ClinicalTrials.gg
RecruitingNCT07781267CAH - RECUpdated Aug 24, 2026

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

An observational study in Classic Congenital Adrenal Hyperplasia and 21-Hydroxylase Deficiency, sponsored by University Hospital, Lille. Recruiting at 1 site in France. Open to female participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-08-24.

Sponsored by University Hospital, Lille · Observational

From the registry’s dates

  • Started Jul 2026; still recruiting 4 months later.

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Study type
Observational
Model
Other
Time perspective
Cross-sectional
Enrollment
40
Ages
18 Years to 65 Years
Sex
Female
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 21 studies in Adrenal Hyperplasia, Congenital with a site in France — 6 open to participants now, 8 under way, 4 of them phase 3. Adrenal Hyperplasia, Congenital · France.

Planned enrollment
8th of 10
40 · median 94
Started
2026
with 3 others
Observational
10 of 21
3 open now
Registered
21st of 21
by date

Among the 21 studies in Adrenal Hyperplasia, Congenital with a site in France, this one is the 8th largest by planned enrollment of the 10 observational ones that give a count, is one of 4 that started in 2026, is one of 10 observational ones, and was the 21st registered.

Adrenal Hyperplasia, Congenital

101 studies on the registry are indexed under Adrenal Hyperplasia, Congenital; 28 are open to participants now.

Browse Adrenal Hyperplasia, Congenital studies →

Open to participants now

6 of the 21 studies in Adrenal Hyperplasia, Congenital with a site in France are open now. Recruiting first, the newest first:

All 6 open studies →

A study can be open while its sites in France have not opened yet or have stopped. Only those recruiting at a site in France →

Who these studies take

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 to 65 Years · female · no healthy volunteers.

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02

Study 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.

03

Conditions studied

  • Classic Congenital Adrenal Hyperplasia
  • 21-Hydroxylase Deficiency

Keywords

  • congenital adrenal hyperplasia
  • regret
  • surgery
  • treatment
  • quality of life
04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with classic congenital adrenal hyperplasia (CAH) followed in the departments of gynecology, endocrinology, and pediatrics at Lille University Hospital, France.

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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

Exclusion criteria

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
  • Severe cognitive impairment or psychiatric condition preventing reliable questionnaire completion
Terms in these criteria, in plain language(1)

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.

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.

05

Study design

Observational model
Other
Time perspective
Cross-sectional
Enrollment
40 participants (estimated)
Target follow-up
1 Week
Patient registry
Yes

Interventions

  • Otherquestionnaire

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

06

What researchers measure

Primary outcomes

  1. Regret related to pediatric management

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

    Time frame: At study inclusion (baseline)

Secondary outcomes

  1. Quality of life

    Quality of life assessed by the WHOQOL-BREF questionnaire

    Time frame: at study inclusion (baseline)

  2. Sexual function

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

    Time frame: at study inclusion (baseline)

  3. Symptoms of anxiety and depression

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

    Time frame: at study inclusion

  4. Adaptation of hormonal treatment from adolescence to adulthood

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

    Time frame: at study inclusion (baseline)

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Jul 2026 (actual). Primary completion is estimated for Mar 2027, 8 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 19, 2026
First posted
Aug 24, 2026
StartActual
Jul 8, 2026
Primary completionEst.
Mar 8, 2027
CompletionEst.
Mar 8, 2027
Last update
Aug 24, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 24, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07781267
Responsible party
Sponsor
First posted
Aug 24, 2026
Start date
Jul 8, 2026
Primary completion
Mar 8, 2027 (estimated)
Completion
Mar 8, 2027 (estimated)
Last update
Aug 24, 2026

Study contacts

Sophie CATTEAU JONARD, PhD
Contact
Sophie.catteau@chu-lille.fr
+33 3 20 44 63 09

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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