<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03760835</url>
  </required_header>
  <id_info>
    <org_study_id>140/16</org_study_id>
    <nct_id>NCT03760835</nct_id>
  </id_info>
  <brief_title>Congenital Adrenal Hyperplasia Once Daily Hydrocortisone Treatment</brief_title>
  <acronym>CareOnTIME</acronym>
  <official_title>Congenital Adrenal Hyperplasia: Innovative Once Daily Dual Release Hydrocortisone Treatment</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Federico II University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Federico II University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a controlled, open study designed to compare the effects of dual-release&#xD;
      hydrocortisone preparations versus conventional glucocorticoid therapy on clinical,&#xD;
      anthropometric parameters, metabolic syndrome, hormonal profile, bone status, quality of&#xD;
      life, reproductive, sexual and psychological functions and treatment compliance in patients&#xD;
      affected by congenital adrenal hyperplasia due to 21 OH deficiency.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Congenital adrenal hyperplasia due to 21-hydroxylase deficiency is an autosomal recessive&#xD;
      disorder characterized by cortisol and in some cases aldosterone deficiency, associated with&#xD;
      androgen excess. Treatment goals are to replace cortisol deficiency, to control androgen&#xD;
      levels, while avoiding the adverse effects of exogenous glucocorticoids. A variety of&#xD;
      glucocorticoid treatments have been used in an attempt to control the overnight increase in&#xD;
      adrenal androgens. However, there is no consensus on the optimum management of congenital&#xD;
      adrenal hyperplasia adults. Current evidence in patients with adrenal insufficiency suggests&#xD;
      that the inability of current regimens to replace physiological circadian cortisol levels,&#xD;
      leads to adverse clinical outcomes, including metabolic syndrome, insulin resistance,&#xD;
      increased risk factors for cardiovascular diseases, bone and immune alterations, sleep&#xD;
      disturbances and quality of life impairment. Moreover, the risk for poor treatment&#xD;
      compliance, in case of multiple daily doses treatment regimens, should not be excluded. In&#xD;
      this trial a dual-release hydrocortisone preparation, that been able to mimic the circadian&#xD;
      pattern of circulating cortisol, was studied in patients with adrenal insufficiency due to&#xD;
      congenital adrenal hyperplasia.&#xD;
&#xD;
      All patients with a diagnosis of congenital adrenal hyperplasia due to 21-hydroxylase&#xD;
      deficiency, irrespective of glucocorticoid treatment, are eligible for the inclusion in the&#xD;
      study and may be asked to participate in the study. Patients are followed during the course&#xD;
      of routine clinical practice for the duration of time that the study is active.&#xD;
&#xD;
      ARM1: Conventional glucocorticoid therapy is continued as before entering the study&#xD;
&#xD;
      ARM2: Dual release hydrocortisone oral tablets is administered once-daily in the fasting&#xD;
      state. The dose is kept the same as patients had before entering the trial.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">August 11, 2016</start_date>
  <completion_date type="Anticipated">December 31, 2023</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2023</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from baseline in measurement of total and LDL cholesterol (mg/dl)</measure>
    <time_frame>0, + 6 months, + 12 months, +24 months</time_frame>
    <description>Single outcome measurement of cholesterol levels (mg/dl)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in measurement of glycaemia (mg/dl)</measure>
    <time_frame>0, + 6 months, + 12 months, +24 months</time_frame>
    <description>Measure of glycaemia (mg/dl)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in measurement of BMI (Kg/m2)</measure>
    <time_frame>0, + 6 months, + 12 months, +24 months</time_frame>
    <description>Measure of BMI (Kg/m2)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in measurement of blood pressure (mmHg)</measure>
    <time_frame>0, + 6 months, + 12 months, +24 months</time_frame>
    <description>Measure of blood pressure (mmHg)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in measurement of insulinemia (μU/mL)</measure>
    <time_frame>0, + 6 months, + 12 months, +24 months</time_frame>
    <description>Measure of insulinemia (μU/mL)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in measurement of triglycerides (mg/dl)</measure>
    <time_frame>0, + 6 months, + 12 months, +24 months</time_frame>
    <description>Measure of triglycerides (mg/dl)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in measurement of HDL-cholesterol (mg/dl)</measure>
