Congenital Adrenal Hyperplasia Clinical Trial
Official title:
Comparisons of Different Forms of Glucocorticoid on the Recovery of Reproductive Function in Patients With 21α-hydroxylase Deficiency
The purpose of this study is to conduct an open, randomized controlled clinical trial, evaluating the effects of different dosage forms of glucocorticoid on the Recovery of Reproductive Function in Patients With 21α-hydroxylase Deficiency.
In the present study, about 120 patients who are more than 14 years old and diagnosed with
21-hydroxylase deficiency will be enrolled from Ruijin Hospital, Shanghai Jiao Tong
University School of Medicine in China. Randomisation was computer generated and stratified
by subtype and gender. After screening, eligible subjects will be randomly treated with
equivalent dose of hydrocortisone, prednisone or dexamethasone for one year.
The treatment regimen was as follows. Firstly, at least one month washout period (withdrawal)
was performed before treatment. The initial dose of hydrocortisone (20mg/tablet) was
15mg/m2/day to the maximum dose of 60mg, which was orally administered in three times, with
the dose ratio of 2:1:3, and the administration time was 8:00-15:00-21:00. The initial dose
of prednisone (5mg/tablet) was 3mg/m2/day to the maximum dose of 15mg. The dosage ratio was
1:2 and the administration time was 8:00 and 21:00. The initial dose of dexamethasone
(0.75mg/tablet) was 0.3mg/m2/day to the maximum dose of 0.75mg and the administration time
was 21:00.
The primary objective was to evaluate the effects of different dosage forms of glucocorticoid
on the recovery of reproductive function in patients with 21α-hydroxylase deficiency. The
primary end point is to evaluate menstrual cycles with ovulation in female patients
(including menstrual period, menstrual frequency per year) and sperm count in male patients
among the three groups. The secondary endpoint were: 1) The levels of progesterone, 17OHP,
testosterone, androstenedione, sex hormone binding protein were measured at follicular phase
in female patients and male unlimited in the first month and every three months thereafter;
2) The change of BMI, waist circumference, hip circumference, visceral and subcutaneous fat
area, body and liver fat content after one year treatment; 3) The change of blood pressure,
fasting blood glucose, fasting insulin, HbA1c, blood lipid profile after one year treatment;
4) The change of bone mineral density after one year; 5) The change of mental health status
compared with baseline after one year follow-up.
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