Clinical findings with the dienogest-containing oral contraceptive Valette((R))

The reliable contraceptive effects of the combination drug Valette(R) conta ining 0.03 mg ethinylestradiol and 2.0 mg dienogest were confirmed by the r esults of a phase III study which revealed an unadjusted Pearl index of 0.6 8 and an adjusted Pearl Index of 0.21. Calculations according to the life-t able method revealed a cumulative failure rate of 0.0052 after six cycles, of 0.0076 after 12 cycles, and of 0.0089 after 18 and 22 cycles of treatmen t. These data demonstrate that the efficacy of the ethinylestradiol-dienoge st combination is comparable to that of other monophasic low dose oral cont raceptives containing 0.03 mg ethinylestradiol. They also confirm previous observations that the failure rate of oral contraception is highest during the first year of use. Similar to comparable low dose oral contraceptives, the use of ethinylestradiol and dienogest is associated with an increased r ate of intermenstrual bleeding during the first cycle of treatment. Thereaf ter, the cycle control improves progressively, and after the third to fifth cycle, the rate of irregular bleeding is below that of pretreatment cycles . The proportion of women without withdrawal bleeding is small, and the str ength and duration of this bleeding progressively decreases with time. Pret reatment dysmenorrhoea also disappeared with increasing treatment cycles, d emonstrating a therapeutic effect of this combination. No clinically releva nt effects on various laboratory parameters were observed. Renin activity, angiotensin II, aldosterone, or endothelin-l were unchanged, which might ex plain the lack of influence on blood pressure. The levels of 3,5,3'-tri-iod othyronine (T-3) and thyroxine (T-4) increased significantly, those of free T-3 (FT3) were only slightly elevated and those of free T-4 (FT4) were red uced, while thyroid-stimulating hormone (TSH) was not affected. There was n o important influence of ethinylestradiol and dienogest on hematological or other clinical laboratory serum parameters; however, this drug combination caused slight hyperinsulinemia and insulin resistance. Glucose and HbA1c r emained unaltered. The change in lipid metabolism corresponds to the effect s of other formulations with a predominance of the effect of the estrogen c omponent. There was an increase in HDL-cholesterol, triglycerides, apolipop rotein A1 and B, but no change in LDL-cholesterol. The effects may be favor able rather than deleterious. The changes of hemostatic parameters were com parable to those observed with other oral contraceptives containing a proge stin with no or weak androgenic properties. For most of the pro-coagulatory , anticoagulatory and fibrinolytic parameters, the effects of the combinati on of ethinylestradiol and dienogest were equivalent to those of placebo. ( C) Pious Science. All rights reserved.