Recombinant Human Prolactin for Lactation Induction

This study has been completed.
Information provided by (Responsible Party):
Corrine Welt, Massachusetts General Hospital Identifier:
First received: September 9, 2005
Last updated: May 7, 2013
Last verified: May 2013

The purpose of the study is to assess the safety and determine the effects of the hormone prolactin on lactation (breast milk production).

Condition Intervention Phase
Drug: Recombinant Human Prolactin
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Recombinant Human Prolactin for Lactation Induction in Prolactin Deficient Mothers

Resource links provided by NLM:

Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Breast Milk Production [ Time Frame: 28 days ] [ Designated as safety issue: No ]
    Treatment group

Secondary Outcome Measures:
  • Breast Milk Volume [ Time Frame: 28 days ] [ Designated as safety issue: No ]
    Treatment group

  • Breast Milk Prolactin Levels and Content [ Time Frame: 28 days ] [ Designated as safety issue: No ]
    Treatment group

Enrollment: 6
Study Start Date: January 2005
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: recombinant human prolactin treatment
Open label twice daily recombinant human prolactin
Drug: Recombinant Human Prolactin

  Show Detailed Description


Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Healthy women, aged 18-45 years
  • Prolactin deficiency due to congenital deficiency, surgery or radiation, or Sheehan's syndrome during the current or previous pregnancies, for women who desire to breastfeed their infants.
  • Postpartum at the time of study participation
  • Milk must fail to come in by 2-4 days after delivery.
  • Prolactin levels will be less than the lower limit of normal for the assay performed. If a subject is postpartum, prolactin levels will be less than the normal range for postpartum women (<= 138.0 ± 11.9 ng/mL).
  • Free T4 index must be normal either on or off thyroid hormone replacement.
  • Fasting am cortisol or 1 hour Cortrosyn 0.25 mg stimulated cortisol must be normal (>18 mg/dL). If it is not normal, subjects must be on glucocorticoid replacement and have no symptoms of adrenal insufficiency.
  • History of normal spontaneous puberty or Tanner stage V breast development after previous estrogen replacement therapy.

Exclusion Criteria:

  • Current use of medications known to increase or decrease prolactin
  • Anatomical breast abnormalities
  • Previous mammoplasty
  • Breast augmentation
  • Current use of hormonal contraception
  • Allergies to mannitol
  • Medications contraindicated for breastfeeding mothers
  Contacts and Locations
Please refer to this study by its identifier: NCT00181623

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

No publications provided by Massachusetts General Hospital

Additional publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Corrine Welt, Associate Professor of Medicine, Massachusetts General Hospital Identifier: NCT00181623     History of Changes
Other Study ID Numbers: 2003P001209-1
Study First Received: September 9, 2005
Results First Received: February 5, 2013
Last Updated: May 7, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Massachusetts General Hospital:
Primary lactation insufficiency processed this record on April 17, 2014