At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 122 enrolled
Drug / intervention
Makena® (Hydroxyprogesterone Caproate Injection, 250 mg/mL) +1 moredrug
Likely dose
Makena® (Hydroxyprogesterone Caproate Injection, 250 mg/mL)from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Multi-Center, Randomized, Open-Label Study 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
In Brief
A Phase 1 clinical trial evaluating Makena® (Hydroxyprogesterone Caproate Injection, 250 mg/mL) for Comparing Bioavailability When Makena® is Administered in Healthy Post-menopausal Women. Completed, enrolled 122 participants across 5 sites.
Detailed Summary
To demonstrate that a single dose of Makena® delivered SQ via auto-injector has comparable bioavailability to a single IM injection of Makena®.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--
Timeline
Phase 1CompletedFinished
2017201820192020202120222023202420252026
Enrollment StartSep 2016
First PostedOct 2016
Primary CompletionDec 2016
Study CompletionMar 2017
TodayJul 2026
First PostedOct 21, 2016
Enrollment StartSep 1, 2016
Primary CompletionDec 1, 2016
Study CompletionMar 1, 2017
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 9.7 years ago
Interventions
Makena® (Hydroxyprogesterone Caproate Injection, 250 mg/mL)drug
Makena® (Hydroxyprogesterone Caproate Injection, 250 mg/mL)drug