Recombinant Human Prolactin for Lactation Induction

Completed · Phase 2

Conditions studied: Lactation

In brief

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

Key facts

Study ID

NCT00181610

Run by

Massachusetts General Hospital

People needed

11

Starts

2004-09-01

Expected to finish

2010-09-01

Last updated by the study team

2018-01-03

Who can join

Age: 18 and older, up to 45. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Massachusetts General Hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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