The Safety and Efficacy of Recombinant Human Prolactin

NCT ID: NCT00438490

Last Updated: 2018-01-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-04-30
• Study Completion Date: 2011-03-31

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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

recombinant human prolactin

Recombinant Human Prolactin 60 mcg/kg once daily subcutaneous injection

Group Type: EXPERIMENTAL

Recombinant Human Prolactin

Intervention Type: DRUG

Placebo

Normal saline placebo subcutaneous injection

Group Type: PLACEBO_COMPARATOR

Recombinant Human Prolactin

Intervention Type: DRUG

Interventions

Recombinant Human Prolactin

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Corrine Welt

Associate Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Corrine K. Welt, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

Corrine Welt

Boston, Massachusetts, United States

Countries

United States

References

Page-Wilson G, Smith PC, Welt CK. Short-term prolactin administration causes expressible galactorrhea but does not affect bone turnover: pilot data for a new lactation agent. Int Breastfeed J. 2007 Jul 24;2:10. doi: 10.1186/1746-4358-2-10.

Reference Type: DERIVED

PMID: 17650319 (View on PubMed)

Other Identifiers

2001-P-001057

Identifier Type: -

Identifier Source: org_study_id