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PubMed2005

Oestrogen and stroke in women: assessment of risk.

The Women's Health Initiative reported an increased risk of stroke with hormone therapy, which has had a major effect on the use of these drugs. The increased risk was unexpected because research with animals showed that oestrogen reduces the extent of experimental strokes, and in human beings, oestrogen improves endothelial-dependent blood flow and lipid profiles. The mechanisms of risk might be related to oestrogen's proinflammatory and prothrombotic effects. However, the overall risk is still uncertain because of the complex actions of oestrogen at different doses, with or without progesterone, and the presence or absence of atherosclerotic risk factors. A similar debate about oral contraceptives and stroke risk in young women continues as data accumulate. Further studies are needed to identify the mechanisms of risk of stroke with oestrogen, as well as the risk factors that put women at particularly high risk of stroke with these hormones.

Aged↗
PubMed1986

Evaluation of a new triphasic oral contraceptive in private practice.

We evaluated the clinical and metabolic effects of a new triphasic regimen developed in the continuing attempt to reduce the dose of estrogen and progestogen in oral contraceptives. A combination of ethinyl estradiol (EE) and levonorgestrel (LNg) was used (six tablets with 30 micrograms EE + 50 micrograms LNg, five tablets with 40 micrograms EE + 75 micrograms LNg, and 10 tablets with 30 micrograms EE + 125 micrograms LNg), also known as Triphasil (Wyeth). In a private practice, 409 subjects participated in 7,286 treatment cycles. Three pregnancies occurred, all due to subject failure. Menstrual regulation was excellent and the incidence of side effects extremely low. Withdrawals from the study for possibly drug-related medical reasons totaled 9.0% through 56 cycles of treatment. Metabolic changes also were evaluated in 14 of these women over a 6-month period. The only statistically significant increase in carbohydrate values occurred at 6 months. The mean glucose level at 30 minutes of the oral glucose tolerance test was above the baseline mean value, but serum insulin levels showed no statistically significant deviation. Lipid values presented are total lipids, total cholesterol, triglycerides, alpha-, beta-, and pre-beta-lipoproteins, and high density and low density lipoprotein cholesterol. There was no statistically significant difference between the mean values at baseline and those during treatment for any lipid variable. These results indicate that this triphasic oral contraceptive has a high degree of efficacy, a low incidence of side effects, excellent cycle control, and high subject compliance, and would seem to indicate a minimal influence on the metabolism of lipids and carbohydrates in the small number of subjects studied.

Blood Glucose↗
PubMed1999

Ethnicity and contraceptive use in sub-Saharan Africa: the case of Ghana.

Using a sub-sample of ever-married women from the 1993 Ghana Demographic and Health Survey (GDHS), this study examines differentials in contraceptive use in six cultural groups: Ga-Adangbe, Twi, Fante/other Akans, Ewe, Guan/others and Mole-Dagbani. Multivariate analysis is used to explore whether reported ethnic differentials in contraceptive use can be attributed to ethnicity or to other characteristics that distinguish the ethnic groups. Overall, the findings are generally more consistent with the 'characteristics' hypothesis, because contraceptive use differentials by ethnic group is accounted for by differences in socioeconomic and demographic characteristics of these women. However, for the Fante/other Akans, even after the necessary controls, ethnicity continued to emerge as a significant determinant of contraceptive use. Programmatic implications of these results are discussed.

Adolescent↗
PubMed1987

The reduction in risk of ovarian cancer associated with oral-contraceptive use.

Although several studies have reported that the use of oral contraceptives decreases the risk of ovarian cancer, it is not clear whether the effect varies according to the oral-contraceptive formulation or the histologic type of cancer. To characterize this association more fully, we used data from a case-control study, the Cancer and Steroid Hormone Study. From 1980 to 1982, 546 women 20 to 54 years of age with ovarian cancer were enrolled from eight population-based cancer registries. The controls were 4228 women selected from the same areas. Women who had used oral contraceptives had a risk of epithelial ovarian cancer of 0.6 (95 percent confidence interval, 0.5 to 0.7) as compared with those who had never used them. This protective effect was seen in women who had used oral contraceptives for as little as three to six months, and it continued for 15 years after use ended; it was independent of the specific oral-contraceptive formulation and of the histologic type of epithelial ovarian cancer. (We could not adequately assess the association with nonepithelial ovarian cancers because of an insufficient number of cases.) We conclude that the use of oral contraceptives decreases the risk of epithelial ovarian cancer.

