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Query: UMLS:C0547004 (Intermenstrual bleeding)
 32 document(s) hit in 31,850,051 MEDLINE articles (0.00 seconds)

Clinical experience with Femovan (Schering AG, Berlin), a combined oral contraceptive containing 0.075 mg gestodene and 0.030 mg ethinyl estradiol, in 3267 women at 165 hospitals and private practices in Germany, from December 1985-February 1988, is presented. 46% were new pill users, 54% switched from other formulations, usually contained 0.030 mg ethinyl estradiol and levonorgestrel, desogestrel, norethisterone or lynestrenol. Each subject gave informed consent, was within 10% of normal weight, kept a menstrual diary, and attended for follow-up at 3, 6, 9, 12, 15 and 18 months. They averaged 24.7 years old. 98.7% continued for 6 cycles; 56.6% for 12 cycles and 33.4% for 18 cycles. While 90% of the dropouts did not return for follow up, stated reasons for stopping were 10.3% for minor side effects of headaches, intermenstrual bleeding and weight gain, and 8 for planned pregnancy. 7 pregnancies were recorded, 5 related to errors in taking tablets or 2 or more pills, giving a Pearl Index of 0.065 for method failure and 0.16 for patient failure. Both the flow and duration of menstrual bleeding tended to decrease. Intermenstrual bleeding occurred in 15.9% of new pill users, declining to 3.7% of all women by the 4th-6th cycles, often associated with omitted pills. There were no significant changes in weight or systolic or diastolic blood pressure. Numbers of complaints of minor side effects decreased or disappeared in 50-85%. Acne developed in 58 women but declined to 14 women after 12 cycles; acne pre-existed in 377 women improved in 41% after 3 cycles.
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PMID:Long-term experience with a low-dose oral contraceptive. 215 May 81

The new low-dose combination oral contraceptive (OC) containing 75 micrograms of the new progestogen gestodene (GTD) plus 30 micrograms ethinyl estradiol (EE) was clinically tested and compared with a levonorgestrel (LNG) combined pill (150 micrograms LNG plus 30 micrograms EE). In a randomized clinical comparative study (A), 176 women were treated with the GTD-containing pill and 185 with the LNG-containing pill for six cycles. This study was followed by a second multicenter study (B) covering 707 patients taking the GTD-containing pill for up to 24 cycles (total, 9,947 cycles). In a third study (C), metabolic effects were assessed using a randomly organized baseline control trial (pretreatment/treatment cycles); 30 patients received the GTD-containing pill and 30 received the LNG-containing pill. Carbohydrate metabolism, lipid metabolism, and blood clotting were investigated, and an interim analysis was performed after six OC cycles. No pregnancies and no severe side effects occurred in any of the studies. Intermenstrual bleeding decreased as usual during treatment. In the total number of gestodene cycles in studies A and B, there was a 6.9% incidence of spotting, a 0.8% incidence of breakthrough bleeding, and a 0.7% incidence of both spotting and breakthrough bleeding in studies A and B patients taking gestodene. Amenorrhea occurred in 0.6% of cycles. Body weight remained unchanged (+/- 2 kg) after 24 cycles in 80.5% of study B patients taking gestodene. Blood pressure remained normal in about 95% of all study B patients; a normalization was observed in greater than 60% of patients with previously elevated blood pressure. No clinically relevant changes in carbohydrate metabolism, lipid metabolism, or blood clotting were observed in study C. The new GTD-containing low-dose combination pill proved to be a safe and reliable contraceptive agent.
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PMID:Clinical and metabolic effects of gestodene and levonorgestrel. 290 45

A comparative clinical trial of two combined oral contraceptives (OCs) with equivalent estrogen content, but different amounts of progestogens, was conducted at the Centro Medico Especializado em Planejamento Familiar in Rio Clara, Brazil. The study was designed to determine the differences in discontinuation rates between Norinyl 1/35 (Syntex) and Brevicon (Syntex) as well as the frequency of selected side effects which might contribute to method discontinuation. Both OCs contain 0.035 mg of ethinyl estradiol; Brevicon contains 0.5 mg and Norinyl 1/35 contains 1 mg norethindrone. Three-hundred women enrolled in the study were randomly assigned to either the Norinyl 1/35 or Brevicon OCs and follow-up visits were scheduled at 1, 4, 8 and 12 months after admission. Intermenstrual bleeding was reported by significantly more women in the Brevicon group than in the Norinyl group (p less than 0.05), and significantly more Brevicon users reported an increase in intermenstrual bleeding. At the end of the study period, no differences were found between the two OC groups in terms of discontinuation rates, but a large number of women in each group discontinued for menstrual problems. The total discontinuation rates at 11 months for both groups were extremely high: 68.2 for the Norinyl 1/35 group and 75.2 for the Brevicon users. The largest group of discontinuations were comprised of those discontinuing for menstrual problems, other personal reasons, planned pregnancy and side effects.
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PMID:A comparative clinical trial of Norinyl 1/35 versus Brevicon in Rio Clara, Brazil. 305 83

