Lanreotide as Primary Treatment for Acromegalic Patients With Pituitary Gland Macroadenoma
Lanreotide as Primary Treatment for Acromegalic Patients With Pituitary Gland Macroadenoma
Acromegaly is a chronic disease caused by excessive secretion of growth hormone (GH) and
 mainly due to benign tumour localized in the pituitary gland.

 The disease develops insidiously, causing a gradual progression of symptoms; consequently
 most patients are diagnosed in their fourth decade of life.

 Administration of somatostatin analogues such as lanreotide have been shown to result in
 normalisation or the decrease of GH and insulin growth factor (IGF-1) levels and improvement
 of clinical symptoms in acromegalic patients. The purpose of this study is to evaluate
 whether lanreotide is also effective on tumour volume reduction (tumour shrinkage) and the
 benefits of this potential tumour shrinkage on disease symptoms and patient's quality of
 life.
Inclusion Criteria:

 -  The patient has given written informed consent prior to any study related procedures

 -  The patient is male or female and is aged between 18 and 75 years, inclusive,

 -  Diagnosis of acromegaly defined by i) GH nadir > 1 ng/mL as assessed by an oral
 glucose tolerance test for non diabetic patients (central laboratory results) or a
 mean GH level > 1 ng/mL based on 5 samples taken every 10 to 15 minutes for diabetic
 patients ( central laboratory results) AND ii) IGF-1 concentrations elevated above the
 age- and sex-matched normal range for diabetic and non diabetic patients (central
 laboratory results),

 -  The patient has a pituitary adenoma with a diameter greater than or equal to 10 mm
 based on Magnetic Resonance Imaging (MRI) central reading,

 -  The patient has no visual field defect identified at the visual evaluation, performed
 by Goldman Visual Fields Analyser and Automated visual field static perimeter, except
 visual field abnormality at the time of screening and that is in the investigator's
 Clinical judgement:

 -  Not related to the pituitary adenoma

 -  Clinically stable condition not presumed to change during the study period

 -  Not modifying the ability to evaluate visual field changes related to the
 macroadenoma

 Exclusion Criteria:

 -  The patient has a history of hypersensitivity to Lanreotide or drugs with a similar
 chemical structure,

 -  The patient has received any unlicensed drug within the 30 days prior to the screening
 visit or is scheduled to receive an unlicensed drug during the course of the study,

 -  The patient is likely to require treatment during the study with somatostatin
 analogues other than Lanreotide Autogel 120 mg, dopamine agonist, GH receptor
 antagonist (pegvisomant), and Cyclosporine or drugs that are not permitted by the
 study protocol,

 -  The patient is a female at risk of pregnancy during the study and is not using
 acceptable contraceptive methods. Females of childbearing potential must provide a
 negative pregnancy test at start of study and must be using oral, double barrier
 (condom with spermicidal jelly, foam suppository, or film; diaphragm with spermicide;
 or male condom and diaphragm with spermicide), injectable contraception or an intra
 uterine device. Non childbearing potential is defined as post-menopause for at least 1
 year, surgical sterilisation or hysterectomy at least three months before the start of
 the study,

 -  The patient is pregnant or lactating,

 -  The patient has a history of, or known current, problems with alcohol abuse,

 -  The patient has any mental condition rendering the patient unable to understand the
 nature, scope and possible consequences of the study, and/or evidence of an
 uncooperative attitude.

 -  The patient has abnormal baseline findings, any other medical condition(s) or
 laboratory findings that, in the opinion of the Investigator, might jeopardize the
 patient's safety or decrease the chance of obtaining satisfactory data needed to
 achieve the objective(s) of the study,

 -  The patient has undergone pituitary surgery or pituitary radiotherapy prior to study
 entry,

 -  The patient has previously been treated with a somatostatin analogue,

 -  The patient has received a dopamine agonist or a GH receptor antagonist (pegvisomant)
 prior to study entry,

 -  The patient is expected to require pituitary surgery (adenomectomy) or to receive
 radiotherapy during the study period,

 -  Patients with suspected associated prolactinoma: prolactin level > 100 ng/mL (central
 laboratory results),

 -  Patient is allergic to Gadolinium (MRI contrast agent) or has acute or chronic severe
 renal insufficiency (glomerular filtration rate <30 mL/min/1.73m2),

 -  Patient known by Investigator, to have congenital or acquired optic nerve disease or
 any visual abnormality with risk of worsening during the course of the study (e.g
 glaucoma), influencing ability to evaluate Visual Field changes related to the
 macroadenoma.