The Medical Letter on Drugs and Therapeutics
Progesterone for Prevention of Premature Birth
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The FDA recently approved the marketing of hydroxyprogesterone caproate injection (Makena – Ther-Rx) for prevention of preterm birth in women with a singleton pregnancy who have a history of singleton spontaneous preterm birth.

MECHANISM OF ACTION — Progesterone suppresses uterine contraction, apparently by decreasing the expression of genes that encode contraction-associated proteins in the myometrium.1

CLINICAL STUDIES — Previous Preterm Birth – FDA approval of Makena was based on a randomized, double-blind, placebo-controlled trial in 463 pregnant women with a history of spontaneous preterm birth. The trial, which was not funded by the manufacturer of Makena and used a nonbranded formulation of 17-alpha hydroxyprogesterone caproate, found that weekly 250-mg intramuscular injections of the drug, beginning at ... more      

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Title: Progesterone for Prevention of Premature Birth
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