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PubMed2005

[Safety evaluation of a transdermal contraceptive system with an oral contraceptive].

OBJECTIVE: evaluation of the frequency of adverse events during the therapy with a transdermal contraceptive system (TCS) in comparison to an oral contraceptive. MATERIAL AND METHODS: 20 healthy women aged 23.8 +/- 4.1 years without contraindication to steroid hormonal therapy and a history of dermal hypersensitivity to adhesive applications. All patients were treated with either contraceptive patches containing 20 microg ethinyl estradiol (EE) and 150 microg norelgestromin (17-dNGM) or a monophasic oral contraceptive containing 20 microg EE and 150 microg desogestrel during 6 cycles. Safety evaluation was based on the frequency of adverse effects, changes in physical and gynecological examinations. RESULTS: The incidence of most adverse effects was similar between the transdermal and oral contraceptive therapies, except of a higher incidence of breast pain, dysmenorrhoea and application site reactions in the patch group. 50% of patients demonstrated gastro-intestinal complaints in the oral contraceptive group. None of the patients discontinued the hormonal contraceptive therapies due to adverse effects. CONCLUSION: The study suggests that a transdermal contraceptive system is a safe and well tolerated therapy.

Administration, Cutaneous↗
PubMed1966

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↗
PubMed1995

Natural killer cell activity is reduced in association with oral contraceptive use.

Oral contraceptive (OC) use has been associated with increased incidence of a number of infections, but the mechanisms behind these changes is unclear. The present study compared OC users and nonusers in natural killer (NK) cell activity, NK phenotype, and illness frequency. Subjects were 55 female medical students (19 OC users, 36 nonusers). Three blood samples were obtained, 1 mo apart. Natural cytotoxicity was tested with a 51Cr assay. Self reports of illness symptoms during the previous week were collected at each blood sampling. NK phenotype number was assessed by flow cytometry. Oral contraceptive users had lower natural cytotoxicity and increased frequency of sneezing, gastrointestinal distress, runny nose, sore throat, coughing, and total illness symptoms, relative to nonusers. No differences were found between OC users and nonusers in NK phenotype number. These findings support the hypothesis that differences between users and nonusers in infection rates might be due to alterations in NK activity.

Adult↗
PubMed1991

A multicentre study of coagulation and haemostatic variables during oral contraception: variations with four formulations. Task Force on Oral Contraceptives--WHO Special Programme of Research, Development and Research Training in Human Reproduction, World Health Organization, Geneva, Switzerland.

OBJECTIVE: To explore the extent to which progestogen type and oestrogen and progestogen dose may modify the effects of combined oral contraceptives (OC) on coagulation and haemostasis. DESIGN: Randomized double-blind clinical trial. SETTING: Gynaecological clinics in Salvador (Brazil), Santiago (Chile), Singapore, and Dublin (Ireland). SUBJECTS: 622 women aged 18-35 years who had opted for oral contraception. A contrast group of 155 women who were not to receive OC was also studied. Both groups included approximately equal numbers from each of the four centres. INTERVENTIONS: Treatment of approximately equal numbers of women at each centre with one of the following OC preparations for at least 12 months: Norethisterone acetate (NEA) 1 mg + ethinyl oestradiol (EE) 50 micrograms; levonorgestrel (LNG) 250 micrograms + EE 50 micrograms; LNG 250 micrograms + EE 30 micrograms; LNG 150 micrograms + EE 30 micrograms. MAIN OUTCOME MEASURES: Changes over 12 months in 12 coagulation and haemostatic variables. RESULTS: At 12-month follow-up, the women on each OC preparation showed acceleration of prothrombin time and increase in factor X and fibrinogen. With the OC containing NEA there was also a persistent rise in factor VIIC, and reduction of antithrombin III and alpha 2-antiplasmin. The formulation which contained low doses of both LNG and EE showed the least adverse coagulation changes. Large increases in fibrinolysis were found in all OC groups. CONCLUSIONS: The adverse effects of combined OC on clotting are affected by the type and dose of progestogen as well as the dose of oestrogen.

Adolescent↗
PubMed1988

Reduced anaerobic glycolysis in oral contraceptive users.

Oral contraceptives containing combinations of estrogens and progestogens are known to impair glucose tolerance. The biochemical mechanisms underlying this lesion are speculative. In the present study women treated with OC for periods exceeding 10 cycles showed significant reduction in the activity of the key glycolytic enzyme phosphofructokinase (40%) and the levels of lactate (42%) in the erythrocytes compared to controls. These observations in women are analogous to those made earlier in female rats.

Adult↗
PubMed1997

Ovarian volume in gynecologically healthy women using no contraception, or using IUD or oral contraception.

