Non Interventional Post Marketing Programme in Acromegaly
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The purpose of this study, is to assess the safety and local tolerability of the long-term use of Somatuline Autogel when administered by patients or their partners ("Home Injection Group") and the safety and local tolerability in patients receiving their injection from a healthcare professional (HCP) ("Reference Group").
An Observational, Multicentre, Open Label, Non Interventional Programme to Assess the Long-term Safety and Efficacy of Somatuline® Autogel® in the Treatment of Acromegaly When Administered by Patients or Their Partners ("Home Injection Group") or Administered by Healthcare Professionals.
Study Start Date
Actual Primary Completion Date
Actual Study Completion Date
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Ages Eligible for Study:
18 Years and older (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Patients with Acromegaly seen in routine clinic
The patient must give written (personally signed and dated) informed consent for their data to be included in the database for this post-marketing surveillance programme and any subsequent analysis.
The patient must have been receiving treatment with Somatuline Autogel at a stable dose for at least 4 months.
The patient must have a diagnosis of acromegaly.
The patient must be at least 18 years of age.
For patients receiving or intending to receive Somatuline Autogel by home injection:
The patient must be able to store Somatuline Autogel safely in a refrigerator in their own home and either collect it from their general practitioner/pharmacy on a monthly basis, or receive the medication by a home delivery service.
The patient is pregnant or breast-feeding, unless continued treatment with Somatuline Autogel is clearly needed (as determined by the treating clinician).