Pregnancy Clinical Trial
Official title:
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
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.
n/a
Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label
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