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Biphasic versus triphasic oral contraceptives for contraception.

BACKGROUND: Side effects caused by oral contraceptives discourage compliance with, and continuation of, oral contraceptives. A suggested disadvantage of biphasic compared to triphasic oral contraceptive pills is an increase in breakthrough bleeding. We conducted this systematic review to examine this potential disadvantage. OBJECTIVES: To compare biphasic with triphasic oral contraceptives in terms of efficacy, cycle control, and discontinuation due to side effects. SEARCH STRATEGY: We searched MEDLINE, EMBASE, POPLINE, LILACS and CENTRAL. We searched the reference lists of relevant articles and book chapters. We also contacted the authors of relevant studies and pharmaceutical companies in Europe and the USA. SELECTION CRITERIA: We included randomized controlled trials comparing any biphasic with any triphasic oral contraceptive when used to prevent pregnancy. DATA COLLECTION AND ANALYSIS: We examined the studies found during the searches for possible inclusion and assessed methodological quality using Cochrane guidelines. We contacted the authors of included studies and of possibly randomized studies for supplemental information about the methods and outcomes. We entered the data into RevMan. We calculated Peto odds ratios for incidence of discontinuation due to medical reasons, intermenstrual bleeding, and absence of withdrawal bleeding. MAIN RESULTS: Only two trials of limited quality met our inclusion criteria. Larranaga 1978 compared two biphasic pills and one triphasic pill, each containing levonorgestrel and ethinyl estradiol. No important differences emerged, and the frequency of discontinuation due to medical problems was similar with all three pills. Percival-Smith 1990 compared a biphasic pill containing norethindrone (Ortho 10/11) with a triphasic pill containing levonorgestrel (Triphasil) and with another triphasic containing norethindrone (Ortho 7/7/7). The biphasic pill had inferior cycle control compared with the levonorgestrel triphasic. The odds ratio of cycles with intermenstrual bleeding was 1.7 (95% CI 1.3 to 2.2) for the biphasic compared with the triphasic levonorgestrel pill. The odds ratio of cycles without withdrawal bleeding was 6.5 (95% CI 3.1 to 13). In contrast, cycle control with the biphasic pill was comparable to that of the triphasic containing the same progestin (norethindrone). AUTHORS' CONCLUSIONS: The available evidence is limited and the internal validity of these trials is questionable. Given the high losses to follow up, these reports may even be considered observational. Given that caveat, the biphasic pill containing norethindrone was associated with inferior cycle control compared with the triphasic pill containing levonorgestrel. The choice of progestin may be more important than the phasic regimen in determining bleeding patterns.

Contraception↗

Health care provider and contraceptive care setting: the relationship to contraceptive behavior.

This study examines contraceptive delivery characteristics and their association with contraceptive behavior. Data were collected in telephone interviews from a national sample of 1057 women who were using female contraceptives. The overwhelming majority of the sample obtained contraceptive services from gynecologists and other physician specialists and were seen in private facilities. Whereas nearly half of the providers recommended use of specific methods, only one-fourth discouraged use of particular methods. The pill was both the most frequently recommended and most commonly discouraged method. With regards to the provision of contraceptive information, practitioners were most likely to discuss the effectiveness of a method. In three of the four categories examined, a higher percentage of non-MDs than MDs gave information to their patients. Although the majority of women reported they were satisfied with the quality of care, mean satisfaction ratings were higher for female providers compared to male providers.

Adolescent↗

Contraceptive efficacy, compliance and beyond: factors related to satisfaction with once-weekly transdermal compared with oral contraception.

OBJECTIVE: To investigate contraceptive efficacy, compliance and user's satisfaction with transdermal versus oral contraception (OC). STUDY DESIGN: Randomized, open-label, parallel-group trial conducted at 65 centers in Europe and South Africa. One thousand four hundred and eighty-nine women received a contraceptive patch (n = 846) or an OC (n = 643) for 6 or 13 cycles. RESULTS: Overall/method-failure Pearl Indices were 0.88/0.66 with the patch and 0.56/0.28 with the OC (p = n.s.). Compliance was higher at all age groups with the patch compared to the OC. Significantly more users were very satisfied with the contraceptive patch than with the OC. The percentage of patch users being very satisfied increased with age whereas it did not in the OC group. Likewise, improvements of premenstrual symptoms as well as emotional and physical well-being increased with age in the patch-group in contrast to the OC group. Ratings of satisfaction with the study medication correlated weakly with emotional (r = 0.33) and physical well-being (r = 0.39) as well as premenstrual symptoms (r = 0.30; p < 0.001). CONCLUSION: Contraceptive efficacy of the patch is comparable to OC, but compliance is consistently better at all age groups. Higher satisfaction with the patch at increasing age may be attributed to improvements in emotional and physical well-being as well as reduction of premenstrual symptoms.

