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Query: UMLS:C0745411 (irregular bleeding)
 386 document(s) hit in 31,850,051 MEDLINE articles (0.00 seconds)

Highlights of papers presented at an international symposium on advantages and risks of oral contraceptives, and the details of the results of 2 studies are discussed. 1 study compared the effects of a combination of 30 mcg of ethinyl estradiol and 150 mcg of levonorgestrel with a reduced dose 3-phase combination of these hormones; it involved 489 women with 2777 menstrual cycles for a 6-month period. No pregnancies occurred. Missed menstruation occurred in 0.9% of the cycles with the 3-phase combination, contrasted with 2.3% of the 30/150 mcg combination group. Bleeding disorders were more frequent in the 30/150 pill group (15.7% vs. 10.1%). Spotting occurred in 8% of cases in both groups. The 3-phase pills proved to be safe and were preferred because they caused less bleeding. Another study compared the effects of 2 Swedish-made contraceptives by administering Neovletta (N) to 50%, Trionetta (T) to 25%, and Trionetta 28 (T 28) to another 25% of the 862 women with 6472 menstrual cycles who participated at 12 family planning centers in Sweden. T and N contain the same amount of estrogens, but T contains 40% less gestagen than N. The T 28 treatment also included 7 placebo tablets. Results showed that only 1 pregnancy occurred in the T group, despite a high rate of failure to take the pills (8.1-9.4%). Menstruation was normalized in both the N group (90.4%) and the T group (94.2%) reaching the normal 28 (+ or - 2) days cycle. Missed menstruation occurred in 0.6% of the T group as opposed to 2.3% of the N group. There was a significant difference in spotting and irregular bleeding between the 2 groups: 6.3%-15.8% for N and 3.0-9.0% for T. Also, there was a higher rate of bleeding problems for T 28 than for T. 8.6-8.8% of women in both groups quit the experiment because of complications, e.g., bleeding, nausea, headache, and hypertension. Both pills proved to be reliable and safe, but the new 3-phase preparation, T, is recommended because it does not reduce the beneficial HDL cholesterol as does N.
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PMID:[Report from an international symposium about advantages and risks of oral contraceptives. Amsterdam, March 1982]. 692 Nov 98

Results of a randomized, double-blind study of 2 daily oral contraceptives are reported, both containing 3 mg norethisterone acetate; 1 also contained 50 mcg ethinyl estradiol, while the other contained a mixture of micronized 4 mg estradiol plus 2 mg estriol. The trial was conducted at WHO CCR's (Collaborating Centres for Clinical Research) in Bangkok, Bombay, Singapore, and Szeged, Hungary. Of the 925 women who entered the study, 458 received the product containing "natural" estrogens and 467 received the product containing ethinyl estradiol. Analysis of admission characteristics showed that the 2 groups were very closely matched. No statistically significant difference in contraceptive efficacy between the 2 products was found; both have annual failure rates of approximately 1/100 women. The discontinuation rate after 1 year was 51.5 for the "natural" estrogen product and 48.4 for the 1 containing synthetic estrogen. Discontinuation for menstrual irregularities was significantly higher for the "natural" estrogen preparation. During both the 1st 3 treatment cycles and the 10th-12th cycles, the incidence of various menstrual irregularities (amenorrhea, and infrequent, prolonged, frequent, or irregular bleeding) was significantly higher in the "natural" estrogen contraceptive. Adverse clinical associations were those commonly reported with other combined orals. It is concluded that the high incidence of menstrual irregularities associated with the particular combination of norethisterone acetate and "natural" estrogens renders it less suitable for general use in family planning programs than those combinations containing synthetic estrogens such as ethinyl estradiol.
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PMID:A randomized, double-blind study of two combined oral contraceptives containing the same progestogen, but different estrogens. World Health Organization Task Force on Oral Contraception. 742 56

