Cushing syndrome MedDRA version: 9.1 Level: LLT Classification code 10011652 Term: Cushing's syndrome
Conditions
Interventions
Trade Name: DOSTINEX
Pharmaceutical Form: Tablet
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: .5-
Trade Name: NIZORAL
Pharmaceutical Form: Tablet
Concentration
Sponsors
ASSOCIAZIONE ITALIANA ENDOCRINOLOGIA-METABOLISMO-IPOFISI
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1 Age above 18 and below 65 years 2 Diagnosis of Cushing s syndrome due to pituitary or adrenal tumor or ectopic ACTH secretion, performed by the standard diagnostic procedures evaluation of urinary cortisol secretion, cortisol circadian rhythm,low-dose and high-dose dexamethasone test, CRH and/or DDAVP test 3 Documentation of baseline cortisol urinary levels at least two times higher and less than four times lower than the upper limit of normal range 4 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 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1 Pregnancy or Lactation; 2 Documented intolerance to cabergoline; 3 Liver, renal or cardiovascular insufficiency; 4 Specific conditions and/or tumor characteristics which require an immediate alternmative treatment aggressivity of the neoplasm or sever organ compromission
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluation of the effectiveness of cabergoline in inducing ACTH and cortisol secretion inhibition in patients with Cushing syndrome;Secondary Objective: Evaluation of the effectiveness of cabergoline in inducing tumor shrinkage and the improvement of the systemic complications of hypercortisolism, inlcuding metabolic systemic arterial hypertension, diabetes mellitus or impairment of glucose tolerance, dyslipidemia , cardiovascular thichening of intima-media of the main vessels, presence of atherosclerotic plaques, cardiac hypertrophy and dysfuncion osteoarticular osteoporosis, osteoarthrosis , reproductive-sexual gonadal dysfunction, sexual dysfunction complications, and on the quality of life;Primary end point(s): Percentage of normalization of cortisol secretion | — |
Countries
Italy
Outcome results
None listed