title: Short-term prolactin administration causes expressible galactorrhea but does not affect bone turnover: pilot data for a new lactation agent.
abstract: BACKGROUND
  Medications used to augment lactation increase prolactin secretion but can have intolerable side effects. We examined the biological activity of recombinant human prolactin (r-hPRL) as preliminary data for its use to augment lactation.
  
  
  METHODS
  Healthy, non-postpartum women (n = 21) with regular menstrual cycles underwent a seven day randomized, double-blind, placebo-controlled trial of r-hPRL. Expressible galactorrhea, markers of bone turnover, calcium homeostasis and gonadal function were measured and side effects recorded.
  
  
  RESULTS
  Prolactin levels increased during r-hPRL administration (20.0 +/- 2.8 to 231.7 +/- 48.9 microg/L at 6 hours; p < 0.05). Five of nine participants who received r-hPRL developed expressible galactorrhea (p < 0.001). Urinary deoxypyridinoline decreased and bone specific alkaline phosphatase increased in r-hPRL and placebo groups. Menstrual cycle lengths were not altered and side effects were similar between r-hPRL and placebo groups.
  
  
  CONCLUSIONS
  In summary, r-hPRL can cause expressible galactorrhea. Seven days of r-hPRL administration does not adversely affect bone turnover or menstrual cyclicity. Thus, r-hPRL may be a viable option for short-term lactation augmentation.
  
  
  BACKGROUND
  Clinical Trials.gov NCT00438490.
authors.affiliation: Reproductive Endocrine Unit, Massachusetts General Hospital, Boston, USA. gpagewilson@partners.org
authors.forename: Gabrielle
authors.initials: G
authors.lastname: Page-Wilson
authors.forename: Patricia C
authors.initials: PC
authors.lastname: Smith
authors.forename: Corrine K
authors.initials: CK
authors.lastname: Welt