Efficacy and Tolerability of Lanreotide (Autogel 120 mg) in Patients With Acromegaly

Phase III, Multicentre, Open Clinical Study on the Efficacy and Tolerability of a New Slow-release Formulation of Lanreotide (Autogel 120 mg) in Patients With Active Acromegaly

The purpose of the protocol, is to evaluate if lanreotide Autogel 120 mg is effective in the control of Growth Hormone (GH) secretion in patients with active acromegaly.

Inclusion Criteria:

• Documented diagnosis of active acromegaly, defined by serum GH levels above 5 µg/L, absence of reduction of serum GH levels below 1µg/L after oral glucose tolerance test (OGTT) and abnormal IGF-1 values

Exclusion Criteria:

• Patients who have undergone pituitary surgery less than 3 months before selection
• Patients previously treated with radiotherapy
• Patients previously treated with somatostatin analogue except for a pre-surgical treatment not longer than 3 months