Assessment of the Ability of Subjects With Acromegaly or Their Partners to Administer Somatuline Autogel
Condition: Acromegaly
MeSH terms: Acromegaly
Intervention: Somatuline Autogel (lanreotide acetate); Home administration
Intervention description: Injections; Questionnaire
Intervention MeSH terms: Lanreotide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 59.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Acromegaly; Somatostatin Analogs; Somatuline® Autogel®; lanreotide; growth hormone; IGF-1; Inappropriate Growth Hormone Secretion Syndrome; Somatotropin Hypersecretion Syndrome; Inappropriate GH Secretion Syndrome

Summary:

      The purpose of this study is to determine whether subjects with acromegaly (or their
      partners) are able to self administer Somatuline Autogel at home.
    

Eligibility criteria:

        Inclusion Criteria:

          -  The subject must give signed informed consent before any study-related activities.

          -  The partner, if applicable, must give signed informed consent before administration of
             Somatuline Autogel.

          -  The subject must be able to understand the protocol requirements.

          -  The subject must have a clinical diagnosis of acromegaly due to pituitary tumor.

          -  The subject must be treated with a long-acting somatostatin analogue with or without a
             dopamine agonist and have been on the current medical regimen for at least 3 months
             prior to screening and have IGF-1 levels no higher than 10% above the upper limit of
             the normal range for age and gender at the screening visit or be somatostatin analogue
             naïve (if the subject is treated with a dopamine agonist he/she must have been on the
             current dose for at least 3 months prior to screening).

          -  Subjects who are treated with a dopamine agonist have to stay on their current dose
             for the duration of the study.

          -  Switch subjects must have had their last pre-study routine clinical treatment with
             Sandostatin LAR between 28 and 35 days before Visit 2 (enrollment).

          -  The subject must be able to store the study medication in a refrigerator in his/her
             own or his/her partner's home.

          -  The subject must be ≥18 years of age.

          -  Female subjects of childbearing potential must use adequate contraception.

          -  Female subjects of childbearing potential who are taking oral contraceptives must
             agree to stay on their current contraceptive dose for the duration of the study.

          -  The partner, if applicable, must be ≥18 years of age.

        Exclusion Criteria:

          -  The subject has had pituitary surgery (adenomectomy) within 3 months prior to
             screening.

          -  The subject has received pituitary radiotherapy within 3 years prior to screening.

          -  The subject has received a GH receptor antagonist within 6 months prior to screening.

          -  The subject is currently on a higher dose of Sandostatin LAR than 30mg q28d

          -  The subject is pregnant or breastfeeding.

          -  The subject has clinically significant renal or hepatic abnormalities.

          -  The subject has a symptomatic, untreated biliary lithiasis.

          -  The subject has uncontrolled diabetes or thyroid disease.

          -  The subject has a known hypersensitivity to any of the test materials or related
             compounds.

          -  The subject is unable or unwilling to comply with the protocol.

          -  The subject has received any investigational drug within 30 days prior to screening.

          -  The subject has participated in a medical device study within 30 days prior to
             screening.

          -  The subject has previously participated in this study.