Stepwise Medical Treatment of Cushing*s Disease: a prospective open label multi-center trial with SOM230 mono- and combination therapy with dopamine agonists and ketoconazole

Phase 2

Recruiting

• Conditions: Cushing's disease; hypercortisolism; 10021112

• Registration Number: NL-OMON30660
• Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 11 June 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 16

Inclusion Criteria

Patients with Cushing's disease, i.e. with hypercortisolism due to an ACTH-producing pituitary adenoma. Eligible for enrolment are: naive patients with Cushing*s disease, patients with residual hypercortisolism after recent transsphenoidal adenomectomy and patients with recurrent Cushing*s disease.

Exclusion Criteria

- Patients with poorly controlled diabetes mellitus indicated by a HbA1c % > 8.5 %.
- Patients with a disturbed liver function indicated by serum bilirubin, ALAT, ASAT
or alkaline phosphatase levels > 2.5 x ULN.
- Patients with renal insufficiency indicated by serum creatinine levels > 2.0 x ULN
- Patients with symptomatic cholelithiasis.
- Pregnant patients or patients who desire to become pregnant during the study
period.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary outcome measure of the study is normalization of cortisol<br /><br>production which is assessed by measurement of urinary cortisol excretion and<br /><br>plasma and salivary cortisol levels. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secundary utcome measures include quality of life scores and bone metabolism-<br /><br>and clotting parameters.</p><br>