Study of Cabergoline in Treatment of Corticotroph Pituitary Tumor

This study was designed to check the efficacy of a new oral medical drug treatment, namely Cabergoline, for the treatment of Cushing Disease due to pituitary adenoma.

Background: Cabergoline is a Dopamine 2 receptor agonist. Corticotroph adenoma has shown to have the D2 receptor in in vitro studies.

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Key information

Conditions

Cushing's Disease ACTH-Secreting Pituitary Adenoma Adenoma Brain Diseases Central Nervous System Diseases Corticotroph Adenoma Endocrine Gland Neoplasms Endocrine System Diseases Hyperpituitarism Hypothalamic Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Nervous System Diseases Pituitary ACTH Hypersecretion Pituitary Diseases Pituitary Neoplasms

Age range

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Seth GSMC & KEM hospital

Mumbai, Maharashtra, 4000012, India

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Patient with Cushing's disease uncured biochemically after pituitary surgery with adenoma on histopathology

Exclusion criteria

Patient's intolerance to drug or known sensitivity to ergot derivatives
Pregnancy, lactation or female wishing to be pregnant
Any serious medical illness
Patient on any drugs known to have an interaction with cabergoline including antihypertensives like reserpine and methyl dopa, neuroleptics, metoclopramide, etc

Treatment and study plan

cabergoline

Drug

Dose 1 mg/week in divided doses, increased by 1 mg/week every month, to the maximum of 5 mg/week. If response is seen than the dose at which response is seen is continued until the end of the study.

Primary outcomes

Response in term of mid night cortisol < 5.0 mcg/dl and/or Standard two day dexamethasone suppression test < 1.8 mcg/dl

Sponsors and collaborators

Lead sponsor

Seth Gordhandas Sunderdas Medical College

Other

Registry information

Important dates

Study start: 2007
First posted: Apr 29, 2009
Registry last updated: Apr 29, 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