At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 11 enrolled
Drug / intervention
Recombinant Human Prolactin +2 moredrug
Likely dose
60 mcg/kg intravenously every 12 or 24 hoursAI-extracted
Key inclusion· 4
- ✓Healthy women aged 18–45 years
- ✓Lactation insufficiency postpartum
- ✓Mothers pumping breast milk for premature infants in the NICU
- ✓Given birth at ≥24 weeks gestation, recruited 4–8 weeks postpartum
Key exclusion· 6
- ✕Medications known to increase prolactin
- ✕Anatomical breast abnormalities
- ✕Medications contraindicated in breastfeeding mothers
- ✕Allergy to mannitol
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Recombinant Human Prolactin for Lactation Induction in Mothers of Premature Infants
In Brief
A Phase 2 clinical trial evaluating Recombinant Human Prolactin, Recombinant human prolactin, and 1 other intervention for Lactation. Completed, enrolled 11 participants across 1 site.
Detailed Summary
The purpose of the study is to assess the safety and determine the effects of the hormone prolactin on lactation (breast milk production).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLactation
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartSep 2004
First PostedSep 2005
Primary CompletionSep 2010
TodayJul 2026
First PostedSep 16, 2005
Enrollment StartSep 1, 2004
Primary CompletionSep 1, 2010
TodayJul 2, 2026
Enrollment to primary: 6 yearsPosted 20.8 years ago
Interventions
Recombinant Human Prolactindrug
60 mcg/kg every 12 hours
Recombinant human prolactinbiological
60 mcg/kg given every 12 hours or every 24 hours
Normal Salinebiological
twice per day