OBJECTIVE: The aim of this study was to determine the ovarian volume by transvaginal ultrasonography in a gynecologically healthy population of women using no contraception, using intrauterine contraceptive device, or using oral contraceptive. MATERIALS AND METHOD: The study had a cross-sectional design. The ovaries of 428 women aged 1445 who contacted the family planning clinic in the county of Funen were examined. Most of the statistical analyses were carried out using standard techniques. However polynominal regression analysis was used to model ovarian volumes as a function of the day of cycle. RESULTS: No differences between the volumes of the right and the left ovary were found in any of the groups. Significant differences were found between the ovarian volumes of the three groups. The ovarian volumes were found to be largest in women using intrauterine contraceptive device, lesser in women using no contraception and smallest in women using oral contraception. A significant difference was found of the ovarian volumes throughout the menstrual cycle in women who were not using oral contraception. The ovarian volumes did not change throughout the menstrual cycle in women using oral contraception. In women not using oral contraception the largest ovary increased in volume from the start of the cycle to day 19, thereafter the volume declined. No evidence of any change of volume over the menstrual cycle was found in the smallest ovary and, for women using oral contraception, both ovaries. There was no correlation between age, height, weight, parity, and ovarian volume in any of the groups. CONCLUSION: The ovarian volumes, in gynecologically healthy women using intrauterine contraceptive device, are larger than in women using no contraception. It appears that oral contraception reduces the volumes of both ovaries in all phases of the menstrual cycle to equal levels.

Adult↗
PubMed2003

Angioedema and oral contraception.

BACKGROUND: Oral contraceptives can precipitate attacks of hereditary angioedema (ANE) or induce acquired forms. OBJECTIVE: We studied 5 patients who had an ANE which had begun under oral contraception and disappeared after stopping the pill. METHODS: We explored the clinical and biological characteristics of these patients. RESULTS: The symptoms developed during the first year or later after starting contraception; the patients reported relapsing swelling of the lips, hands, larynx and abdomen. All women had normal serum C4 and C1 inhibitor (C1Inh) antigen levels, but a lowered C1Inh activity, with a marked protein cleavage on the immunoblot. The suppression of the pill was associated with the regression of the edema and normalization of C1Inh function. CONCLUSION: The mechanism of these ANE is unknown. The could be due to a modulation of C1Inh expression upon androgens or an imbalance between coagulation proteins favoring C1Inh cleavage by its target proteases.

Adult↗
PubMed1994

Oral contraception and stroke. Evidence from the Royal College of General Practitioners' Oral Contraception Study.

BACKGROUND AND PURPOSE: A nested case-control analysis of data collected during the prospective Royal College of General Practitioners' Oral Contraception Study was performed to examine the relation between use of oral contraception and risk of stroke. METHODS: The 253 women who had a first-ever stroke (International Classification of Diseases, eighth revision, codes 4300 to 4389) or amaurosis fugax (code 3791) between 1968 and 1990 (case subjects) were compared with 759 women who did not have this diagnosis (control subjects). RESULTS: Smoking, social class, and history of hypertension were found to be important risk factors for stroke. Women who had ever used oral contraceptives had an increased risk of all stroke (odds ratio, 1.5; 95% confidence interval, 1.1 to 2.0, adjusted for smoking and social class) and of a fatal event (adjusted odds ratio, 2.3; 95% confidence interval, 1.2 to 4.4). A significant doubling of all stroke risk was observed among current users, an effect that was apparent in both smokers and nonsmokers. Former users had a small nonsignificant elevation in risk of all stroke but a stronger risk of a fatal event. The effects in former users appeared to be restricted to women who smoked. CONCLUSIONS: Current users of oral contraceptives appeared to be at increased risk of stroke. There is some evidence that former users may also have a persisting effect, although further research is needed to confirm these observations.

Adult↗
PubMed1996

p53 mutations in hepatocellular carcinoma related to oral contraceptive use.

Oral contraceptives (OCs) are implicated in the development of hepatocellular carcinoma (HCC). Mitogenic stimulation may be the primary mechanism of tumorigenesis, but other factors may also contribute. Mutational spectrum analysis can provide insights into pathogenesis, therefore we analyzed the p53 tumor suppressor gene in 10 HCCs from women with a history of OC use. All were non-Asians whose average OC use was 6.7 years (range 2 months-13 years) and whose mean age at HCC diagnosis was 48.8 years (range 21-67 years). Each tumor was analyzed by immunohistochemistry, DNA sequencing and allelic deletion analysis. Three tumors were positive by p53 immunohistochemistry; allelic deletion analysis identified loss of heterozygosity in one of four informative cases. Two p53 point mutations were found in one tumor containing moderately and well-differentiated components; this patient was negative for all serological markers of hepatitis B and C infections. Both components showed p53 protein accumulation and a GTTval-->GCTala mutation at codon 274. In addition, a silent mutation (ACCthr-->ACTthr) at codon 140 of the p53 gene was detected in the moderately differentiated component of the tumor. These preliminary data indicate that p53 mutations are uncommon in OC-related HCCs. One of the two detected mutations was a G:C-->A:T transition at a non-CpG site, which is characteristic of DNA damage by free radicals. These data support a model whereby estrogens contribute to HCC development primarily through mitogen stimulation and secondarily by mutagenesis via hydroxyl radicals produced during estrogen metabolism. Confirmational analysis of a larger series is warranted.

