Phase 2
N=11
Recombinant Human Prolactin for Lactation Induction
Lactation
Bottom Line
View on ClinicalTrials.gov: NCT00181610 ↗Enrolled (actual)
11
Serious AEs
0.0%
Results posted
May 2013
Primary outcome: Primary: Change in Breast Milk Volume Baseline to 7 Days — -12; 429; 44 % change from baseline
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Recombinant Human Prolactin (Drug); Recombinant human prolactin (Biological); Normal Saline (Biological)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Massachusetts General Hospital
- Primary completion
- Sep 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Breast Milk Volume Baseline to 7 Days |
-12; 429; 44 | — |
| SECONDARY Breast Milk Prolactin Levels |
60; 118; 118 | — |
Summary
The purpose of the study is to assess the safety and determine the effects of the hormone prolactin on lactation (breast milk production).
Eligibility Criteria
Inclusion Criteria
- Healthy women, aged 18-45 years
- Lactation insufficiency postpartum
- Subjects will be women with children in the neonatal Intensive Care Unit (ICU) who are pumping breast milk for their infant's nutritional support and to maintain their milk supply.
- Subjects will have given birth at a gestational age of at least 24 weeks, and will generally be recruited 4-8 weeks postpartum.
Exclusion Criteria
- Medications known to increase prolactin
- Anatomical breast abnormalities
- Use of medication contraindicated in breastfeeding mothers
- Allergies to mannitol
- Current use of hormonal contraception
- Previous mammoplasty or breast augmentation, unless they have successfully nursed an infant for 3 months in the past without requiring supplemental formula.
Data sourced from ClinicalTrials.gov (NCT00181610). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.