gestodene and Body-Weight

To estimate whether continuous oral contraceptive pills (OCPs) will result in more pain relief in primary dysmenorrhea patients than cyclic OCPs, which induce withdrawal bleeding with associated pain and symptoms.. We conducted a double-blind, randomized, controlled trial comparing continuous to a cyclic 21-7 OCP regimen (gestodene 0.075 mg and ethinyl estradiol 20 microgram) for 6 months in 38 primary dysmenorrhea patients. The primary outcome was the difference in subjective perception of pain as measured by the visual analog scale over a period of 6 months.. Twenty-nine patients completed the study. In both groups, pain reduction measured by visual analog scale declined over time and was significant at 6 months compared with baseline, with no difference between groups. Continuous regimen was superior to cyclic regimen after 1 month (mean difference -27.3, 95% confidence interval [CI] -40.5 to -14.2; P<.001) and 3 months (mean difference -17.8, 95% CI -33.4 to -2.1; P=.03) of treatment. Secondary outcomes noted no difference between groups in terms of menstrual distress as measured by the Moos Menstrual Distress Questionnaire. After 6 months, there was an increase in weight and a decrease in systolic blood pressure in the continuous group compared with the cyclic group.. Both regimens of OCPs are effective in the treatment of primary dysmenorrhea. Continuous OCPs outperform cyclic OCPs in the short term, but this difference is lost after 6 months.. ClinicalTrials.gov, www.clinicaltrials.gov, NCT00517556.. I.

Topics: Adolescent; Adult; Blood Pressure; Body Weight; Contraceptives, Oral; Drug Therapy, Combination; Dysmenorrhea; Ethinyl Estradiol; Female; Humans; Norpregnenes; Pain; Pain Measurement; Treatment Outcome; Young Adult

The attempt to decrease the hormonal components of combined estrogen/progestin-containing oral formulations has led to use of low-dose formulations. The monophasic formulation containing ethinyl estradiol 20 micrograms (EE20) plus gestodene 75 micrograms (GSD75) was studied in an open, non-comparative, multicenter, clinical trial investigating its efficacy, safety, effects on body weight, blood pressure and sexual function. To evaluate the impact on sexual function, the Golombok Rust Questionnaire on Sexual Satisfaction (GRISS) was used. The study population comprised 216 women treated for 1 year. The EE20/GSD75 formulation did not show any significant effect on blood pressure, hematological parameters, body weight or sexual function. The treatment was well tolerated with a high compliance rate by the patients, with a low rate of estrogen-dependent symptoms. Moreover, there was no overall effect on sexual function, with no disturbance of sexual behavior or activity. In conclusion, our data show that the EE20/GSD75 has a very good tolerability profile, without any significant side-effects.

Topics: Adult; Blood Pressure; Body Weight; Contraceptives, Oral, Combined; Drug Administration Schedule; Drug Combinations; Ethinyl Estradiol; Female; Humans; Italy; Norpregnenes; Patient Compliance; Sexuality; Surveys and Questionnaires; Treatment Outcome

Increases in blood pressure and weight are consequences of increased fluid retention following oral contraceptives administration. Hypertension and weight increase are particularly frequent in women over 35 years of age. The aim of the present study was to evaluate the clinical and hormonal effects of a new extra-low dose oral contraceptive [15 microg ethinyl estradiol (EE) and 60 microg gestodene (GSD)] on the renin-aldosterone system in a group of women aged 35-39 years treated for 3 months compared with a formulation containing the same hormones at a higher dose. Eighteen healthy women, age 35-39 years, were divided into two groups. The first group (10 women) used Arianna, Schering, 15 microg EE/60 microg GSD (EE15/GSD60); the second group (8 women) used Fedra, Schering, 20 microg EE/75 microg GSD (EE20/GSD75). Blood samples were obtained before the study and after 3 months of contraceptive use for assay of renin and aldosterone. Blood pressure was also measured on both occasions. No significant changes in plasma renin activity (PRA) or plasma concentrations of aldosterone were observed between the two groups after 3 months of contraceptive use. The mean increase in body weight after 3 months of contraceptive use was 350 +/- 100 g for EE20/GSD75 and 300 +/- 50 g for EE15/GSD60. There was a mean increase of 4 mm Hg for systolic pressure and 2 mm Hg for diastolic pressure in women on EE20/GSD75 and corresponding increases of 3 and 2 mm Hg in women on EE15/GSD60. The changes were not significant in any case. The results of the present study show that the formulations were well tolerated and provided good control of the menstrual cycle in all 18 women. The contraceptive formulations EE20/GSD75 and EE15/GSD60 have no clinical impact on blood pressure, PRA, or aldosterone in this age group.

