The Safety and Efficacy of Recombinant Human Prolactin - Full Text View

Sponsor:	Massachusetts General Hospital
Information provided by:	Massachusetts General Hospital
ClinicalTrials.gov Identifier:	NCT00438490

Purpose

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.

Condition	Intervention	Phase
Healthy	Drug: Recombinant Human Prolactin	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Phase 2 Study of Recombinant Human Prolactin Efficacy and Safety

Resource links provided by NLM:

MedlinePlus related topics: Menstruation

Drug Information available for: Prolactin

U.S. FDA Resources

Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:

Galactorrhea

Secondary Outcome Measures:

Bone Turnover-deoxypyridinoline, N-telopeptide, bone specific Alkaline Phosphatase
Menstrual cycle length
Reproductive hormones-LH, FSH, Estradiol

Estimated Enrollment:	20
Study Start Date:	April 2002
Estimated Study Completion Date:	December 2003

Detailed Description:

There are no FDA approved medications in the U.S. to augment lactation. Metoclopramide is used off-label but can have intolerable side effects. We examined the biological activity and safety of recombinant human prolactin (r-hPRL) as preliminary data for its use to augment lactation. Healthy, non-postpartum women (n=21) with regular menstrual cycles underwent a 7 day randomized, double-blind, placebo-controlled trial of r-hPRL. Galactorrhea, markers of bone turnover, calcium homeostasis and gonadal function were measured and side effects recorded.

Eligibility

Ages Eligible for Study:	18 Years to 40 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Healthy Subjects will meet the following criteria:

18 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.

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00438490

Locations

United States, Massachusetts
Corrine Welt
Boston, Massachusetts, United States, 02114

Sponsors and Collaborators

Massachusetts General Hospital

Investigators

Principal Investigator:

Corrine K. Welt, MD

Massachusetts General Hospital

More Information

No publications provided

Study ID Numbers:	2001-P-001057
Study First Received:	February 20, 2007
Last Updated:	February 21, 2007
ClinicalTrials.gov Identifier:	NCT00438490 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Massachusetts General Hospital:

galactorrhea
prolactin
bone turnover

menstrual cycle
Control Groups
Women

ClinicalTrials.gov processed this record on November 27, 2009