Crinone Gel

Progesterone is a naturally occurring progestin. In the body, it is synthesized in the ovaries, testes, placenta, and adrenal cortex. Progesterone may be given orally, parenterally, or vaginally. The hormone is primarily used to treat amenorrhea and abnormal uterine bleeding, and also to prevent endometrial hyperplasia in postmenopausal women taking estrogen therapy. The drug is sometimes used off-label for premenstrual dysphoric disorder (PMDD), and has historically been used as a contraceptive. Progesterone is also used to prevent early pregnancy failure in women with corpus luteum insufficiency, including women undergoing assisted reproductive technology (ART)Progesterone also helps reduce the risk for preterm birth in selected patients. In women with single-gestation pregnancies and a history of spontaneous preterm delivery, antenatal progesterone therapy effectively decreases the risk of recurrent preterm delivery. Progesterone supplementation is beneficial in these women starting at 16 to 24 weeks gestation and continuing through 34 weeks gestation. It is not yet clear if the drug is beneficial at reducing the risk of preterm birth in multiple gestation pregnancies.456 Progesterone was first marketed medicinally in 1939, which was prior to the modern FDA drug approval process; the injection and various bulk products for extemporaneous compounding of vaginal suppositories and other dosage forms have long been available. A progesterone-containing intrauterine device was available for contraception but is no longer marketed. In May 1998, oral micronized progesterone capsules were first FDA-approved. In May 1997, a progesterone vaginal gel was FDA-approved for use in an Assisted Reproductive Technology (ART) program; a progesterone vaginal insert used for this purpose was FDA-approved in June 2007.