Administration, Cutaneous↗

Prescribing and managing oral contraceptive pills and emergency contraception for adolescents.

Combination OCPs are safe and effective ways to prevent unintended adolescent pregnancy if they are used properly. Numerous noncontraceptive benefits of OCPs can bolster continued combination OCP use. Progestin-only OCPs are an option, particularly for young women with medical contraindications to taking estrogens; however, because of their lower efficacy, progestin-only pills are not the first choice for oral contraception for adolescents. Health care providers can give young women a second chance to prevent unintended pregnancy by improving their access to emergency contraception through educating and counseling about emergency contraception at all office visits, by prescribing emergency contraceptive pills in advance, or by prescribing emergency contraceptive pills over the telephone.

Adolescent↗

Communication about contraception and knowledge of oral contraceptives amongst Norwegian high school students.

Communication about contraception and specific knowledge of oral contraceptives (OCs) were examined in a sample (n = 4,650) of Norwegian high school students. Data were collected through a 44-item questionnaire especially developed for the study. The response rate was 73% and data from a total of 1,714 girls and 1,389 boys were eligible for analyses. More females (83%) than males (54%) discussed contraception at least monthly. Discussions were predominantly held with peers and not adults. Females were far more knowledgeable about OCs than males. Respondents knew more about side effects and the pill's relative efficacy than about risks of cancer and tromboembolism. The most significant predictors of high knowledge scores were gender and OC use (females). Also predictive of high knowledge scores were frequent discussions about contraception with peers. Talks about contraception with health workers were unrelated to knowledge scores.

Adolescent↗

A comparative study on the effects of a contraceptive vaginal ring NuvaRing and an oral contraceptive on carbohydrate metabolism and adrenal and thyroid function.

OBJECTIVES: To compare carbohydrate metabolism, adrenal and thyroid function during use of a combined contraceptive vaginal ring (NuvaRing, NV Organon, Oss, The Netherlands) with those of a combined oral contraceptive. METHODS: Healthy women aged 18-40 years used either the vaginal ring, delivering 15 microg ethinylestradiol and 120 microg of etonogestrel per day, or a combined oral contraceptive containing 30 microg ethinylestradiol and 150 microg levonorgestrel, for six cycles. Each cycle comprised 3 weeks of use of the ring or the pill followed by 1 ring- or pill-free week. The following parameters were measured at baseline and at the end of cycles 3 and 6: carbohydrate metabolism (glucose, insulin, glycosylated hemoglobin); adrenal function (total cortisol, cortisol binding globulin, dehydroepiandrosterone sulfate); thyroid function (thyroid stimulating hormone, free thyroxine). RESULTS: Small and similar increases in insulin were seen in both groups. Concentrations of cortisol binding globulin and total cortisol rose significantly less during ring use than during combined oral contraceptive use (cycle 3, p= 0.0002; cycle 6, p < 0.0001). Levels of dehydroepiandrosterone sulfate did not change in either group. Thyroid stimulating hormone levels increased significantly more in the ring group at cycle 3 (p = 0.0016) but free thyroxine levels were unchanged in both groups. CONCLUSIONS: Both the vaginal ring and the oral contraceptive have no clinically relevant effects on carbohydrate metabolism, adrenal or thyroid function.

Adolescent↗

The transdermal contraceptive patch: a new approach to hormonal contraception.

