• Galactorrhea
  

• Bone Turnover-deoxypyridinoline, N-telopeptide, bone specific Alkaline Phosphatase
  
• Menstrual cycle length
  
• Reproductive hormones-LH, FSH, Estradiol
  

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.