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NCT Number: NCT07781267

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

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Questionnaire

Other

Standardized questionnaires assessing regret related to pediatric management, quality of life, sexual function, and psychological outcomes.

Primary outcomes

  1. Regret related to pediatric management

    Time frame: At study inclusion (baseline)

    Regret related to pediatric management assessed by the Decision Regret Scale (DRS)

Secondary outcomes

  1. Quality of life

    Time frame: at study inclusion (baseline)

    Quality of life assessed by the WHOQOL-BREF questionnaire

  2. Sexual function

    Time frame: at study inclusion (baseline)

    Sexual function assessed by the Arizona Sexual Experience Scale (ASEX)

  3. Symptoms of anxiety and depression

    Time frame: at study inclusion

    Symptoms of anxiety and depression assessed by the Hospital Anxiety and Depression Scale (HADS)

  4. Adaptation of hormonal treatment from adolescence to adulthood

    Time frame: at study inclusion (baseline)

    Adaptation of hormonal treatments from adolescence to adulthood, assessed from medical history

Study contacts

Contact information is provided by the study sponsor or research team.

Sophie CATTEAU JONARD, PhD

CONTACT

[email protected]

+33 3 20 44 63 09

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Registry information

Official study title

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

Acronym: CAH - REC

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Aug 24, 2026
Registry last updated
Aug 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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