NCT00181649

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).

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Sep 2006

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 9, 2005

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 16, 2005

Completed
12 months until next milestone

Study Start

First participant enrolled

September 1, 2006

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2011

Completed
Last Updated

May 9, 2013

Status Verified

May 1, 2013

Enrollment Period

4.7 years

First QC Date

September 9, 2005

Last Update Submit

May 8, 2013

Conditions

Lactation

Keywords

LactationBreastfeedingAdoptive mothersProlactinRelative lactation insufficiency

Outcome Measures

Primary Outcomes (1)

  • Breast milk production

    28 days

Secondary Outcomes (2)

  • Breast milk volume

    28 days

  • Breast milk prolactin levels and content

    28 days

Study Arms (1)

Recombinant human prolactin

EXPERIMENTAL
Drug: Recombinant human prolactin

Interventions

Recombinant human prolactinDRUG
Recombinant human prolactin

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (2)

  • Powe CE, Puopolo KM, Newburg DS, Lonnerdal B, Chen C, Allen M, Merewood A, Worden S, Welt CK. Effects of recombinant human prolactin on breast milk composition. Pediatrics. 2011 Feb;127(2):e359-66. doi: 10.1542/peds.2010-1627. Epub 2011 Jan 24.

    PMID: 21262884RESULT

  • Powe CE, Allen M, Puopolo KM, Merewood A, Worden S, Johnson LC, Fleischman A, Welt CK. Recombinant human prolactin for the treatment of lactation insufficiency. Clin Endocrinol (Oxf). 2010 Nov;73(5):645-53. doi: 10.1111/j.1365-2265.2010.03850.x.

    PMID: 20718766RESULT

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Study Officials

  • Corrine K Welt, MD

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Medicine

Study Record Dates

First Submitted

September 9, 2005

First Posted

September 16, 2005

Study Start

September 1, 2006

Primary Completion

May 1, 2011

Study Completion

May 1, 2011

Last Updated

May 9, 2013

Record last verified: 2013-05

Locations

US(1)