Recombinant Human Prolactin for Lactation Induction
Completed · Phase 2
Conditions studied: Lactation
In brief
The purpose of the study is to assess the safety and determine the effects of the hormone prolactin on lactation (breast milk production).
Key facts
- Study ID
- NCT00181623
- Run by
- Massachusetts General Hospital
- People needed
- 6
- Starts
- 2005-01-01
- Expected to finish
- 2011-05-01
- Last updated by the study team
- 2017-12-11
Who can join
Age: 18 and older, up to 45. Sex: female. Healthy volunteers: not accepted.
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
Where it is running
- Massachusetts General Hospital — Boston, Massachusetts, United States
Full record on ClinicalTrials.gov
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