Adult↗
PubMed1995

Sixteen-year-old oral contraceptive users in Finland, 1981-1993.

While adolescent fertility and abortion rates continue to decline in Finland, regional variations in teenage pregnancies persist, particularly among 16-17-year-olds. We studied differences in the use of oral contraceptives (OCs) among 16-year-old girls according to sociodemographic variables between 1981 and 1993. Questionnaires were mailed to national samples (N = 462-1594) of 16-year-old girls biannually, giving response rates ranging from 86% to 91% (the Adolescent Health and Lifestyle Survey). The increasing trend in OC use levelled off in 1989 at around 17-19%. OC use was most frequent in the lower socioeconomic groups, least frequent in the rural areas, but did not vary significantly according to region of the country. The pace of adopting OCs did not vary across the socioeconomic groups or regions. The socioeconomic and regional distributions of OC use were consistent with previous studies on teenage sexual activity. The results suggest equal accessibility of family planning services; regional variation in pregnancy rates cannot be explained by unequal distribution of OC use.

Adolescent↗
PubMed2002

[Trends of OC use 1980-1999 in a German cohort of women].

INTRODUCTION: There is no doubt, oral contraceptives are a safe, reversible and commonly used method of contraception. Ever use is about 80 % in developed countries and current use of OCs about 40 %. Almost all information about prevalence of OC use came from cross-sectional studies and did not distinguish between high- and low-dose OCs. This paper deals with the prevalence of OC use as it was observed during lifetime of a large cohort of German women by calendar year and estrogen content. METHODS: The prevalence of OC use between 1980 to 1999 was analysed on occasion of an interim analysis of the German cohort study on women's health. This analysis is based on more than 10 000 women with about 390 000 women-years of observation. RESULTS: The proportion of women under the age of 50, that ever used OCs, increased steeply from 1980, i. e. from 62 % (1980) to about 90 % from 1996 onward. The proportion of current users in a given calendar year rose from 44 % (1980) to 49 % (1991-95) and dropped after the "pill crisis 1995". The percentage of current users who used high-estrogen-dose OCs dropped from 32 % (1980) to 5 % (1999). In contrast, the percentage of users of low-dose OCs of the 2nd generation steeply increased as was the percentage of users of the 3rd generation pills, however the latter dropped after 1995. CONCLUSION: The high acceptance of oral contraceptives despite many "pill crises" underlines the continuously high appreciation of their efficacy on the one hand, but underscores also the high responsibility of physicians and industry concerning surveillance or reduction of discussed side effects.

Adolescent↗
PubMed2003

FFPRHC Guidance (October 2003): First prescription of combined oral contraception.

The Guidance provides information for clinicians on the steps to be taken before providing a woman with her first prescription for combined oral contraception. It updates and replaces previous Faculty Guidance. A key to the grades of recommendations, based on levels of evidence, is given at the end of this document. Details of the methods used by the Clinical Effectiveness Unit (CEU) in developing this Guidance, and evidence tables summarising the research basis of the recommendations, are available on the Faculty website (www.ffprhc.org.uk). Abbreviations used include: blood pressure (BP), body mass (BMI), bone mineral density (BMD), breakthrough bleeding (BTB), British National Formulary (BNF), combined oral contraception (COC), Committee on Safety of Medicines (CSM), confidence interval (CI), deep vein thrombosis (DVT), emergency contraception (EC), ethinyl oestradiol (EE), Faculty Aid to Continuing Professional Development Topics (FACT), Family Planning Association (fpa), follicule-stimulating homone (FSH), general practitioner (GP), intermenstrual bleeding (IMB), luteinising hormone (LT), microgram, myocardial infarction (MI), odds ratio (OR), oral contraception (OC), pulmonary embolism (PE), relative risk (RR), Scottish Intercollegiate Guideline Network (SIGN), sexually transmitted infection (STI), Summary of Product Characteristics (SPCs), venous thomboembolism (VTE), World Health Organization (WHO), WHO Medical Eligibility Criteria (WHOMEC), WHO Selected Practice Recommendations (WHOSPR).

Age Factors↗
PubMed2003

Contraceptive vaccines.

