The Safety and Efficacy of Recombinant Human Prolactin

Phase 2

Completed

• Conditions: Healthy
• Interventions: Drug: Recombinant Human Prolactin

• Registration Number: NCT00438490
• Lead Sponsor: Massachusetts General Hospital

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2002-04
• Study First Submitted: 2007-02-20
• Study First Submitted QC: 2007-02-21
• Study First Posted: 2007-02-22
• Primary Completion: 2011-03
• Study Completion: 2011-03
• Results First Submitted: 2013-02-05
• Results First Submitted QC: 2013-03-10
• Results First Posted: 2013-04-18
• Status Verified: 2017-12
• Last Update Submitted: 2017-12-31
• Last Update Posted: 2018-01-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 21

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
recombinant human prolactin	Recombinant Human Prolactin	Recombinant Human Prolactin 60 mcg/kg once daily subcutaneous injection
Placebo	Recombinant Human Prolactin	Normal saline placebo subcutaneous injection

Primary Outcome Measures

Name	Time	Method
Galactorrhea	7 days	Galactorrhea is breast milk production.

Secondary Outcome Measures

Name	Time	Method
Menstrual Cycle Length	28 days
N-telopeptide	7 days
Estradiol	7 days

Trial Locations

Locations (1)

Corrine Welt; 🇺🇸 Boston, Massachusetts, United States