Pharmacokinetic Study of Makena® (Hydroxyprogesterone Caproate Injection, 250 mg/mL) and Its Metabolites in Blood

A Multi-Center, Non-Randomized Pharmacokinetic Study of Makena® (Hydroxyprogesterone Caproate Injection, 250 mg/mL) and Its Metabolites in Blood of Women With a Singleton Pregnancy and a Previous Singleton Spontaneous Preterm Delivery

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01899846

Enrollment

Registered

2013-07-16

Start date

2013-07-31

Completion date

2014-08-31

Last updated

2014-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pregnancy

Keywords

Makena, Pharmacokinetics, Prior preterm delivery, Hydroxyprogesterone Caproate, 17P

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 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.

Interventions

DRUGHydroxyprogesterone caproate 250 mg/ml

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Age ≥ 18 years. * Singleton gestation. * Gestational age 16 weeks 0 days to 20 weeks 6 days. * Previous singleton spontaneous preterm delivery

Exclusion criteria

* 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.

Design outcomes

Primary

Measure	Time frame
Plasma concentrations of hydroxyprogesterone caproate and metabolites	First dose, 24 - 28 weeks gestation, 32 - 36 weeks gestation

Secondary

Measure	Time frame
Plasma concentrations of hydroxyprogesterone caproate and metabolites	Up to 28 days following last dose given in week 36

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026