Clinical Trial: The Safety and Efficacy of Recombinant Human Prolactin
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Phase 2 Study of Recombinant Human Prolactin Efficacy and Safety
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 Summary: 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.
Sponsor: Massachusetts General Hospital
Current Primary Outcome: Galactorrhea [ Time Frame: 7 days ]
Original Primary Outcome: Galactorrhea
Current Secondary Outcome:
- Bone Turnover-deoxypyridinoline, N-telopeptide, Bone Specific Alkaline Phosphatase [ Time Frame: 7 days ]
- Menstrual Cycle Length [ Time Frame: 28 days ]
- Reproductive Hormones-LH, FSH, Estradiol [ Time Frame: 7 days ]
Original Secondary Outcome:
- Bone Turnover-deoxypyridinoline, N-telopeptide, Bone Specific Alkaline Phosphatase
- Menstrual Cycle Length
- Reproductive Hormones-LH, FSH, Estradiol
Information By: Massachusetts General Hospital
Dates:
Date Received: February 20, 2007
Date Started: April 2002
Date Completion:
Last Updated: April 17, 2013
Last Verified: April 2013