The effect on blood pressure of a monophasic oral contraceptive containing ethinylestradiol and gestodene.

ABSTRACT

To obtain an overview of the effect of monophasic gestodene on blood pressure and to determine the frequency of "OC elevated BP/hypertension," the results of blood pressure monitoring from four clinical studies of contraceptive efficacy and safety have been retrospectively analyzed. A total of 1930 women took part in the studies, which recorded BP for up to 24 cycles. Analysis of results revealed that 97 women (5.0%) showed an increase in blood pressure from previously normal to elevated values while taking monophasic gestodene, with only 26 (1.35%) fulfilling the criteria of "OC elevated BP/hypertension." Only four women dropped out of the trials due to hypertensive blood pressure values, while 67 women (3.5%) experienced a normalization of previously elevated blood pressure measurements. In conclusion, this analysis has confirmed that gestodene has a negligible effect on blood pressure, with increased BP a relatively rare event.

ABSTRACT

PIP Schering AG (manufacturer of a monophasic oral contraceptive [OC] containing 75 mcg gestodene plus 30 mcg ethinyl estradiol) in Berlin, Germany, conducted a retrospective analysis of blood pressure measurements from 4 clinical trials of the contraceptive efficacy and safety of monophasic gestodene to examine gestodene's effect on blood pressure and the incidence of OC-related blood pressure/ hypertension. (OC-related blood pressure/hypertension is defined as women with neither history of hypertension nor elevated blood pressure before OC use develop increased blood pressure or hypertension that is reversible once OC use ceases.) The clinical trials recorded the blood pressure of 1930 women for up to 24 cycles. Most women (89.9%) experienced no change in their blood pressure during OC use. 97 women (5%) experienced an increase in blood pressure. 26 women (1.35%) had OC-elevated blood pressure/hypertension. Four women left the trials due to hypertension. 67 women (3.5%) who had elevated blood pressure before OC use attained normalization of blood pressure during OC use. These results show that the gestodene-containing OC had an insignificant effect on blood pressure and that elevated blood pressure rarely occurred.