Official Title: “Phase 2 Study of Recombinant Human Prolactin Efficacy and Safety”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

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.

Intervention(s) in this Clinical Trial

• Drug: Recombinant Human Prolactin

Primary Measures

• Galactorrhea

Secondary Measures

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

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.

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 40 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: Massachusetts General Hospital

Overall Clinical Trial Officials and Contacts

Corrine K. Welt, MD Principal Investigator Massachusetts General Hospital  

Information obtained from ClinicalTrials.gov on November 19, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00438490

Study ID Number: 2001-P-001057

ClinicalTrials.gov Identifier: NCT00438490

Health Authority: United States: Food and Drug Administration