[Clinical study on the contraceptive effectiveness of trisiston from the Jenapharm firm]

Now triphasic contraceptive preparations are used widely. Some news low dose formulations are available on the market, among them Trisiston. The study was conducted to confirm clinically acceptance and effectiveness of Trisiston. There were 437 volunteers mostly multiparous, with a mean age of +/- 25 years who participated in a multi center study. They were taking pills for a 3 to 12 cycles. Cumulatively 4026 cycles were observed. The investigation was conducted according special protocol. At the admission a complete medical history was obtained and a general physical and gynecological examination was performed. All subject were controlled every 3rd month included laboratory tests (blood levels of Hb, WBC, RBC, ESR, carbohydrate metabolism, clotting factors, bilirubin, creatinine, protein, glucose, albumin, LDL, HDL). There was no case of pregnancy. Pearl index = 0. The Trisiston was well tolerated by most of women (80%). Some effects like headache, vertigo, mastalgia, spotting and breakthrough bleeding, loss of libido, premenstrual syndrome were observed in 20% patients, soma of our patients (20%) discontinued contraceptive.