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NCT01899846 · ClinicalTrials.gov registry record · Phase 1
Pharmacokinetic Study of Makena® (Hydroxyprogesterone Caproate Injection, 250 mg/mL) and Its Metabolites in Blood
A Phase 1 study of Pregnancy, sponsored by Lumara Health.
- Completed
- Registry status
- Phase 1
- Development phase
- 30
- Enrollment target
- 6
- Study locations
NCT01899846: Completed Phase 1 study of Pregnancy, sponsored by Lumara Health.
NCT01899846 is a Phase 1 study of Pregnancy that has completed, run by Lumara Health. The registered enrollment target is 30 participants, below the 873-participant average among 191 other Pregnancy trials with a reported enrollment target (97% lower). The trial reports 6 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01899846, a Phase 1 study of Pregnancy, has completed, sponsored by Lumara Health.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 30 participants
- Enrollment target
- 6
- Study locations
Study Summary
This study will evaluate the levels of hydroxyprogesterone caproate and it's metabolites in blood throughout pregnancy There will be 3 cohorts of subjects Cohort 1 (6 subjects) will have daily blood draws in the morning at approximately the same time each day for one week following their first dose of Makena and will have blood drawn immediately prior to 2 successive Makena doses during Epoch 1 (24 - 28 weeks) and Epoch 2 (32 - 36 weeks) Cohort 2 (8 subjects) will have blood drawn to determine the trough concentration 7 days after their first dose of Makena. Subjects will have daily blood draws for one week following a dose of Makena given in Epoch 1 (24 - 28 weeks) and blood drawn immediately prior to 2 successive doses during Epoch 2 (32 - 36 weeks) Cohort 3 (16 subjects) will have blood drawn to determine the trough concentration 7 days after their first dose of Makena. Subjects will have blood drawn immediately prior to 2 successive doses in Epoch 1 (24 - 28 weeks) and daily blood draws for one week following a dose of Makena given during Epoch 2 (32 - 36 weeks) A maximum of 10 subjects will be monitored on selected days following a completed course of Makena therapy to determine the terminal elimination phase.
Conditions Studied
Interventions
- DRUG Hydroxyprogesterone caproate 250 mg/ml
Study Locations (6)
North Carolina
- University of North Carolina at Chapel Hill Hospital - Chapel Hill
- Duke University - Durham
Florida
- Altus Research, Inc. - Lake Worth
Idaho
- Rosemark WomenCare Specialists - Idaho Falls
Illinois
- Northwestern University Department of Obstetrics and Gynecology - Chicago
Wisconsin
- The University of Wisconsin - Madison
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2013-07 |
| Est. Completion | 2014-08 |
| Phase | Phase 1 |
What the finished NCT01899846 record still lists
NCT01899846 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 873-participant average among 191 other Pregnancy trials with a reported enrollment target (97% lower).
The record links to 1 condition, with Pregnancy appearing as the primary indexed condition, and to 1 intervention - of which Hydroxyprogesterone caproate 250 mg/ml is the first listed.
NCT01899846 lists 6 locations in 5 states (North Carolina, Florida, Idaho).
Frequently Asked Questions
What is clinical trial NCT01899846 about?
NCT01899846 is a clinical study titled "Pharmacokinetic Study of Makena® (Hydroxyprogesterone Caproate Injection, 250 mg/mL) and Its Metabolites in Blood". This study will evaluate the levels of hydroxyprogesterone caproate and it's metabolites in blood throughout pregnancy There will be 3 cohorts of subjects Cohort 1 (6 subjects) will have daily blood draws in the morning at approximately the same time each day for one week following their first dos...
What is the current status of trial NCT01899846?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2013-07. Estimated completion is 2014-08.
What conditions does trial NCT01899846 study?
This clinical trial studies the following conditions: Pregnancy.
What interventions are being tested in trial NCT01899846?
The interventions under investigation include: Hydroxyprogesterone caproate 250 mg/ml (DRUG).
Who is sponsoring clinical trial NCT01899846?
This trial is sponsored by Lumara Health, which has 6 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01899846 being conducted?
This trial has 6 study locations across Florida, Idaho, Illinois, North Carolina, Wisconsin. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Pregnancy
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01899846's enrollment target sits among peer trials
30 170th of 191 higher than 19 of 191 other Pregnancy trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Pregnancy 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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