Lanreotide Autogel 120 mg at Extended Dosing Intervals (>4 Weeks) in Acromegalic Subjects (SOMACROL)

Ipsen

Status: Completed

Conditions: Acromegaly

Study type: Observational

Funder types: Industry

Identifiers

NCT02807233

A-ES-52030-352

IPS-SOM-2015-01 (Other Identifier)

Details and patient eligibility

About

The purpose of this study is to evaluate the effectiveness in IGF-1 control of lanreotide Autogel (ATG) 120 mg at extended dosing intervals (EDIs) (>4 weeks) in subjects with acromegaly in daily clinical practice.

Enrollment: 115 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Men or women aged ≥ 18 years
• Diagnosed with acromegaly
• Receiving treatment with ATG 120 mg at extended dosing intervals (> 4 weeks) for at least six months before the study visit.
• Assay data (blood GH and IGF-1 levels) from immediately before the study visit (performed at least six months after starting the treatment) is available.
• Able to sign the informed consent form for study participation.

Exclusion criteria

• Received radiation therapy treatment in the last six months.
• Active participation in another clinical study.
• Physical or mental disorders that, in the investigator's opinion, could affect their ability to sign the informed consent form.
• Pregnancy or breastfeeding for female patients.
• No data in their medical records on the treatment start date for ATG 120 mg at extended dosing intervals or on changes to the schedule of administration over the last six months.