Somatuline Autogel: Acromegaly Self/Partner Injection Study

A Phase IV, Multicentre, Open Label, Controlled Study to Assess the Ability of Patients With Acromegaly, or Their Partners, to Administer Somatuline Autogel.

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00149188

Enrollment

Registered

2005-09-08

Start date

2004-02-29

Completion date

2005-08-24

Last updated

2019-08-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acromegaly

Keywords

Growth Hormone

Brief summary

The purpose of this study is to allow patients with acromegaly, or their partners, to learn how to successfully inject Somatuline Autogel at home. Ability to perform unsupervised injections whilst maintaining adequate disease control will be assessed.

Interventions

DRUGLanreotide (Autogel formulation)

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* The patient must have a clinical diagnosis of acromegaly * The patient must have been tested and shown to have a GH level less than or equal to 10 micrograms/L within 28 days prior to the baseline visit * The patient must be currently treated with Somatuline Autogel and have been stable on their current dose for at least 6 months immediately prior to screening * The patient must be able to store study medication in a refrigerator in their own home

Exclusion criteria

* The patient has had pituitary surgery (adenomectomy) within 6 months prior to screening * The patient has received pituitary radiotherapy within one year prior to screening * The patient is likely to require pituitary surgery (adenomectomy) or to receive radiotherapy during the study period * The patient is currently receiving a GH antagonist or a somatostatin analogue other than Somatuline Autogel

Design outcomes

Primary

Measure	Time frame
To assess the ability of patients or their partners to perform unsupervised Somatuline Autogel injections.	—

Secondary

Measure	Time frame
To assess whether administration of unsupervised injections of Somatuline Autogel has any effect on GH and IGF-1 control or serum lanreotide levels.	—
To assess patient/partner and healthcare professional experience with unsupervised injections.	—
To assess the safety of patients or their partners performance of unsupervised Somatuline Autogel injections.	—

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026