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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.

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.

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Two triphasic oral contraceptives containing either gestodene or norethindrone as the progestogenic compound combined with ethinyl estradiol were compared in a randomized clinical trial to assess their contraceptive reliability, clinical tolerance and cycle control. Both preparations were effective in preventing pregnancy. The gestodene preparation proved significantly superior regarding cycle control and general tolerance.

PIP: In Germany, researchers randomly placed 126 women into a group taking a triphasic oral contraceptive (OC) with gestodene and 128 women into another group taking triphasic norethindrone to do a 1-year controlled, multicenter open trial examining contraceptive efficacy, cycle control, and general tolerance. No one became pregnant during the study, despite mistakes in pill intake in 32 (2.5%) and 44 (3.7%) pill cycles of the gestodene group and norethindrone group, respectively. Women in the gestodene group experienced spotting at a higher rate than those in the norethindrone group (27% vs. 15.8%; p .05). The difference remained significant even when the researchers examined only 1st-time OC users (10.2% vs. 5%; p .05). On the other hand, breakthrough bleeding occurred less often in women in the gestodene group (19.3% vs. 29.6%). Over time, women in the norethindrone group were more likely to gain more than 2 kg than those in the gestodene group. Neither group experienced changes in blood pressure. Neither OC caused any serious adverse events, e.g., thromboembolism. The most common subjective adverse events were painful menstrual periods, breast tension, and headache. The incidence of acne increased in the norethindrone group. Adverse events were responsible for 3.5% of women in the gestodene group and 11.3% in the norethindrone group dropping out, sometimes citing more than 1 adverse event. Women in the norethindrone group were more likely to drop out because of adverse events than were those in the gestodene group (50% of all dropouts vs. 25%; p .05). Triphasic gestodene had better cycle control and was better tolerated than triphasic norethindrone. Weight gain and acne were less common in the gestodene group than the norethindrone group. In conclusion, triphasic gestodene is superior to that of triphasic norethindrone.

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A triphasic oral contraceptive containing ethinyl estradiol and gestodene was used by 1933 women for up to 36 cycles in order to evaluate contraceptive efficacy, general tolerance and cycle control. Altogether, 30,763 treatment cycles were recorded. Two pregnancies were seen, both of them classified as user failure. The rates of spotting and breakthrough bleeding fell below the rates of the pre-treatment cycle after the first three months of treatment. Adverse events were mostly minor with breast tension and headaches the most common complaints. After the first three cycles, the incidence of most complaints was the same as or even lower than in the pre-treatment cycle. Blood pressure and body weight remained practically unchanged. The trial preparation provided reliable contraception with good general tolerance and cycle control when taken for up to three years.

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