    <time_frame>0, + 6 months, + 12 months, +24 months</time_frame>
    <description>Measure of HDL-cholesterol (mg/dl)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in measurement of Glycated Haemoglobin (%)</measure>
    <time_frame>0, + 6 months, + 12 months, +24 months</time_frame>
    <description>Measure of Glycated Haemoglobin (%)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in bone mineral density</measure>
    <time_frame>0, + 12 months, +24 months</time_frame>
    <description>Bone mineral density quantified by Dual X-Ray Absorptiometry (DEXA)]</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in quality of life</measure>
    <time_frame>0, + 6 months, + 12 months, +24 months</time_frame>
    <description>Quality of life will be measured by Addison Quality of Life (AddiQol) questionnaire, used to assess quality of life in patients suffering from adrenal insufficiency. Each question has a score ranging from 1 to 4. Total score (minimum: 30; maximum: 120) is obtained summing each question score. The higher the scores are, the better the quality of life is. No clear cut-offs are defined.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in sex function in males</measure>
    <time_frame>0, + 6 months, + 12 months, +24 months</time_frame>
    <description>Sex function will be measured by International Index of Erectile Function (IIEF) questionnaire. IIEF is divided into five function domains: Erectile function (Q1-5, Q15; score range Q1-5: 0-5; score range Q15: 1-5), Orgasmic function (Q9-10; score range Q9: 0-5; score range Q10: 1-5), Sexual desire (Q11-12; score range: 1-5), Intercourse satisfaction (Q6-8; score range: 0-5), Overall satisfaction (Q13-14; score range: 1-5). The higher the domain scores are, the better the male sexual functions are.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in sex function in females</measure>
    <time_frame>0, + 6 months, + 12 months, +24 months</time_frame>
    <description>Sex function will be measured by Female Sexual Function Index (FSFI) questionnaire. FSFI is divided into six domains: Desire (Q1-2; score range: 1-5), Arousal (Q3-6; score range: 0-5), Lubrification (Q7-10; score range: 0-5), Orgasm (Q11-13; score range: 0-5), Satisfaction (Q14-16; score range Q14: 0-5; score range Q15-16: 1-5), Pain (Q17-19; score range: 0-5). To obtain the full scale score (ranging from 2 to 36), each domain score range should be corrected by an individual factor (Desire: 0.6; Arousal and Lubrification: 0.3; Orgasm, Satisfaction and Pain: 0.4). The higher the score is, the better the female sexual function is.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in depression status</measure>
    <time_frame>0, + 6 months, + 12 months, +24 months</time_frame>
    <description>Depression status will be measured by Beck Depression Inventory Test (BDI-II) questionnaire. Each question has a score ranging from 0 to 3. Total score (minimum: 0; maximum: 63) is obtained summing each question score. Scores range from minimum (0-13), mild (14-19), moderate (20-28), severe (29-63)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in treatment compliance</measure>
    <time_frame>0, + 6 months, + 12 months, +24 months</time_frame>
    <description>Treatment compliance will be measured by Morisky Medical Adherence Scale-8 questionnaire. Each question has a score ranging from 0 to 1. Low Adherence (&lt; 6); Medium Adherence (6 to &lt;8); High Adherence (= 8)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of Treatment Adverse Events (safety analysis)</measure>
    <time_frame>0, + 6 months, + 12 months, +24 months</time_frame>
    <description>Number of participants with treatment-related adverse events as assessed by Common Terminology Criteria for Adverse Events version 4.0 (not a scale)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in androgens levels</measure>
    <time_frame>0, + 6 months, + 12 months, +24 months</time_frame>
    <description>Measure of androstenedione/testosterone ratio</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in sperm concentration</measure>
    <time_frame>0, + 6 months, + 12 months, +24 months</time_frame>
    <description>Evaluation of sperm concentration according to WHO criteria</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in ovarian follicles reserve</measure>
    <time_frame>0, + 6 months, + 12 months, +24 months</time_frame>
    <description>Evaluation of number of ovarian follicles by conventional ultrasound imaging</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">150</enrollment>
  <condition>Congenital Adrenal Hyperplasia</condition>
  <arm_group>
    <arm_group_label>Dual-release hydrocortisone</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Conventional glucocorticoids</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Conventional Glucocorticoids (immediate release hydrocortisone, cortisone acetate, prednisone, prednisolone, dexamethasone)</intervention_name>
