Phase 2
N=6
Recombinant Human Prolactin for Lactation Induction
Lactation
Bottom Line
View on ClinicalTrials.gov: NCT00181623 ↗Enrolled (actual)
6
Serious AEs
0.0%
Results posted
May 2013
Primary outcome: Primary: Breast Milk Production — 66.1 mL/day
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Recombinant Human Prolactin (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Massachusetts General Hospital
- Primary completion
- May 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Breast Milk Production |
66.1 | — |
| SECONDARY Breast Milk Prolactin Levels |
118 | — |
Summary
The purpose of the study is to assess the safety and determine the effects of the hormone prolactin on lactation (breast milk production).
Eligibility 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 ( 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
Data sourced from ClinicalTrials.gov (NCT00181623). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.