About Hydroxyprogesterone Caproate

Hydroxyprogesterone Caproate(17α-Hydroxyprogesterone caproate )is a synthetic steroid hormone that is similar to medroxyprogesterone acetate and megestrol acetate. It is an ester derivative of 17α-hydroxyprogesterone formed from caproic acid (hexanoic acid).
17α-Hydroxyprogesterone caproate was previously marketed under the trade name Delalutin by Squibb, which was approved by the U.S. Food and Drug Administration (FDA) in 1956 and withdrawn from marketing in 1999.
Cytyc is seeking FDA approval to market 17α-hydroxyprogesterone caproate under the trade name Gestiva for prevention of preterm delivery in women with a history of preterm delivery.
The use of 17-hydroxyprogesterone caproate in pregnancy to prevent preterm birth is not recommended without further study according to two authorities. A 2006 Cochrane Review concluded "...important maternal and infant outcomes have been poorly reported to date... information regarding the potential harms of progesterone therapy to prevent preterm birth is limited".There was a similar conclusion from a review by Marc Keirse of Flinders University. Three clinical studies in singleton pregnancies of 250 mg/week of intramuscular 17-hydroxyprogesterone caproate have all shown a trend for an increase in pregnancy loss due to miscarriage compared to placebo. The FDA expressed concern about miscarriage at the 2006 advisory committee meeting; the committee voted unanimously that further study was needed to evaluate the potential association of 17OHP-C with increased risk of second trimester miscarriage and stillbirth.