Topics: Adult; Aldosterone; Blood Pressure; Body Weight; Contraceptives, Oral; Drug Evaluation; Ethinyl Estradiol; Female; Humans; Hypertension; Norpregnenes; Renin

This prospective, open, randomized study was conducted to compare the contraceptive reliability, cycle control, and tolerability of a 23-day regimen with 20 microg ethinyl estradiol (EE) and 75 microg gestodene (GSD) and a 21-day regimen with 20 microg EE and 150 microg desogestrel (DSG). Participants took either 23 tablets with active substances plus 5 placebo tablets (23-day EE/GSD) or 21 tablets with active substances followed by 7 days without pill-taking (21-day EE/DSG). Contraceptive efficacy, cycle control, and tolerability were evaluated over a period of seven cycles. Efficacy data gathered from 5967 treatment cycles (23-day EE/GSD: 2975 cycles; 21-day EE/DSG: 2992 cycles) were obtained from 890 participants (445 in each group). Both preparations proved to be effective contraceptives and provided good cycle control. No pregnancy during treatment was recorded. This resulted in a study Pearl Index of 0.0 for both treatments. For 23-day EE/GSD, 32.4% of participants reported at least one intracyclic bleeding episode during Cycles 2-4 (primary target) compared to 31.5% for 21-day EE/DSG. In the 23-day EE/GSD group, intracyclic bleeding episodes were reported by 48.8% of the participants in Cycle 1 but in only 15.1% in Cycle 7, and in the 21-day regimen group by 43.4% in Cycle 1 and only 14.2% in Cycle 7. Overall, intracyclic bleeding was reported in 20.9% of cycles for both treatments.A greater number of 23-day EE/GSD participants had shorter withdrawal bleeding periods than with 21-day EE/DSG. In significantly (p <0.0001) more cycles in the 23-day EE/GSD group participants reported withdrawal bleeding periods that lasted only 1-4 days compared to the 21-day EE/DSG group. For the majority of the treatment cycles, the median number of bleeding days in the 23-day EE/GSD group was 4 days and in the 21-day EE/DSG group 5 days. Both preparations were well tolerated and showed a similar adverse events pattern. The discontinuation rate because of adverse events was low (23-day EE/GSD: 6.1%; 21-day EE/DSG: 5.6%). No serious vascular adverse events were reported. More than 82% in the 23-day EE/GSD group and 79% in the 21-day EE/DSG group either lost more than 2 kg of weight or did not gain weight during the study. The treatment effect on blood pressure was negligible. There were no appreciable changes in mean laboratory values over the course of the study compared to baseline.

Topics: Adolescent; Adult; Blood Pressure; Body Weight; Contraceptives, Oral, Combined; Desogestrel; Ethinyl Estradiol; Female; Humans; Menstrual Cycle; Norpregnenes; Time Factors; Treatment Outcome; Uterine Hemorrhage

