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We examined the biological activity of recombinant human prolactin (r-hPRL) as preliminary data for its use to augment lactation.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>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.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Prolactin levels increased during r-hPRL administration (20.0 \u00b1 2.8 to 231.7 \u00b1 48.9 \u03bcg\/L at 6 hours; p &lt; 0.05). Five of nine participants who received r-hPRL developed expressible galactorrhea (p &lt; 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.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>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.<\/jats:p><\/jats:sec><jats:sec><jats:title>Trial registration<\/jats:title><jats:p>Clinical Trials.gov NCT00438490<\/jats:p><\/jats:sec>","DOI":"10.1186\/1746-4358-2-10","type":"journal-article","created":{"date-parts":[[2007,7,24]],"date-time":"2007-07-24T18:13:55Z","timestamp":1185300835000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":6,"title":["Short-term prolactin administration causes expressible galactorrhea but does not affect bone turnover: pilot data for a new lactation agent"],"prefix":"10.1186","volume":"2","author":[{"given":"Gabrielle","family":"Page-Wilson","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Patricia C","family":"Smith","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Corrine K","family":"Welt","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"297","published-online":{"date-parts":[[2007,7,24]]},"reference":[{"key":"39_CR1","doi-asserted-by":"crossref","unstructured":"Breastfeeding and the use of human milk. 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