Recombinant Human Prolactin for Lactation Induction (NCT00181623) | Clinical Trial Compass
CompletedPhase 2
Recombinant Human Prolactin for Lactation Induction
United States6 participantsStarted 2005-01
Plain-language summary
The purpose of the study is to assess the safety and determine the effects of the hormone prolactin on lactation (breast milk production).
Who can participate
Age range18 Years – 45 Years
SexFEMALE
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Inclusion Criteria:
* 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 Criteria:
* 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