gestodene and Weight-Gain

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

This clinical investigation of a low-dose, monophasic gestodene-containing oral contraceptive (75 micrograms gestodene/30 micrograms ethinylestradiol), investigated contraceptive efficacy, tolerability, cycle control and compliance in 5602 adolescents. The investigation was carried out over a period of 6 cycles. The average age of the study population was 16.4 years; however, only 12 women (0.2%) were under the age of 14. With regard to contraceptive efficacy, during the course of the study there were 5 pregnancies, of which 3 were attributed to user failure. Two pregnancies were recorded as method failure, giving a Pearl Index of 0.08. Cycle control with monophasic gestodene was observed to be excellent. The incidence of spotting and breakthrough bleeding was low and declined during the course of the study, as did amenorrhea. The preparation was tolerated well and the incidence of side-effects was low, with only 4.4% of women withdrawing from the study due to adverse events. An increase in body weight was uncommon, and, at cycle 6, 91.2% of women had not gained weight. At the end of the study, 85.0% of women rated monophasic gestodene as good and 9.6% as satisfactory.

Topics: Adolescent; Blood Pressure; Contraceptives, Oral; Female; Humans; Menstrual Cycle; Norpregnenes; Pregnancy; Uterine Hemorrhage; Weight Gain

The efficacy, cycle control, subjective complaints, and safety of monophasic preparations of the oral contraceptives containing gestodene 75 mcg plus ethinyl estradiol 30 mcg versus desogestrel 150 mcg plus ethinyl estradiol 30 mcg were compared in a 6-cycle, open-label, parallel, randomized, multicenter phase IV clinical study in Latin America. Of a total of 176 women in each group, 163 in the gestodene group and 160 in the desogestrel group completed 6 cycles, providing data for 1,015 and 1,006 cycles, respectively. Subject compliance was excellent; pills were missed during only 6.9% of the cycles in each group. No woman became pregnant during the study. Gestodene group exhibited significantly better cycle control as evidenced by the lower incidence of breakthrough bleeding and spotting. Spotting in some cycles was reported by 11.9% of women taking the gestodene-combination compared with 21% of women taking the desogestrel-combination. Based on number of women, 86.4% of the gestodene group reported all cycles were normal (no BTB) compared with 76.7% of the desogestrel group. Also, the women in the gestodene group reported a significantly lower incidence of nuisance side effects during treatment cycles. No amenorrhea was observed for either group. There were no clinically significant differences between groups with respect to body weight, blood pressure, or laboratory evaluations. Seven women withdrew from the gestodene group and 8 women withdrew from the desogestrel group because of adverse reactions. The results of this study indicate that, although both OCs provided effective contraception, in comparison to the desogestrel-combination, the gestodene-containing OC is associated with better cycle control, less bleeding, and fewer subjective complaints.

Topics: Adolescent; Adult; Contraceptives, Oral, Combined; Desogestrel; Female; Humans; Latin America; Menstrual Cycle; Norpregnenes; Weight Gain

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

In a large and open prospective multicenter trial of 12,250 cycles from 2,378 women, contraceptive efficacy, clinical tolerance and acceptability of a new monophasic contraceptive combination containing 75 mcg gestodene (delta-5-levonorgestrel) and 30 mcg ethinyl oestradiol were studied. The objective was to assess efficacy, safety, side effects and cycle control of this oral contraceptive on healthy women using no other additional birth control methods. Two women became pregnant (0.016%) during the trial; both were patient failures. There was no effect on systolic or diastolic pressures. An average weight increase of 0.3 kg was noted. Cycle control was excellent with 95% of the cycles free of spotting and 98% free of breakthrough bleeding after six cycles. No serious complications occurred. There was an overall incidence of 14% reported side effects (after six cycles), indicating that the hormonal combination is well tolerated. It should be noted that 41.4% of the patients had some complaint before starting the treatment. For all complaints, a highly significant improvement was seen during the treatment.. In a large and open prospective multicenter trial of 12,250 cycles from 2378 women, contraceptive efficacy, clinical tolerance, and acceptability of a new monophasic oral contraceptive (OC) containing 75 mcg gestodene (delta-5-levonorgestrel) and 30 mcg ethinyl estradiol (EE) were studied. The objective was to assess efficacy, safety, side effects, and cycle control for this OC on healthy women using no other additional birth control methods. 2 women became pregnant (0.016%) during the trial; both were patient failures. There were no side effects on systolic or diastolic pressure. An average weight increase of 0.3 kg was noted. Cycle control was excellent with 95% of the cycles free of spotting and 98% free of breakthrough bleeding after 6 cycles. no serious complications occurred. There was an overall incidence of 14% who reported side effects after 6 cycles, indicating that the hormonal combination is well-tolerated. It should be noted that 41.4% of the patients had some complaint prior to the start of treatment. For all complaints, a highly significant improvement was seen during treatment.

Topics: Adolescent; Adult; Amenorrhea; Blood Pressure; Contraceptives, Oral, Combined; Ethinyl Estradiol; Female; Humans; Menstrual Cycle; Norpregnenes; Patient Acceptance of Health Care; Prospective Studies; Weight Gain

This open-label study evaluated the effects on body fat of the use of a low-dose oral contraceptive (gestodene75/EE20) in a group of 61 women (OC-U group) as compared to a nonuser group (OC-N group) of 51 women who did not receive an oral contraceptive. Weight, body mass index (BMI), waist-over-hip ratio and body composition data, obtained by bioelectrical impedance [percentages of body fat (%FAT), water (%TBW) and lean mass (%FFM)], were assessed before and after six treatment cycles. Baseline OC-U group weight, BMI, %FAT, %TBW and %FFM did not differ from the OC-N group, either at baseline or at the end of the study, and did not significantly change within each group during the study. Also, there was no modification of fat distribution in either group. Among women in the OC-U group, there was a slight increase in total cholesterol levels and a trend towards higher triglycerides levels. No changes were detected in blood pressure. In conclusion, this low-dose oral contraceptive did not affect weight or body composition. Thus, our data suggest that gestodene75/EE20 represents an appropriate OC choice and may enhance compliance of women who mistakenly believe that the use of oral contraceptives always leads to weight gain.

Topics: Adolescent; Adult; Body Composition; Body Mass Index; Case-Control Studies; Cholesterol; Contraceptives, Oral, Synthetic; Drug Administration Schedule; Electric Impedance; Female; Humans; Middle Aged; Norpregnenes; Prospective Studies; Triglycerides; Waist-Hip Ratio; Weight Gain

The aim of the study was to evaluate the acceptance and tolerance of combined low-dose oral contraceptives (OCs) (containing 20 micro g ethinylestradiol and 75 micro g gestodene) in a cohort of Polish women, and to present a relationship between the use of combined OCs and changes in body weight. Changes in body weight with combined low-dose OC have not been demonstrated in placebo-controlled trials, nor were such trials performed in a population whose nutritional/dietary habits and lifestyle resemble that of the population of Poland. We performed the clinical study on a group of 800 patients living in several regions of Poland. Patients used the low-dose OC for a period of 6 months. They were assessed every third cycle of OC use (initial examination and examinations after three and six cycles of OC use). On the basis of this investigation, a relationship between OC use and weight gain was not found.

Topics: Adult; Body Mass Index; Contraceptives, Oral; Ethinyl Estradiol; Feeding Behavior; Female; Humans; Life Style; Norpregnenes; Nutritional Physiological Phenomena; Poland; Weight Gain