    <description>Treatment of congenital adrenal hyperplasia</description>
    <arm_group_label>Conventional glucocorticoids</arm_group_label>
    <arm_group_label>Dual-release hydrocortisone</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dual release hydrocortisone (plenadren)</intervention_name>
    <description>Treatment of congenital adrenal hyperplasia</description>
    <arm_group_label>Dual-release hydrocortisone</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  males and females aged &gt;18 years;&#xD;
&#xD;
          -  established diagnosis of adrenal insufficiency in congenital adrenal hyperplasia due&#xD;
             to 21-hydroxylase deficiency;&#xD;
&#xD;
          -  stably treated with conventional glucocorticoids, available to change their regimen&#xD;
             according to random allocation&#xD;
&#xD;
          -  written informed consent/assent to participate in the study in compliance with local&#xD;
             regulations.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  clinical or laboratory signs of severe cerebral, respiratory, hepatobiliary or&#xD;
             pancreatic diseases, renal dysfunction, gastrointestinal emptying, or motility&#xD;
             disturbances (i.e. chronic diarrhea), significant psychiatric illnesses;&#xD;
&#xD;
          -  history of/or current alcohol and/or drug abuse;&#xD;
&#xD;
          -  night shift workers;&#xD;
&#xD;
          -  underlying diseases that could necessitate treatment with glucocorticoids;&#xD;
&#xD;
          -  therapies with hepatic enzyme induction drugs interfering with glucocorticoid&#xD;
             kinetics, or immunosuppressive steroid therapy;&#xD;
&#xD;
          -  patients with a documented intolerance/known hypersensitivity to dual release&#xD;
             hydrocortisone;&#xD;
&#xD;
          -  vulnerable populations, such as elderly, cancer patients, pregnant and lactating&#xD;
             women;&#xD;
&#xD;
          -  history of non-compliance to medical regimens, or potentially unreliable patients&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Rosario Pivonello, M.D., PhD, Professor</last_name>
    <phone>+390817464983</phone>
    <email>rosario.pivonello@unina.it</email>
  </overall_contact>
  <location>
    <facility>
      <name>Federico II University</name>
      <address>
        <city>Naples</city>
        <zip>80131</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Rosario Pivonello, MD,PhD,Professor</last_name>
      <phone>+390817464983</phone>
      <email>rosario.pivonello@unina.it</email>
    </contact>
    <investigator>
      <last_name>Rosario Pivonello, MD, PhD, Professor</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Chiara Simeoli, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Maria Cristina De Martino, MD, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Rosario Ferrigno, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>March 2022</verification_date>
  <study_first_submitted>November 9, 2018</study_first_submitted>
  <study_first_submitted_qc>November 29, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 30, 2018</study_first_posted>
  <last_update_submitted>March 21, 2022</last_update_submitted>
  <last_update_submitted_qc>March 21, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 22, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Federico II University</investigator_affiliation>
    <investigator_full_name>Prof. Rosario Pivonello</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>congenital adrenal hyperplasia</keyword>
  <keyword>glucocorticoid treatment</keyword>
  <keyword>dual release hydrocortisone</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Adrenal Hyperplasia, Congenital</mesh_term>
    <mesh_term>Adrenogenital Syndrome</mesh_term>
    <mesh_term>Adrenocortical Hyperfunction</mesh_term>
    <mesh_term>Hyperplasia</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dexamethasone</mesh_term>
    <mesh_term>Prednisone</mesh_term>
    <mesh_term>Prednisolone</mesh_term>
    <mesh_term>Hydrocortisone</mesh_term>
    <mesh_term>Hydrocortisone 17-butyrate 21-propionate</mesh_term>
    <mesh_term>Hydrocortisone acetate</mesh_term>
    <mesh_term>Hydrocortisone hemisuccinate</mesh_term>
    <mesh_term>Cortisone</mesh_term>
    <mesh_term>Glucocorticoids</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03760835
org study id: 140/16
nct id: NCT03760835
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is a controlled, open study designed to compare the effects of dual-release
      hydrocortisone preparations versus conventional glucocorticoid therapy on clinical,
      anthropometric parameters, metabolic syndrome, hormonal profile, bone status, quality of
      life, reproductive, sexual and psychological functions and treatment compliance in patients
      affected by congenital adrenal hyperplasia due to 21 OH deficiency.
