Efficacy and tolerability of the dienogest-containing oral contraceptive Valette((R)). Results of a postmarketing surveillance study

The efficacy and safety of the new, low dose, 21-day combination oral contr aceptive Valette(R) containing 30 mu g of ethinylestradiol and 2 mg of dien ogest was evaluated in a prospective six-cycle, open-label, multicenter pos tmarketing surveillance study. A total of 16,267 women were enrolled and ha d 92,146 documented cycles of exposure. Eleven pregnancies occurred during treatment, the unadjusted Pearl Index being 0.14. Of these, at least four p regnancies were observed in women with intake failures. A total of 333 (2.0 %) women stopped Valette(R) before the end of the observational period and withdrew from the study for nonmedical reasons, 1,563 (9.6%) for medical re asons, and 100 (0.61%) without giving any reason. The incidence of breakthr ough bleeding and spotting were highest in the first treatment cycle (5.0 a nd 3.4%, respectively) and then declined rapidly to a very low level. The r ate of withdrawal bleeding (silent menstruation) was about 2% throughout th e study, affecting 5.9% of all women. The most commonly reported adverse ev ents in this study which were considered at least possibly drug related wer e mastalgia (1.5%), weight gain (1.1%), headache (1.1%), nausea/vomiting (1 .0%), dysmenorrhea (0.35%), decreased libido (0.32%) depressive state (0.29 %) and nonspecific abdominal pain (0.14%), the incidence being therefore ve ry low. This formulation provides a very high contraceptive efficacy in rou tine practice with excellent cycle control, tolerability and compliance as indicated in preceding clinical phase III studies. (C) Prous Science. All r ights reserved.