Clinical and metabolic study of a new pill containing 20 mcg ethinylestradiol plus 0.150 mg desogestrel.

ABSTRACT

PIP: The clinical and metabolic effects of short-term treatment with an oral contraceptive (OC) containing 0.150 mg desogestrel and 20 mcg ethinyl estradiol were evaluated in 17 healthy subjects 19-37 years of age. Despite its low estrogen content, the OC exerted good menstrual cycle control and the incidence of irregular bleeding was low. Side effects often associated with OC use, such as weight gain or changes in blood pressure, did not occur. Moreover, there was improvement of premenstrual symptoms during pill use. The formulation induced a significant increase of fibrinopeptide A plasma levels, although the resulting peptide increase was lower than that induced by OCs containing 30 mcg ethinyl estradiol. No significant alterations of plasma total cholesterol and low-density lipoprotein cholesterol (LDL-C) were recorded, but triglyceride concentrations, high-density lipoprotein cholesterol (HDL-C), and the HDL-C/LDL-C ratio significantly increased. Also observed was a significant increase in concentrations of apolipoproteins AI and AII. Finally, the OC did not alter fasting insulin and glucose levels or their response to an oral glucose tolerance test. These find ngs refute the belief that doses lower than 30 mcg of ethinyl estradiol are inadequate for maintaining satisfactory contraceptive efficacy and good cycle control. The advantages of using a lower estrogen dose were evident both in terms of the low incidence of side effects and the lack of effects on the coagulation system. The present results suggest that this OC formulation could further minimize the thrombogenic effects of low-dose OCs. In addition, this formulation retains the effects on lipid metabolism of OCs containing desogestrel.