The control of human fertility would be revolutionised by the development of a safe, effective, long-acting contraceptive vaccine. The pursuit of this objective has involved the selection of appropriate targets within the reproductive process that are amenable to interference with antibodies. To date, three major targets have been researched. The zona pellucida (ZP) plays key roles in folliculogenesis, fertilisation and early development, and is comprised of powerful cell-specific antigens. The induction of infertility requires high ZP antibody titres that are difficult to maintain without inducing ovarian pathology characterised by a premature loss of primordial follicles. As a premature menopause would be a high price to pay for long-term contraception, this approach to a vaccine cannot progress until the cause of the ovarian pathology has been resolved. Sperm surface antigens represent another promising approach to contraceptive vaccine development. While there is some clinical data to support the likely efficacy of this strategy, none of the gamete-specific molecules characterised to date have fulfilled this promise. Anti-human chorionic gonadotropin (hCG) vaccines terminate pregnancy by preventing the maternal recognition of pregnancy. This vaccine has reached the stage of clinical trials, and preliminary indications are that the approach is safe and potentially effective. However, reliability may be an issue, given the observed inter-individual variability in antibody generation. The future of contraceptive vaccine development will clearly involve a continuation of the intense search for suitable targets and the development of improved immunisation procedures that exploit the latest innovations in vaccine technology.

Adjuvants, Immunologic↗
PubMed1984

Use of oral contraceptives in women with cystic fibrosis.

Oral contraceptive pills (OCP) represent the most common contraceptive method among teenagers and young adults. Because many women with cystic fibrosis (CF) are now surviving into childbearing age and are at risk for the complications of pregnancy in CF, oral contraceptive use may be indicated. However, it has been suggested that OCP use by CF patients may be associated with deterioration in pulmonary function. Ten adolescent and young adult women with CF and moderate-to-severe obstructive lung disease were studied while taking a combination oral contraceptive pill (Ovral 28). No significant deterioration was found in clinical status or pulmonary function. Careful follow-up should nevertheless be continued to monitor for other adverse effects of oral contraceptive use in CF, such as cholelithiasis.

Adolescent↗
PubMed1998

Introduction of cyclofem once-a-month injectable contraceptive in Mexico.

A large introductory study of Cyclofem, a once-a-month injectable contraceptive, was conducted in three Mexican provinces. A total of 3457 healthy women participated: 640 women from rural areas (community-based component) and 2817 women from urban and suburban areas (health center-based component). A total of 20,316 women-months of treatment experience were accumulated during a one year period. Cyclofem proved its use-effectiveness (pregnancy rate of 0.03%) and its safety under routine service conditions of family planning facilities in Mexico. The overall life table continuation rate at 1 year was 26.1%. Higher continuation rates were observed in the community-based component (36.6%) as compared to the health center component (23.7%). The most common reason for method discontinuation was change of address. Only 15% of the discontinuations were attributable to the injectable contraceptive method, with the overall 1 year discontinuation rate for bleeding problems (including amenorrhea) was < 11%. These observations underscore the importance of appropriate counseling and follow-up measures, providing convenient access to repeat injections, and other service delivery issues related to continuation of Cyclofem. The results of this trial have once again demonstrated that Cyclofem is a highly effective method with an acceptable side effect profile. In addition, the study provided the elements for its approval by local health authorities and its inclusion into the Ministry of Health Family Planning Program.

Adolescent↗
PubMed2005

Change in bone mineral density among adolescent women using and discontinuing depot medroxyprogesterone acetate contraception.

BACKGROUND: Several studies report an association between depot medroxyprogesterone acetate (DMPA) injectable contraception and decreased bone mineral density. Adolescents, who are still gaining bone, may be particularly affected, but there has been little study of the association in adolescent users and none following discontinuation. OBJECTIVE: To evaluate bone mineral density changes in adolescents using and discontinuing use of DMPA contraception. DESIGN: A population-based prospective cohort study. PARTICIPANTS: One hundred seventy adolescent women, aged 14 to 18 years; 80 baseline DMPA users and 90 age-similar, unexposed comparison women. Sixty-one participants discontinued DMPA use during follow-up. MAIN OUTCOME MEASURE: Bone mineral density, measured every 6 months for 24 to 36 months at the hip, spine, and whole body, comparing mean bone mineral density changes in DMPA users and discontinuers with nonusers. RESULTS: Among DMPA users, bone mineral density declined significantly relative to nonusers at the hip and spine but not the whole body. Annualized mean percentage changes, adjusted for covariates, were hip, -1.81% vs -0.19%; P<.001; spine, -0.97% vs 1.32%; P<.001, and whole body, 0.73% vs 0.88%; P = .78 for DMPA users vs nonusers, respectively. New users lost bone mineral density more rapidly than prevalent users. Discontinuers experienced significantly increased bone mineral density relative to nonusers at all anatomical sites; annualized mean percentage changes were hip, 1.34% vs -0.19%; P = .004; spine, 2.86% vs 1.32%; P = .004; and whole body, 3.56% vs 0.88%; P<.001. CONCLUSIONS: Use of DMPA contraception in adolescents was associated with significant continuous losses of bone mineral density at the hip and spine. However, significant gains postdiscontinuation provide evidence that the loss of bone mass is apparently reversed.

