Conditions: Healthy
Keywords: galactorrhea prolactin bone turnover menstrual cycle Control Groups Women
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 21
Healthy volunteers: yes

Brief summary:
Medications used to increase breast milk production increase prolactin secretion, the main hormone of lactation. There are no FDA approved medications used to improve breast feeding, but metoclopramide is used off-label and can have intolerable side effects. We examined the biological activity and safety of recombinant human prolactin (r-hPRL) as a potential medication to augment lactation. In this study, the effect of r-hPRL on breast milk production in women who did not recently deliver a baby and its effect on the bones and menstrual cycle were tested.

Detailed description:
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.

Arms:
arm 1: Recombinant Human Prolactin 60 mcg/kg once daily subcutaneous injection arm 2: Normal saline placebo subcutaneous injection

Interventions: intervention 1: Recombinant Human Prolactin
Intervention descriptions: intervention 1: None

Protocol document: