CompletedPhase 2

The Safety and Efficacy of Recombinant Human Prolactin

United States21 participantsStarted 2002-04

Plain-language 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.

Who can participate

Age range18 Years – 40 Years

SexFEMALE

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Inclusion 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

What they're measuring

Galactorrhea

Timeframe: 7 days

Trial details

NCT IDNCT00438490

SponsorMassachusetts General Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2011-03

Results submitted2013-02-05

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