The Safety and Efficacy of Recombinant Human Prolactin

Massachusetts General Hospital21 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Healthy

Interventions

Recombinant Human ProlactinDRUG

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 40 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Corrine Welt

Boston, Massachusetts, United States

Outcomes

Primary Outcomes

Galactorrhea

Galactorrhea is breast milk production.

Time frame: 7 days

Secondary Outcomes

N-telopeptide

Time frame: 7 days

Menstrual Cycle Length

Time frame: 28 days

Estradiol

Time frame: 7 days

Data from ClinicalTrials.gov

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