Clinical profile of Valette®

Studies have been undertaken to investigate the modulatory effects of a combination of 30 μg ethinylestradiol and 2.00 mg dienogest (Valette®) on ovarian function and on the hemostatic system. Modulation of ovarian function was investigated by hormone assays and ultrasonography. Effects on the hemostatic system were investigated in a double-blind, randomized, placebo-controlled study. In the ovulation inhibition study, none of the subjects had ovulatory cycles, and only one subject in the first cycle (4%) showed active follicle-like structures. Endometrial thickness was reduced to less than 10 mm. It was noted that Valette had a balanced effect on the hemostatic system, stimulating both procoagulatory and fibrinolytic activities. The present data combine to show that Valette is a reliable ovulation inhibitor with an efficacy comparable to other low-dose preparations.