To assess the contraceptive efficacy, cycle control and acceptability of two monophasic oral contraceptives containing either 30 micrograms ethinylestradiol plus 150 micrograms desogestrel or 30 micrograms ethinylestradiol plus 75 micrograms gestodene.. In a randomized, open-label, six-cycle, group-comparative, multicenter study performed in Brazil, pregnancies, cycle-control parameters, incidence of side-effects and the presence and severity of acne vulgaris were assessed, and blood pressure and body weight were measured at pretreatment and after one, three and six cycles of oral contraceptive use.. Of the 595 women enrolled, 274 (86.7%) in the desogestrel/ethinylestradiol group and 227 (81.4%) in the gestodene/ethinylestradiol group completed the six cycles, providing data for 1753 and 1487 treatment cycles, respectively. Two pregnancies occurred, one of which (in the desogestrel/ethinylestradiol group) was attributed to user failure, whilst the other (in the gestodene/ethinylestradiol group) was thought to result from method failure. Cycle control was observed to be excellent; the incidences of irregular bleeding and minor side-effects were low in both groups and decreased after an initial increase in the first cycle. Pre-existing acne improved in both groups, whereas blood pressure and body weight remained essentially unchanged.. Both desogestrel/ethinylestradiol and gestodene/ethinylestradiol provide effective oral contraception with comparable cycle control and acceptability.

Topics: Acne Vulgaris; Adult; Blood Pressure; Body Weight; Brazil; Contraceptives, Oral, Combined; Contraceptives, Oral, Synthetic; Desogestrel; Estradiol Congeners; Ethinyl Estradiol; Female; Humans; Menstrual Cycle; Norpregnenes; Progesterone Congeners; Severity of Illness Index; Uterine Hemorrhage

In a prospective open-label multicenter trial, safety, tolerance, cycle control and changes in lipid metabolism before and during intake of a low-dose hormonal contraceptive (gestodene 75 mcg + ethinylestradiol 30 mcg) have been investigated under normal conditions of a general or gynecology practice (232 testing physicians, 1321 women). The atherogenic index remained almost unchanged over six cycles observed (3.3 before drug intake vs. 3.28 after drug intake, cycle 6). HDL cholesterol levels increased significantly in the period between prestudy and cycle 6 (+4.4%, p < 0.0001). A very good cycle control was demonstrated, and reliable contraception was achieved, combined with excellent general tolerance. The preparation conclusively suits very well for oral hormonal contraception.

Topics: Adult; Arteriosclerosis; Blood Pressure; Body Weight; Contraceptives, Oral, Combined; Ethinyl Estradiol; Female; Humans; Lipids; Norpregnenes; Progesterone Congeners; Prospective Studies

To determine prospectively whether the use of low-dose estrogen oral contraceptives (OC) is associated with changes in weight, body composition, or fat distribution.. Anthropometric measurements were performed in 49 healthy young (16 to 21 years old) women before commencement of OC use (30 micrograms ethinyl estradiol [EF2] plus 75 micrograms gestodene) and after three and six treatment cycles. Thirty one age- and weight-matched women who were not using OC served as controls.. Outpatient gynecological clinic of Hadassah Medical Center, a tertiary level hospital, and the "Shilo" voluntary service for the prevention of unwanted pregnancy.. Anthropometric measurements included body mass index (BMI), waist-to-hip girth ratio, and body composition (the percentage of body fat and water), estimated by mean of infrared interactance.. In the group of OC users, baseline BMI, percent fat, percent water, and waist-to-hip girth ratio were 21.1 +/- 0.32 (kg/m2), 23.8% +/- 0.63%, 57.4% +/- 0.39%, and 0.73 +/- 0.01, respectively, and did not change significantly after six cycles (20.6 +/- 0.41 [kg/m2], 23.9% +/- 0.57%, 58.1% +/- 0.49%, and 0.72 +/- 0.03, respectively). These measurements were not significantly different when compared with the nonusers. Fifteen OC users (30.6%) gained weight (> 0.5 kg). Weight gain was due to a significant accumulation of fat (from 22.5% +/- 1.1% to 25.6% +/- 0.74%), whereas the percentage of body water remained stable. The waist-to-hip girth ratio also was not changed significantly. Similarly, 11 nonusers (35.4%) gained weight because of similar nonabdominal fat accumulation. Ten OC users (20.4%) lost weight (57 kg +/- 1.51 to 55.4 +/- 1.47 [mean +/- SEM]) and 6 nonusers (19.3%) also lost weight (59 kg +/- 1.42 to 57.3 +/- 1.92). In both groups the loss of weight was not associated with significant change in body composition.. The use of low-dose OC (EE2 plus gestodene) was not associated with overall impact on weight, body composition, or fat distribution. However, when weight gain did occur during OC use, it was due to increase in body fat and not in volume of body water, and it was not associated with changes in fat distribution.

