The Safety and Efficacy of Recombinant Human Prolactin

December 31, 2017 updated by: Corrine Welt, Massachusetts General Hospital

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 Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

21

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Corrine Welt

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: recombinant human prolactin
Recombinant Human Prolactin 60 mcg/kg once daily subcutaneous injection
Drug: Recombinant Human Prolactin
Placebo Comparator: Placebo
Normal saline placebo subcutaneous injection
Drug: Recombinant Human Prolactin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Galactorrhea
Time Frame: 7 days
Galactorrhea is breast milk production.
7 days

Secondary Outcome Measures

Outcome Measure
Time Frame
N-telopeptide
Time Frame: 7 days
7 days
Menstrual Cycle Length
Time Frame: 28 days
28 days
Estradiol
Time Frame: 7 days
7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Massachusetts General Hospital

Investigators

  • Principal Investigator: Corrine K. Welt, MD, Massachusetts General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2002

Primary Completion (Actual)

March 1, 2011

Study Completion (Actual)

March 1, 2011

Study Registration Dates

First Submitted

February 20, 2007

First Submitted That Met QC Criteria

February 21, 2007

First Posted (Estimate)

February 22, 2007

Study Record Updates

Last Update Posted (Actual)

January 3, 2018

Last Update Submitted That Met QC Criteria

December 31, 2017

Last Verified

December 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2001-P-001057

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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