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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: Completed Phase 1 study, sponsored by AMAG Pharmaceuticals.
NCT02940522 is a Phase 1 study that has completed, run by AMAG Pharmaceuticals. The registered enrollment target is 122 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (103% higher). According to ClinicalTrials.gov, the official US trial registry.
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®.
Primary Outcome
Comparison of areas under the curve (AUC) to the last time with a concentration ≥ LLOQ \[AUC0-t\] and to infinity \[AUCinf\] for the Primary PK Population
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 |
What the finished NCT02940522 record still lists
NCT02940522 is an interventional study that assigns participants to a tested intervention. The registered 122 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (103% higher).
The record links to 0 conditions, and to 1 intervention - of which Makena® (Hydroxyprogesterone Caproate Injection, 250 mg/mL) is the first listed.
NCT02940522 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02940522's enrollment target sits among peer trials
122 475th of 2000 higher than 1,525 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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