Topics: Adipose Tissue; Adolescent; Adult; Analysis of Variance; Body Composition; Body Mass Index; Body Weight; Contraceptives, Oral, Combined; Ethinyl Estradiol; Female; Humans; Norpregnenes; Probability; Progesterone Congeners; Prospective Studies; Reference Values

Changes in endogenous androgen metabolism were compared in healthy women taking one of four low-dose modern oral contraceptives (OCs). One hundred women were randomized to (1) 35 micrograms ethinyl estradiol (EE) + 250 micrograms norgestimate (Cilest); (2) 20 micrograms EE + 150 micrograms desogestrel (Mercilon); (3) 30 micrograms EE + 150 micrograms desogestrel (Marvelon); or (4) 30 micrograms EE + 75 micrograms gestodene (Femodene). During the luteal phase of the pretreatment cycle, body weight and blood pressure were recorded, and plasma levels of the following variables were recorded: sex-hormone-binding globulin (SHBG), cortisol-binding globulin (CBG), testosterone, free testosterone, dihydrotestosterone, androstenedione, dihydroepiandrosterone sulfate (DHEAS), and hydroxyprogesterone. The free androgen index was also calculated. These variables were remeasured during the third week of OC intake and during the fourth and sixth cycles. There were no statistically significant differences in androgenic variables among the four OCs. The DHEAS concentration decreased less with the 20 micrograms EE + desogestrel formulation compared with either 30 micrograms EE + desogesterel or norgestimate-containing formulations (20% vs. 45%). Concentrations of SHBG and CBG increased significantly in all four groups (average 263 +/- 119% and 94 +/- 26%, respectively); CBG increased less in women taking 20 micrograms EE + desogestrel (about 75%) than in the other formulations (about 100%). The four modern, low-dose OCs tested had similar impacts on endogenous androgen metabolism, yielding significant decreases in testosterone, dihydrotestosterone, androstenedione, and DHEAS. All of these formulations may be beneficial in women with androgen-related syndromes such as acne and hirsutism. Large studies are under way to establish which of the third-generation OCs is the least androgenic. In vitro studies suggest that norgestimate has the least androgenic profile.

Topics: Adult; Androgens; Blood Pressure; Body Weight; Carrier Proteins; Contraceptives, Oral, Combined; Dehydroepiandrosterone; Dehydroepiandrosterone Sulfate; Desogestrel; Dihydrotestosterone; Dose-Response Relationship, Drug; Ethinyl Estradiol; Female; Humans; Hydroxyprogesterones; Norgestrel; Norpregnenes; Progesterone Congeners; Prospective Studies; Serum Albumin; Sex Hormone-Binding Globulin; Testosterone

