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

Study Overview
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Brief Summary
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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.

Official Title
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Observational, Multicenter, Cross-sectional, Observational Study to Evaluate the Effectiveness in Routine Clinical Practice of Lanreotide Autogel 120 mg at Extended Dosing Intervals (>4 Weeks) for the Treatment of Acromegaly: SOMACROL Study.

Conditions
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Acromegaly

Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of subjects with a normal Insulin-like Growth Factor 1 (IGF-1) level in the assay before the study visit. |  | Day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of subjects with Growth hormone (GH) levels ≤ 2.5 ng/mL or ≤ 1 ng/mL in the assay before the study visit. |  | Day 1 | 
| Percentage of subjects treated with lanreotide autogel (ATG) 120 mg for ≥ 6 months with dosing intervals of five, six, seven or eight weeks. |  | Day 1 | 
| Percentage of subjects whose dosing regimen has been changed in the six months before the study. |  | Day 1 | 
| Preference for self-administered injections or administration in an outpatient clinic by a medical professional. |  | Day 1 | 
| Acromegaly Quality of Life Questionnaire (AcroQoL) in subjects after ≥ 5 months of treatment with ATG 120 mg at extended dosing intervals. | Total score and score per domain | Day 1 | 
| EuroQol-5D (EQ-5D) questionnaire in subjects after ≥ 5 months of treatment with ATG 120 mg at extended dosing intervals. | Total score and score per domain | Day 1 | 
| Treatment Satisfaction Questionnaire for Medication-9 (TSMQ-9) in subjects treated with ATG 120 mg at extended dosing intervals after ≥ 5 months. | Total score and score per domain | Day 1 | 
| Variations between theoretical and real treatment compliance for non-medical reasons. |  | Day 1 |