ClinicalTrials.gov record NCT07781267

Pediatric Congenital Adrenal Hyperplasia Management: Regret and Long-term Outcomes

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Sep 17, 2026

Evaluation of Potential Regret Related to Pediatric Surgical and Medical Management of Congenital Adrenal Hyperplasia, and Analysis of Long-term Outcomes.

StatusRecruitingThe study is currently enrolling participants. Only the study team can say whether a particular person can join.
Study typeObservationalA study in which researchers do not assign participants to a treatment or other intervention. They observe or measure what happens, which may include study visits, tests, questionnaires or a review of medical records.
Age18 years old and older
SexFemale
LocationFrance
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This observational, cross-sectional study looks at adults diagnosed in childhood with classic congenital adrenal hyperplasia (21-hydroxylase deficiency). Participants complete standardized questionnaires about regret, quality of life, sexual function, and mental health; researchers also review medical history to document hormonal treatment changes. The main goal is to measure how common regret is about pediatric management and to compare it with quality-of-life and treatment-adaptation data.

What it is studying. The study measures the prevalence of regret related to pediatric medical and surgical care and examines how that regret relates to quality of life, sexual function, psychological symptoms, and how hormonal treatment was adapted from adolescence to adulthood.

What the researchers hope to learn. To estimate how common regret is after pediatric CAH management and to describe its relationship with quality of life, sexual function, anxiety/depression, and hormonal treatment adaptation in adulthood.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

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.

Interventions being studied

Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.

Other
  • questionnaire

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

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

Study description and what participation involves

The registry record has no detailed description beyond the summary above.

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

At study inclusion participants will complete standardized questionnaires about regret (Decision Regret Scale), quality of life (WHOQOL‑BREF), sexual function (ASEX), and symptoms of anxiety and depression (HADS). Researchers will also collect clinical information and past medical and surgical history from records to assess how hormonal treatment was adapted from adolescence to adulthood. The record states that the patient-reported questionnaires are assessed in female participants, while male participants (if included) are intended to be evaluated for the hormonal‑treatment adaptation only. This is a one-time, cross-sectional assessment with a target duration of about one week around study inclusion.

How the study is structured. This is an observational, cross-sectional study. At a single time point participants complete standardized questionnaires (Decision Regret Scale, WHOQOL-BREF, Arizona Sexual Experience Scale, Hospital Anxiety and Depression Scale). Medical records are reviewed to document past medical and surgical history and to assess adaptation of hormonal treatment from adolescence to adulthood. According to the registry, patient-reported outcomes (regret, quality of life, sexual function, psychological outcomes) are assessed in female participants only; male participants are included for the evaluation of hormonal treatment adaptation.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

  • This is an observational study, so the study itself gives no treatment. What would taking part involve for me, and would it change my usual care?
  • The listed sites are in France. Is any of them reachable for me, and does the study help with travel?
  • Which of the eligibility criteria would need to be checked with tests before I could join?

More on congenital adrenal hyperplasia

Clinical trials43 trials listed for congenital adrenal hyperplasiaEvery trial the registry lists for congenital adrenal hyperplasia, with recruitment status, phase and sites, updated from ClinicalTrials.gov.See all trials →Research updatesWhat changed in congenital adrenal hyperplasia researchLatest monthly update: September 2026. Includes: Bedtime hydrocortisone. New research summarized each month in plain language, with links to every source paper.Read the latest update →

Important dates

Study start
Jul 8, 2026
Primary completion
Mar 8, 2027 (estimated)
Study completion
Mar 8, 2027 (estimated)
Target enrollment
40 participants (estimated)
Last updated on registry
Aug 24, 2026
Data verified
Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor
University Hospital, Lille

Central study contact

If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.

Participating sites (1)

Terms used on this page · explanations by MedicalUpdates.ai

primary outcome
The main result the study is designed to measure and report on. Other results, called secondary outcomes, are also collected.
written informed consent
The process of explaining a study, including its risks and what participation involves, so that a person can decide freely whether to take part. Consent is usually documented in writing, and a participant can choose to leave the study later.
Inclusion Criteria
The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
Exclusion Criteria
The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this website; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

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