Clinical trial NCT00438490: The Safety and Efficacy of Recombinant Human Prolactin
Official title: Phase 2 Study of Recombinant Human Prolactin Efficacy and Safety
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Healthy
Keywords: galactorrhea
prolactin
bone turnover
menstrual cycle
Control Groups
Women
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2007-02-22
Enrollment: 21
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

Healthy Subjects will meet the following criteria:

1. 18 to 40 years of age
2. Normal weight (BMI 17 to £ 30 kg/m2)
3. Good general health
4. On no medications for at least 3 months before the study
5. Regular menstrual cycles every 25-35 days with ovulation documented by a luteal phase progesterone level
6. No evidence of androgen excess
7. Normal TSH, prolactin and hematocrit
8. No current interest in conception
9. No history of osteoporosis
10. No use of medications known to affect bone turnover
11. No alcoholism
12. No smoking
13. 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.

Primary outcomes:
measure: Galactorrhea
timeFrame: 7 days
Secondary outcomes:
measure: N-telopeptide
timeFrame: 7 days
measure: Menstrual Cycle Length
timeFrame: 28 days
measure: Estradiol
timeFrame: 7 days
Other outcomes:
Locations:
city: Boston
country: United States
facility: Corrine Welt
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Corrine K. Welt, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Page-Wilson G, Smith PC, Welt CK. Short-term prolactin administration causes expressible galactorrhea but does not affect bone turnover: pilot data for a new lactation agent. Int Breastfeed J. 2007 Jul 24;2:10. doi: 10.1186/1746-4358-2-10.