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

NCT04536662 | Unknown Phase 4

• 1 other identifier: CCEMD-20200819
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Congenital Adrenal Hyperplasia

Outcome Measures

Primary Outcomes (2)

• The number of ovulatory menstruation in female patients

  up to 1 year

• The average sperm count in male patients

  up to 1 year

Secondary Outcomes (14)

• The average levels of progesterone

  up to 1 year

• Mean serum concentrations of 17OHP

  up to 1 year

• Mean serum concentrations of testosterone

  up to 1 year

• Mean serum concentrations of androstenedione

  up to 1 year

• Change in BMI

  up to 1 year

Study Arms (3)

Group hydrocortisone

EXPERIMENTAL

Drug: Hydrocortisone

Group Prednisone

EXPERIMENTAL

Drug: Prednisone

Group Dexamethasone

EXPERIMENTAL

Drug: Dexamethasone

Interventions

Hydrocortisone DRUG

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.

Group hydrocortisone

Prednisone DRUG

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.

Group Prednisone

Dexamethasone DRUG

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.

Group Dexamethasone

Eligibility Criteria

• Age: 14 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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;
• Age: \>14 years old;
• Post-puberty;

You may not qualify if:

• Other diseases present with adrenocortical dysfunction, such as primary adrenal hypofunction, Cushing's syndrome, pituitary tumor, etc;
• Other diseases with hyperandrogenemia were not treated, such as ovarian tumor;
• Other diseases with HPG axis dysfunction were not treated, such as severe obesity (BMI \> 35kg / m2), anorexia nervosa, thyroid dysfunction, etc;
• Other diseases causing ovarian dysfunction, such as ovarian tumor, endometriosis, primary ovarian failure, etc;
• History of adrenal and / or pituitary surgery;
• Elevated AST/ALT (AST \> 35 U/L, ALT \> 55 U/L)
• 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.
• Other diseases may lead to the failure of research intervention;
• Are currently participating in another intervention study or participating in other drug clinical trials within 30 days;
• No informed consent was signed;
• According to the researcher's judgment, there is any situation affecting the study compliance;
• Any other circumstances that are considered by the doctor to be prohibited from participating in the trial.

Sponsors & Collaborators

• Shanghai Jiao Tong University School of Medicine: lead

Study Sites (1)

Ruijin hospital,Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200025, China

Location

MeSH Terms

Conditions

Adrenal Hyperplasia, Congenital

Interventions

Hydrocortisone; Prednisone; Dexamethasone

Condition Hierarchy (Ancestors)

Adrenogenital Syndrome; Disorders of Sex Development; Urogenital Abnormalities; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Genetic Diseases, Inborn; Steroid Metabolism, Inborn Errors; Metabolism, Inborn Errors; Metabolic Diseases; Nutritional and Metabolic Diseases; Adrenal Gland Diseases; Endocrine System Diseases; Gonadal Disorders

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; 11-Hydroxycorticosteroids; Hydroxycorticosteroids; Adrenal Cortex Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; 17-Hydroxycorticosteroids; Pregnadienediols; Pregnadienes; Pregnadienetriols; Steroids, Fluorinated

Central Study Contacts

Guang Ning, MD, PHD

CONTACT

+8621-64370045; guangning@medmail.com.cn

Shouyue Sun, Master of Medicine

CONTACT

+8621-64370045; ssy10926@rjh.com.cn

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 23, 2020
• First Posted: September 2, 2020
• Study Start: October 1, 2020
• Primary Completion: September 30, 2022
• Study Completion: December 31, 2022
• Last Updated: September 2, 2020

Record last verified: 2020-08

Locations

CN (1)