NCT07781267 Pediatric Congenital Adrenal Hyperplasia Management: Regret and Long-term Outcomes
| NCT ID | NCT07781267 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Lille |
| Condition | Classic Congenital Adrenal Hyperplasia |
| Study Type | OBSERVATIONAL |
| Enrollment | 40 participants |
| Start Date | 2026-07-08 |
| Primary Completion | 2027-03-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 40 participants in total. It began in 2026-07-08 with a primary completion date of 2027-03-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Congenital adrenal hyperplasia (CAH) due to 21-hydroxylase deficiency is a chronic endocrine disorder, often diagnosed in the neonatal period. Severe forms may lead to genital virilization in afected girls and adrenal crises. Management includes lifelong hormone replacement therapy and, historically, early genital surgery, although recent guidelines recommend delaying non-urgent procedures to preserve patient autonomy.This study hypothesizes that pediatric management, particularly early surgical interventions, may influence long-term satisfaction and the expression of regret in adulthood. We will conduct an observational cross-sectional study including adult patients diagnosed with CAH during childhood. Data will be collected using standardized questionnaires assessing medical regret, quality of life, sexual function, and psychological outcomes, together with clinical characteristics and past medical and surgical history.The primary outcome is the prevalence of regret related to pediatric care. Secondary outcomes include quality of life, sexual satisfaction, psychological status, and adaptation of hormonal therapy from adolescence to adulthood. Patient-reported outcomes (regret, quality of life, sexual function, and psychological outcomes) will be assessed in female participants only, male participants will be included for the evaluation of hormonal treatment adaptation.
Eligibility Criteria
Inclusion Criteria: * Adult patients aged 18 years or older * Diagnosis of classic congenital adrenal hyperplasia due to 21-hydroxylase deficiency * Followed at Lille University Hospital * Able to understand the study information and complete the questionnaires in French * Having provided written informed consent Exclusion Criteria: * Patients younger than 18 years * Non-classic forms of congenital adrenal hyperplasia * Inability to understand the study information or to complete the questionnaires * Refusal to participate or lack of informed consent * Severe cognitive impairment or psychiatric condition preventing reliable questionnaire completion
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07781267 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 65 Years, studying Classic Congenital Adrenal Hyperplasia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07781267 currently recruiting?
Yes, NCT07781267 is actively recruiting participants. Contact the research team at Sophie.catteau@chu-lille.fr for enrollment information.
Where is the NCT07781267 trial being conducted?
This trial is being conducted at Lille, France.
Who is sponsoring the NCT07781267 clinical trial?
NCT07781267 is sponsored by University Hospital, Lille. The trial plans to enroll 40 participants.