The Safety and Efficacy of Recombinant Human Prolactin

Completed · Phase 2 · Has a placebo group

Conditions studied: Healthy

In brief

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.

Key facts

Study ID

NCT00438490

Run by

Massachusetts General Hospital

People needed

21

Starts

2002-04-01

Expected to finish

2011-03-01

Last updated by the study team

2018-01-03

Who can join

Age: 18 and older, up to 40. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• Healthy Subjects will meet the following 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
• No history of osteoporosis
• No use of medications known to affect bone turnover
• No alcoholism
• No smoking
• No history of medical problems or treatment known to affect bone turnover.

You may not qualify if…

• Subjects will be excluded for pregnancy or evidence of breast masses.

Where it is running

• Corrine Welt — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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