Phase 2 Completed N=11 Randomized Double-blind Treatment

Recombinant Human Prolactin for Lactation Induction

lactation

Source: ClinicalTrials.gov NCT00181610 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

May 2013

Primary outcomePrimary: Change in Breast Milk Volume Baseline to 7 Days — -12; 429; 44 % change from baseline

Summary

The purpose of the study is to assess the safety and determine the effects of the hormone prolactin on lactation (breast milk production).

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	—

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.

View full record on ClinicalTrials.gov →

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. Informational only — not medical advice.