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

Efficacy, cycle control, tolerance, and adverse events were studied in a clinical Phase IV study using a new progestogen, gestodene, in an amount of 75 micrograms combined with 30 micrograms ethinylestradiol. The study was performed as a multicenter trial in 96,000 patients over a period of 6 cycles. Half of the patients taking the new preparation were first-time OC users, the other half switched from another OC. With regard to contraceptive efficacy, the life-table analysis showed a value of 0.032% for method failure and 0.114% for patient failure. The correspondent Pearl-Index is 0.062 and 0.22. The new drug was found acceptable by more than 90% of the women involved in the trial. Dysmenorrhea present in the "switchers" mostly disappeared on the new OC, while body weight and blood pressure remained virtually unchanged. Thus, it can be concluded that blood pressure and body weight behaviour is similar to that seen with other low-dose OCs. The new combined pill offers excellent cycle stability and has a very favourable effect on dysmenorrhea. The number of clinically diagnosed thrombotic events documented in this study was 0.65 per 1000 woman-years (TWY) and does not exceed the range of events seen in groups of women using non-hormonal methods of contraception (Oxford-FPA study 0.4/TWY and RCGP study 0.8/TWY).. Efficacy, cycle control, tolerance, and adverse events were studied in a clinical phase IV study using a new progestogen, gestodene, in an amount of 75 mcg combined with 30 mcg ethinyl estradiol. The study was performed as a multicenter trial in 96,000 patients over a period of 6 cycles. 1/2 of the patients taking the new preparation were 1st-time OC users, the other 1.2 switched from another OC. With regard to contraceptive efficacy, the life table analysis showed a value of 0.032% for method failure and 0.114% for patient failure. The correspondent Pearl Index is 0.062 and 0.22. The new drug was found acceptable by more than 90% of the women involved in this trial. Dysmenorrhea present in those who switched disappeared for the most part with this new OC, while body weight and blood pressure remained virtually unchanged. Thus, it can be concluded that blood pressure and body weight behavior is similar to that seen with other low-dose OCs. The new combined pill offers excellent cycle stability and has a very favorable effect on dysmenorrhea. The number of clinically diagnoses thrombotic events documented in this study was 0.65/1000 woman-years (TWY) and does not exceed the range of events seen in groups of women using nonhormonal methods of contraception (Oxford-FPA study 0.4/TWY and RCGP study 0.8/TWY).

Topics: Adult; Blood Pressure; Body Weight; Contraceptives, Oral, Combined; Dose-Response Relationship, Drug; Drug Evaluation; Dysmenorrhea; Ethinyl Estradiol; Female; Humans; Norpregnenes; Ovulation; Thromboembolism

The monophasic low-dose contraceptive containing 30 micrograms of ethinyl estradiol and 75 micrograms of gestodene has been tested in numerous clinical studies to determine contraceptive reliability, cycle control, and influence on metabolism and to uncover concomitant symptoms. Clinical data have been derived from continuous phase III studies. Now that the preparation has been introduced in several countries, the opportunity to assemble comprehensive experience has been taken by initiating phase IV studies. Documentation on 600,000 therapy cycles with monophasic gestodene among 100,000 women is already available. The drop-out rate was low. A large number of women participated in the clinical studies for a long time--some up to 3 years. Study results showed that contraceptive reliability was high and cycle control was excellent. The gestodene combination was well tolerated. The frequency of concomitant symptoms was low. The monophasic gestodene meets the basic criteria essential for an oral contraceptive.

Topics: Adult; Blood Pressure; Body Weight; Contraceptives, Oral, Combined; Drug Evaluation; Ethinyl Estradiol; Female; Humans; Menstrual Cycle; Norpregnenes; Patient Dropouts; Pregnancy

The monophasic combination preparation containing 30 micrograms ethinyl estradiol and 75 micrograms gestodene was tested for contraceptive reliability, cycle control and tolerability in a total of seven phase III clinical studies. A total of 6,854 women were included in these studies, and 69,978 cycles were monitored. Following the commercial introduction of the preparation, further clinical data were obtained with a broader user population. In Germany it was possible to implement an extraordinarily extensive phase IV study in a very short period of time. A total of 523,477 treatment cycles in 95,906 women were included in the analysis. So, for what is probably the first time, a prospective general clinical study for an oral contraceptive was conducted of the same magnitude as the biggest cohort epidemiologic studies. The results of the various phase III and phase IV studies are in close agreement. The combination preparation containing gestodene proved to have high contraceptive reliability and gave excellent cycle control. It was well tolerated and the frequency of adverse reactions was low. To summarize, the monophasic gestodene completely fulfills the demands made of oral contraceptives today.

