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NCT02940522 · ClinicalTrials.gov registry record · Phase 1

Comparing Bioavailability When Preservative-free Makena® (Hydroxyprogesterone Caproate Injection, 250 mg/mL) is Administered as an Intramuscular Manual Injection or as a Subcutaneous Injection Using an Auto-injector in Healthy Post-menopausal Women

A Phase 1 study, sponsored by AMAG Pharmaceuticals.

Completed
Registry status
Phase 1
Development phase
122
Enrollment target

NCT02940522 is a Phase 1 study that has completed, run by AMAG Pharmaceuticals. The registered enrollment target is 122 participants.

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The verdict

NCT02940522, a Phase 1 study, has completed, sponsored by AMAG Pharmaceuticals.

COMPLETED
Registry status
Phase 1
Development phase
122 participants
Enrollment target

Study Summary

To demonstrate that a single dose of Makena® delivered SQ via auto-injector has comparable bioavailability to a single IM injection of Makena®.

Interventions

  • DRUG Makena® (Hydroxyprogesterone Caproate Injection, 250 mg/mL)

Trial Details

FieldValue
Enrollment Target 122 participants
Start Date 2016-09
Est. Completion 2017-03
Phase Phase 1

Sponsor

AMAG Pharmaceuticals

23 total trials

What the Registry Record Tells You About NCT02940522

The ClinicalTrials.gov registry entry for NCT02940522 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 122 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is AMAG Pharmaceuticals, which has 23 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which Makena® (Hydroxyprogesterone Caproate Injection, 250 mg/mL) is the first listed.

NCT02940522 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT02940522 about?

NCT02940522 is a clinical study titled "Comparing Bioavailability When Preservative-free Makena® (Hydroxyprogesterone Caproate Injection, 250 mg/mL) is Administered as an Intramuscular Manual Injection or as a Subcutaneous Injection Using an Auto-injector in Healthy Post-menopausal Women". To demonstrate that a single dose of Makena® delivered SQ via auto-injector has comparable bioavailability to a single IM injection of Makena®.

What is the current status of trial NCT02940522?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 122 participants. The study started on 2016-09. Estimated completion is 2017-03.

What interventions are being tested in trial NCT02940522?

The interventions under investigation include: Makena® (Hydroxyprogesterone Caproate Injection, 250 mg/mL) (DRUG).

Who is sponsoring clinical trial NCT02940522?

This trial is sponsored by AMAG Pharmaceuticals, which has 23 total clinical trials registered on ClinicalTrials.gov.

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

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, or report a data error.