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Recombinant Human Prolactin for Lactation Induction

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00181623
First Posted: September 16, 2005
Last Update Posted: May 9, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Corrine Welt, Massachusetts General Hospital
  Purpose
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00181623


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Corrine Welt, Associate Professor of Medicine, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00181623     History of Changes
Other Study ID Numbers: 2003P001209-1
First Submitted: September 9, 2005
First Posted: September 16, 2005
Results First Submitted: February 5, 2013
Results First Posted: May 9, 2013
Last Update Posted: May 9, 2013
Last Verified: May 2013

Keywords provided by Corrine Welt, Massachusetts General Hospital:
Lactation
Breastfeeding
Prolactin
Primary lactation insufficiency