CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 21 enrolled
Drug / intervention
Recombinant Human Prolactindrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00438490
NCT00438490Phase 2Completed

Phase 2 Study of Recombinant Human Prolactin Efficacy and Safety

Massachusetts General Hospital·interventional·Posted Feb 22, 2007·Updated Jan 3, 2018

In Brief

A Phase 2 clinical trial evaluating Recombinant Human Prolactin for Healthy. Completed, enrolled 21 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 22, 2007
Enrollment StartApr 1, 2002
Primary CompletionMar 1, 2011
TodayJul 2, 2026
Enrollment to primary: 8.9 yearsPosted 19.4 years ago

Interventions

Recombinant Human Prolactindrug