Short and Long Term Efficacy of Combined Cabergoline and Octreotide Treatment in Acromegalic Patients

In acromegaly, nearly 40% of patients fail to control GH/IGF-I levels with somatostatin analogues (SA). Dopaminergic agonists (DA) are even less effective, but combination therapy with SA and DA normalizes IGF-I levels in 33-56% of patients in short-term studies. This study was designed to evaluate short and long term efficacy of cabergoline in controlling IGF-I levels in acromegalic patients receiving octreotide.

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Key information

Conditions

Acromegaly Bone Diseases Bone Diseases, Endocrine Brain Diseases Central Nervous System Diseases Endocrine System Diseases Hyperpituitarism Hypothalamic Diseases Musculoskeletal Diseases Nervous System Diseases Pituitary Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Federal University of Sao Paulo

São Paulo, 04039030, Brazil

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Active disease, under octreotide treatment at least 9 months

Exclusion criteria

Cabergoline allergy

Treatment and study plan

cabergoline

Drug

cabergoline doses were increased at 6-week intervals, starting at 1.0mg/week followed by 2.0 and 3.5mg/week. Hormonal evaluations (IGF-I, GH and PRL) started before the first dose and were repeated at 6-week intervals after each cabergoline dose and after cabergoline withdrawal

Other names: cabergoline-Dostinex

Primary outcomes

Control of IGF-I levels

Time frame: six months

Secondary outcomes

control IGI-I levels

Time frame: six months

Sponsors and collaborators

Lead sponsor

Federal University of São Paulo

Other

Registry information

Official study title

Short and Long Term Efficacy of Combined Treatment in Controlling IGI-I Levels in Acromegaly

Important dates

Study start: 2005
Primary completion: 2007
Study completion: 2008
First posted: Nov 17, 2009
Registry last updated: Nov 17, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed