Complications of oral contraceptive agents-a symposium. Effects of oral contraceptives on carbohydrate metabolism.
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Carbohydrate Metabolism↗
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Results for “CONTRACEPTIVES, ORAL”
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Ceylon: continuing practice of contraception by acceptors of oral contraceptives and intrauterine devices in a field programme.
A follow-up study of oral-contraceptive and intrauterine-device acceptors in the early years of the Ceylon family planning programme was undertaken to determine the effect of a 1968 policy decision to cut the per cycle price of oral contraceptives by half and to allow nonclinical prescription and distribution of the pills by trained field midwives under medical supervision. While pill acceptance increased, study findings suggest that continuation did not. On balance, the intrauterine device proved much more effective than oral contraceptives in preventing unplanned pregnancies, reflecting the higher continuation rates of IUD acceptors. Although the availability of both methods clearly contributed to expansion of the programme, the demographic and administrative implications of initial choice of method, and the finding that pregnancy rates for pill users are not lower than for IUD wearers, suggest the need for more realistic counselling by clinic and field staff at the time of choice.
Adult↗
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.
The results are reported of a randomized, double-blind study of two daily oral contraceptives, both containing 3mg norethisterone acetate; one also contained 50 microgram ethinyl estradiol, while the other contained a mixture of micronized 4mg estradiol plus 2mg estriol. The trial was conducted to a common protocol at WHO Collaborating Centres for Clinical Research (CCCR's) in Bangkok, Bombay, Singapore and Szeged. 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 two groups were very closely matched. There was no statistically significant difference in contraceptive efficacy between the two products; both have annual failure rates of approximately 1 per 100 women. The discontinuation rate after one year was 51.5 for the "natural" estrogen product and 48.4 for the one containing synthetic estrogen. Discontinuation for menstrual irregularities was significantly higher for the "natural" estrogen preparation. During both the first three treatment cycles and the tenth to twelfth cycles, the incidence of various menstrual irregularities was significantly higher in the "natural" estrogen contraceptive. Adverse clinical associations were those commonly reported with other combined oral contraceptives for both preparations. 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 programmes than combinations containing synthetic estrogens, such as ethinyl estradiol.
Adolescent↗
The WHO multicentre trial of the vasopressor effects of combined oral contraceptives: 2. Lack of effect of estrogen. Task Force on Oral Contraceptives. WHO Special Programme of Research, Development and Research Training in Human Reproduction.
Changes in blood pressure were measured in a randomized double-blind trial of 680 women using oral contraceptives containing either 50 or 30 ug of ethinyl estradiol combined with 250 mg levonorgestrel. The trial was done in 6 centres in Thailand, India, Zambia, Cuba, The Philippines, and Hungary. There were no significant differences between the two pills at any of 4 follow-up visits at approximately 3, 6, 9 and 12 months, nor in the life-table probability of developing hypertension within one year. These findings are evidence against the hypothesis that it is the estrogen in oral contraceptives which causes their vasopressor effect.
Adolescent↗
Oral contraceptives and lipids and lipoproteins: Part I--Variations in mean levels by oral contraceptive type.
A randomized clinical trial of oral contraceptives evaluated 67 women on 50 micrograms ethinyl estradiol (EE) and 1.0 mg norethindrone (NE), 61 women on 35 micrograms EE and 1.0 mg NE, and 64 women on 35 micrograms EE and 0.5 mg NE. Fasting lipids and lipoproteins were measured at baseline, three, six and nine months. All groups showed an increase in plasma total cholesterol, triglycerides, low-density lipoprotein/apolipoprotein B and apolipoprotein A-1. The group taking the preparation with 0.5 mg of NE was the only one to result in an elevation of high-density lipoprotein cholesterol; the other two groups showed declines in the mean levels of this lipoprotein over the study time period. Mean changes in lipid/lipoprotein levels associated with oral contraceptive use appear to be at least partially related to the doses of the contraceptive steroids.
Adolescent↗
Risk of cancer development in relation to oral contraception.
Combined oral contraceptives (COCs) are among the most widely used effective and reversible means of family planning. Their beneficial effects are well documented, but many questions are still raised concerning a possible association between the use of COCs and the development of cancer. The authors provide a broad and up-to-date review of the literature regarding the relation between COC use and carcinogenesis in different organs. Studies have not unequivocally confirmed that such a relation exists with regard to breast cancer. Much research focused on the influence COC use could have on the incidence of cervical cancer; most of it was analyzed by J. Smith and co-workers. These authors confirmed the existence of a weak relation between COC use and the development of cervical carcinoma, especially in women using COCs for longer periods. Ovarian carcinoma has the worst prognosis of all cancers of reproductive organs in women. The risk of developing ovarian cancer in women using COCs is at least 40% smaller than in other women; the degree of protection given by COCs is directly proportional to the duration of use of this form of contraception. Reliable scientific data prove convincingly that the risk of endometrial cancer is smaller in women who used COCs than in women who never took them.
Breast Neoplasms↗
Tentative guidelines and practical suggestions to avoid venous thromboembolism during oral contraceptive therapy.
Oral contraceptive therapy (OCT) is widely used in the world. It is usually safe and effective but side effects are occasionally seen. Venous thromboembolism is one of the most feared side effects. To avoid this complication adequate guidelines are needed. These have to take into account family history, personal history, and suitable laboratory investigations. The presence of an idiopathic venous thrombosis in the family or in the personal history is of paramount importance. However it is often difficult to ascertain whether a venous thrombosis is idiopathic or not. Even when there is doubt, a coagulation study should be carried out. An adequate coagulation study in this case should include at least an evaluation of antithrombin, protein C, and protein S. A search for homozygosity of factor V Leiden appears advisable. These defects represent absolute contraindications to the use of OCT. Relative contraindications may be represented by other minor coagulation disorders such as heterozygous factor V Leiden, fibrinolysis defects, and a G-to-A 20210 prothrombin abnormality. Other noncoagulation-related conditions such as hypertension, liver damage, and obesity may represent absolute or relative contraindications to the use of OCT.
Contraceptives, Oral↗
Proposal of a flow chart for thrombosis-free oral contraceptive therapy.
Oral contraceptive therapy (OCT) is associated with a fourfold increase in the risk for venous thromboembolism (VTE). Women with congenital defects have a much higher risk. Because it is impossible to screen all women undergoing OCT, it is advisable to adopt some guidelines in an attempt to define the group of women who may be particularly exposed to the risk of VTE. On the basis of experience and that in the literature, two flow charts are used that are simple and reliable. The two flow charts are based on an accurate family and personal history so that an extensive investigation can be carried out only for women who show a positive family or personal history for idiopathic thrombosis. The definition of idiopathic thrombosis may be difficult, particularly in the case of family members. In case of doubt the thrombotic event should be considered as idiopathic. The two flow charts are not intended to eliminate the OCT-related VTE but represent only an attempt to decrease the prevalence of this complication.
Contraceptives, Oral↗
Cancer of the breast and reproductive tract in relation to use of oral contraceptives.
Effects of oral contraception on cancers of the female breast and reproductive tract are critically reviewed from human studies reported since 1980. The cumulative risk of breast cancer through 59 years of age appears to bear no relationship to oral contraceptive (OC) use whatsoever. Studies restricted to women under age 45, however, raise concern about a possible adverse effect from OC use before a first-term pregnancy. A duration-related protective effect against endometrial cancer occurs from use of combined OCs. The risk is reduced by about 40% with 2 years of use, and by about 60% with 4 or more years of oral contraception. Oral contraception in excess of 3 years protects against ovarian cancer. Four years of use confers a 50% reduction in risk and 7 or more years of use confers a 60%-80% reduction in ovarian cancer risk. Studies of cervical dysplasia and carcinoma in situ suggest elevated risks with 2 or more years of OC use, although results are difficult to interpret in view of numerous factors that might distort the findings. The risk of invasive cervical cancer appear to be unaffected by up to 5 years of oral contraception. Beyond this, there is evidence suggesting an elevated risk which approaches a 2-fold increase at 10 years of use. Cancers of the vagina and fallopian tube are extremely rare. Their risks have yet to be characterized in relation to oral contraception.
Adolescent↗
The estrogenic activity of synthetic progestins used in oral contraceptives.
BACKGROUND: Oral contraceptives (OC) contain an orally active estrogen in combination with an orally active synthetic progestin derived from 19-nortestosterone. OC have had an enormous positive impact on public health for the past three decades, and in the main, there has been a remarkably low incidence of troublesome side effects. Although estrogens are implicated in an increased incidence of breast and endometrial cancer, epidemiologic studies have not provided convincing evidence to support a direct correlation between OC use and an increase in breast cancer incidence. By contrast, OC do cause a decrease in the incidence of endometrial and ovarian carcinoma. During the past decade, several isolated reports have linked an increased incidence of breast cancer with the use of synthetic progestins. No mechanism for the proliferative potential of progestins has been offered. Therefore, the authors investigated this problem to formulate a hypothesis, based on laboratory data, that might be evaluated in populations at risk. METHODS: The synthetic progestins (19-nortestosterone derivatives) chosen for the study were norethynodrel, norethindrone, norgestrel (levonorgestrel), and gestodene. These were compared with the actions of medroxyprogesterone acetate (MPA). To determine whether the progestins produced their effects via the ER, the cells were transfected with a chloramphenicol acetyl transferase (CAT) reporter gene containing an estrogen response element only activated by ER. RESULTS: The 19-nortestosterone derivatives all stimulated the growth of estrogen receptor (ER)-positive but not ER-negative breast cancer cells in culture. Antiestrogens, but not the antiprogestin mifepristone (also known as RU 486), inhibited progestin-stimulated cell proliferation. MPA did not stimulate cell proliferation. All the synthetic progestins that increased replication also activated CAT. Activation was blocked by antiestrogens but not by mifepristone; the synthetic progestin MPA was inactive. CONCLUSIONS: These studies provided direct evidence that some synthetic progestins exert estrogenic effects through the ER. The results demonstrated that progestins can have a dual effect on estrogen target tissues either to stimulate or differentiate cells. The results suggest that some beneficial estrogen-like effects could be produced by synthetic progestins (e.g., bone preservation), but epidemiologic studies of OC use should focus of the "total estrogen" content to establish whether some formulations place some groups of women at greater risk of having breast cancer.
Breast Neoplasms↗
Mortality associated with oral contraceptive use: 25 year follow up of cohort of 46 000 women from Royal College of General Practitioners' oral contraception study.
OBJECTIVE: To describe the long term effects of the use of oral contraceptives on mortality. DESIGN: Cohort study with 25 year follow up. Details of oral contraceptive use and of morbidity and mortality were reported six monthly by general practitioners. 75% of the original cohort was "flagged" on the NHS central registers. SETTING: 1400 general practices throughout Britain. SUBJECTS: 46 000 women, half of whom were using oral contraceptives at recruitment in 1968-9. Median age at end of follow up was 49 years. MAIN OUTCOME MEASURES: Relative risks of death adjusted for age, parity, social class, and smoking. RESULTS: Over the 25 year follow up 1599 deaths were reported. Over the entire period of follow up the risk of death from all causes was similar in ever users and never users of oral contraceptives (relative risk=1.0, 95% confidence interval 0.9 to 1.1; P=0.7) and the risk of death for most specific causes did not differ significantly in the two groups. However, among current and recent (within 10 years) users the relative risk of death from ovarian cancer was 0.2 (0.1 to 0.8; P=0.01), from cervical cancer 2.5 (1.1 to 6.1; P=0.04), and from cerebrovascular disease 1.9 (1.2 to 3.1, P=0.009). By contrast, for women who had stopped use >/= 10 years previously there were no significant excesses or deficits either overall or for any specific cause of death. CONCLUSION: Oral contraceptives seem to have their main effect on mortality while they are being used and in the 10 years after use ceases. Ten or more years after use ceases mortality in past users is similar to that in never users.
Cause of Death↗
Oral contraceptives and gallbladder disease. Royal College of General Practitioners' oral contraception study.
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Cholecystitis↗
Clinical comparison of monophasic oral contraceptive preparations of gestodene/ethinyl estradiol and desogestrel/ethinyl estradiol. Latin American Oral Contraceptive Study Group.
The efficacy, cycle control, subjective complaints, and safety of monophasic preparations of the oral contraceptives containing gestodene 75 mcg plus ethinyl estradiol 30 mcg versus desogestrel 150 mcg plus ethinyl estradiol 30 mcg were compared in a 6-cycle, open-label, parallel, randomized, multicenter phase IV clinical study in Latin America. Of a total of 176 women in each group, 163 in the gestodene group and 160 in the desogestrel group completed 6 cycles, providing data for 1,015 and 1,006 cycles, respectively. Subject compliance was excellent; pills were missed during only 6.9% of the cycles in each group. No woman became pregnant during the study. Gestodene group exhibited significantly better cycle control as evidenced by the lower incidence of breakthrough bleeding and spotting. Spotting in some cycles was reported by 11.9% of women taking the gestodene-combination compared with 21% of women taking the desogestrel-combination. Based on number of women, 86.4% of the gestodene group reported all cycles were normal (no BTB) compared with 76.7% of the desogestrel group. Also, the women in the gestodene group reported a significantly lower incidence of nuisance side effects during treatment cycles. No amenorrhea was observed for either group. There were no clinically significant differences between groups with respect to body weight, blood pressure, or laboratory evaluations. Seven women withdrew from the gestodene group and 8 women withdrew from the desogestrel group because of adverse reactions. The results of this study indicate that, although both OCs provided effective contraception, in comparison to the desogestrel-combination, the gestodene-containing OC is associated with better cycle control, less bleeding, and fewer subjective complaints.
Adolescent↗
Third generation oral contraceptives and risk of myocardial infarction: an international case-control study. Transnational Research Group on Oral Contraceptives and the Health of Young Women.
OBJECTIVE: To test whether use of combined oral contraceptives containing third generation progestogens is associated with altered risk of myocardial infarction. DESIGN: Matched case-control study. SETTING: 16 centres in Austria, France, Germany, Switzerland, and the United Kingdom. SUBJECTS: Cases were 153 women aged 16-44 with a myocardial infarction event. Controls were 498 women (at least 3 controls per case) unaffected by myocardial infarction who were matched with their corresponding case for age and for hospital or community setting within four months of the index infarction. MAIN OUTCOME MEASURES: Odds ratios derived with stratified analyses and unconditional logistic regression to adjust for potential confounding variables. RESULTS: The estimated odds ratio for myocardial infarction of third compared with second generation oral contraceptives among all 651 study subjects was 0.36 (95% confidence interval 0.1 to 1.2) (P = 0.11). The odds ratio for the United Kingdom and Germany alone was 0.45 (0.1 to 1.8) (P = 0.26). Other odds ratios for the five countries were 3.1 (1.5 to 6.3) (P = 0.003) for use of second generation products v no current use and 1.1 (0.4 to 3.4) (P = 0.9) for use of third generation products v no current use. Among the confounding variables the independent contribution of smoking (for which adjustment was made in the above estimates) proved to be important (10.1 (5.7 to 17.9), P < 0.001). CONCLUSION: An odds ratio of 0.45 with wide confidence intervals shows that third generation oral contraceptives compared with second generation products are associated with a reduced risk of myocardial infarction or with no difference. This finding from an interim analysis should be interpreted with extreme caution. However, the excess risk of venous thromboembolism associated with the use of third generation products may be balanced by the reduced risk of myocardial infarction associated with the same products.
Adolescent↗
Should oral contraceptive users be screened for factor V Leiden? Oral contraceptives are not the only effective contraceptives.
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Contraceptives, Oral↗
Oral contraceptives and thromboembolic disease. II. Estrogen content of oral contraceptives.
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Contraceptives, Oral↗
A multicentre study of coagulation and haemostatic variables during oral contraception: variations with geographical location and ethnicity. Task Force on Oral Contraceptives--WHO Special Programme of Research, Development and Research Training in Human Reproduction.
A comparative study of the effects of combined oral contraceptives (OC) on coagulation and fibrinolytic variables using standardized laboratory technique and methodology has been performed in Dublin (Ireland), Salvador (Brazil), Santiago (Chile) and Singapore. Of 777 entrants to the study, 622 were randomly allocated to receive one of four different OC formulations. The remainder did not opt for OC. The progestogenic component was levonorgestrel (LNG) in three of the OC formulations and norethisterone acetate (NEA) in the fourth. Results for the three LNG user groups were pooled. The changes in haematological variables observed over 12 months in the LNG and NEA users were examined in relation to the changes seen in the women not on OC. Women in Salvador differed markedly from those in the other three centres, in showing no acceleration of the prothrombin time and no increase in either fibrin plate lysis or plasminogen following the use of OC. After adjusting the findings in OC users for those in non-users, significant differences in response between centres were also detected for activated partial thromboplastin time (accelerated only in Dublin and Santiago), factor VII activity (increased mainly in Salvador and Santiago) and fibrinogen (for which the most marked changes were an increase in Dublin and a decrease in Salvador). This variability between centres in the effects of OC on coagulation and fibrinolysis suggests that OC administration in different populations may not carry equal thrombotic risks.
Adult↗
Cycle control, tolerability, and satisfaction among women switching from 30-35 microg ethinyl estradiol-containing oral contraceptives to the triphasic norgestimate/25 microg ethinyl estradiol-containing oral contraceptive Ortho Tri-Cyclen LO.
OBJECTIVE: To determine cycle control, tolerability, and satisfaction among women (aged 18-45) switching from oral contraceptives (OCs) containing 30-35 microg ethinyl estradiol (EE) to Ortho Tri-Cyclen LO (norgestimate 180/215/250 microg/EE 25 microg) and Loestrin Fe 1/20 (norethindrone acetate 1 mg/EE 20 microg). DESIGN: A subset of patients from a study comparing Ortho Tri-Cyclen LO (N = 864) with Loestrin Fe 1/20 (N = 565) was analyzed. The subset was defined as those who had taken a 30-35 microg EE-containing OC within 60 days of study start. The total number of cycles of exposure for the subset was 6,054 for Ortho Tri-Cyclen LO and 3,814 for Loestrin Fe 1/20. Additional analyses evaluated switchovers from Ortho Tri-Cyclen to Ortho Tri-Cyclen LO (N = 111). MAIN OUTCOME MEASURES: Cycle control was assessed by daily diary cards reporting the frequency, severity, and duration of bleeding/spotting. Discontinuation rates due to adverse events (AEs) were considered to reflect tolerability. Satisfaction was evaluated by questionnaire. RESULTS: The proportion of cycles in which subjects experienced breakthrough bleeding and/or spotting was significantly lower with Ortho Tri-Cyclen LO than Loestrin Fe 1/20. Discontinuations due to AEs and serious AEs were comparable for Ortho Tri-Cyclen LO (3.4% and 0.6%, respectively) and Loestrin Fe 1/20 (3.2% and 0.7%, respectively). More women on Ortho Tri-Cyclen LO versus Loestrin Fe 1/20 were very or somewhat satisfied at Cycle 6 (86% vs. 81.1%; P < 0.05) and last visit (81.6% vs. 78.1%; P < 0.05). At Cycle 6, 89.3% of Ortho Tri-Cyclen to Ortho Tri-Cyclen LO switchovers were very or somewhat satisfied, and 72.6% desired to continue taking Ortho Tri-Cyclen LO after study conclusion. Conclusions-Switchovers from OCs containing 30-35 microg EE to Ortho Tri-Cyclen LO had excellent cycle control and tolerability, and were satisfied.
Adolescent↗