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Related Experiment Videos

Double blind randomized study using oral or injectable bromocriptine in patients with hyperprolactinaemia

E Ciccarelli1, S Grottoli, C Miola

  • 1Department of Clinical Pathophysiology, University of Turin, Italy.

Clinical Endocrinology
|February 1, 1994
PubMed
Summary

Injectable bromocriptine offers prolonged normoprolactinaemia in hyperprolactinaemia patients compared to oral administration. Both forms showed similar tolerability, but injectable bromocriptine resulted in higher serum drug levels.

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Area of Science:

  • Endocrinology
  • Pharmacology

Background:

  • Hyperprolactinaemia is a condition characterized by elevated prolactin levels.
  • A new long-acting injectable bromocriptine formulation is now available for managing hyperprolactinaemic patients.
  • Evaluating the comparative efficacy and tolerability of injectable versus oral bromocriptine is crucial for treatment optimization.

Purpose of the Study:

  • To compare the efficacy of injectable bromocriptine against its oral form in treating hyperprolactinaemia.
  • To assess the tolerability profiles of both injectable and oral bromocriptine formulations.
  • To evaluate the duration of normoprolactinaemia induced by each administration route.

Main Methods:

  • A double-blind, randomized study design was employed.
  • Patients received either intramuscular bromocriptine injection (50 mg) with oral placebo or oral bromocriptine (7.5 mg daily) with placebo injection for 28 days.

Related Experiment Videos

  • Plasma prolactin (PRL) and serum bromocriptine levels were monitored over 42 days, with tumor imaging (CT/MRI) assessed before and after treatment.

    • Main Results:

    • Both groups achieved significant reductions in PRL levels.
    • Injectable bromocriptine led to more frequent and prolonged normoprolactinaemia compared to oral bromocriptine.
    • Significantly higher serum bromocriptine levels were observed in the injectable group, with no difference in tolerability or side-effect incidence.

    Conclusions:

    • Injectable bromocriptine demonstrates superior efficacy in achieving sustained normoprolactinaemia in hyperprolactinaemic patients.
    • The injectable formulation results in higher systemic bromocriptine exposure.
    • Route of administration does not influence the tolerability of bromocriptine.