A) Men and women aged 18 to 75 years with hypercortisolism due to ACTH-dependent Cushing's syndrome will be treated in the period between diagnosis and planned surgery or radiation therapy. B) Men and women aged 18 to 75 years due to ACTH-dependent Cushing's syndrome who have persistent hypercortisolism post-surgery or post-radiotherapy.
Conditions
Interventions
Product Name: cabergoline
Pharmaceutical Form: Tablet
Sponsors
Swedish Pituitary Study group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients with ACTH-dependent Cushings' syndrome who have urinary free cortisol levels at least 20% above the upper reference level either A) prior to surgery and/or radiotherapy or B) post surgery and or radiotherapy - Informed dated and signed consent - Fertile women most use safe anti-conception 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) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Patients with severe hypecortisolism who will require immediate surgery or treatment with other cortisol-lowering medications (metopyrone, ketokonazole or lysodren). - Pregnancy and lactation - Abuse of alcohol or other drugs - Patients who for other reasons are unable to comply with the study protocol - Psychiatric and neurologic symptoms - Moderate to severe hepatic disease - Patients with clinical significant cardiac vavular disease. In the case the patient has responded well to treatment and wishes to continue treatment with cabergoline after the 6-week study period, an echocardiography with assessment of the cardiac valves must be performed before continued treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: This is an exploratory short-term study to assess the effect of cabergoline on cortisol levels in patients with Cushing's disease in the period between diagnosis and surgery and/ or radiotherapy, and in patients not cured by surgery and/or radiotherapy. ;Secondary Objective: To assess the effects of cabergoline on signs and symptoms caused by hypercortisolism (high blood pressure, hyperglycemia, weight, waist/hip ratio) perceived well-being, and adverse events.;Primary end point(s): Number of patients with a urinary cortisol level below the upper reference level for normal at any time during treatment with cabergoline. | — |
Countries
Sweden
Outcome results
None listed