Status:
WITHDRAWN
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
Subjects will participate in a randomized, double-blind, placebo-controlled, crossover trial comparing breast pumping, alone, to breast pumping and r-hPRL. Subjects will have one week of instruction w...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2011
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00181649
Start Date
September 1 2006
End Date
May 1 2011
Last Update
May 9 2013
Active Locations (1)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114