The Safety and Efficacy of Recombinant Human Prolactin

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.

Inclusion Criteria:

Healthy Subjects will meet the following criteria:

1. 18 to 40 years of age

2. Normal weight (BMI 17 to £ 30 kg/m2)

3. Good general health

4. On no medications for at least 3 months before the study

5. Regular menstrual cycles every 25-35 days with ovulation documented by a luteal phase
progesterone level

6. No evidence of androgen excess

7. Normal TSH, prolactin and hematocrit

8. No current interest in conception

9. No history of osteoporosis

10. No use of medications known to affect bone turnover

11. No alcoholism

12. No smoking

13. No history of medical problems or treatment known to affect bone turnover.

Exclusion Criteria:

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