gestodene and Dysmenorrhea

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

Topics: Adolescent; Adult; Contraceptives, Oral, Synthetic; Dysmenorrhea; Female; Humans; Menstrual Cycle; Norpregnenes; Progesterone Congeners; Time Factors

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

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.

Topics: Adult; Contraceptives, Oral, Combined; Dysmenorrhea; Ethinyl Estradiol; Female; Follow-Up Studies; Humans; Menstrual Cycle; Middle Aged; Norpregnenes; Patient Compliance; Pregnancy

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

Limited attention has been focused on the medical treatment of bowel endometriosis. This study evaluates the efficacy of administration of a continuous low-dose oral contraceptive in treating pain and other symptoms associated with colorectal endometriotic nodules, as evaluated by rectal endoscopic ultrasonography.. Prospective observational study.. Academic Department of San Raffaele Scientific Institute, Obstetrics and Gynecology Unit.. Symptomatic women of reproductive age (n=26) with colorectal nodules infiltrating at least the bowel muscularis propria and without a stenosis >50%. In 31% of the patients, endoscopic ultrasonography permitted diagnosis of nodules located more than 10 cm from the anal rim.. Patients received a continuous low-dose oral contraceptive containing 15 μg ethinylestradiol and 60 μg gestodene for 12 months. Subjective symptoms were prospectively evaluated, and nodule volumes were monitored using endoscopic ultrasonography.. Nodule measurements were performed at baseline and after 12 months of treatment. Symptoms at the start and after 12 months were evaluated.. A significant improvement in the intensity of all the considered symptoms (dysmenorrhea, non-menstrual pelvic pain, deep dyspareunia and painful defecation) was seen when evaluated by a visual analog scale. A reduction in terms of both diameter (mean reduction 26%) and volume of the nodules (mean reduction 62%) was observed after a 12 month period.. A continuous low-dose oral contraceptive therapy may reduce bowel endometriosis-associated symptoms. In addition, this therapy induces a significant volumetric reduction of colorectal plaques when evaluated by endoscopic ultrasonography.

Topics: Adult; Colonic Diseases; Contraceptives, Oral, Synthetic; Dose-Response Relationship, Drug; Drug Combinations; Dysmenorrhea; Dyspareunia; Endometriosis; Endosonography; Ethinyl Estradiol; Female; Humans; Norpregnenes; Pain Measurement; Pelvic Pain; Prospective Studies; Rectal Diseases

Membranous dysmenorrhea involves the spontaneous slough of the endometrium in one cylindrical or membranous piece that retains the shape of the uterine cavity. Because this entity is rarely mentioned in the medical literature, the purpose of this report is to describe two such cases.. An 18-year-old nullipara with regular menstrual cycles presented with membranous dysmenorrhea after taking the contraceptive Gynera (Gestodene 0.075 mg, ethinyl estradiol 0.030 mg). Symptoms disappeared when the medication was discontinued. The second patient, a 26-year-old woman, gravida 1, para 1, was on a 10-day monthly regimen of Provera (medroxyprogesterone acetate) 2.5 mg/day for dysfunctional uterine bleeding. When the Provera dose was increased to 10 mg/day, the symptoms disappeared.. Membranous dysmenorrhea is "a disease of theories" with various recommended medications. When this condition is caused by iatrogenic treatment, the best approach is to discontinue the offending drug or change its dosage.

Topics: Adolescent; Adult; Contraceptives, Oral; Decidua; Dose-Response Relationship, Drug; Dysmenorrhea; Endometrium; Female; Humans; Medroxyprogesterone Acetate; Membranes; Menstruation Disturbances; Norpregnenes; Pregnancy; Vaginal Diseases