Addison s disease MedDRA version: 9.1 Level: LLT Classification code 10056485
Conditions
Interventions
Product Name: DHEA
Pharmaceutical Form: Tablet
INN or Proposed INN: DEHYDROEPIANDROSTERONE
CAS Number: N53-43-0
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
Sponsors
AZIENDA SANITARIA OSPEDALIERA "S. GIOVANNI BATTISTA DI TORINO"
Eligibility
Sex/Gender
All
Inclusion criteria
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
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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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). | — |
Countries
Italy
Outcome results
None listed