Topics: Adolescent; Adult; Blood Pressure; Body Weight; Contraceptives, Oral, Combined; Ethinyl Estradiol; Evaluation Studies as Topic; Female; Humans; Menstrual Cycle; Norpregnenes; Thromboembolism

We evaluated the effects on glucose and lipid metabolism in 57 healthy volunteers randomly assigned to one of three low-dose oral contraceptives: two monophasic (desogestrel + ethinylestradiol, EE, and cyproterone acetate + EE) and one triphasic (gestodene + EE) contraceptives. Glucose and insulin responses during OGTT were slightly affected by the cyproterone pill. The insulin area/glucose area ratio and HbA1c level were unchanged in all women. No preparation affected total and LDL-cholesterol levels. Triglycerides rose in all groups, while HDL-CH did only in women taking the two monophasic pills. The three low-dose pills assessed in this study have negligible effects on glucose and lipid metabolism.. In a study of low-dose oral contraceptives, it was found that the low dosage caused insignificant effects on glucose and lipid metabolism. 57 women of good health were studied and divided into 3 groups determined by the preparation given: monophasic desogestrel, monophasic cyproterone acetate, and triphasic gestodene. There was no family history of diabetes mellitus nor was there hyperlipoproteinemia in any of the women. Among the 3 groups, there were negligible differences concerning glucose and insulin levels and lipid profiles. This held true at both the beginning and concluding stages of the study. In all of the women, the insulin area/glucose area ratio was unaffected. Lipid metabolism and hyperglycemia have been linked to heart disease, and other reports have shown glucose and lipid abnormalities produced in women taking the 2 most popular progestins, norgestrel and norethindrone. Thus, the minor effects on carbohydrate and lipid metabolism found in these tests are significant.

Topics: Adult; Androgen Antagonists; Blood Glucose; Body Weight; Cholesterol; Contraceptives, Oral, Combined; Cyproterone; Cyproterone Acetate; Desogestrel; Ethinyl Estradiol; Female; Glucose Tolerance Test; Humans; Insulin; Norpregnenes; Progesterone Congeners; Random Allocation; Reference Values; Triglycerides

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

In three ongoing open studies conducted by 50 investigators in Europe, South America, and New Zealand, 639 subjects followed a new triphasic regimen of gestodene (GTD) and ethinyl estradiol (EE) for 3,020 cycles. One study used GTD + EE only, but in each of the other two studies a comparator oral contraceptive (OC) also was given: norethisterone (NET) + EE in one and desogestrel (DSG) + EE in the other. The objective of all three studies was to assess the efficacy, cycle control, and safety of the triphasic GTD + EE. The following is a report of the interim results. Statistical analysis was performed only on differences between groups in the incidences of bleeding irregularities. During six treatment cycles, subjects either followed the GTD + EE regimen (50 micrograms GTD + 30 micrograms EE for 6 days, 70 micrograms GTD + 40 micrograms EE for 5 days, and 100 micrograms GTD + 30 micrograms EE for 10 days) or took triphasic NET + EE or monophasic DSG + EE. Each cycle concluded with a seven-day hiatus in study medication. No pregnancies occurred with any of the contraceptive preparations (Pearl Index = 0). Compliance was good in all studies and a majority of subjects were still participants at cycle 6. Normal bleeding was reported during 92% of the total evaluable cycles of GTD + EE use. Cycle control with GTD + EE was superior to that with NET + EE or DSG + EE: Breakthrough bleeding occurred in 1.5% of the pooled GTD + EE cycles versus 6.6% of the NET + EE cycles and 2.6% of the DSG + EE cycles; spotting occurred in 4.5% of the GTD + EE cycles versus 9.7% of the NET + EE cycles and 10.3% of the DSG + EE cycles; and breakthrough bleeding plus spotting occurred in 2.1% of the GTD + EE cycles versus 8.1% of the NET + EE cycles and 4.6% of the DSG + EE cycles. Amenorrhea occurred in 2.0% of the cycles with NET + EE, but was reported by only 0.3% of all the subjects given GTD + EE and 0.7% of those given DSG + EE. Cycle length and intensity of bleeding changed little during the use of any of the study preparations. Mean length of withdrawal bleeding during the GTD + EE regimen shortened from 4.5 days (prestudy) to 4.0 days. With each OC, the subjects' mean weight during cycles 3 and 6 differed less than 0.5 kg from baseline values.(ABSTRACT TRUNCATED AT 400 WORDS)

