Clinical experience with Valette®

Abstract

The objectives of the studies were to determine the contraceptive efficacy, cycle stability and tolerability of a low-dose monophasic preparation containing dienogest 2 mg and ethinylestradiol 0.03 mg, and to investigate its influence on excessive sebaceous gland secretion of the scalp and skin over six cycles.Two open, multicenter postmarketing surveillance studies involving healthy women were carried out. Study 1 enrolled 16 087 subjects with a mean age of 24.3 ± 7.2 years to investigate contraceptive reliability, cycle control and tolerability; Study 2 involved 10 718 subjects with a mean age of 23.6 ± 6.9 years to assess sebaceous gland activity by the presence of grease on the hair and skin, and frequency of hair washes per week.Eleven pregnancies occurred during the first study, giving an unadjusted Pearl index of 0.14. The incidence of intermenstrual bleeding (spotting and breakthrough bleeding) and amenorrhea progressively declined during the study to ≤ 1% by cycle 6. A total of 353 (2.2%) women discontinued treatment because of adverse events. Tolerability was good or very good in over 85% of subjects. A decrease in the incidence of moderate and severe greasy hair and skin corresponded to an increase in mild or non-greasy status and a decline in frequency of hair washes. Subjective analysis of the effect on the greasiness of skin and hair revealed treatment as very good in 37% of women, good in 51%, satisfactory in 9% and unsatisfactory in only 3% of women.A low-dose combined oral contraceptive containing dienogest provides reliable contraception and good cycle control and is well tolerated by users. Furthermore, this preparation may be particularly suitable for women with excessive sebum production of the scalp and skin who require contraceptive protection.