NCT00181623

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

87
On Track

Trial Health Score

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

Enrollment
6

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jan 2005

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

January 1, 2005

Completed
8 months until next milestone

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
5.6 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
2 years until next milestone

Results Posted

Study results publicly available

May 9, 2013

Completed
Last Updated

December 11, 2017

Status Verified

December 1, 2017

Enrollment Period

6.3 years

First QC Date

September 9, 2005

Results QC Date

February 5, 2013

Last Update Submit

December 8, 2017

Conditions

Lactation

Keywords

LactationBreastfeedingProlactinPrimary lactation insufficiency

Outcome Measures

Primary Outcomes (1)

  • Breast Milk Production

    Treatment group

    28 days

Secondary Outcomes (1)

  • Breast Milk Prolactin Levels

    28 days

Study Arms (1)

recombinant human prolactin treatment

EXPERIMENTAL

Open label twice daily recombinant human prolactin

Drug: Recombinant Human Prolactin

Interventions

Recombinant Human ProlactinDRUG
recombinant human prolactin treatment

Eligibility Criteria

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (2)

  • Iwama S, Welt CK, Romero CJ, Radovick S, Caturegli P. Isolated prolactin deficiency associated with serum autoantibodies against prolactin-secreting cells. J Clin Endocrinol Metab. 2013 Oct;98(10):3920-5. doi: 10.1210/jc.2013-2411. Epub 2013 Aug 12.

    PMID: 23940128DERIVED

  • 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: 21262884DERIVED

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Limitations and Caveats

Small numbers as this was an orphan disease trial.

Results Point of Contact

Title
Corrine Welt, MD
Organization
Massachusetts General Hospital
cwelt@partners.org
617-716-8437

Study Officials

  • Corrine K Welt, MD

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

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

January 1, 2005

Primary Completion

May 1, 2011

Study Completion

May 1, 2011

Last Updated

December 11, 2017

Results First Posted

May 9, 2013

Record last verified: 2017-12

Locations

US(1)