Status:
COMPLETED
Pharmacokinetic Study of Makena® (Hydroxyprogesterone Caproate Injection, 250 mg/mL) and Its Metabolites in Blood
Lead Sponsor:
Lumara Health, Inc.
Conditions:
Pregnancy
Eligibility:
FEMALE
18+ years
Phase:
PHASE1
Brief 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...
Eligibility Criteria
Inclusion
- Age ≥ 18 years.
- Singleton gestation.
- Gestational age 16 weeks 0 days to 20 weeks 6 days.
- Previous singleton spontaneous preterm delivery
Exclusion
- Multifetal gestation.
- Known major fetal anomaly or fetal demise.
- Progestin treatment in any form in the 4 weeks prior to study entry.
- Heparin therapy during current pregnancy or history of thromboembolic disease.
- Maternal medical/obstetrical complications including hypertension requiring medication or seizure disorder.
- uterine anomaly other than fibroids
- Known hypersensitivity to hydroxyprogesterone caproate injection or its components.
- Any significant medical disorder that, in the opinion of the investigator, would be a contraindication to the use of the drug or would preclude accurate evaluation of the subject's condition or outcome or compromise the subject's safety in the study.
Key Trial Info
Start Date :
July 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2014
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT01899846
Start Date
July 1 2013
End Date
August 1 2014
Last Update
August 18 2014
Active Locations (6)
Enter a location and click search to find clinical trials sorted by distance.
1
Altus Research, Inc.
Lake Worth, Florida, United States, 33461
2
Rosemark WomenCare Specialists
Idaho Falls, Idaho, United States, 83404
3
Northwestern University Department of Obstetrics and Gynecology
Chicago, Illinois, United States, 60611
4
University of North Carolina at Chapel Hill Hospital
Chapel Hill, North Carolina, United States, 27599