Recombinant Human Prolactin for Lactation Induction

• Status: Completed
• Trial end date: 2011-05-01
• Target enrollment: 0
• Participant gender: Female

Summary

The purpose of the study is to assess the safety and determine the effects of the hormone prolactin on lactation (breast milk production).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Massachusetts General Hospital

Criteria

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