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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. According to ClinicalTrials.gov, the official US trial registry.

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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.

Interventions

  • DRUG Recombinant Human Prolactin

Trial Details

FieldValue
Enrollment Target 21 participants
Start Date 2002-04
Est. Completion 2011-03
Phase Phase 2

Sponsor

Massachusetts General Hospital

2,032 total trials

What the Registry Record Tells You About NCT00438490

The ClinicalTrials.gov registry entry for NCT00438490 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 21 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Massachusetts General Hospital, which has 2,032 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which Recombinant Human Prolactin is the first listed.

NCT00438490 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, the data changelog, or report a data error.