The transdermal contraceptive patch delivers ethinyl estradiol and norelgestromin (17-deacetylnorgestimate) at a rate over seven days that results in efficacy paralleling that achieved with oral contraceptives. Due to the pharmacokinetics of the system, adequate steroid levels are maintained for two days beyond the recommended duration of use of an individual patch, with resulting maintenance of efficacy. With perfect use, the failure rate is 0.70 pregnancies per 100 woman-years and for typical use, the rate is 0.88 pregnancies per 100 woman-years. Body weight above 90 kilograms (198 pounds) is associated with lower efficacy. Cycle control is similar to that achieved by oral contraceptives. With the exception of a transient increase in breast tenderness, the side effect profile is similar to that noted by oral contraceptive users. A major advantage of this method compared to oral contraceptives is a nearly 90% perfect adherence to the dosing schedule across all age groups. Partial or total detachment of the patch occurs at an overall rate of 3.8%. This rate is not affected by warm humid climates, vigorous exercise, or exposure to saunas or water baths.

Adhesiveness↗

Comparison of metabolic and clinical effects of four oral contraceptive formulations and a contraceptive vaginal ring.

A group of 100 women desiring OC received one of the following four formulations on a randomized basis: (1) mestranol 50 micrograms and norethindrone 1 mg, , (2) ethinyl estradiol 50 micrograms and norethindrone 1 mg, (3) ethinyl estradiol 35 micrograms and norethindrone 1 mg, and (4) ethinyl estradiol 30 micrograms and levonorgestrel 150 mg. An additional 10 women received a CVR containing levonorgestrel and estradiol. Measurement of a large number of serum chemistries, lipids, proteins, clotting factors, and liver enzymes was obtained before and 3 and 6 months after starting medication. Clinical factors such as weight, blood pressure, bleeding or spotting, or any adverse side effects were also recorded. There was no significant difference in the metabolic parameters measured among the four oral contraceptives except the increase in angiotensinogen was slightly less in the groups receiving the compounds with 30 or 35 micrograms estrogen and the groups receiving the norgestrel compound had no increase in triglycerides and a slight decrease in cholesterol levels. When the CVR was compared with all oral contraceptives it was found to produce no change in angiotensinogen levels and a decrease in triglycerides. Some of each group of OC users had a lowering of antithrombin III to abnormal levels but none of the CVR users had his amount of decrease. As oral steroids with 30 or 35 micrograms of estrogen do not produce significantly less metabolic alteration than do compounds with 50 micrograms of estrogen, it is unlikely that their use will reduce the incidence of the uncommon serious adverse effects associated with OC use. However, since the CVR's did not increase angiotensinogen, their use as contraceptives will most likely not produce hypertension and possibly the other serious circulatory problems which are increased in some OC users.

Adolescent↗

[Hormonal contraception and lipid metabolism. Prospective and retrospective studies of lipid metabolic parameters during the use of contraceptives].

Remarkable changes of several parameters of lipid metabolism were observed in a retrospective study of women, who had used different oral contraceptives for a longer time, in comparison with women without any hormonal contraception. In contrast, under the conditions of a prospective double-blind study no statistically significant alterations of the same parameters were seen under the use of two oral contraceptives different in dosage. Nevertheless, oral contraceptives should not be prescribed to patients with hyperlipidaemia.

Adult↗

The effect of a contraceptive vaginal ring and oral contraceptives on the vaginal flora.

Premenopausal women seeking a steroid contraceptive method were allowed to choose between a contraceptive vaginal ring (CVR) containing levonorgestrel and estradiol used in a 3-week in, 1-week out regimen (n=20) and an oral contraceptive (OC) containing levonorgestrel and ethinyl estradiol in a 28-day regimen (n = 10). Cultures from the posterior vaginal fornix were obtained before therapy in both groups and monthly for 6 months for the CVR group and after 1, 3, and 6 months for the OC group. These cultures were streaked on specific media to provide quantitative aerobic and anaerobic, lactobacillus, Candida sp., Gardnerella vaginalis and Neisseria gonorrhoeae counts in micro-organisms per milliliter. A comparison of the number and types of organisms isolated from vaginal cultures obtained initially and at 6 months demonstrated no statistically significant differences in colony counts between CVR and OC users. The results of this study suggest that the use of the CVR is not associated with a greater growth of pathogens than is oral administration of a progestin and estrogen combination.

Adult↗

European Society of Contraception oral contraceptives survey update: birth control methods in "Europe of the 12".