Absorptiometry, Photon↗
PubMedDate not supplied

The role of epidemiology in the regulation of oral contraceptives.

The U.S. Food and Drug Administration (FDA) has relied to a great degree on epidemiologic studies in the regulation of oral contraceptives (OC). These epidemiologic studies range from individual case reports of adverse reactions to case-control studies and cohort studies. Important findings about adverse reactions to OCs have been communicated through "labeling," which includes information leaflets provided as package inserts for physicians and patients. Also, the FDA communicates its position through publications in medical journals, the FDA Drug Bulletin, public advisory committee meetings, workshops, and symposia. The agency responds to new epidemiologic information; labeling guidelines are under continuing review and revision. Patterns of oral contraceptive use have been affected by the dissemination of this information. There has been a decline in the use of OCs, a shift to formulations with lesser steroidal content, and a greater emphasis on OC use in optimal groups, such as young, nonsmoking women. Considered for future epidemiologic studies that may have an impact on regulatory action are a clarification of the role of various progestins in regard to blood lipid alteration and atherogenesis, a delineation of the possible persistence of cardiovascular risk after termination of OC use, and further clarification in regard to neoplasia, particularly breast and cervical carcinoma.

Contraceptives, Oral↗
PubMed1995

Oral contraceptives and breast cancer risk among younger women.

BACKGROUND: Several studies have suggested a link between oral contraceptive use and breast cancer in younger women, but it is possible that chance or bias, including selective screening of contraceptive users, contributed to the putative association. PURPOSE: Given that oral contraceptives were first marketed in the United States in the early 1960s, we conducted a population-based case-control study to examine the relationship between use of oral contraceptives and breast cancer among women in a recently assembled cohort, focusing on women younger than 45 years of age who had the opportunity for exposure throughout their entire reproductive years. METHODS: Breast cancer patients and healthy control subjects were identified, the latter group by random-digit dialing, in Atlanta, Ga., Seattle/Puget Sound, Wash., and central New Jersey. In Seattle and New Jersey, the study was confined to women 20 through 44 years of age; in Atlanta the age range was extended through 54 years. Patients included women with in situ or invasive breast cancer newly diagnosed during the period of May 1, 1990, through December 31, 1992. In-person interviews were completed by 2203 (86.4%) of 2551 eligible patients and 2009 (78.1%) of 2571 eligible control subjects. Analyses focused on women younger than 45 years of age (1648 patients and 1505 control subjects) to maximize opportunities for extended exposure. Logistic regression analyses were used to obtain maximum likelihood estimates of relative risks (RRs) and their 95% confidence intervals (CIs). RESULTS: Among women younger than 45 years, oral contraceptive use for 6 months or longer was associated with an RR for breast cancer of 1.3 (95% CI = 1.1-1.5). Risks were enhanced for breast cancers occurring prior to age 35 years (RR = 1.7; 95% CI = 1.2-2.6), with the RR rising to 2.2 (95% CI = 1.2-4.1) for users of 10 or more years. The RR for breast cancer for those whose oral contraceptive use began early (before age 18 years) and continued long-term (> 10 years) was even higher (RR = 3.1; 95% CI = 1.4-6.7). The RRs observed for those who used oral contraceptives within 5 years of cancer diagnosis were higher than for those who had not, with the effect most marked for women younger than age 35 years (RR = 2.0; 95% CI = 1.3-3.1). Oral contraceptive associations were also strongest for cancers diagnosed at advanced stages. Evaluation of screening histories and methods of diagnosis failed to support the speculation that associations could be due to selective screening. Among women 45 years of age and older, no associations of risk with use of oral contraceptives were noted. CONCLUSIONS: The relationship between oral contraceptives and breast cancer in young women appears to have a biologic basis rather than to be an artifact or the result of bias.

