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NCT00438490 · ClinicalTrials.gov registry record · Phase 2
The Safety and Efficacy of Recombinant Human Prolactin
A Phase 2 study, sponsored by Massachusetts General Hospital.
- Completed
- Registry status
- Phase 2
- Development phase
- 21
- Enrollment target
NCT00438490: Completed Phase 2 study, sponsored by Massachusetts General Hospital.
NCT00438490 is a Phase 2 study that has completed, run by Massachusetts General Hospital. The registered enrollment target is 21 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (84% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00438490, a Phase 2 study, has completed, sponsored by Massachusetts General Hospital.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 21 participants
- Enrollment target
Study 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.
Primary Outcome
Galactorrhea is breast milk production.
Interventions
- DRUG Recombinant Human Prolactin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2002-04 |
| Est. Completion | 2011-03 |
| Phase | Phase 2 |
What the finished NCT00438490 record still lists
NCT00438490 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 21 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (84% lower).
The record links to 0 conditions, and to 1 intervention - of which Recombinant Human Prolactin is the first listed.
NCT00438490 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00438490 about?
NCT00438490 is a clinical study titled "The Safety and Efficacy of Recombinant Human Prolactin". 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 s...
What is the current status of trial NCT00438490?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 21 participants. The study started on 2002-04. Estimated completion is 2011-03.
What interventions are being tested in trial NCT00438490?
The interventions under investigation include: Recombinant Human Prolactin (DRUG).
Who is sponsoring clinical trial NCT00438490?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00438490's enrollment target sits among peer trials
21 1794th of 2000 higher than 196 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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