17-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).

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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under the trade name Delalutin by Squibb, which was approved by the U.S. Food and Drug Administration (FDA) in 1956 and withdrawn from marketing in 1999.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.

Safety

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".^[1] There was a similar conclusion from a review by Marc Keirse of Flinders University.^[2] 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.^[3][4][5][6] 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.^[7] A toxicology study in rhesus monkeys resulted in the death of all rhesus fetuses exposed to 1 and 10 times the human dose equivalent of 17-hydroxyprogesterone caproate.^[8] as of 2008, 17-hydroxyprogesterone caproate is a category D progestin according to the FDA (that is, there is evidence of fetal harm). There is speculation that the castor oil in the 17-hydroxyprogesterone caproate formulation may not be beneficial for pregnancy.^[9][10]

Notes

Sources

• FDA Reproductive Health Drugs Advisory Committee. August 29, 2006 Meeting to discuss NDA 21-945 Gestiva (Adeza Biomedical)
  17α-hydroxyprogesterone caproate injection, 250 mg/mL, for the proposed indication: prevention of preterm delivery in women with a history of a prior preterm delivery.
• Adeza Biomedical (October 23, 2006) Receives FDA Approvable Letter For Gestiva
• Adeza gets orphan drug designation for Gestiva (January 31, 2007)
• Cytyc Acquires Adeza Biomedical Corporation (April 3, 2007)
  Adeza's name changed to Cytyc Prenatal Products Corp.