Adult↗
PubMedDate not supplied

A decade of Nepal's family planning program: achievements and prospects.

Knowledge and practice of family planning in Nepal increased considerably from mid-1976 through mid-1986, with significant improvements in the availability of and accessibility to contraceptives. However, a proportionately larger share of the achievements were made during 1976-81 than in 1981-86. The impact on fertility of contraceptive use during the decade was minimal. Knowledge and use of reversible contraceptive methods remained very low, primarily because of the continued strong emphasis on sterilization in Nepal's family planning program. Consequently, the welfare of many couples who may be in need of contraception for spacing births, but not necessarily for terminating childbearing, does not appear to be adequately addressed by the program. A more balanced emphasis on reversible methods of contraception does not necessarily imply that a substantially higher level of contraceptive prevalence would be required to reach the fertility target. Several steps to improve program performance and contraceptive method mix are suggested.

Adolescent↗
PubMed1995

Transdermal estrogen with a levonorgestrel-releasing intrauterine device for climacteric complaints: clinical and endometrial responses.

OBJECTIVE: Our purpose was to study the effects of intrauterine release of a daily dose of 20 micrograms levonorgestrel by an intrauterine device on climacteric symptoms, bleeding pattern, and endometrial histologic features in postmenopausal women receiving transdermal estrogen replacement therapy. STUDY DESIGN: Forty parous postmenopausal women were randomly allocated into two groups for 1 year: 20 women receiving a continuous transdermal daily dose of 50 micrograms of estradiol had a levonorgestrel-releasing intrauterine contraceptive device inserted, and the control group of 20 women received a continuous oral dose of 2 mg of estradiol valerate and 1 mg of norethisterone acetate daily. The climacteric symptoms, bleeding patterns, endometrial thickness, and endometrial changes in biopsy samples were analyzed. Serum levels of estradiol in both groups and levonorgestrel levels in the intrauterine device group were also determined. RESULTS: Both treatment regimens effectively relieved climacteric symptoms. Spotting was more common in the intrauterine contraceptive device group than in the oral therapy group for the first 3 months. After that, the proportion of women without any bleeding was similar in both groups. Two patients in each group dropped out because of bleeding. CONCLUSION: These preliminary findings suggest that the levonorgestrel-releasing intrauterine contraceptive device is a useful alternative mode of progestin administration for certain selected women receiving estrogen replacement therapy.

Administration, Cutaneous↗
PubMed1993

Respecting the autonomy of chronic mentally ill women in decisions about contraception.

Treatment of women patients with chronic mental illness who are at risk of unwanted pregnancies presents ethical challenges to the clinician who wishes to respect the patient's autonomy while also helping her avert the potential adverse consequences of unwanted pregnancy. The clinician who simply allows the patient to continue at risk or coerces her into using contraception may not have adequately considered the variable nature of the patient's autonomy. The authors suggest that the clinician should assess and treat conditions underlying the patient's variable impairment of autonomy to maximize her ability to participate in family planning decisions. Case examples are used to illustrate assessment of patients' decision-making capacity, development of family planning approaches that respect patients' autonomy, and use of a newly available contraceptive implant.

Adult↗
PubMed1998

Oral contraceptive discontinuation: a prospective evaluation of frequency and reasons.

OBJECTIVES: Our purpose was to define the frequency and reasons for oral contraceptive discontinuation and subsequent contraceptive behavior. STUDY DESIGN: A nationwide prospective study of 1657 women initiating or switching to the use of a new contraceptive from private practices, clinics, and a health maintenance organization was performed. RESULTS: Six months after a new oral contraceptive prescription, 68% of new starts and 84% of switchers still used oral contraceptives. Of women who discontinued, 46% did so because of side effects, whereas 23% had no continuing need. More than four fifths of women who discontinued oral contraceptives but remained at risk of unintended pregnancy either failed to adopt another method or adopted a less effective method. Fifteen percent of women who discontinued oral contraceptives resumed their use within the 7-month follow-up period. CONCLUSIONS: Counseling should emphasize the possibility of side effects, stressing the fact that most will be transient, and the need to identify a backup method. Follow-up visits should be scheduled for 1 to 2 months after a prescription is written.

Adult↗