A monophasic oral contraceptive (OC) containing 30 mcg ethinyl estradiol and 150 mcg desogestrel is the most commonly used OC in Europe. Desogestrel alone inhibits ovulation at 60 mcg/day. Breakthrough bleeding occurs in about 2.5% of all cycles. Intermenstrual bleeding occurs in about 8% of cycles. It is most common in cycle 1 and then decreases with subsequent cycles. Few women using this combined OC discontinue because of bleeding problems. Desogestrel's low androgenicity accounts for low incidences of acne and hirsutism. The combined OC causes few minor side effects. It appears to increase high density lipoprotein-cholesterol levels and to decrease low density lipoprotein-cholesterol levels. Even though various monophasic OCs significantly increase the area under the curve (AUC) for glucose, insulin, and C-peptide, the desogestrel-OC was the least active for glucose at 50% and one of the two lowest for insulin (20%) and C-peptide (16%). The increased AUCs signify a moderate slowed response to glucose loading and increased insulin resistance, rather than a diabetes-like situation. The trends in values for fibrinolytic activity and for fibrinogen suggest that the desogestrel-OC activates the clotting system, but European studies show that the clotting behavior activated by the desogestrel-OC is no different than that activated by a gestodene-monophasic OC. Desogestrel has a long half-life (23.8 hours) which prolongs the period during which women who miss 1-2 pills can be protected from pregnancy. In conclusion, the desogestrel-OC provides reliable contraception and good cycle control. It causes few side effects, a positive overall effect on lipid metabolism, and minimal effects on carbohydrate metabolism and hemostasis.
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PMID:Clinical review of a monophasic oral contraceptive containing desogestrel and ethinyl estradiol. 826 Sep 69

Researchers compared the efficacy, safety, and acceptability of a triphasic oral contraceptive (OC), Triquilar, with those of a monophasic OC, Lo-Femenal, among 1088 women attending clinics in Chile, the Dominican Republic, Ecuador, Sri Lanka, and the Sudan. Both OCs contained levonorgestrel and ethinyl estradiol. 90% of women in each group exhibited good user compliance. Only 1 unplanned pregnancy occurred in each group, and both pregnancies were attributed to user failure. The gross cumulative efficacy rates at 11 months were 0.3/100 woman-years for the triphasic OC and 0.2/100 woman-years for the monophasic OC. The continuation rate at 11 months was lower for Lo-Femenal than it was for Triquilar (80.8% vs. 84.6%), but the difference was not significant. The leading side-effect-related reason for discontinuation in both groups was headache. Another key reason for OC discontinuation in both groups was personal reasons, such as planning a pregnancy. Most women in both groups did not have menstrual complaints (78.8% for the Triquilar group and 77.1% for the Lo-Femenal group). Intermenstrual bleeding rates were low (7.6% for the Triquilar group and 9% for the Lo-Femenal group). Significant intercenter differences for women reporting intermenstrual bleeding and side effects (e.g., headaches) existed (p .05). Women from both groups at the clinic in the Sudan always had lower reports of intermenstrual bleeding than those at the other clinics. In fact, no woman discontinued OC use because of intermenstrual bleeding in the Sudan. Women in Sri Lanka reported fewer side effects than those in other countries, suggesting they could better tolerate OCs than the other women. This multicenter study's findings indicates that both Triquilar and Lo-Femenal are effective and safe. In addition, they exhibit good cycle control.
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PMID:A multicenter comparative trial of triphasic and monophasic, low-dose combined oral contraceptives. 833 88