Adult↗
PubMed1996

[Diabetes regulation and oral contraceptives. Lipoporotein metabolism in women with insulin dependent diabetes mellitus using oral contraceptives].

In an open prospective study we evaluated the glycaemic control and lipoprotein metabolism in 22 women with uncomplicated insulin dependent diabetes mellitus during one year of oral contraception with ethinyl oestradiol and gestodene. Twenty women of comparable diabetic status using non hormonal contraception served as controls. No changes in glycaemic control were observed in any of the groups. In the oral contraceptive group decreased serum levels of low-density lipoprotein cholesterol and increased levels of triglycerides and lipoprotein A were noted whereas total cholesterol and high-density lipoprotein cholesterol levels were unchanged. In the control group a decrease of low-density lipoprotein cholesterol was observed. No effect of tobacco smoking on glycometabolic control or lipoprotein metabolism could be demonstrated during hormonal intake. In conclusion, we found no evidence of impaired glycometabolic control or adverse changes in serum levels of lipoproteins known to be associated to atherosclerosis in diabetic women during one year of oral contraception with ethinyl oestradiol and gestodene.

Adolescent↗
PubMed1990

Factors affecting the enterohepatic circulation of oral contraceptive steroids.

Oral contraceptive steroids may undergo enterohepatic circulation, but it is relevant for only estrogens, because these compounds can be directly conjugated in the liver. Animal studies show convincing evidence of the importance of the enterohepatic circulation, but studies in humans are much less convincing. The importance of the route and the rate of metabolism of ethinyl estradiol are reviewed. Some antibiotics have been reported anecdotally to reduce the efficacy of oral contraceptive steroids, but controlled studies have not confirmed this observation. Although gut flora are altered by oral antibiotics, the blood levels of ethinyl estradiol are not reduced, and one antibiotic at least (cotrimoxazole) enhances the activity of ethinyl estradiol.

Anti-Bacterial Agents↗
PubMed1989

The WHO multicentre trial of the vasopressor effects of combined oral contraceptives: 1. Comparisons with IUD. Task Force on Oral Contraceptives. WHO Special Programme of Research, Development and Research Training in Human Reproduction.

Changes in blood pressure were measured at three-monthly intervals over one year in a prospective study of 704 women using an oral contraceptive (OC) containing levonorgestrel 250 ug with ethinyl estradiol 50 ug and 703 women using an intrauterine device (IUD). The study was conducted in 11 centres in seven developing and three developed countries. Women using OC developed systolic blood pressures which were 3.6-5.0 mmHg higher than those using IUDs; their diastolic pressures became 1.9-2.7 mm higher. The OC-induced change was not affected by climate, age, a family history of hypertension, stroke or heart disease or by a history of hypertension in pregnancy. The life-table rate of hypertension (BP 140/90 or more) in the first year of OC treatment was 0.6 +/- 0.4 in the developing countries and 1.1 +/- 0.8 in the developed ones, per 100 woman-years of use. The vasopressor response to OC varied widely between centres but was not obviously related to the economic development of the country.

Adolescent↗
PubMed1989

Oral contraception, smoking and inflammatory bowel disease--findings in the Royal College of General Practitioners Oral Contraception Study.

Data from the Royal College of General Practitioners Oral Contraception Study have been examined to determine whether oral contraceptive use was associated with the development of Crohn's disease or ulcerative colitis. Over a 17 year period Crohn's disease developed in 42 women and ulcerative colitis in 78. The incidence of both diseases was greater in oral contraceptive users compared to non-users with the rate ratio for Crohn's disease being 1.7 (95% confidence limits, 0.88, 3.2) and for ulcerative colitis being 1.3 (95% confidence limits 0.82, 2.0). For both diseases incidence was unrelated to parity or social class, but women smoking at recruitment had a greater incidence of Crohn's disease (rate ratio 1.8, 95% confidence limits 0.93, 3.3) and a reduced incidence of ulcerative colitis (rate ratio 0.68, 95% confidence limits 0.41, 1.1). Although these results are based on small numbers and could be chance findings, they are consistent with other studies showing associations between oral contraceptive use, smoking and the development of Crohn's disease and ulcerative colitis.

Adolescent↗