Study of Cabergoline in Treatment of Corticotroph Pituitary Tumor

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)

Interventions

  • Drug: Cabergoline
    • 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.

Arms, Groups and Cohorts

  • Experimental: Cabergoline

Clinical Trial Outcome Measures

Primary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 12 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Seth Gordhandas Sunderdas Medical College
  • Provider of Information About this Clinical Study
    • Dr Nalini S Shah, Seth Gordhandas Sunderdas Medical College& KEM Hospital
  • Overall Official(s)
    • Nalini S Shah, DM, Principal Investigator, Seth GSMC and KEM hospital, Mumbai

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