Physicians recruited 882 women into a multicenter trial of a new biphasic oral contraceptive (OC) (25 mcg + 125 mcg desogestrel and 40 mcg + 30 mcg ethinyl estradiol). Trial sites were in Belgium, Denmark, Finland, France, Germany, Norway, Sweden, and the former Yugoslavia. After 3 cycles, women who had switched from using another OC in the 2 months before the study (switchers) were less likely to continue the new OC than were women who had not used any OC in the last 2 months (starters) (6 cycles = 87.2% vs. 90.6%, 12 cycles = 74.7% vs. 79.5%; and 18 cycles = 59.8% vs. 64.9%). Withdrawal bleeding did not occur in 3.2% of all cycles. Absence of withdrawal bleeding became less common over time (cycle 1 = 7.6%, cycle 3 = 5%, cycle 6 = 3.2%, and cycle 18 = 1.8%). Duration of withdrawal bleeding was no more than 5 days in 80% of all women. More and more women had no more than 5 days of withdrawal bleeding as time passed (cycle 1 = 81.7%, cycle 6 = 85.6%, and cycle 18 = 90.6%). Irregular bleeding was more common in the first cycles of the study than in subsequent cycles (e.g., spotting during cycles 1-3 = 8.5-4.8% vs. 3.7-3.1% during cycles 6-18). By cycle 18, 96% of all women had no irregular bleeding. The drop-out rate for irregular bleeding was 2.2% at the end of the study. In 5% of cycles, at least 1 tablet was forgotten. In the first cycles, starters were somewhat more likely to complain of nausea, headache, and breast tenderness than switchers (e.g., nausea, cycle 1 = 5.8% vs. 3.4%). The gap between the 2 groups disappeared after 3 cycles. Starters were more likely to have minor complaints before OC use than after OC use (e.g., 6.5% fewer frequencies of headaches at 18 months). These findings show that the new OC has very good cycle control and a agreeable side effect profile.
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PMID:Cycle control and side effects of a new combiphasic oral contraceptive regimen. 794 27

A double-blind, randomized, multicenter study compared 2 combined oral contraceptives containing 150 mcg desogestrel and either 30 mcg (Marvelon/Desolett) or 20 mcg (Mercilon) of ethinyl estradiol, focusing on reliable pregnancy prevention and cycle control. The women were 300 Norwegians, 500 Swedes, and 200 Danes, 52% of whom switched from a prior brand of pill. Women completed bleeding diaries: all bleeding that did not start in the 7-day tablet-free interval and last for 7 or fewer days was considered irregular bleeding, either breakthrough bleeding or spotting. The 2 groups were similar except that those taking the 150/20 combination were slightly older. There were 2 pregnancies with the 20 mcg combination and 3 with the 30 mcg pill, 2 of which were considered method failures. In 8573 cycles analyzed there were more instances of irregular bleeding and amenorrhea with the 20 mcg pill than with the 30 mcg pill. Duration of breakthrough bleeding was not significantly different. Irregular bleeding was also more common n women switching from another brand of pill to a lower estrogen dose pill. Blood pressure decreased slightly on the 20 mcg ill and body weight rose slightly on the 30 mcg pill, but hemoglobin did not change. More women dropped out or chose not to continue taking the 150/20 mcg pill because of side effects, usually irregular bleeding, mood changes, dizziness, or weight gain. Despite these differences, there were enough women who tolerated the lower dose combination pill to merit continuing to take it.
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PMID:Comparative profiles of reliability, cycle control and side effects of two oral contraceptive formulations containing 150 micrograms desogestrel and either 30 micrograms or 20 micrograms ethinyl oestradiol. 821 4

