The Safety and Efficacy of Recombinant Human Prolactin

• Status: Completed
• Trial end date: 2011-03-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Massachusetts General Hospital

Criteria

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.