Chronocort vs Standard Therapy for Congenital Adrenal Hyperplasia
(CONnECT Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial compares Chronocort®, a slow-releasing cortisol medication, with another form of cortisol treatment in people aged 16 and over who have Congenital Adrenal Hyperplasia (CAH). CAH patients need hormone replacement because their bodies can't produce enough cortisol. Chronocort® aims to provide a more stable hormone level throughout the day. Chronocort is a modified-release hydrocortisone developed to replace the cortisol rhythm in patients with congenital adrenal hyperplasia.
Will I have to stop taking my current medications?
The trial requires participants to be on stable glucocorticoid therapy for at least 3 months before joining, so you won't need to stop taking your current glucocorticoid medications. However, if you are on other steroids for conditions besides CAH, you may need to stop those.
How does the drug Chronocort differ from standard treatments for congenital adrenal hyperplasia?
What data supports the effectiveness of the drug Chronocort for treating congenital adrenal hyperplasia?
Who Is on the Research Team?
Principal Investigator
Principal Investigator
Neurocrine UK Limited
Are You a Good Fit for This Trial?
This trial is for individuals over 16 with classic Congenital Adrenal Hyperplasia (CAH) treated with certain steroids for at least 3 months. They must not be pregnant, breastfeeding, or planning to become pregnant and agree to use contraception. Exclusions include previous Chronocort exposure, weight under 45 kg, night shift workers, certain medical conditions including uncontrolled diabetes, and those on other steroid treatments.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either Chronocort or immediate-release hydrocortisone replacement therapy for 28 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Chronocort
- Cortef
Find a Clinic Near You
Who Is Running the Clinical Trial?
Neurocrine UK Limited
Lead Sponsor
Diurnal Limited
Lead Sponsor