Menstrual bleeding patterns were investigated in young women taking either a levonorgestrel triphasic, Triquilar, or a norethindrone triphasic, Ortho 7/7/7, two commonly prescribed low-dose oral contraceptives. The levonorgestrel triphasic contains ethinyl estradiol (EE) 30 micrograms + levonorgestrel (LNG) 50 micrograms for the first six days, EE 40 micrograms + LNG 75 micrograms for the following five days, and EE 30 micrograms + LNG 125 micrograms for the last ten days. The norethindrone triphasic contains EE 35 micrograms + norethindrone (NET) 0.5 mg for the first seven days, EE 35 micrograms + NET 0.75 mg for the following seven days and EE 35 micrograms + NET 1.0 mg for the last seven days. Three hundred women from 16 to 25 years of age were randomized to the levonorgestrel triphasic (n = 150) or the norethindrone triphasic (n = 150) groups. Assessments were made from daily diary cards and from bimonthly investigator interviews over 6 pill cycles. The results showed a higher incidence of intermenstrual bleeding (breakthrough bleeding and/or spotting) in the norethindrone triphasic group (NET group) than in the levonorgestrel triphasic group (LNG group): 44.9% of patients (66/147) randomized to the LNG group reported intermenstrual bleeding one or more times during the study compared with 61.9% (91/147) randomized to the NET group (p = 0.0036). Furthermore, in subjects who did not miss any pills, the proportion of patients with intermenstrual bleeding in each cycle was significantly greater (p < 0.02, cycles 1-4, 6; p > 0.05, cycle 5) and was experienced for more days per cycle (p < 0.05, cycle 1) and for more cycles per patient (p < 0.05, 5 cycles) in the NET group compared with the LNG group. Intermenstrual bleeding was also less frequently observed in the LNG group than in the NET group in patients who missed pills (p < 0.05, cycles 3, 5 and 6). In addition, early withdrawal bleeding occurred more often in the NET group than in the LNG group (p < 0.05, cycles 1, 3 and 4). The incidence of amenorrhea was similar in both groups. These results demonstrate a significantly lower incidence of intermenstrual bleeding and therefore better cycle control with the levonorgestrel triphasic Triquilar, compared with the norethindrone triphasic Ortho 7/7/7.
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PMID:A clinical comparison of two triphasic oral contraceptives with levonorgestrel or norethindrone: a prospective, randomized, single-blind study. 843 1

Manufacturers have steadily been decreasing the amounts of estrogen and progestin in oral contraceptives (OCs) in an effort to enhance safety and tolerability while preserving contraceptive efficacy. A new formulation containing 20 microg ethinyl estradiol (EE) and 100 microg levonorgestrel (LNG)--representing the lowest available contraceptive dose of each hormone--has undergone extensive clinical testing in the United States and Germany. A total of 1590 women in 61 centers received 20 microg EE and 100 microg LNG for 6 cycles. Overall, 4 pregnancies possibly related to treatment failure were reported, reflecting an overall Pearl Index (number of pregnancies per 100 woman-years of treatment) of 0.65 and a failure rate of 0.34%. Cycle control was typical of low-dose OC use. Spotting and breakthrough bleeding occurred most commonly during the earlier cycles in each study. Adverse events were typical of those seen with OC use and led to study discontinuation in 6.6% of the women. Intermenstrual bleeding was the cause for early study withdrawal in 2.6% of women. The study results suggest that the combination of 20 microg EE and 100 microg LNG offers the benefits of low hormone content with good contraceptive efficacy, cycle control, and tolerability.
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PMID:International clinical experience with a new low-dose, monophasic oral contraceptive containing levonorgestrel 100 microg and ethinyl estradiol 20 microg. 1009 Apr 29

Between the fall of 1991 and the fall of 1992, 1500 physicians from throughout France followed 5989 women, 13-56 years old, using the combined oral contraceptive (OC) Moneva (30 mcg ethinyl estradiol and 75 mcg of the new generation progestogen, gestodene) for 3-6 months for a total of 29,000 cycles. Moneva was prescribed in 60% of the cases because the women did not tolerate a previous OC. Moneva effectively prevented pregnancy. It reduced the rate of abnormal cycles (5.4% of cycles vs. 0.9% at 3 months and 0.6% at 6 months). Intermenstrual bleeding also decreased in frequency from 13.8% to 6.1% at 6 months. Amenorrhea occurred less often with Moneva (2.8% vs. 1.1% at 3 and 6 months). Moneva also reduced the length of the menstrual period (20.7% of women with long period vs. 3.3% at 6 months) and excessive menstruation (1.4% vs. 0.2% at 6 months). Pain during menstruation, breast tenderness, and secondary effects occurred less frequently as well (37.1% vs. 13.5% at 3 months and 9/7% at 6 months, 13% vs. 7.9% at 6 months, and 15.1% vs. 11.1% at 3 months and 9% at 6 months, respectively). Secondary effects included headaches, nausea, and heavy legs. Moneva did not affect body weight or arterial blood pressure. 95% of women who took Moneva for 6 months were satisfied with it. 83.8% said that they would continue to use it. In conclusion, Moneva is an effective, safe, tolerable, and acceptable OC for women of all ages.
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PMID:[Oral contraception with Moneva: findings of a cohort study of 6000 women]. 1231 72