The Safety and Efficacy of Recombinant Human Prolactin

Study Overview
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Brief Summary
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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.

Detailed Description
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There are no FDA approved medications in the U.S. to augment lactation. Metoclopramide is used off-label but can have intolerable side effects. We examined the biological activity and safety of recombinant human prolactin (r-hPRL) as preliminary data for its use to augment lactation. Healthy, non-postpartum women (n=21) with regular menstrual cycles underwent a 7 day randomized, double-blind, placebo-controlled trial of r-hPRL. Galactorrhea, markers of bone turnover, calcium homeostasis and gonadal function were measured and side effects recorded.

Official Title
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Phase 2 Study of Recombinant Human Prolactin Efficacy and Safety

Conditions
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Healthy

Intervention / Treatment
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* Drug: Recombinant Human Prolactin


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: recombinant human prolactin<br>Recombinant Human Prolactin 60 mcg/kg once daily subcutaneous injection | Drug: Recombinant Human Prolactin<br> <br> |
| Placebo Comparator: Placebo<br>Normal saline placebo subcutaneous injection | Drug: Recombinant Human Prolactin<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Galactorrhea | Galactorrhea is breast milk production. | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| N-telopeptide |  | 7 days | 
| Menstrual Cycle Length |  | 28 days | 
| Estradiol |  | 7 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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galactorrhea, prolactin, bone turnover, menstrual cycle, Control Groups, Women