This report combines the data obtained in three multicenter efficacy studies with a new triphasic oral contraceptive combination containing desogestrel (DSG) and ethinyl estradiol (EE). The studies were conducted at 40 investigational sites in the United States (38 centers) and Canada (2 centers) in support of the FDA approval of the product. In total, 1,095 subjects were exposed to the study medication for 11,231 cycles, corresponding to approximately 864 woman-years of use. Of these subjects, 414 completed at least 13 cycles of treatment. Contraceptive efficacy was high; six pregnancies occurred during the in-treatment period (two due to method failure and four due to user failure), corresponding to Pearl Indices of 0.23 and 0.46, respectively. The incidence of irregular bleeding was low, and the acceptability was excellent as evidenced by the low incidence of drug-related drop-outs. No drug-related serious adverse experiences were reported, and the incidence of other drug-related adverse experiences was generally low and decreased with continued use. No effects were seen on blood pressure, body mass index, laboratory parameters, cervical cytology and breast nodularity. These studies demonstrate that triphasic DSG/EE is an effective and acceptable triphasic oral contraceptive preparation with excellent cycle control and no significant physiologic effects.
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PMID:Safety and efficacy of a triphasic oral contraceptive containing desogestrel: results of three multicenter trials. 822 60

A leading patient complaint is headaches which tend to occur more often in women than men. Nonvascular headache is the most common and is caused by tension or muscle contraction. Oral contraceptives (OCs) do not affect nonvascular headaches. They can also be safely used in women who experience common migraines whose symptoms do not become more severe or frequent during OC use. On the other hand, women who have classic migraine (headache accompanied by focal neurologic symptoms) or common migraine with symptoms becoming more severe or frequent during OC use should discontinue OC use. Instead, they should use a barrier method or the IUD. Estradiol treatment appears to be effective in treating menstrual migraine. Since the data are inconclusive about the effect of OCs on young women who have experienced a stroke or transient ischemic attacks, it would be best for them to use a barrier method. Most antiepileptic drugs (phenobarbital, phenytoin, paramethadione, and carbamazepine) cause enzyme induction which may be linked to decreased levels of estrogen and increases in irregular bleeding, thereby increasing the likelihood of an epileptic OC user becoming pregnant. Possible contraceptive failure exposes a developing fetus to the teratogenic properties of the antiepileptic drugs. Thus, physicians should prescribe OCs with 50 mcg of ethinyl estradiol rather than 35 mcg ethinyl estradiol. Epileptic women can also use Depo-Provera, because it is not only effective in preventing pregnancy but reduces seizure frequency. It is important for any contraceptive method chosen for epileptic women to be effective because pregnancy intensifies seizures which in turn can damage the mother and/or fetus and cause neonatal distress.
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PMID:Contraceptive methods for women with neurologic disorders. 851 48

In the Dominican Republic, clinical researchers randomly assigned 150 users of the contraceptive implant Norplant who came to Profamilia's Family Planning Clinic in Santo Domingo complaining of bleeding irregularities to one of three treatment groups. They aimed to evaluate the effectiveness of a combined oral contraceptive (OC) with 250 mcg levonorgestrel and 50 mcg ethinyl estradiol (EE) and of 50 mcg EE alone in treating bleeding irregularities. Bleeding irregularities were defined as prolonged bleeding (i.e., 8 or more continuous days of bleeding or spotting) or irregular bleeding (i.e., current bleeding episode initiated after a bleeding-free interval of less than 15 days). Age, parity, duration of Norplant use, and length of bleeding episode before treatment were similar in all three groups (i.e., OC, EE, and placebo). The OC group was significantly more likely to experience ceased bleeding within three days than the two other groups (91% vs. 67% for EE group [p 0.01 from OC group] and 15% for placebo group [p 0.0005 from both treatments]). Bleeding lasting for at least one week occurred less often in the OC group than the two other groups (2% vs. 14% for EE group and 50% for placebo group [p 0.0005 for both treatments]). Duration of bleeding was significantly lower in the OC group than the other two groups (2.6 days vs. 5.4 days for EE group and 12.3 days for placebo group; p 0.0001). Even though women in both hormonal treatment groups were more likely to experience gastralgia or nausea than the placebo group (33-40% vs. 4%; p 0.005), the side effects rarely interrupted treatment. These findings suggested that the OC is a very good effective treatment for bleeding irregularities and is a practical treatment since it is available at all Profamilia clinic sites.
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PMID:Hormonal treatment for bleeding irregularities in Norplant implant users. 863 69