The European Society of Contraception developed a survey to examine birth control methods in the 12 countries++ of the European Community. Responses to those questions relating to prescribing++ practices of oral contraceptives (OCs) are presented herein. The survey was sent to 400 physicians. One hundred two responded, most from France, Belgium, and the United Kingdom. The responses revealed that the most popular OCs are modern combined formulations containing low doses of ethinyl estradiol and progestogens such as norgestimate, desogestrel, gestodene, and levonorgestrel. More than half of physicians prescribe a particular formulation because of its tolerability and 20% because of its hormonal content. More than 90% prescribe OCs to healthy, nonsmoking women over 40. However, three fourths will not prescribe OCs to smokers over 35. Half of physicians recommend mammography for their older OC patients. Half also recommend cholesterol screening, but 8% only for women over 30. Most physicians are no longer reluctant to prescribe OCs to their diabetic patients: 61% prescribe OCs for women with non-insulin-dependent diabetes, 56% for those with insulin-dependent diabetes, and 85% for those with a history of gestational diabetes. Despite recent studies showing no relation between past OC use and cardiovascular disease, 42% of physicians said that their greatest OC-related health concern is cardiovascular disease. One third cited noncompliance as their greatest concern. These results reveal inhomogeneous prescribing practices for OCs among European physicians. ¿Over-screening¿--not prescribing the pill because of perceived (but not necessarily real) health risks--may be depriving many women of the contraceptive and noncontraceptive benefits of OCs. Complete and accurate information--as promoted by the European Society of Contraception--is one way to combat such overscreening.

Adult↗

Risk of cervical dysplasia in users of oral contraceptives, intrauterine devices or depot-medroxyprogesterone acetate. The New Zealand Contraception and Health Study Group.

Three cohorts of women aged 20-39 attending medical practitioners or family planning clinics in New Zealand for contraceptive advice were followed prospectively for five years. The three cohorts were defined by use (or at least prescription) of one of three study contraceptive methods at the time of beginning of follow-up--oral contraceptives (OC), intrauterine devices (IUD) or depot-medroxyprogesterone acetate (MPA)--and numbered 2469, 2072 and 1721 women, respectively. Follow-up was intended to be annual and included cervical smear as well as interim contraceptive and medical histories. A positive outcome (referred to here as 'dysplasia') was any degree of definite dysplasia or carcinoma of the cervix diagnosed cytologically by a central study laboratory, and confirmed by histology or analysis of DNA ploidy. In the three cohorts (OC, IUD and MPA, respectively), 12,839, 10,774 and 8,984 person-years of follow-up were accumulated and 125, 92 and 101 cases of dysplasia were confirmed. Crude annual rates of dysplasia per 1,000 person-years were approximately the same in the OC (9.6) and IUD (8.4) cohorts. Crude rates were higher in the MPA cohort (11.3 per 1,000 person-years). However, important confounding factors, principally smoking and sexual behavior, were identified with rate ratios ranging between 1 and 3 over the range of the potentially confounding variables, and multivariate analyses revealed no evidence of increased risk for the MPA cohort when these factors were taken into account. At least over the short term, there appears to be no difference in risk of cervical dysplasia between women using these three methods of contraception if differences between groups in respect to known confounding factors are taken into account.

Adolescent↗

Post-marketing surveillance of Norplant contraceptive implants: I. Contraceptive efficacy and reproductive health.

