Study of Cabergoline in Treatment of Corticotroph Pituitary Tumor

Phase 3

Completed

• Conditions: Cushing's Disease; Corticotroph Adenoma
• Interventions: Drug: Cabergoline

• Registration Number: NCT00889525
• Lead Sponsor: Seth Gordhandas Sunderdas Medical College

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-11
• Status Verified: 2009-04
• Study First Submitted: 2009-04-27
• Study First Submitted QC: 2009-04-28
• Last Update Submitted: 2009-04-28
• Study First Posted: 2009-04-29
• Last Update Posted: 2009-04-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cabergoline	Cabergoline	-

Primary Outcome Measures

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

Trial Locations

Locations (1)

Seth GSMC & KEM hospital; 🇮🇳 Mumbai, Maharashtra, India