The Safety and Efficacy of Recombinant Human Prolactin

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Corrine Welt, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00438490
First received: February 20, 2007
Last updated: April 17, 2013
Last verified: April 2013
  Purpose

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.


Condition Intervention Phase
Healthy
Drug: Recombinant Human Prolactin
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase 2 Study of Recombinant Human Prolactin Efficacy and Safety

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Galactorrhea [ Time Frame: 7 days ] [ Designated as safety issue: No ]
    Galactorrhea is breast milk production.


Secondary Outcome Measures:
  • Bone Turnover-deoxypyridinoline, N-telopeptide, Bone Specific Alkaline Phosphatase [ Time Frame: 7 days ] [ Designated as safety issue: No ]
  • Menstrual Cycle Length [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • Reproductive Hormones-LH, FSH, Estradiol [ Time Frame: 7 days ] [ Designated as safety issue: No ]

Enrollment: 21
Study Start Date: April 2002
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00438490

Locations
United States, Massachusetts
Corrine Welt
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: Corrine K. Welt, MD Massachusetts General Hospital
  More Information

No publications provided

Responsible Party: Corrine Welt, Associate Professor of Medicine, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00438490     History of Changes
Other Study ID Numbers: 2001-P-001057
Study First Received: February 20, 2007
Results First Received: February 5, 2013
Last Updated: April 17, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Massachusetts General Hospital:
galactorrhea
prolactin
bone turnover
menstrual cycle
Control Groups
Women

ClinicalTrials.gov processed this record on April 17, 2014