Phase 2
N=21
The Safety and Efficacy of Recombinant Human Prolactin
Healthy
Bottom Line
View on ClinicalTrials.gov: NCT00438490 ↗Enrolled (actual)
21
Serious AEs
0.0%
Results posted
Apr 2013
Primary outcome: Primary: Galactorrhea — 0; 56 percentage of participants
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
- Mar 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Galactorrhea |
0; 56 | — |
| SECONDARY N-telopeptide |
7.4; 6.9 | — |
| SECONDARY Menstrual Cycle Length |
28.8; 30.1 | — |
| SECONDARY Estradiol |
634; 467 | — |
Summary
Medications used to increase breast milk production increase prolactin secretion, the main hormone of lactation. There are no FDA approved medications used to improve breast feeding, but metoclopramide is used off-label and can have intolerable side effects. We examined the biological activity and safety of recombinant human prolactin (r-hPRL) as a potential medication to augment lactation. In this study, the effect of r-hPRL on breast milk production in women who did not recently deliver a baby and its effect on the bones and menstrual cycle were tested.
Eligibility Criteria
Inclusion Criteria
Healthy Subjects will meet the following criteria:
- 18 to 40 years of age
- Normal weight (BMI 17 to £ 30 kg/m2)
- Good general health
- On no medications for at least 3 months before the study
- Regular menstrual cycles every 25-35 days with ovulation documented by a luteal phase progesterone level
- No evidence of androgen excess
- Normal TSH, prolactin and hematocrit
- No current interest in conception
- No history of osteoporosis
- No use of medications known to affect bone turnover
- No alcoholism
- No smoking
- No history of medical problems or treatment known to affect bone turnover.
Exclusion Criteria
Subjects will be excluded for pregnancy or evidence of breast masses.
Data sourced from ClinicalTrials.gov (NCT00438490). 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.