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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.
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
| Field | Value |
|---|---|
| Enrollment Target | 122 participants |
| Start Date | 2016-09 |
| Est. Completion | 2017-03 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗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.
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