The Safety and Efficacy of Recombinant Human Prolactin

Mass General Brigham

Status and phase: Completed; Phase 2

Conditions: Healthy

Treatments: Drug: Recombinant Human Prolactin

Study type: Interventional

Funder types: Other

Identifiers

NCT00438490

2001-P-001057

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 21 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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21 participants in 2 patient groups, including a placebo group

recombinant human prolactin

Experimental group

Description:

Recombinant Human Prolactin 60 mcg/kg once daily subcutaneous injection

Treatment:

Drug: Recombinant Human Prolactin

Placebo

Placebo Comparator group

Description:

Normal saline placebo subcutaneous injection

Treatment:

Drug: Recombinant Human Prolactin