NCT00438490

Brief Summary

Medications used to increase breast milk production increase prolactin secretion, the main hormone of lactation. There are no FDA approved medications used to improve breast feeding, but metoclopramide is used off-label and can have intolerable side effects. We examined the biological activity and safety of recombinant human prolactin (r-hPRL) as a potential medication to augment lactation. In this study, the effect of r-hPRL on breast milk production in women who did not recently deliver a baby and its effect on the bones and menstrual cycle were tested.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
21

participants targeted

Target at below P25 for phase_2 healthy

Timeline
Completed

Started Apr 2002

Longer than P75 for phase_2 healthy

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

April 1, 2002

Completed
4.9 years until next milestone

First Submitted

Initial submission to the registry

February 20, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 22, 2007

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed
2.1 years until next milestone

Results Posted

Study results publicly available

April 18, 2013

Completed
Last Updated

January 3, 2018

Status Verified

December 1, 2017

Enrollment Period

8.9 years

First QC Date

February 20, 2007

Results QC Date

February 5, 2013

Last Update Submit

December 31, 2017

Conditions

Healthy

Keywords

galactorrheaprolactinbone turnovermenstrual cycleControl GroupsWomen

Outcome Measures

Primary Outcomes (1)

  • Galactorrhea

    Galactorrhea is breast milk production.

    7 days

Secondary Outcomes (3)

  • N-telopeptide

    7 days

  • Menstrual Cycle Length

    28 days

  • Estradiol

    7 days

Study Arms (2)

recombinant human prolactin

EXPERIMENTAL

Recombinant Human Prolactin 60 mcg/kg once daily subcutaneous injection

Drug: Recombinant Human Prolactin

Placebo

PLACEBO COMPARATOR

Normal saline placebo subcutaneous injection

Drug: Recombinant Human Prolactin

Interventions

Recombinant Human ProlactinDRUG
Placeborecombinant human prolactin

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy Subjects will meet the following criteria:
  • to 40 years of age
  • Normal weight (BMI 17 to £ 30 kg/m2)
  • Good general health
  • On no medications for at least 3 months before the study
  • Regular menstrual cycles every 25-35 days with ovulation documented by a luteal phase progesterone level
  • No evidence of androgen excess
  • Normal TSH, prolactin and hematocrit
  • No current interest in conception
  • No history of osteoporosis
  • No use of medications known to affect bone turnover
  • No alcoholism
  • No smoking
  • No history of medical problems or treatment known to affect bone turnover.

You may not qualify if:

  • Subjects will be excluded for pregnancy or evidence of breast masses.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Corrine Welt

Boston, Massachusetts, 02114, United States

Location

Related Publications (1)

  • Page-Wilson G, Smith PC, Welt CK. Short-term prolactin administration causes expressible galactorrhea but does not affect bone turnover: pilot data for a new lactation agent. Int Breastfeed J. 2007 Jul 24;2:10. doi: 10.1186/1746-4358-2-10.

    PMID: 17650319DERIVED

MeSH Terms

Conditions

Galactorrhea

Condition Hierarchy (Ancestors)

Lactation DisordersPuerperal DisordersPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Results Point of Contact

Title
Corrine Welt, MD
Organization
Massachusetts General Hospital
cwelt@partners.org
617-726-8437

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
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Medicine

Study Record Dates

First Submitted

February 20, 2007

First Posted

February 22, 2007

Study Start

April 1, 2002

Primary Completion

March 1, 2011

Study Completion

March 1, 2011

Last Updated

January 3, 2018

Results First Posted

April 18, 2013

Record last verified: 2017-12

Locations

US(1)