Status:
COMPLETED
The Safety and Efficacy of Recombinant Human Prolactin
Lead Sponsor:
Massachusetts General Hospital
Conditions:
Healthy
Eligibility:
FEMALE
18-40 years
Phase:
PHASE2
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 metoclopramid...
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 recomb...
Eligibility Criteria
Inclusion
- 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
- Subjects will be excluded for pregnancy or evidence of breast masses.
Key Trial Info
Start Date :
April 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2011
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT00438490
Start Date
April 1 2002
End Date
March 1 2011
Last Update
January 3 2018
Active Locations (1)
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1
Corrine Welt
Boston, Massachusetts, United States, 02114