Congenital Adrenal HyperplasiaPhase 4CGP21NCT04536662
Comparisons of Different Forms of Glucocorticoid on the Recovery of Reproductive Function in Patients With 21α-hydroxylase Deficiency
A Phase 4 study testing Hydrocortisone, Prednisone and Dexamethasone in people with Congenital Adrenal Hyperplasia, run by Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 14 to 45 years
- Conditions the study is for
- Congenital Adrenal Hyperplasia
- What is being tested?
- Hydrocortisone, Prednisone and Dexamethasone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2020to 31 Dec 2022
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 45 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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;
Who cannot join
- 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)
Show all 12Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Ruijin hospital,Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200025
About this study
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.
Read the detailed description
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.
- Conditions
- Congenital Adrenal Hyperplasia
- Being tested
- Hydrocortisone, Prednisone, Dexamethasone
- Medical subject headings
- Adrenal Hyperplasia, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HydrocortisoneDrug
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.
PrednisoneDrug
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.
DexamethasoneDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Group hydrocortisone | Experimental | Not described Receives: Drug: Hydrocortisone |
| Group Prednisone | Experimental | Not described Receives: Drug: Prednisone |
| Group Dexamethasone | Experimental | Not described Receives: Drug: Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of ovulatory menstruation in female patients
Measured: up to 1 year
The average sperm count in male patients
Measured: up to 1 year
Secondary outcomes (14)
The average levels of progesterone
Progesterone will be detected at follicular phase (day 2~8) in female patients.
Measured: up to 1 year
Mean serum concentrations of 17OHP
Measured: up to 1 year
Mean serum concentrations of testosterone
Measured: up to 1 year
Mean serum concentrations of androstenedione
Measured: up to 1 year
Change in BMI
Measured: up to 1 year
Change in waist circumference
Measured: up to 1 year
Change in blood pressure
Measured: up to 1 year
Change in fasting glucose levels
Measured: up to 1 year
Change in fasting insulin levels
Measured: up to 1 year
Change in 2-hour postprandial glucose levels
Measured: up to 1 year
Change in 2-hour postprandial insulin levels
Measured: up to 1 year
Change in bone mineral density
Measured: up to 1 year
Change in blood metabolomics profile measurement
In aid of LC/MS and GC-MS technique, we will measure the metabolomics molecular profile in blood samples before and after treatment. The metabolomics measurement will help to detect the profile of all kinds of hormones, bile acid species, lipids species and amino acid species.
Measured: up to 1 year
mental health status
The Self-reporting inventory ( SCL-90) will be used to evaluate the changes of patients' psychological state at baseline and after one-year treatment from 10 aspects, including somatization, obsessive-compulsive symptoms, interpersonal sensitivity, depression, anxiety, hostility, terror, paranoia, psychotic and others.
Measured: up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2020
- Study start1 Oct 2020 (estimated)
- Primary completion30 Sep 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital Adrenal HyperplasiaStudies of the same condition, open and under way.
- More trials run by Shanghai Jiao Tong University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Jiao Tong University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guang Ning, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04536662
- Sponsor's protocol ID
- CCEMD-20200819
- Acronym
- CGP21
- Status last verified
- Aug 2020
- First submitted
- 23 Aug 2020
- Last updated
- 2 Sep 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparisons of Different Forms of Glucocorticoid on the Recovery of Reproductive Function in Patients With 21α-hydroxylase Deficiency
- ClinicalTrials.gov ID
- NCT04536662
- Acronym / sponsor ID
- CGP21 / CCEMD-20200819
- Conditions
- Congenital Adrenal Hyperplasia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- 1 Oct 2020 (estimated)
- Primary completion
- 30 Sep 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 2 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group hydrocortisone | Experimental | Drug: Hydrocortisone |
| Group Prednisone | Experimental | Drug: Prednisone |
| Group Dexamethasone | Experimental | Drug: Dexamethasone |
Who may qualify
- Ages
- 14 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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;
Key exclusion criteria (12 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HydrocortisoneThe 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. | Drug | Group hydrocortisone |
| PrednisoneThe 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. | Drug | Group Prednisone |
| DexamethasoneThe 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. | Drug | Group Dexamethasone |
Primary outcome
The number of ovulatory menstruation in female patients
Time frame: up to 1 year
The average sperm count in male patients
Time frame: up to 1 year
14 secondary outcomes
The average levels of progesterone
Time frame: up to 1 year
Mean serum concentrations of 17OHP
Time frame: up to 1 year
Mean serum concentrations of testosterone
Time frame: up to 1 year
Mean serum concentrations of androstenedione
Time frame: up to 1 year
Change in BMI
Time frame: up to 1 year
Change in waist circumference
Time frame: up to 1 year
Change in blood pressure
Time frame: up to 1 year
Change in fasting glucose levels
Time frame: up to 1 year
Change in fasting insulin levels
Time frame: up to 1 year
Change in 2-hour postprandial glucose levels
Time frame: up to 1 year
Change in 2-hour postprandial insulin levels
Time frame: up to 1 year
Change in bone mineral density
Time frame: up to 1 year
Change in blood metabolomics profile measurement
Time frame: up to 1 year
mental health status
Time frame: up to 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Hydrocortisone, Prednisone and Dexamethasone in people with Congenital Adrenal Hyperplasia, run by Shanghai Jiao Tong University School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Guang Ning, MD, PHD (+8621-64370045 ext. 671817, guangning@medmail.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number of ovulatory menstruation in female patients (time frame: up to 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2020.