Congenital adrenal hyperplasia due to 21-hydroxylase deficiency is an autosomal recessive
      disorder characterized by cortisol and in some cases aldosterone deficiency, associated with
      androgen excess. Treatment goals are to replace cortisol deficiency, to control androgen
      levels, while avoiding the adverse effects of exogenous glucocorticoids. A variety of
      glucocorticoid treatments have been used in an attempt to control the overnight increase in
      adrenal androgens. However, there is no consensus on the optimum management of congenital
      adrenal hyperplasia adults. Current evidence in patients with adrenal insufficiency suggests
      that the inability of current regimens to replace physiological circadian cortisol levels,
      leads to adverse clinical outcomes, including metabolic syndrome, insulin resistance,
      increased risk factors for cardiovascular diseases, bone and immune alterations, sleep
      disturbances and quality of life impairment. Moreover, the risk for poor treatment
      compliance, in case of multiple daily doses treatment regimens, should not be excluded. In
      this trial a dual-release hydrocortisone preparation, that been able to mimic the circadian
      pattern of circulating cortisol, was studied in patients with adrenal insufficiency due to
      congenital adrenal hyperplasia.

      All patients with a diagnosis of congenital adrenal hyperplasia due to 21-hydroxylase
      deficiency, irrespective of glucocorticoid treatment, are eligible for the inclusion in the
      study and may be asked to participate in the study. Patients are followed during the course
      of routine clinical practice for the duration of time that the study is active.

      ARM1: Conventional glucocorticoid therapy is continued as before entering the study

      ARM2: Dual release hydrocortisone oral tablets is administered once-daily in the fasting
      state. The dose is kept the same as patients had before entering the trial.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change from baseline in measurement of total and LDL cholesterol (mg/dl)
time frame: 0, + 6 months, + 12 months, +24 months
description: Single outcome measurement of cholesterol levels (mg/dl)
measure: Change from baseline in measurement of glycaemia (mg/dl)
time frame: 0, + 6 months, + 12 months, +24 months
description: Measure of glycaemia (mg/dl)
measure: Change from baseline in measurement of BMI (Kg/m2)
time frame: 0, + 6 months, + 12 months, +24 months
description: Measure of BMI (Kg/m2)
measure: Change from baseline in measurement of blood pressure (mmHg)
time frame: 0, + 6 months, + 12 months, +24 months
description: Measure of blood pressure (mmHg)
measure: Change from baseline in measurement of insulinemia (μU/mL)
time frame: 0, + 6 months, + 12 months, +24 months
description: Measure of insulinemia (μU/mL)
measure: Change from baseline in measurement of triglycerides (mg/dl)
time frame: 0, + 6 months, + 12 months, +24 months
description: Measure of triglycerides (mg/dl)
measure: Change from baseline in measurement of HDL-cholesterol (mg/dl)
time frame: 0, + 6 months, + 12 months, +24 months
description: Measure of HDL-cholesterol (mg/dl)
measure: Change from baseline in measurement of Glycated Haemoglobin (%)
time frame: 0, + 6 months, + 12 months, +24 months
description: Measure of Glycated Haemoglobin (%)
measure: Changes in bone mineral density
time frame: 0, + 12 months, +24 months
description: Bone mineral density quantified by Dual X-Ray Absorptiometry (DEXA)]
measure: Changes in quality of life
time frame: 0, + 6 months, + 12 months, +24 months
description: Quality of life will be measured by Addison Quality of Life (AddiQol) questionnaire, used to assess quality of life in patients suffering from adrenal insufficiency. Each question has a score ranging from 1 to 4. Total score (minimum: 30; maximum: 120) is obtained summing each question score. The higher the scores are, the better the quality of life is. No clear cut-offs are defined.