The subject of this study to examine the safety and contraceptive efficacy of Norplant, we undertook a 5-year study of follow-up of women initiating use of Norplant, intrauterine device (IUD) or sterilization in eight developing countries. Women attending family clinics were enrolled if they consented and were medically eligible to use Norplant, IUD, or female sterilization. Women who chose to initiate use of IUDs or surgical sterilization served as controls and were frequency matched in 5-year age-bands with women who chose to use Norplant. At admission women had a physical examination, and their medical histories, demographic, and socio-economic characteristics were recorded. Follow-up visits were scheduled in the first 6 weeks after admission and semi-annually thereafter for 5 years irrespective of change of contraceptive method. Incidence rate ratios of health events were estimated for initial and current contraceptive method use. This paper reports reproductive health events and contraceptive efficacy. Altogether, 7,977 women initiating use of Norplant, 6,625 of IUD, and 1,419 of surgical sterilization were admitted. Their mean ages at initiation were 28.5, 28.5, and 29.6 years, respectively. More than 99% were married or cohabiting, and parous. Five-year follow-up was completed by 94.6% of the women. By the end of 5 years, the mean duration of first segment use per initiator was 4.16 years for Norplant, 4.10 years for IUDs, and 4.96 years for sterilization accounting for 39,337 woman-years for Norplant, 31,915 for IUDs, and 7,071 for sterilization. The study accumulated 78,323 woman-years of observation. Pearl pregnancy rates for Norplant, copper IUDs and female sterilization were 0.27, 0.88, and 0.17 per 100 woman-years, respectively. Users of Norplant, copper IUDs, and sterilization had rates of ectopic pregnancy of 0.30, 0.68, and 0.13 per 1,000 woman-years, respectively. Major health events related to the reproductive system were rare. Rates of acute PID were significantly lower among Norplant users than IUD users (p = 0.004). The rate of ovarian enlargement was significantly higher in Norplant users than controls (p <0.001), but not rates of hospitalization for this condition. Vaginitis and vaginal discharge, and low abdominal pain were significantly less frequent in Norplant users than in the other groups. Bleeding disturbances were more frequent among Norplant users than controls but not anemia. The study confirms the high contraceptive efficacy of Norplant, copper IUDs, and female sterilization. The incidence rates of major reproductive health problems were low. There was no significant excess of serious reproductive morbidity among users of Norplant compared to users of IUDs and sterilization.

Abdominal Pain↗

The effect of low-dose combined oral contraceptive pills versus injectable contraceptive (Depot Provera) on liver function tests of women with compensated bilharzial liver fibrosis.

This was an open comparative trial of two types of hormonal contraceptives, a low-dose combined oral contraceptive and the injectable depot-medroxyprogerone acetate, with a control group using an intrauterine device (copper T-380). Clients were recruited from bilharzial patients attending the maternal-child health and family centers affiliated with the National Liver Institute. Clients with compensated bilharzial liver disease were chosen and were divided into three subgroups according to their own preference for the method of contraception. Baseline, 2-, and 4-months liver function tests were compared, and abdominal ultrasound scanning of the liver was done. There was a nonsignificant change in liver function tests, and the portal vein diameter measured by ultrasound scanning was not changed with steroidal contraceptives. The use of combined oral contraceptive containing low-dose estrogen or using depot medroxyprogertone acetate injectables are safe and can be prescribed in cases with compensated bilharzial hepatic fibrosis with normal function.

Alanine Transaminase↗

A comparative investigation of contraceptive reliability, cycle control and tolerance of two monophasic oral contraceptives containing either drospirenone or desogestrel.

OBJECTIVE: To assess the contraceptive reliability, cycle control and tolerance of a new monophasic oral contraceptive (Yasmin) containing 30 microg ethinylestradiol and 3 mg drospirenone and compare it with a preparation containing an equal dose of ethinylestradiol combined with 150 microg desogestrel (Marvelon). METHODS: A multicenter, open-label, randomized study was carried out in 26 European centers. Contraceptive efficacy, cycle control and tolerance (including body weight, blood pressure and heart rate) were assessed over 26 cycles, plus a 3-month follow-up period. RESULTS: Of 900 women who were randomized, 887 started treatment and 627 completed the 26 cycles plus follow-up (310 in the ethinylestradiol/drospirenone group and 317 in the ethinylestradiol/desogestrel group). Both study preparations were found to be effective with regard to contraceptive reliability and cycle control was good. There were six pregnancies (three in each group), but none were considered to have been the result of method failures. The subjective and objective tolerances were good in both groups. A statistically significant difference was found in body weight changes between the two groups. While there was an increase in mean body weight in the ethinylestradiol/desogestrel group from cycle 5 onward, the mean body weight per cycle in the ethinylestradiol/drospirenone group was slightly below the baseline value throughout the study. The incidence ofpremenstrual symptoms was higher in the ethinylestradiol/drospirenone group than in the ethinylestradiol/desogestrel group during the 6 months prior to the study, but lower during treatment. The rates ofdysmenorrhea were identical under both treatments but the symptoms were more often mild and less often severe in the ethinylestradiol/drospirenone group. CONCLUSION: The combination of 30 microg ethinylestradiol combined with 3 mg drospirenone provides effective oral contraception and good cycle control, and is well tolerated. Ethinylestradiol/drospirenone had a more favorable effect on body weight than ethinylestradiol/desogestrel, with the mean body weight remaining lower than baseline for the majority of the women.

