EFFECTS OF DHEA TREATMENT ON ANTHROPOMETRIC AND METABOLIC PARAMETERS, AND ON QUALITY OF LIFE (QOL) IN PATIENTS WITH ADDISON S DISEASE UNDER GLUCORTICOID-MINERALCORTICOID SUBSTITUTIVE TREATMENT - ND

Conditions: Addison s disease
MedDRA version: 9.1Level: LLTClassification code 10056485

Registration Number: EUCTR2009-018209-32-IT

Lead Sponsor: AZIENDA SANITARIA OSPEDALIERA S. GIOVANNI BATTISTA DI TORINO

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

Addison s disease of various aetiology, both sex, age between 18 and 65 years.
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
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

pregnancy or breast feeding, prior or active malignancies, severe neurological or psychiatric diseases under neuroactive drugs (eg. epilepsy, major depression), prior major cardiovascular diseases (eg. cardiac or cerebral stroke).

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: to determine the effect of a 24-month DHEA therapy (50 mg daily) on clinical parameters (weight, body mass index, waist circumference, blood pressure), metabolic parameters (glucose and lipids) and on quality of life (QoL);Secondary Objective: to evaluate hormonal changes induced by DHEA treatment; to assess side effects, if any, of a long-term DHEA treatment.;Primary end point(s): To find differences between patients under DHEA treatment versus patients under placebo in terms of clinical parameters (weight loss, body mass index and waist circumference reduction, blood pressure decrease), metabolic parameters (improvement of glucose tolerance evaluated by fasting glucose and insulin levels as well as during OGTT, lowering of total cholesterol and triglycerides, increasing of HDL-cholesterol and lowering of LDL-cholesterol) and of QoL (improvement of QoL).

Secondary Outcome Measures