EFFECTIVENESS AND TOLERABILITY OF TREATMENT WITH CABERGOLINE IN PATIENTS WITH CUSHING S SYNDROME - CABERGOLINE IN CUSHING S SYNDROME

Conditions: Cushing syndrome
MedDRA version: 9.1Level: LLTClassification code 10011652Term: Cushing's syndrome

Registration Number: EUCTR2006-005218-11-IT

Lead Sponsor: ASSOCIAZIONE ITALIANA ENDOCRINOLOGIA-METABOLISMO-IPOFISI

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

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

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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures