therapy with Plenadren in patients with central hypoadrenalism.

Conditions: Central hypoadrenalism
MedDRA version: 16.1Level: LLTClassification code 10020936Term: HypoadrenalismSystem Organ Class: 100000004860
Therapeutic area: Diseases [C] - Hormonal diseases [C19]

Registration Number: EUCTR2013-004028-12-IT

Lead Sponsor: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

•Age > 18 years
•Diagnosis of central hypoadrenalism
•Other pituitary deficiencies in adequate replacement therapy
•Therapy with cortisone acetate from at least six months
•Symptoms of over- and under-treatment
•Informed consent

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5

Exclusion Criteria

•Pregnancy
•Breast feeding
•Estroprogestinic therapy
•Steroids assumption

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the medium-term effects of the therapy with modified-release hydrocortisone on glucose, bone metabolism, and quality of life, compared to the classical therapy;Secondary Objective: To compare cortisol absorption pattern through evaluation of salivary cortisol, between patients treated with cortisone acetate and Plenadren.;Primary end point(s): Evaluation of effects of Plenadren on:<br>- glucose metabolism (modifications of fasting glucose and glycated haemoglobin)<br>- bone metabolism (modification of bone mineral density, BMD)<br>- blood pressure (modification of systolic and diastolic blood pressure)<br>- quality of life (modification evaluated by specific questionnaires);Timepoint(s) of evaluation of this end point: 18 months

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Cortisol absorption pattern through evaluation of salivary cortisol during therapy with Plenadren.;Timepoint(s) of evaluation of this end point: 3 months