Crinone natural vaginal progesterone data

COB said it has completed and analyzed its three pivotal studies of Crinone, and plans to file a U.S. NDA in mid-year. Crinone delivers natural progesterone using COB's bioadhesive delivery system.The incidence of depression, emotional liability, sleep disorders, headache and bloating, which rise significantly with synthetic progestins, decreased when Crinone was added to estrogen, COB said.

The studies tested doses of 45 and 90 mg in 110 women with secondary amenorrhea (loss of menstrual period). About 80 percent of patients menstruated after both doses of Crinone. ...