measure: Changes in sex function in males
time frame: 0, + 6 months, + 12 months, +24 months
description: Sex function will be measured by International Index of Erectile Function (IIEF) questionnaire. IIEF is divided into five function domains: Erectile function (Q1-5, Q15; score range Q1-5: 0-5; score range Q15: 1-5), Orgasmic function (Q9-10; score range Q9: 0-5; score range Q10: 1-5), Sexual desire (Q11-12; score range: 1-5), Intercourse satisfaction (Q6-8; score range: 0-5), Overall satisfaction (Q13-14; score range: 1-5). The higher the domain scores are, the better the male sexual functions are.
measure: Changes in sex function in females
time frame: 0, + 6 months, + 12 months, +24 months
description: Sex function will be measured by Female Sexual Function Index (FSFI) questionnaire. FSFI is divided into six domains: Desire (Q1-2; score range: 1-5), Arousal (Q3-6; score range: 0-5), Lubrification (Q7-10; score range: 0-5), Orgasm (Q11-13; score range: 0-5), Satisfaction (Q14-16; score range Q14: 0-5; score range Q15-16: 1-5), Pain (Q17-19; score range: 0-5). To obtain the full scale score (ranging from 2 to 36), each domain score range should be corrected by an individual factor (Desire: 0.6; Arousal and Lubrification: 0.3; Orgasm, Satisfaction and Pain: 0.4). The higher the score is, the better the female sexual function is.
measure: Changes in depression status
time frame: 0, + 6 months, + 12 months, +24 months
description: Depression status will be measured by Beck Depression Inventory Test (BDI-II) questionnaire. Each question has a score ranging from 0 to 3. Total score (minimum: 0; maximum: 63) is obtained summing each question score. Scores range from minimum (0-13), mild (14-19), moderate (20-28), severe (29-63)
measure: Changes in treatment compliance
time frame: 0, + 6 months, + 12 months, +24 months
description: Treatment compliance will be measured by Morisky Medical Adherence Scale-8 questionnaire. Each question has a score ranging from 0 to 1. Low Adherence (< 6); Medium Adherence (6 to <8); High Adherence (= 8)
measure: Incidence of Treatment Adverse Events (safety analysis)
time frame: 0, + 6 months, + 12 months, +24 months
description: Number of participants with treatment-related adverse events as assessed by Common Terminology Criteria for Adverse Events version 4.0 (not a scale)
measure: Changes in androgens levels
time frame: 0, + 6 months, + 12 months, +24 months
description: Measure of androstenedione/testosterone ratio
measure: Changes in sperm concentration
time frame: 0, + 6 months, + 12 months, +24 months
description: Evaluation of sperm concentration according to WHO criteria
measure: Changes in ovarian follicles reserve
time frame: 0, + 6 months, + 12 months, +24 months
description: Evaluation of number of ovarian follicles by conventional ultrasound imaging
arm group label: Dual-release hydrocortisone
arm group type: Experimental
arm group label: Conventional glucocorticoids
arm group type: Active Comparator
intervention type: Drug
intervention name: Conventional Glucocorticoids (immediate release hydrocortisone, cortisone acetate, prednisone, prednisolone, dexamethasone)
description: Treatment of congenital adrenal hyperplasia
arm group label: Conventional glucocorticoids
arm group label: Dual-release hydrocortisone
intervention type: Drug
intervention name: Dual release hydrocortisone (plenadren)
description: Treatment of congenital adrenal hyperplasia
arm group label: Dual-release hydrocortisone
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Rosario Pivonello, M.D., PhD, Professor
phone: +390817464983
email: rosario.pivonello@unina.it
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
investigator: 
investigator: 
country: Italy
responsible party type: Principal Investigator
investigator affiliation: Federico II University
investigator full name: Prof. Rosario Pivonello
investigator title: Associate Professor
mesh term: Adrenal Hyperplasia, Congenital
mesh term: Adrenogenital Syndrome
mesh term: Adrenocortical Hyperfunction
mesh term: Hyperplasia
mesh term: Dexamethasone
mesh term: Prednisone
mesh term: Prednisolone
mesh term: Hydrocortisone
mesh term: Hydrocortisone 17-butyrate 21-propionate
mesh term: Hydrocortisone acetate
mesh term: Hydrocortisone hemisuccinate
mesh term: Cortisone
mesh term: Glucocorticoids
sharing ipd: No