drugset / Trial / NCT00438490

The Safety and Efficacy of Recombinant Human Prolactin

NCT00438490 ↗

Phase 2 Completed 21 enrolled Massachusetts General Hospital
RandomizedParallel-groupTriple-blindTreatment

Summary

Medications used to increase breast milk production increase prolactin secretion, the main hormone of lactation. There are no FDA approved medications used to improve breast feeding, but metoclopramide is used off-label and can have intolerable side effects. We examined the biological activity and safety of recombinant human prolactin (r-hPRL) as a potential medication to augment lactation. In this study, the effect of r-hPRL on breast milk production in women who did not recently deliver a baby and its effect on the bones and menstrual cycle were tested.

Timeline

Start
2002-04
Primary completion
2011-03
Completion
2011-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Recombinant Human Prolactin Protein / enzyme biologic 60 ug/kg Subcutaneous

Indications

No indication recorded.