CHU de Lille
Lille, 59000, France
Location status: Recruiting
Location contact
Sophie CATTEAU JONARD, PhD
CONTACT
Sophie CATTEAU JONARD, PhD
PRINCIPAL_INVESTIGATOR
NCT Number: NCT07781267
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.
Interested in participating?
Request Info18 year–65 year
Female
Observational
Lille, 59000, France
Location status: Recruiting
Sophie CATTEAU JONARD, PhD
CONTACT
Sophie CATTEAU JONARD, PhD
PRINCIPAL_INVESTIGATOR
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Standardized questionnaires assessing regret related to pediatric management, quality of life, sexual function, and psychological outcomes.
Time frame: At study inclusion (baseline)
Regret related to pediatric management assessed by the Decision Regret Scale (DRS)
Time frame: at study inclusion (baseline)
Quality of life assessed by the WHOQOL-BREF questionnaire
Time frame: at study inclusion (baseline)
Sexual function assessed by the Arizona Sexual Experience Scale (ASEX)
Time frame: at study inclusion
Symptoms of anxiety and depression assessed by the Hospital Anxiety and Depression Scale (HADS)
Time frame: at study inclusion (baseline)
Adaptation of hormonal treatments from adolescence to adulthood, assessed from medical history
Contact information is provided by the study sponsor or research team.
University Hospital, Lille
Other
Evaluation of Potential Regret Related to Pediatric Surgical and Medical Management of Congenital Adrenal Hyperplasia, and Analysis of Long-term Outcomes.
Acronym: CAH - REC
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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