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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
Lactation Drug: Recombinant Human Prolactin Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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 Corrine Welt, Massachusetts General Hospital:

Primary Outcome Measures:
  • Breast Milk Production [ Time Frame: 28 days ]
    Treatment group

Secondary Outcome Measures:
  • Breast Milk Volume [ Time Frame: 28 days ]
    Treatment group

  • Breast Milk Prolactin Levels and Content [ Time Frame: 28 days ]
    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   (Adult)
Sexes 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

Keywords provided by Corrine Welt, Massachusetts General Hospital:
Primary lactation insufficiency processed this record on September 21, 2017