Endometrin

Endometrin (progesterone) Vaginal Insert 100 mg is a brand of micronized progesterone inserts for luteal support, from Ferring Pharmaceuticals in Parsippany, New Jersey, which was FDA-approved in June 2007 for use in the United States.

Inactive ingredients include lactose monohydrate, polyvinylpyrrolidone, adipic acid, and sodium bicarbonate. Other progesterone formulations—via oral pill or intramuscular injection—contain peanut or sesame oil, which may cause allergic reactions in some people. Endometrin is free of these substances.

Endometrin is used for luteal support, facilitating for embryo implantation and early pregnancy by supplementation of corpus luteal function as part of an Assisted Reproductive Technology (ART) treatment program for infertile women or women undergoing ART treatment due to male factor infertility.

The dose of Endometrin is a 100-mg insert, administered vaginally two or three times daily starting the day after egg retrieval and continuing for up to 10 weeks' total duration. The safety and effectiveness of Endometrin was demonstrated in the largest US IVF trial to date including 1,211 women.

Indication
Endometrin administered as a progesterone vaginal insert is indicated to support embryo implantation and early pregnancy by supplementation of corpus luteal function as part of an Assisted Reproductive Technology (ART) treatment for infertile women or women undergoing ART treatment due to male factor infertility.

Important Safety Information
Only physicians thoroughly familiar with infertility treatment should prescribe Endometrin. In clinical trials (n=808), adverse reactions that occurred at a rate greater than or equal to 2% included: uterine spasm (3% to 4%) and vaginal bleeding (3%). Vaginal irritation, itching, burning or discomfort, urticaria, and peripheral edema were reported at an incidence of less than 2%. Endometrin is expected to have adverse reactions similar to other drugs containing progesterone (breast tenderness, bloating, mood swings, irritability, and drowsiness).