Comparisons of Different Forms of Glucocorticoid on the Recovery of Reproductive Function in Patients With 21α-hydroxylase Deficiency

• Status: Not yet recruiting
• Trial end date: 2022-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shanghai Jiao Tong University School of Medicine
• Treatments: Dexamethasone; Hydrocortisone; Prednisone

Criteria

Inclusion Criteria:

1. Patients diagnosed with 21α-OHD. The reference standard was baseline 17OHP (in the morning of follicular phase in female patients, men unlimited) or after cosyntropin stiimulation > 10ng/ml;

2. Age: >14 years old;

3. Post-puberty;

Exclusion Criteria:

1. Other diseases present with adrenocortical dysfunction, such as primary adrenal hypofunction, Cushing's syndrome, pituitary tumor, etc;

2. Other diseases with hyperandrogenemia were not treated, such as ovarian tumor;

3. Other diseases with HPG axis dysfunction were not treated, such as severe obesity (BMI > 35kg / m2), anorexia nervosa, thyroid dysfunction, etc;

4. Other diseases causing ovarian dysfunction, such as ovarian tumor, endometriosis, primary ovarian failure, etc;

5. History of adrenal and / or pituitary surgery;

6. Elevated AST/ALT (AST > 35 U/L, ALT > 55 U/L)

7. Other diseases need glucocorticoid treatment, such as autoimmune diseases such as systemic lupus erythematosus and rheumatoid arthritis, autoimmune diseases such as wind dampness heat, rheumatic myocarditis, idiopathic pulmonary fibrosis, autoimmune liver disease, inflammatory bowel disease and amyloidosis, and allergic diseases such as bronchial asthma, exogenous allergic alveolitis and serum diseases, acute urticaria, vascular edema, hematological diseases such as idiopathic thrombocytopenic purpura, immune hemolysis and aplastic anemia, granulocytopenia, other iritis, keratitis, severe drug-induced dermatitis, eczema, etc.

8. Other diseases may lead to the failure of research intervention;

9. Are currently participating in another intervention study or participating in other drug clinical trials within 30 days;

10. No informed consent was signed;

11. According to the researcher's judgment, there is any situation affecting the study compliance;

12. Any other circumstances that are considered by the doctor to be prohibited from participating in the trial.