The Safety and Efficacy of Recombinant Human Prolactin

There are no FDA approved medications in the U.S. to augment lactation. Metoclopramide is used off-label but can have intolerable side effects. We examined the biological activity and safety of recombinant human prolactin (r-hPRL) as preliminary data for its use to augment lactation. Healthy, non-postpartum women (n=21) with regular menstrual cycles underwent a 7 day randomized, double-blind, placebo-controlled trial of r-hPRL. Galactorrhea, markers of bone turnover, calcium homeostasis and gonadal function were measured and side effects recorded.

Inclusion criteria

Healthy Subjects will meet the following criteria:

• 18 to 40 years of age
• Normal weight (BMI 17 to £ 30 kg/m2)
• Good general health
• On no medications for at least 3 months before the study
• Regular menstrual cycles every 25-35 days with ovulation documented by a luteal phase progesterone level
• No evidence of androgen excess
• Normal TSH, prolactin and hematocrit
• No current interest in conception
• No history of osteoporosis
• No use of medications known to affect bone turnover
• No alcoholism
• No smoking
• No history of medical problems or treatment known to affect bone turnover.

Exclusion criteria

Subjects will be excluded for pregnancy or evidence of breast masses.