An observational study in Congenital Adrenal Hyperplasia, sponsored by IRCCS Azienda Ospedaliero-Universitaria di Bologna. Recruiting at 1 site in Italy. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-12-31.
Sponsored by IRCCS Azienda Ospedaliero-Universitaria di Bologna · Observational
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Among 16 studies in Adrenal Hyperplasia, Congenital with a site in Italy — 9 open to participants now, 11 under way, 4 of them phase 3. Adrenal Hyperplasia, Congenital · Italy.
Among the 16 studies in Adrenal Hyperplasia, Congenital with a site in Italy, this one is one of 2 that started in 2022, is one of 6 observational ones, reaches primary completion later than 10 of the 10 other live ones, and was the 10th registered.
101 studies on the registry are indexed under Adrenal Hyperplasia, Congenital; 28 are open to participants now.
Browse Adrenal Hyperplasia, Congenital studies →9 of the 16 studies in Adrenal Hyperplasia, Congenital with a site in Italy are open now. Recruiting first, the newest first:
Azienda Ospedaliero-Universitaria di Modena · Sites in Italy
Ages 18+
Crinetics Pharmaceuticals Inc. · Sites in Italy, United States, Argentina and 10 more countries
Ages 1–17
Crinetics Pharmaceuticals Inc. · Sites in Italy, United States, Argentina and 12 more countries
Ages 18–74
IRCCS Azienda Ospedaliero-Universitaria di Bologna · Sites in Italy
Ages 1–35
Crinetics Pharmaceuticals Inc. · Sites in Italy, United States, Argentina and 3 more countries
Ages 16–74
A study can be open while its sites in Italy have not opened yet or have stopped. Only those recruiting at a site in Italy →
Of the 20 Adrenal Hyperplasia, Congenital studies recruiting now, 10 (50%) set no upper age limit and 9 (45%) stop at 75 or younger; 7 take children under 18; none take healthy volunteers.
This study: 18 Years and older · male · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
16 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 1 · Phase 2 6 · Phase 3 4 · Phase 4 1
First in 2012; this study’s year is marked. 2 started in 2022.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 30 is below the median of 61 across 44 observational studies indexed under Adrenal Hyperplasia, Congenital.
Median enrollment 127 across the 10 interventional studies, 40 across the 6 observational. Of the 5 that completed or were terminated, 3 (60%) have results posted.
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10 of 16 have an industry lead sponsor. The 9 most frequent:
IRCCS Azienda Ospedaliero-Universitaria di Bologna is the lead sponsor of 513 studies on the registry; 288 are open to participants now.
IRCCS Azienda Ospedaliero-Universitaria di Bologna has 3 studies filed under Adrenal Hyperplasia, Congenital — fewer than ten, so there is no comparison to draw.
3 of the studies in Adrenal Hyperplasia, Congenital with a site in Italy that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07144163Phase 3Crinetics Pharmaceuticals Inc.A Study to Evaluate Atumelnant in Adults With Congenital Adrenal Hyperplasia | 2027-05 |
| NCT07473804IRCCS Azienda Ospedaliero-Universitaria di BolognaSyndromes With Neonatal Salt Loss: Not Only Congenital Adrenal Hyperplasia Due to 21-hydroxylase Deficiency (21OH-ISC) | 2026-12-31 |
| NCT03760835Federico II UniversityCongenital Adrenal Hyperplasia Once Daily Hydrocortisone Treatment | 2026-12-31 |
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Among the 16 studies in Adrenal Hyperplasia, Congenital with a site in Italy, from their registry updates:
This tab as a report to print or save as PDF → With an account.
Observational, retrospective, prospective, single-center cohort study. Participation in the registry will be offered consecutively to any patient with the disease, newly diagnosed or with documented diagnosis made at another center, at any stage of the disease. Laboratory tests, imaging study for patient monitoring and care procedures all will be conducted in accordance with normal clinical practice.
Observational, retrospective, prospective, single-center cohort study conducted at the UOC of Endocrinology and Diabetes Prevention and Treatment of IRCCS AOU of Bologna. Participation in the Registry will be offered consecutively to any patient with the disease, newly diagnosed or with documented diagnosis made at another Center, at any stage of the disease. Laboratory tests, imaging study for patient monitoring, and care procedures all will be conducted in accordance with normal clinical practice.
For the retrospective phase, patients whose diagnosis of CAH was made on or after 01/01/1960 will be enrolled, and observation related to this phase will be extended until this study is approved.
The study population is partly from direct access at the U.O.C. of Endocrinology and Diabetes Prevention and Treatment, as the regional referral center for this rare disease (congenital adrenal hyperplasia).
The potentially involved cohort is estimated to be about 30 patients at the time the registry was established. It is assumed that both retrospective and prospective phases can be completed in 15 subjects and retrospective alone in the remaining 15 subjects.
The registry may become the reference for calculating incidence and prevalence in Emilia Romagna of the disease under study.
The study population partly comes from direct access at the O.U. of Endocrinology and Diabetes Prevention and Treatment, as a regional referral center for this rare disease (congenital adrenal hyperplasia). A second part afferents instead from the O.U. of Pediatrics of the Polyclinic through the "interdepartmental procedure for the management of the transition of patients with endocrine-metabolic diseases from pediatric endocrinology to adult endocrinology."
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.
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.
Creation of an electronic registry
The primary objective of the study is to create an electronic registry and, through the data contained therein, to describe the clinical-laboratory aspects, prevalence, and type of alterations in gonadal function of a cohort of male patients, aged 18 years or older, with congenital adrenal hyperplasia from 21-hydroxylase deficiency regardless of the time of diagnosis.
Time frame: through study completion, an average on 31 December 2032
Plan to share: No
No publications or documents are linked to this record.
Started Jun 2022 (actual). Primary completion is estimated for Jun 2032, 120 months after the start.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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Adrenal Hyperplasia, Congenital →
IRCCS Azienda Ospedaliero-Universitaria di Bologna →