Recombinant Human Prolactin for Lactation Induction

This study has been withdrawn prior to enrollment.
(Not able to recruit any subjects.)
Sponsor:
Information provided by (Responsible Party):
Corrine Welt, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00181649
First received: September 9, 2005
Last updated: May 8, 2013
Last verified: May 2013
  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
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 Adoptive 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 ]

Secondary Outcome Measures:
  • Breast milk volume [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • Breast milk prolactin levels and content [ Time Frame: 28 days ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: September 2006
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 Drug: Recombinant human prolactin

Detailed Description:

Subjects will participate in a randomized, double-blind, placebo-controlled, crossover trial comparing breast pumping, alone, to breast pumping and r-hPRL. Subjects will have one week of instruction with the breast pump alone. Subsequently, subjects will receive 2 weeks of r-hPRL or placebo followed by 2 weeks of the alternate treatment.

Week 1: Study day 1, a baseline prolactin level will be obtained and subjects will be taught to use an electrical, hospital grade breast pump by a designated lactation consultant. Subjects will pump for 10 minutes at each breast. The total volume of milk will be recorded in a diary throughout the study. Prolactin levels will be obtained every 10 minutes for 60 minutes after pumping begins, then every 30 minutes for a total of 3 hours. Subjects will pump 3 times per day increasing to 8 times per day by the end of the first week and will continue this regimen throughout the study.

Week 2: One week after the initial visit, subjects will return to the GCRC for re-evaluation of the pumping technique and the first dose of medication. Subjects will pump for 10 minutes at each breast as on day 1 and prolactin levels will be obtained every 10 minutes for 60 minutes, then every 30 minutes for a total of 3 hours. At 3 hours, r-hPRL 60 mg/kg or placebo will be administered SC. Blood will be drawn every 10 minutes for 60 minutes, every 30 minutes for 2 hours, then at 4, 6 and 8 hours to obtain a peak prolactin level. Vital signs will be monitored every 15 minutes for the first hour, then every 2 hours for a total of 8 hours. Subjects will pump both breasts every 3 hours, starting after the r-hPRL or placebo injection. Subjects will be taught to give themselves SC injections and will administer their second dose of SC r-hPRL or placebo 12 hours after the first dose. Subjects will continue SC r-hPRL or placebo administration every 12 hours for the next 14 days. They will continue to pump daily, approximately every 3 hours, with a 5 hour break in the night to sleep. Subjects will be asked to refrigerate all milk and bring it in to GCRC visits for prolactin levels.

Subjects will return weekly for 4 additional visits (weeks 3, 4, 5, 6). At the weekly visits, blood will be drawn at baseline for a prolactin level and r-hPRL or placebo will be administered. Blood will then be drawn every 10 minutes for 60 minutes, then every 30 minutes for 2 hours, then every 2 hours for a total of 8 hours after the injection. Vital signs will be monitored as described above. At the week 4 visit, subjects will be switched to the alternate treatment for weeks 4 and 5. Subjects will be seen 14 days after their final injection. A baseline prolactin level will be drawn, then milk will be pumped, as previously. Blood will be drawn every 10 minutes for 60 minutes, then every 30 minutes for a total of 3 hours. A 1 cc sample of the milk will also be obtained 14 days after the final injection for analysis of composition. All side effects of r-hPRL will be recorded throughout the study. All milk obtained during the study will be stored and the milk composition will be determined before it is used. Infants receiving milk produced during the study will initially be monitored in the GCRC under the supervision of a neonatologist.

  Eligibility

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

Inclusion Criteria:

  • Healthy, non-postpartum women, aged 18-45 years, who desire to lactate for their adoptive children
  • Normal thyroid-stimulating hormone (TSH) and prolactin level
  • Normal adrenal gland function or taking physiological glucocorticoid replacement
  • No medical illnesses that contraindicate breastfeeding
  • HIV negative
  • Normal breast development

Exclusion Criteria:

  • Use of medications known to increase prolactin
  • Anatomical breast abnormalities
  • Previous mammoplasty or 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 ClinicalTrials.gov identifier: NCT00181649

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:
Responsible Party: Corrine Welt, Associate Professor of Medicine, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00181649     History of Changes
Other Study ID Numbers: 2003P001209-2
Study First Received: September 9, 2005
Last Updated: May 8, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Massachusetts General Hospital:
Lactation
Breastfeeding
Adoptive mothers
Prolactin
Relative lactation insufficiency

ClinicalTrials.gov processed this record on July 23, 2014