gestodene and Headache

The objective of this study was to compare cycle control, efficacy and tolerance of an oral contraceptive containing 20 microg ethinylestradiol and 150 microg desogestrel with a preparation containing 30 microg ethinylestradiol combined with 75 microg gestodene. This study involved 342 women and 4104 cycles use in Argentina, Brazil, Chile, and Mexico. Contraceptive efficacy was good with both formulations. Two pregnancies occurred in the desogestrel group but were not due to method failure. With respect to cycle control, the incidence of intermenstrual bleeding was higher during the first 3 cycles in the desogestrel group; it was significant (p <0.01) during the first 3 days of the cycle for a normal or heavy bleeding only in the Mexican group. Amenorrhea was not reported for any group, but the incidence of dysmenorrhea was significantly higher (p <0.01) in the Brazilian desogestrel group (13.8%) and was significantly lower (p <0.01) in the Mexican gestodene group (8.5%). Adverse events were similar in all the countries with headache, breast tension, and nausea, the most frequently reported symptoms. The range of mean increase in body weight varied from 0.2 kg in the Argentine group to 2.6 kg in the Chilean group (95% confidence limit, +/- 2.51) in the gestodene group, and 0.2 kg in the Argentine group to 2.5 kg in Brazilian group (95% confidence limit, +/- 2.36) in the desogestrel group. Fifteen women discontinued because of headache, but there were no significant differences between the groups regarding discontinuation for this and other medical or non-medical reasons. Both oral contraceptive preparations are reliable and well tolerated, and both have favorable effects on control cycle.

Topics: Adolescent; Adult; Contraceptives, Oral, Hormonal; Desogestrel; Drug Combinations; Ethinyl Estradiol; Female; Headache; Humans; Latin America; Norpregnenes; Pregnancy; Weight Gain

The aim of this study was to compare contraceptive reliability, cycle control and tolerance of an oral contraceptive containing 20 micrograms ethinylestradiol and 75 micrograms gestodene, with a reference preparation containing the same dose of estrogen combined with 150 micrograms desogestrel. This article presents interim data from centers in France and Austria, involving a total of 479 women and 4,991 cycles. Contraceptive reliability was good with both preparations. Two pregnancies occurred in the gestodene group, but neither were due to method failure. In the desogestrel group there were also two pregnancies, of which one was due to method failure. With respect to cycle control, there is a trend towards a lower incidence of intermenstrual bleeding in the gestodene group. The incidence of spotting (scanty bleeding) during the important first three cycles was 3.5% lower in the gestodene group, and over the first six cycles, it was 7.6% lower. Amenorrhea was similar in both groups, but the incidence of dysmenorrhea was significantly lower in the gestodene group (p=0.001). Adverse events were similar in both groups, with headache, breast tension and nausea the most frequently reported symptoms. Body weight remained relatively constant during treatment in both groups, and no hypertension was reported for any woman during the course of the study. In each treatment group, 19 women discontinued because of adverse events. It is concluded that both preparation are reliable and well tolerated oral contraceptives are reliable and well tolerated oral contraceptives; however, there is a more favourable effect on dysmenorrhea by the gestodene formulation.

Topics: Adolescent; Adult; Amenorrhea; Austria; Body Weight; Contraceptives, Oral; Desogestrel; Dose-Response Relationship, Drug; Drug Combinations; Drug Tolerance; Dysmenorrhea; Ethinyl Estradiol; Female; France; Headache; Humans; Longitudinal Studies; Menstrual Cycle; Nausea; Norpregnenes; Progesterone Congeners; Time Factors

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.. 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.

Topics: Acne Vulgaris; Adult; Contraceptives, Oral, Combined; Female; Headache; Humans; Menstrual Cycle; Middle Aged; Norethindrone; Norpregnenes; Patient Dropouts; Progesterone Congeners; Weight Gain

The contraceptive efficacy, cycle control, safety, and subject acceptance of the new contraceptive (OC) preparations containing gestodene (GTD) plus ethinyl estradiol (EE) are being compared with the combination containing desogestrel (DSG) plus EE in a randomized, open-label outpatient study. Interim data from six cycles of this ongoing study were obtained for 378 women receiving 75 micrograms GTD + 30 micrograms EE per day and 384 women receiving 150 micrograms DSG + 30 micrograms EE per day. Each group received OCs for 21 days per cycle. There were no pregnancies in subjects receiving either OC during 1,658 cycles of GTD + EE or 1,707 cycles of DSG + EE use. The continuation rates were similar in the two groups, and no major differences in type or incidence of side effects were observed. There were also no clinically significant changes in blood pressure or body weight in either group. Slightly better cycle control was observed for subjects taking GTD + EE, since the incidence of spotting and breakthrough bleeding was slightly greater for women taking DSG + EE. The incidence of amenorrhea (missed periods) tended to be lower for the subjects taking the GTD-containing preparation: 7 (0.5%) cycles compared with 12 (0.9%) DSG + EE cycles. The GTD + EE-treated subjects also had a lighter menstrual flow. Fewer subjects taking GTD + EE withdrew because of side effects typically associated with OCs. The data from this study indicate that the new combination of GTD + EE provides safe and effective oral contraception, with good tolerance and cycle control.

Topics: Adult; Blood Pressure; Body Weight; Breast; Clinical Trials as Topic; Contraceptives, Oral, Combined; Desogestrel; Ethinyl Estradiol; Female; Follow-Up Studies; Headache; Humans; Menstrual Cycle; Multicenter Studies as Topic; Nausea; Norpregnenes; Random Allocation