Status:
COMPLETED
Recombinant Human Prolactin for Lactation Induction
Lead Sponsor:
Massachusetts General Hospital
Conditions:
Lactation
Eligibility:
FEMALE
18-45 years
Phase:
PHASE2
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).
Detailed Description
The efficacy of recombinant human prolactin (r-hPRL) for treatment of primary lactation insufficiency in women with prolactin deficiency, either congenital or acquired, will be examined. Subjects will...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
Key Trial Info
Start Date :
January 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2011
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT00181623
Start Date
January 1 2005
End Date
May 1 2011
Last Update
December 11 2017
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114