Topics: Adult; Blood Pressure; Body Weight; Contraceptives, Oral, Combined; Desogestrel; Ethinyl Estradiol; Europe; Female; Humans; Menstrual Cycle; Multicenter Studies as Topic; New Zealand; Norethindrone; Norpregnenes; Patient Compliance; South America

Metabolic parameters were studied in 30 patients over 12 treatment cycles in a double-blind randomized comparative trial of the new progestogen gestoden in a triphasic formulation against a fixed dose combination pill containing desogrestrel, in Bandung, Indonesia. The results of this laboratory experience affirm findings in similar previous metabolic studies that: (1) the changes induced by modern low-dose pills are clinically and statistically insignificant; (2) throughout the treatment cycles, the values of the various laboratory tests remain well within the normal range; and (3) the favorable balance between coagulation and fibrinolysis is maintained. Results of lipoprotein, coagulation, fibrinolytic and liver function tests in 27 patients are presented. Gestoden's pharmacologic profile and the worldwide clinical experience with the triphasic gestoden formulation in 4285 women are discussed.

Topics: Blood Coagulation; Blood Pressure; Body Weight; Contraceptives, Oral; Contraceptives, Oral, Combined; Contraceptives, Oral, Sequential; Ethinyl Estradiol; Female; Humans; Lipoproteins; Liver; Liver Function Tests; Norpregnenes

The aim of the study is to follow the influence of the very low dose oral contraception on the blood presure, body weight and general condition of the patients.. 302 women at a mean age of 25.65 +/- 6.81 years were enroled in the study. They were treated with Lindynette-20 (20 mcg ethinyl-estradiol and 75 mcg gestodene) for six months.. The mean systolic and diastolic blood pressure of the patients is as follows: at inclusion--Systolic 106.62 mmHg/Diastolic 67.88 mmHg, at the 3-th month--Systolic 106.84 mmHg/Diastolic 68.00 mmHg and at the 6-th month--Systolic 106.40 mmHg / Diastolic 68.51 mmHg. No statistically significant difference was found (p > 0.05). At the end of the sixth month 89.04% of the patients did not increased their body weight with more than 2 kg, in 6.31% it was reduced with more than 2 kg and in 4.65% was increased with more than 2 kg. The most frequent side effects were: headache (14%), breast tenderness (7%), nausea (3%), emotional instability (6%). At the end of the period most of the patients have excellent--81.13%, very good--17.55% and good--0.99% tolerance to the treatment.. Use of a very low dose oral contraception does not lead to a significant changes in the blood pressure and clinically significant changes in the body weight with an excellent and very good treatment tolerance of the patients.

Topics: Adolescent; Adult; Blood Pressure; Body Weight; Contraception; Contraceptives, Oral, Synthetic; Ethinyl Estradiol; Female; Humans; Norpregnenes; Young Adult

Topics: Adolescent; Adult; Body Weight; Contraceptives, Oral, Combined; Ethinyl Estradiol; Female; Humans; Menstrual Cycle; Norpregnenes

The purpose of this study was to compare cycle control, efficacy and side effects of an oral contraceptive containing 20 microg ethinylestradiol and 75 microg gestodene, with a reference preparation containing 30 microg ethinylestradiol combined with 75 microg gestodene. From the study, it was demonstrated that the two regimens had no difference in cycle control, efficacy, and side effects. The occurrence of spotting and breakthrough bleeding was low and was not different between these two preparations. The most common adverse events in both treatment groups were nausea, vomiting, dizziness, and chloasma. There were no statistically significant change in body weight and blood pressure in both groups at the end of study. It is concluded that both preparations are good cycle control, reliable and low side effects oral contraceptives.

