gestodene and Amenorrhea

To investigate the bleeding pattern and cycle control parameters of a contraceptive patch containing 0.55 mg ethinyl estradiol (EE) and 2.1 mg gestodene (GSD) compared with a patch containing 0.6 mg EE and 6 mg norelgestromin (NGMN).. In this phase III, open-label, randomized, parallel-group trial, healthy women aged 18-35 years (smokers aged 18-30 years) received either the EE/GSD patch (n=200) or the EE/NGMN patch (n=198). Treatment consisted of one patch per week for 3 weeks followed by a 7-day, patch-free interval for seven cycles. Bleeding control was assessed in two 90-day reference periods.. In reference period 1, mean number of bleeding/spotting days was comparable across treatment groups (p>0.05). However, in reference period 2, there were fewer bleeding/spotting days in the EE/GSD patch group (15.7 versus 18.4; p<0.0001). Mean number of bleeding/spotting episodes was comparable across groups for both reference periods, but bleeding/spotting episodes were shorter for the EE/GSD patch than the EE/NGMN patch during reference period 1 (5.13 days versus 5.53 days, respectively; p<0.05) and reference period 2 (5.07 versus 5.66; p=0.0001). Both treatment groups showed a similar frequency of withdrawal bleeding episodes; however, across all seven cycles, the length of these episodes was consistently shorter with the EE/GSD patch (p<0.01). There were no notable treatment differences in intracyclic bleeding.. Bleeding pattern and cycle control achieved with the EE/GSD patch was similar to that of the EE/NGMN patch.. The paper presents data on the bleeding pattern and cycle control parameters of an investigational transdermal contraceptive patch containing EE and GSD compared with an approved contraceptive patch containing EE and NGMN. This descriptive study found that bleeding patterns associated with the EE/GSD patch were similar to those of an EE/NGMN patch providing higher EE exposure.

Topics: Adolescent; Adult; Amenorrhea; Austria; Contraceptive Agents, Female; Czech Republic; Drug Combinations; Estrogens; Ethinyl Estradiol; Female; Humans; Incidence; Mastodynia; Menorrhagia; Menstrual Cycle; Metrorrhagia; Netherlands; Norgestrel; Norpregnenes; Patient Dropouts; Progestins; Transdermal Patch; Young Adult

The aim of this study was to investigate the bleeding pattern and cycle control of a contraceptive patch containing 0.55 mg ethinyl estradiol (EE) and 2.1 mg gestodene (GSD) compared with a combined oral contraceptive (COC) containing 0.02 mg EE and 0.1 mg levonorgestrel (LNG).. In this phase III, randomized, controlled, double-blind, double-dummy, multicenter trial, healthy women aged 18-45 years (smokers aged 18-35 years) received either the EE/GSD patch and a placebo tablet (n=171), or a placebo patch and the COC (n=175) for seven 28-day cycles. Bleeding control was assessed in two 90-day reference periods.. Mean number of bleeding/spotting days was comparable across treatment groups in both reference periods (p>.05). Mean number of bleeding/spotting episodes was also comparable in reference period 1; however, there were fewer bleeding/spotting episodes for COC in reference period 2 (3.4 versus 3.1; p=.01). Mean length of bleeding/spotting episodes was comparable across treatment groups for both reference periods (p>.05). Withdrawal bleeding occurred consistently in both groups over the entire treatment period, but its absence was more common in the COC group in cycles 4 and 6 of reference period 2 (p<.01). Intracyclic bleeding was comparable between groups.. Bleeding pattern and cycle control with the EE/GSD patch was comparable to an EE/LNG-containing COC.. The findings suggest that bleeding patterns with the EE/GSD patch are similar to an EE/LNG-containing COC, except for absence of withdrawal bleeding, which was less common in patch users. The EE/GSD patch may constitute an additional contraceptive option for women.

