Efficacy of Rapid Escalation of Cabergoline in Comparison to Conventional Dosing in Prolactin Secreting Macroadenomas.

Summary

To study the effects of rapid escalation of Cabergoline in comparison to conventional dosing in macroprolactinomas. Rapid escalation of cabergoline may help in earlier normalization of prolactin and shrinkage of tumor mass, and thus decrease the cumulative dose of cabergoline altogether.

Conditions

• Macroprolactinoma

Interventions

DRUG

Cabergoline

In the Conventional escalation group Cabergoline 0.5 mg once a week for 4 weeks and further will be incrementally dose adjusted on the basis of individual PRL values until amelioration of hyper prolactinemia @ 0.5 mg/wk every 4 weeks, till 24 weeks or until primary endpoint. Cabergoline will be maintained at the dose at which PRL will be first normalized till primary end point.

DRUG

cabergoline

In the Rapid escalation group schedule of cabergoline dosing will be as follows: Begin with 0.5 mg twice a week 1. mg twice a week - second week 1.5 mg twice a week - third week 2. mg twice a week - fourth week 4mg/wk would be continued for next 4 weeks. If prolactin does not normalize by 8 weeks, a repeat hike in dose of 1mg/wk will be done every 4 weekly until normalization of prolactin levels and also \>50% decrease in tumor volume. Ceiling dose of Cabergoline will be 12mg/wk.

Sponsors & Collaborators

• Post Graduate Institute of Medical Education and Research, Chandigarh

  lead OTHER

Principal Investigators

• Anil Bhansali, MD DM · Post Graduate Institute of Medical Education and Research, Chandigarh

• Pinaki Dutta, MD DM · Post Graduate Institute of Medical Education and Research, Chandigarh

• Rama Walia, MD DM · Post Graduate Institute of Medical Education and Research, Chandigarh

• Paramjeet Singh, MD · Post Graduate Institute of Medical Education and Research, Chandigarh

• Vishali Gupta, MS · Post Graduate Institute of Medical Education and Research, Chandigarh

• Rajesh Vijaiwergiya, MD DM · Post Graduate Institute of Medical Education and Research, Chandigarh

• Ashu Rastogi, MD · Post Graduate Institute of Medical Education and Research, Chandigarh

• Naresh Sachdeva, PhD · Post Graduate Institute of Medical Education and Research, Chandigarh

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2010-05-31

Primary Completion

2011-12-31

Completion

2012-03-31

Countries

• India

Study Locations