI). Patients with chronic AI are assessed by clinical and biochemical examination and questionnaire to evaluate the quality of hormone replacement therapy with glucocorticoids, education status, cortisol-metabolism, catecholamine deficit, chronic inflammation and variations of the glucocorticoid receptor. AI patients with a high frequency of AC will be compared to matched controls (age, sex and cause of AI) with no AC or a low frequency of AC in the past.
Patients with chronic adrenal insufficiency under hormone replacement therapy with glucocorticoids.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CYP3A (CYP3A4) inhibitors and inducers
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients with a high frequency of adrenal crisis in the past. Intervention: Clinical and biochemical examination (physical examination and blood-sampling before and after oral ingestion of glucocorticoids).
Diagnostic Test: Clinical and biochemical examination.
Patients with no adrenal crisis or a low frequency of AC in the past. Intervention: Clinical and biochemical examination (physical examination and blood-sampling before and after oral ingestion of glucocorticoids).
Diagnostic Test: Clinical and biochemical examination.
Patients with chronic adrenal insufficiency were assessed by clinical and biochemical examination as well as questionnaire to evaluate the quality of hormone replacement therapy with glucocorticoids, education status, cortisol-metabolism, catecholamine deficit, chronic inflammation and variations of the glucocorticoid receptor.
Chronic inflammation (hsCRP, Interleukin-6)
Measurement of hsCRP (mg/dl) and Interleukin-6 (pg/ml) levels. Hypothesis: Patients with chronic adrenal insufficiency and a high frequency of adrenal crisis exhibit higher hsCRP and Interleukin-6 levels.
Time frame: 1 day
Cortisol metabolism
Measurement of cortisol-levels (mg/dl) before as well as 60 min and 120 min after ingestion of hydrocortisone. Hypothesis: Patients with chronic adrenal insufficiency and a high frequency of adrenal crisis exhibit a faster hydrocortisone metabolism.
Time frame: 1 day
Replacement therapy with glucocorticoids
Evaluation of hormone replacement therapy with glucocorticoids by a clinical score. Hypothesis: Patients with chronic adrenal insufficiency and a high frequency of adrenal crisis suffer from under-replacement.
Time frame: 1 day
Replacement therapy with mineralocorticoids
Evaluation of hormone replacement therapy with mineralocorticoids by a clinical and biochemical assessment. Hypothesis: Patients with chronic adrenal insufficiency and a high frequency of adrenal crisis suffer from under-replacement.
Time frame: 1 day
Glucocorticoid-receptor-polymorphisms
Evaluation of glucocorticoid-receptor-polymorphisms (ER 22/23 EK, N363S, bcl1, 9beta, Tth3l). Hypothesis: Patients with chronic adrenal insufficiency and a high frequency of adrenal crisis have a higher prevalence of glucocorticoid-receptor-polymorphisms.
Time frame: 1 day
Catecholamine-levels
Evaluation of catecholamine-levels (ng/l). Hypothesis: Patients with chronic adrenal insufficiency and a high frequency of adrenal crisis have a more pronounced catecholamin-deficit.
Time frame: 1 day
Patient education
Evaluation of patient education by questionnaire. Hypothesis: Patients with chronic adrenal insufficiency and a high frequency of adrenal crisis have a worse education status.
Time frame: 1 day
Plan to share: Undecided
Ran from Nov 2015 to primary completion in Jun 2018, 31 months.
Of 27 observational studies under Adrenal Insufficiency, half reached primary completion within 31 months of starting (the median), counting those still running; a quarter within 22 and three quarters within 98. This study's 31 months is close to that.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Oct 2019. You cannot join it, but the record below documents what was studied.
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Wuerzburg University Hospital