Efficacy of Rapid Escalation of Cabergoline in Comparison to Conventional Dosing in Prolactin Secreting Macroadenomas.
Information source: Postgraduate Institute of Medical Education and Research
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Macroprolactinoma
Intervention: Cabergoline (Drug); cabergoline (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: Postgraduate Institute of Medical Education and Research Official(s) and/or principal investigator(s):
Anil Bhansali, MD DM, Study Chair, Affiliation: Postgraduate Institute of Medical Education and Research
Pinaki Dutta, MD DM, Principal Investigator, Affiliation: Postgraduate Institute of Medical Education and Research
Rama Walia, MD DM, Principal Investigator, Affiliation: Postgraduate Institute of Medical Education and Research
Paramjeet Singh, MD, Principal Investigator, Affiliation: Postgraduate Institute of Medical Education and Research
Vishali Gupta, MS, Principal Investigator, Affiliation: Postgraduate Institute of Medical Education and Research
Rajesh Vijaiwergiya, MD DM, Principal Investigator, Affiliation: Postgraduate Institute of Medical Education and Research
Ashu Rastogi, MD, Principal Investigator, Affiliation: Postgraduate Institute of Medical Education and Research
Naresh Sachdeva, PhD, Principal Investigator, Affiliation: Postgraduate Institute of Medical Education and Research
Overall contact:
Anil Bhansali, MD DM, Phone: 2756583, Email: anilbhansali_endocrine@rediffmail.com
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.
Clinical Details
Official title: Efficacy of Rapid Escalation of Cabergoline in Comparison to Conventional Dosing in Prolactin Secreting Macroadenomas.
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Normoprolactinemia
Secondary outcome: Duration for resolution of Hypogonadism
Detailed description:
The efficacy of cabergoline is dose related and determined by percentage of Dopamine 2
receptor occupancy and prolonged receptor affinity. Activation of membrane receptors and
target cell responses is proportional to the degree of receptor occupancy. Greater the drug
concentration, greater is the binding and receptor occupancy and greater is the efficacy of
the drug. Receptor occupancy can be increased either by using high dose of cabergoline or by
rapid escalation of cabergoline. The patients, who respond to increasing dosages of
cabergoline, probably do so by increased receptor occupancy with higher doses.
Rapid escalation of doses of cabergoline is another approach to increase the drug
concentration and increase the occupancy of the receptor. Earlier decrease in serum
prolactin levels with rapid escalation may help in reducing the cumulative dose of
cabergoline and total duration of treatment. Though studies with high doses of cabergoline
have been performed in prolactinomas with normalization of prolactin levels in almost 100%,
but systematic studies using rapid escalation of cabergoline in prolactinomas are lacking
except the one by Bhansali et al. In their study, serum prolactin became normal in 93 per
cent of the patients with a mean duration of 8. 2 wk. The mean decrease in serum prolactin
was 99 per cent by four weeks, however a similar decrease (93 to 99%) in prolactin was
achieved in other studies with a time lag of 48 to 160 wk. This supports the notion that
rapid hike in doses of cabergoline decreases serum prolactin levels faster and it becomes
normal in the majority of patients earlier6. However it was an uncontrolled study with
limited number of subjects.
Therefore present study was planned to study the efficacy of rapid escalation of Cabergoline
versus conventional dosing in patients with macroprolactinomas. Rapid escalation of
cabergoline dose may help in earlier normalization of prolactin and shrinkage of tumor mass,
and thus decrease the cumulative dose of cabergoline altogether.
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
Males or females presenting with
1. Prolactin secreting macroadenomas (≥10 mm maximum diameter)
2. With/without visual complaints
3. With /without parasellar or suprasellar extension
4. Treatment Naïve
Exclusion Criteria:
1. On treatment with dopamine agonists.
2. Taking other drugs influencing prolactin Levels.
3. Systemic disease like Chronic Kidney Disease, Chronic Lung Disease
4. Other secondary causes of hyperprolactinemia.
5. Prolactin secreting microadenomas
6. Pregnancy during follow up
7. Prolactinoma as part of MEN-1 Syndrome
8. History suggestive of recent apoplexy (3 months)
9. Contraindication to cabergoline therapy like pre existing psychosis.
Locations and Contacts
Anil Bhansali, MD DM, Phone: 2756583, Email: anilbhansali_endocrine@rediffmail.com
Postgraduate Institute of Medical Education and Research, Chandigarh 1700112, India; Recruiting
Anil Bhansali, MD DM, Phone: 2756583, Email: anilbhansali_endocrine@rediffmail.com
Ashu Rastogi, MD, Phone: 09781001046, Email: drpaed@rediffmail.com
Anil Bhansali, MD DM, Principal Investigator
Additional Information
Starting date: May 2010
Last updated: June 11, 2010
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