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Recombinant Human Prolactin for Lactation Induction

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.
ClinicalTrials.gov Identifier: NCT00181623
Recruitment Status : Completed
First Posted : September 16, 2005
Results First Posted : May 9, 2013
Last Update Posted : December 11, 2017
Sponsor:
Information provided by (Responsible Party):
Corrine Welt, Massachusetts General Hospital

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

Condition or disease Intervention/treatment Phase
Lactation Drug: Recombinant Human Prolactin Phase 2

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
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
Study Start Date : January 2005
Primary Completion Date : May 2011
Study Completion Date : May 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breastfeeding
Drug Information available for: Prolactin
U.S. FDA Resources

Arm Intervention/treatment
Experimental: recombinant human prolactin treatment
Open label twice daily recombinant human prolactin
Drug: Recombinant Human Prolactin



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


Secondary Outcome Measures :
  1. Breast Milk Prolactin Levels [ Time Frame: 28 days ]
    Treatment group



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

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

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 Posted: September 16, 2005    Key Record Dates
Results First Posted: May 9, 2013
Last Update Posted: December 11, 2017
Last Verified: December 2017

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