A review of the literature suggests that estrogen, progesterone, and nonsteroidal anti-inflammatory agents have the potential to ameliorate the prolonged bleeding associated with Norplant use. The feasibility of such treatment was investigated in both a pilot study and a multicenter trial. In the pilot study, bleeding episodes were stopped within 5 days (average, 3.1 days) in 8 of the 10 Norplant acceptors with irregular bleeding who received 20 mcg of ethinyl estradiol for 10 days. On the basis of this finding, 44 Norplant users from 5 US sites were administered 20 mcg of ethinyl estradiol for 10 days, 800 mg of ibuprofen 3 times a day for 5 days, or a placebo. Interim analysis of data from the multicenter trial suggests that 1 of these regimens (unknown at this point due to the double-blind nature of the study) produces a reduction in the mean number of spotting days, but there is no difference by treatment group in the number of bleeding days. The mean number of spotting days was reduced (0.23 +or- 0.44) in Group A compared to Group C (1.94 +or- 1.34) during the first 5 days of treatment. The overall mean number of bleeding days was 1.34 days in the first 5 days after treatment initiation and 0.82 during the second 5 days of treatment. Completion of the multicenter trial analysis should provide guidelines on ways to improve the menstrual disturbances that are the major barrier to Norplant use.
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PMID:Management of irregular uterine bleeding and spotting associated with Norplant. 898 42

A clinical study conducted in Indonesia confirmed the effectiveness of ethinyl estradiol and ethinyl estradiol plus levonorgestrel for the treatment of the frequent, prolonged, and irregular bleeding associated with Norplant use. The 91 subjects were randomly allocated to receive, for 3 weeks, 50 mcg of ethinyl estradiol, a combined pill containing 30 mcg of ethinyl estradiol and 150 mcg of levonorgestrel, or a placebo. To date, 48 subjects have completed a 90-day post-treatment menstrual diary. Among this subgroup, only ethinyl estradiol alone reduced significantly (p 0.02) the number of bleeding/spotting days during the 21-day treatment period. In the 90 days after treatment, both ethinyl estradiol and the combined pill significantly (p 0.05) reduced bleeding/spotting compared to the 90 days preceding treatment; moreover, the length of each bleeding/spotting episode was significantly (p 0.05) shorter. Although 84 women completed 2 biopsies (before treatment and at day 14 or 21), adequate endometrial tissue at both time points was obtained from only 33 women. Histopathologic analysis revealed no obvious effect of either ethinyl estradiol or the combination pill on endometrium exposed to the levonorgestrel subdermal implant for an average of 8 months.
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PMID:Oestrogen treatment for increased bleeding in Norplant users: preliminary results. 898 52

In response to concerns about a possible thromboembolism risk, the ethinyl estradiol dose in oral contraceptives (OCs) has been further decreased. This study compared the effectiveness and metabolic effects of combined OCs containing 150 mcg of desogestrel and either 20 or 30 mcg of ethinyl estradiol. 1000 Swedish women requesting an OC were randomly assigned to receive either the 150/20 or 150/30 formulation, with follow-up visits scheduled 3, 6, and 12 months after OC initiation. The only 2 pregnancies attributable to method failure occurred in the 150/30 group. Although bleeding irregularities were more common in the 150/20 group, this incidence steadily decreased over the 12-month study period. Overall, bleeding irregularities were experienced by 9.9% of the 500 women in the 150/20 group and 6.0% of the 500 in the 150/30 group. The total cholesterol level increased significantly in the 150/30 mcg group but not in the lower-dose group. Low density lipoprotein cholesterol decreased only among 150/20 OC users. Total triglycerides increased more in users of the 30 mcg pill. Both pills reduced free testosterone levels substantially, but to the same extent. The small percentage of women who experience irregular bleeding with the lowest-dose OC are likely to accept this discomfort in exchange for its potentially improved safety profile.
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PMID:Clinical experience of a combined oral contraceptive with very low dose ethinyl estradiol. 922 41


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