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CompletedNCT02807233SOMACROLUpdated Aug 5, 2019

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

An observational study in Acromegaly, sponsored by Ipsen. Completed at 39 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-08-05.

Sponsored by Ipsen · Observational

Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
115
Ages
18 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Acromegaly

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03

In context

Acromegaly

203 studies on the registry are indexed under Acromegaly; 19 are open to participants now.

This study's enrollment of 115 is above the median of 100 across 81 observational studies indexed under Acromegaly.

Browse Acromegaly studies →

Lead sponsor

Ipsen is the lead sponsor of 288 studies on the registry; 16 are open to participants now.

Of its 26 completed or terminated interventional studies of FDA-regulated products, 21 (81%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Hospital patients

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
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Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
115 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Percentage of subjects with a normal Insulin-like Growth Factor 1 (IGF-1) level in the assay before the study visit.

    Time frame: Day 1

Secondary outcomes

  1. Percentage of subjects with Growth hormone (GH) levels ≤ 2.5 ng/mL or ≤ 1 ng/mL in the assay before the study visit.

    Time frame: Day 1

  2. Percentage of subjects treated with lanreotide autogel (ATG) 120 mg for ≥ 6 months with dosing intervals of five, six, seven or eight weeks.

    Time frame: Day 1

  3. Percentage of subjects whose dosing regimen has been changed in the six months before the study.

    Time frame: Day 1

  4. Preference for self-administered injections or administration in an outpatient clinic by a medical professional.

    Time frame: Day 1

  5. 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

    Time frame: Day 1

  6. 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

    Time frame: Day 1

  7. 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

    Time frame: Day 1

  8. Variations between theoretical and real treatment compliance for non-medical reasons.

    Time frame: Day 1

07

Study locations

39 sites
  • Hospital de Santa Maria
    Lisbon, 1649-035, Portugal
  • Centro Hospitalar Sao Jöao
    Porto, 4200-319, Portugal
  • Hospital Univ. Nuestra Sra. Candelaria
    Santa Cruz, Tenerife 38010, Spain
  • Complejo Hospitalario Univ. A Coruña
    A Coruña, 15006, Spain
  • Hospital Univ. Príncipe de Asturias
    Alcalá de Henares, 28805, Spain
  • Hospital General Univ. de Alicante
    Alicante, 03010, Spain
  • Hospital Univ. La Ribera
    Alzira, 46600, Spain
  • Hospital Infanta Cristina
    Badajoz, 06006, Spain
  • Hospital Cruces
    Barakaldo, 48903, Spain
  • Hospital Puerta del Mar
    Cadiz, 11009, Spain
  • Hospital Ciudad Real
    Ciudad Real, 13005, Spain
  • Hospital Reina Sofía
    Córdoba, 14004, Spain
  • Hospital de Getafe
    Getafe, 28905, Spain
  • Hospital Univ. Girona Dr. Josep Trueta
    Girona, 17007, Spain
  • Hospital de Jaén
    Jaén, 23005, Spain
  • Hospital Bellvitge
    L'Hospitalet de Llobregat, 08907, Spain
  • Hospital Univ. León
    León, 24001, Spain
  • Hospital Arnau de Vilanova
    Lleida, 25198, Spain
  • Hospital La Princesa
    Madrid, 28006, Spain
  • Hospital Gregorio Marañón
    Madrid, 28007, Spain
  • Hospital La Paz
    Madrid, 28046, Spain
  • Hospital Univv. La Paz
    Madrid, 28046, Spain
  • Hospital Puerta del Hierro
    Madrid, 28222, Spain
  • Hospital Civil de Málaga
    Málaga, 29009, Spain
  • Hospital Virgen de la Victoria
    Málaga, 29010, Spain
  • Hospital Univ. Central de Asturias
    Oviedo, 33011, Spain
  • Hospital Univ. Son Espases
    Palma, 07120, Spain
  • Corporacio Sanitaria Parc Tauli
    Sabadell, 08208, Spain
  • Hospital Infanta Sofía
    San Sebastián de los Reyes, 28702, Spain
  • Hospital Clínico Univ. Santiago
    Santiago de Compostela, 15706, Spain
  • Hospital Virgen del Rocío
    Seville, 41013, Spain
  • Hospital Univ. Alava
    Terrassa, 08221, Spain
  • Hospital Univ. Mutua de Terrassa
    Terrassa, 08221, Spain
  • Hospital Obispo Polanco
    Teruel, 44002, Spain
  • Hospital Virgen de la Salud
    Toledo, 45005, Spain
  • Hospital Clínico de Valencia
    Valencia, 46010, Spain
  • Hospital Univ. La Fe
    Valencia, 46026, Spain
  • Hospital Clínico Univ. Valladolid
    Valladolid, 47003, Spain
  • Hospital Miguel Servet
    Zaragoza, 50009, Spain
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 5, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02807233
Lead sponsor
Ipsen
Responsible party
Sponsor
First posted
Jun 21, 2016
Start date
Jul 2016
Primary completion
Sep 2017
Completion
Sep 2017
Last update
Aug 5, 2019

Study contacts

Ipsen Medical Director
study director · Ipsen

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.

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