Topics: Adult; Blood Pressure; Body Weight; Contraceptives, Oral; Dizziness; Ethinyl Estradiol; Female; Humans; Melanosis; Menstrual Cycle; Nausea; Norpregnenes; Thailand; Uterine Hemorrhage; Vomiting

Evaluation of the impact of an oral contraceptive on body weight with a comparison ofwomen who completed versus women who prematurely discontinued intake.. Data on body weight were retrospectively analyzed from four large prospective clinical trials with an oral contraceptive containing 20 microg ethinylestradiol and 75 microg gestodene (EE/GSD). A total of 1971 young fertile women were included in the evaluation, and 1467 completed 12 cycles.. We found no clinically relevant change of body weight during treatment with an oral contraceptive containing 20 microg ethinylestradiol and 75 microg gestodene in the vast majority of users after 12 treatment cycles. The mean change of body weight was less than 0.3 kg in this time period for all users. Nearly 70% of women experienced a minor change in their body weight of +/- 2 kg. An additional 13% lost more than 2 kg body weight in the course of 12 treatment cycles. A total of 11% increased their weight by 2-4 kg. A total of 1255 (85.5%) of women had a body mass index (BMI) of < or = 25 at baseline compared to 1253 (85.4%) after 12 cycles of treatment. There was no significant difference in the change ofbody weight between the women completing 12 cycles of treatment and those who prematurely discontinued EE/GSD.. This retrospective analysis confirms that there was only a negligible change of body weight during intake of an oral contraceptive containing 20 microg ethinylestradiol and 75 microg gestodene. There was no difference in weight change between the women completing the study or discontinuing intake.

Topics: Adolescent; Adult; Body Weight; Contraceptives, Oral, Combined; Contraceptives, Oral, Synthetic; Drug Combinations; Estradiol Congeners; Ethinyl Estradiol; Female; Humans; Norpregnenes; Patient Compliance; Progesterone Congeners; Retrospective Studies

New steroidal compounds have been recently synthetized and analysed in order to improve the metabolic tolerance of oral contraception. Gestodene, a new progestogen from the 19 nortestosterone series seems to fulfil these conditions. It has also high antigonadotropic effects. The authors report the clinical results of a study with a triphasic combination containing Gestodene. Despite the small doses of hormones, this triphasic combination with Gestodene provides excellent contraceptive efficacy and good cycle control and clinical tolerance.

Topics: Blood Pressure; Body Weight; Contraceptives, Oral; Drug Tolerance; Female; Humans; Menstrual Cycle; Norpregnenes; Progesterone Congeners

The estrogen component used in virtually all oral contraceptive pills today was synthesized in the laboratories of Schering AG in 1938. The progestogen component varies, but levonorgestrel has become the standard among the lowest-dose pills available. Various attempts to modify the levonorgestrel molecule have resulted in new progestogens like norgestimate and desogestrel without much greater biological activity; therefore, further reduction in dose is unlikely. Gestoden, the newest progestogen from the levonorgestrel class, synthesized in Schering AG's laboratories, is different. Its enhanced biological activity allows for a progestogen content in a fixed combination pill half that in other low-dose pills available today. Furthermore, it has an improved pharmacologic profile with favorable dissociation of the androgenic and progestogenic activities. A unique anti-mineralocorticoid action is seen resembling natural progesterone, a property not presently shared with other synthetic progestogens. Results will be presented from clinical trials with a new monophasic gestoden preparation.

Topics: Blood Pressure; Body Weight; Drug Combinations; Ethinyl Estradiol; Female; Humans; Menstrual Cycle; Menstruation; Norpregnenes