Recombinant Human Prolactin for Lactation Induction (NCT00181610) | Clinical Trial Compass
CompletedPhase 2
Recombinant Human Prolactin for Lactation Induction
United States11 participantsStarted 2004-09
Plain-language summary
The purpose of the study is to assess the safety and determine the effects of the hormone prolactin on lactation (breast milk production).
Who can participate
Age range18 Years – 45 Years
SexFEMALE
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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.