Adult↗

Use of oral contraception in the United States, 1965. In only 5 years oral contraception has become a major means of regulating fertility.

This is the first report from the Na-tional Fertility Study, 1965, a survey of the reproductive behavior of a national sample of married women, under the age of 55, living with their husbands. The report presents basic data on the use of oral contraception by women under the age of 45, in relation to age, parity, education, race, and religion. The study leads to certain conclusions, as follows. Present, past, and prospective use vary inversely with the age of the woman and directly with the number of years of schooling; the majority of young women with college training have already used the oral contraceptive. Use by Negroes is somewhat less extensive than use by whites, particularly for ages below 25; some of this difference is explainable by concomitant racial differences in educational level. Negroes seem less likely than whites to use oral contraception for timing early births, and more likely, when they do use it, to be attempting to terminate their fertility. The same observation holds for white Catholics in relation to white non-Catholics. Although the extent of use may be lower among Catholics than non-Catholics, the proportion of Catholics who report use is substantial indeed in view of the persisting theological controversy. The prospects for increased use of oral contraception seem very good at present, but they may be limited by further developments in the technology of fertility regulation. Meanwhile the birth rate has declined substantially. Although much sophisticated analysis of other data from the survey will be required to determine the extent of the contribution of oral contraception to this decline, the findings presented here suggest that the contribution is substantial for young married couples. The major effect on the couple's eventual number of children may be less than the effect on the time pattern of childbearing; in any event, both lower eventual parity and delayed fertility contribute to a decline in the numbers of births from year to year. Whatever the intent may be, it is apparent that young American couples have adopted a new means for achieving their reproductive goals.

Adolescent↗

Breast cancer and oral contraceptives: findings in Oxford-Family Planning Association contraceptive study.

Among the 17 032 women taking part in the Oxford-Family Planning Association contraceptive study, 72 were first diagnosed as having breast cancer between the date they were admitted to the study and 1 September 1980. The relative risk of developing the disease in women who had used oral contraceptives in comparison with those who had never used them was estimated to be 0.96 (95% confidence limits 0.59 to 1.63). Among women aged under 35 years, the corresponding relative risk (based on only 14 women with breast cancer) was estimated to be 0.61. No relation was apparent between the risk of developing breast cancer and duration of oral-contraceptive use or interval since first oral-contraceptive use in any age group. The data in this study are thus reassuring; but observations based on women with long-term use of oral contraceptives, especially those starting to use the preparations at an early age, are few.

Adult↗

[From the prescription of contraceptives to their application. A study of the on-going use of contraceptive methods in immigrant circles during the post-partum period].

PURPOSE: The research presented here aimed at establishing a possible link between the level of integration of an immigrant population and the rate of continuity following a prescription for contraception given to women on leaving the maternity clinic. MATERIALS AND METHODS: From June 1995 to November 1996, a study was conducted in Valence among 71 women who came from Turkey, sub-Saharan Africa and the Maghreb. Out of 87 women interviewed at the maternity, 71 were seen a second time. As well as taking into consideration socio-demographical factors, the study compared the degree of integration with the use of the prescribed contraceptive method six months after leaving the maternity clinic. RESULTS: The study shows that there is no significant link between the level of integration and the continued use of a contraceptive method six months after birth. The only salient fact is that women who had lived less than 10 years in France systematically used a contraceptive method (P = 0.004, relative risk: 1.44, 95% confidence interval: 1.12-1.84). DISCUSSION: Our study would tend towards the following observation: the more recently the immigrant arrived, the more receptive they were towards proposals made by the medical personnel. We consider that rather than it being the case of either total confidence in, or distrust of, medical contraception, the cultural factor remains important and must be taken into account in any approach among this kind of population. It is more a question of community health education than of medical prescription.

Adult↗