Topics: Adolescent; Adult; Amenorrhea; Contraceptive Agents, Female; Contraceptives, Oral, Combined; Double-Blind Method; Drug Combinations; Estrogens; Ethinyl Estradiol; Female; Humans; Levonorgestrel; Menorrhagia; Menstrual Cycle; Metrorrhagia; Norpregnenes; Patient Dropouts; Progestins; Transdermal Patch; United States; Young Adult

The aim of this study was to compare contraceptive reliability, cycle control, and tolerance of an oral contraceptive containing 20 micrograms ethinylestradiol (EE2) and 75 micrograms gestodene (GSD), with a reference preparation containing a similar dose of gestodene but in combination with 30 micrograms ethinylestradiol. A higher incidence of intermenstrual bleeding was apparent under the 20 micrograms EE2 oral contraceptive. For the 20 micrograms EE2 preparation, 47.4% of all women reported spotting at least once over a period of 12 treatment cycles, whereas this figure was 35.5% for the 30 micrograms EE2 pill (p < 0.05). However, the incidence was within a range that corresponds to that of other OCs. The cumulative breakthrough bleeding rates (at least once during the one year of treatment) of 14.5% (20 micrograms EE2) and 11.8% (30 micrograms EE2) of women were not significantly different. In relation to all cycles, the intermenstrual bleeding rates were remarkably lower, indicating that the majority of the volunteers experienced such events only in few cycles under treatment: the spotting rate was 11.5% (20 micrograms EE2) and 7.2% (30 micrograms EE2) of all cycles, and the breakthrough bleeding rate was 2.6% and 1.6% of all cycles, respectively. Three pregnancies were recorded during the study (one in the 20 micrograms EE2 + 75 micrograms GSD group, two in the 30 micrograms EE2 + 75 micrograms GSD group). All three could be explained either by intake irregularities or by circumstances impairing the contraceptive effect. The influence of both treatments on the blood pressure and body weight proved to be extremely slight. Adverse events in both groups were rare and differences in the frequency of adverse events were not apparent. The discontinuation rate due to adverse events, including intermenstrual bleeding, was low (9.8% for 20 micrograms EE2 + 75 micrograms GSD, and 7.2% for 30 micrograms EE2 + 75 micrograms GSD) and was in the lower range known for other oral contraceptives. Both preparations were well accepted by the volunteers. The data obtained demonstrate clinically acceptable cycle control, good tolerance, and a high standard of contraceptive reliability for both drugs. Prescription of the 20 micrograms EE2 preparation could be the first-line therapy in order to provide the lowest amount of EE2 possible. In case of persistent cycle control problems, a switch to the 30 micrograms EE2 drug should be considered.. A double-blind, comparative study of oral contraceptives (OCs) containing 75 mcg of gestodene and either 20 mcg or 30 mcg of ethinyl estradiol (EE2) indicates that the lower-dose formulation neither compromises contraceptive effectiveness nor produces unacceptable cycle control. Study subjects included 649 randomly selected healthy women requesting contraception from 10 family planning centers in Germany; the 20 mcg EE2 pill was evaluated in 428 women for a total of 4470 cycles, while the 30 mcg preparation was tested in 221 women for 2377 cycles. During the 12-month study period, the incidence of at least 1 episode of intermenstrual bleeding (generally in the first cycle) was significantly greater in the 20 mcg EE2 group (47.4%) than in the 30 mcg group (35.5%); however, the cumulative breakthrough bleeding rates (14.5% and 11.8%, respectively) were not dissimilar. In relation to the sum of all cycles, the spotting rates were 11.5% for the 20 mcg EE2 OC and 7.2% for the 30 mcg OC, and the breakthrough bleeding rates were 2.6% and 1.6%, respectively. The 3 pregnancies that occurred all involved user failure. The discontinuation rates due to side effects, including spotting, were 9.8% in the 20 mcg EE2 group and 7.2% in the 30 mcg group. 66.6% of women in the former group and 71.0% of those in the latter group never complained of an adverse effect during the study. The incidences of spotting and discontinuation were well within the range reported for other OCs. These findings indicate that the 20 mcg EE2 preparation should be prescribed first; if cycle control problems persist, a 30 mcg EE2 OC can be considered.

