RESTORE.

Trial name or title	Open‐label Comparison of Chronocort® Versus Standard Glucocorticoid Replacement Therapy (RESTORE).
Methods	Open‐label, Phase 3 RCT. Location: USA. Duration: 52 weeks.
Participants	132 participants. Age: > 16 years. Gender: females and males both eligible. Diagnosis: classical CAH due to 21‐hydroxylase deficiency.
Interventions	Arm 1: HC modified release at 5 mg, 10 mg, 20 mg. Arm 2: HC, DXA, PD or prednisone.
Outcomes	Primary: 17 OHP. Secondary: markers of fertility, hirsutism, acne, HbA1c, body weight, QoL, metabolic screen.
Starting date	April 2018.
Contact information	Diurnal Ltd.
Notes

17 OHP: 17‐hydroxyprogesterone
 ACTH: adrenocorticotrophic hormone
 BMD: bone mineral density
 BMI: body mass index
 CAH: congenital adrenal hyperplasia
 CTX: C‐terminal telopeptide
 DEXA: dual energy x‐ray absorptiometry
 DXA: dexamethasone
 HC: hydroxycortisone
 LDL: low‐density lipoprotein
 PD: prednisolone
 P1NP: N‐terminal propeptide of type I procollagen
 QoL: quality of life
 RCT: randomised controlled trial