Topics: Adult; Amenorrhea; Contraceptives, Oral, Combined; Contraceptives, Oral, Synthetic; Double-Blind Method; Estradiol Congeners; Ethinyl Estradiol; Female; Germany; Humans; Incidence; Menstruation; Norpregnenes; Time Factors; Uterine Hemorrhage

This long-term, open-label multicenter study investigated the clinical efficacy and tolerability of a monophasic oral contraceptive containing 20 micrograms ethinylestradiol and 75 micrograms gestodene. A total of 670 women between the ages of 18 and 45 years received the trial preparation over a 3-year period, giving 19,095 evaluable cycles. Of the 670 participants in the study, 75% completed at least 24 cycles with the trial preparation and 46% remained in the study for the full 3 years. One pregnancy occurred during the study which was considered by the investigator to be the result of misuse of the drug, giving an uncorrected Pearl Index of 0.07. Cycle control with the trial preparation was good, especially in women who did not miss any pills. By cycle 3, only 10.2% of women who had not missed pills reported intermenstrual bleeding (scanty or medium/excessive bleeding) and this decreased to 2.3% by cycle 36. The preparation was well tolerated, with a low incidence of unprompted adverse events. There were no clinically significant changes in mean body weight or blood pressure. Over the 3 years of the study, 10% of women withdrew from the study for reasons related mostly to mild adverse events. Results from this study demonstrate that the trial preparation is a reliable and well-tolerated oral contraceptive that provides good cycle control.

Topics: Adolescent; Adult; Amenorrhea; Contraceptives, Oral, Combined; Dysmenorrhea; Ethinyl Estradiol; Female; Humans; Menstrual Cycle; Norpregnenes; Patient Compliance; Pregnancy; Uterine Hemorrhage

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

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

To report the long-term management of a case of premature ovarian insufficiency of unknown origin in a young woman with Crohn's disease.. Here is reported the case of a 20 years old woman with Crohn's disease presenting with two years amenorrhea and FSH and LH levels of 255 mIU/ml and 182 mIU/ml respectively, who received 10 months corticosteroid treatment followed by 7 years of estro-progestin treatment.. Corticosteroid treatment was ineffective in restoring patients gonadotropin levels as well as ovarian volume, while estro-progestins promoted a prompt reduction in gonadotrophin levels, which returned in the normal range after two years of treatment, as well as restoration of ovarian function, which occurred after four years of estrogens administration, as demonstrated by normal ovarian volume and ovulatory follicles at ultrasound, and by the re-establishment of regular menses after estroprogestin discontinuation.. Long-term suppression of the endogenous gonadotropins using estroprogestins may be suggested as a treatment able to restore ovarian responsiveness even in patients with premature ovarian insufficiency showing highly elevated gonadotropin levels.

Topics: Adult; Amenorrhea; Crohn Disease; Drug Combinations; Ethinyl Estradiol; Female; Follicle Stimulating Hormone; Follow-Up Studies; Humans; Luteinizing Hormone; Norpregnenes; Ovary; Primary Ovarian Insufficiency; Time Factors; Treatment Outcome; Young Adult

This open, prospective, noncomparative study evaluated clinical and metabolic aspects of the use of a contraceptive combination of ethinyl estradiol (30 microg) and gestodene (75 microg) continuously for 24 weeks in 45 women aged 25 +/- 3.7 years. No alterations in weight or blood pressure were observed. Few side effects were recorded. Amenorrhea rates increased from the fourth month of observation onwards, reaching 81.2% by week 24. A reduction in the levels of cholesterol and LDL and an increase in HDL and triglycerides were observed. Insulin levels increased but not significantly, while levels of glycemia remained unchanged. Levels of antithrombin III, fibrinogen and plasminogen activator inhibitor-1 (PAI-1) increased, whereas a reduction was observed in proteins C and S and in prothrombin time (PT). Activated partial thromboplastin time (APTT) remained unchanged. The treatment was associated with satisfactory clinical effects, high rates of amenorrhea after the third treatment cycle, and resulted in metabolic changes similar to those encountered during the classic use of contraceptive pills with monthly interruption for withdrawal bleeding.

Topics: Adolescent; Adult; Amenorrhea; Antithrombin III; Blood Glucose; Cholesterol; Cholesterol, HDL; Cholesterol, LDL; Contraceptives, Oral, Combined; Drug Administration Schedule; Ethinyl Estradiol; Female; Fibrinogen; Humans; Insulin; Norpregnenes; Plasminogen Activator Inhibitor 1; Prospective Studies; Prothrombin Time; Triglycerides