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PubMed1996

Reliability of data from proxy respondents in an international case-control study of cardiovascular disease and oral contraceptives. World Health Organization Collaborative Study of Cardiovascular Disease and Steroid Hormone Contraception.

STUDY OBJECTIVES: To evaluate the reliability of data supplied in a case-control study by proxy respondents for cases who were too ill to do so themselves. DESIGN: A hospital based, case-control study of the current use of oral contraceptives (OC) and cardiovascular diseases. Data from "true" controls matched to a subset of cases were compared with those supplied by proxy respondents about the true controls. SETTING: Hospitals in 21 centres from Africa, Asia, Europe, and Latin America. PATIENTS AND PARTICIPANTS: For a subset of cases, 403 pairs of controls-one "true" and one proxy-were interviewed. "True" controls were matched by age, place, and time of admission and were admitted with 1 of 27 permissible diagnoses not associated with OC use. Proxy controls were either relatives or friends of true controls. MAIN RESULTS: Levels of concordance between data from proxy and true controls were high for most variables regarding recent events, including current OC use, but were greatly diminished when detailed information, particularly from the past, was required. Husbands were usually the best proxy, although this was question-specific. The sensitivity and specificity of proxy responses were 93% (95% confidence intervals: 77%, 99%) and 100% (98%, 100%) respectively, for current use of OC. Assuming the misclassification of current OC use by proxy cases is similar to that produced by proxy controls, the estimated impact of using proxy data on risk estimates associated with current OC use was to bias the overall estimate of risk of stroke by less than 3% and the risks of both acute myocardial infarction and venous thromboembolism by less than 1%. CONCLUSIONS: Friends or relatives, and particularly husbands, provided reliable information when used as proxy respondents for young women. The estimated impact of misclassification by proxy respondents on overall risk estimates in the WHO collaborative study was less than that which would have arisen if information from proxy respondents had not been used.

Adult↗
PubMed2002

Have oral contraceptives reduced the prevalence of acne? a population-based study of acne vulgaris, tobacco smoking and oral contraceptives.

BACKGROUND: The prevalence of acne among adolescents appears to vary geographically. This study was therefore undertaken to describe the prevalence rate of acne among Danish adolescents and to study the possible influence of oral contraceptives (OC) and tobacco smoking on disease prevalence and severity. Both have been suggested to influence acne and are therefore potential confounders in studies of acne prevalence. METHODS: A random sample of 186 15- to 22-year-old subjects participating in a population-based study of allergic diseases in Copenhagen County were also examined for acne. Questionnaire data on demographic variables, acne problems, smoking status and use of OC were recorded, and acne was graded according to the Leeds scale. RESULTS: The prevalence of clinical acne (Leeds score >1) was 40.7% for men and 23.8% for women (odds ratio, OR, acne vs. no acne: 0.46, 95% confidence interval, CI: 0.24-0.85). Acne was perceived as a personal problem by 37.6% of all subjects, and this was associated with clinical acne (OR: 5.5, 95% CI: 2.7-10.9). The use of OC was associated with a significantly lower prevalence of acne (OR: 0.32, 95% CI: 0.11-0.86), while the use of tobacco smoking was not significantly associated with acne (OR: 0.54, 95% CI: 0.17-1.78). CONCLUSION: In congruence with recent reports from other countries, the prevalence rate of acne among adolescents was found to be lower than previously described in older reports. In this population, the use of OC was associated with a lower prevalence of acne.

Acne Vulgaris↗
PubMed2003

Acceptability of emergency contraception in Brazil, Chile, and Mexico: 1 - Perceptions of emergency oral contraceptives.

This article presents the results of a study on the acceptability of emergency contraception (EC) in Brazil, Chile, and Mexico. Opinions of potential users and possible providers were obtained through discussion groups and those of authorities and policy-makers through semi-structured interviews. Most participants had a positive opinion of EC, based on the view that it can help reduce unplanned pregnancy, adolescent pregnancy, and unsafe abortion. Several interviewees felt that all women should be informed about EC, while others viewed it as a method for special situations such as rape and unprotected first sexual intercourse. Concern was expressed that its introduction might be associated with a decrease in condom use, increase in sexually transmitted diseases, and irresponsible or promiscuous sexual behavior among adolescents. The need for EC was clearly perceived by most participants, leading to the conclusion that health authorities have the responsibility of implementing programs for its introduction. Training of health care personnel should include the discussion of reproductive health problems that could be prevented by EC.

Adolescent↗
PubMedDate not supplied

Recent oral contraceptive use patterns in four European countries: evidence for selective prescribing of oral contraceptives containing third-generation progestogens.

A survey among oral contraceptive (OC) prescribers in the United Kingdom, Germany, Sweden and the Netherlands was performed to investigate OC prescription patterns before and after recent publicity in the media about studies reporting a higher risk of venous thromboembolism with OCs containing third-generation progestogens as compared to OCs containing second-generation progestogens. Before this publicity, most physicians prescribed third-generation OCs as their first-choice formulations for normal healthy women as well as for young girls (< 20 years) and older fertile women (30-35 years). In women presenting with cardiovascular risk factors, third-generation progestogens (desogestrel, gestodene) were considered safer and were five times more often prescribed than second-generation preparations (71% versus 14%). Most prescribers considered ethinylestradiol to be the most important component in relation to the risk of venous thromboembolism (71%), myocardial infarction (66%) and stroke (67%). In addition, for women presenting with cardiovascular risk factors, OC preparations containing 20 or 30 micrograms ethinylestradiol were considered safer than preparations containing 35 or 50 micrograms ethinylestradiol. Although the vast majority of prescribers (78%) stated that their attitudes towards safety of third-generation OCs had not changed since the recent publicity and the regulatory actions in some countries, 56% had changed their prescribing practice, largely due to patient concern about the safety of third-generation OCs. The results from this survey strongly suggest that, prior to the recent publicity, most prescribers considered third-generation OCs to be safer than second-generation preparations. Because of this perceived better safety profile, physicians have selectively been prescribing third-generation OCs to women at increased risk of cardiovascular disease. This pattern of selective OC prescribing may have seriously biased the results of the recently published studies on OCs and venous thromboembolism in favor of second-generation OCs.

Adult↗
PubMed2000

[A beam of dawn light of study on gossypol as a safe, effective, and reversible male antifertility contraceptive--evaluation of the studies by using low dose gossypol combined with steroid hormone for male contraception].

The present paper is an evaluation of the studies of two articles published in this issue of the journal which adopted a new regimen of low dose gossypol(12 mg.kg-1.d-1) combined with steroid hormones (methyltestosterone 20 mg.kg-1.d-1 and ethinyl estradiol 100 micrograms.kg-1.d-1) for 6 weeks as initial dose, and a similar low dose gossypol alone for 12 weeks as maintenance dose. Results showed that the dosage regimen could damage the epididymal sperms and onset of antifertility within 6 weeks in male rats, and prevent the incidence of the side effect of irreversible azoospermia. There was no adverse effect in viscera tissues, and the infertility could be reversible in about 6 weeks following withdrawal of gossypol. Male volunteers taking low dose gossypol (15 mg/d) could induce antifertility within 12 weeks, then followed by a maintenance dose of gossypol(10 mg/d) for 44 weeks. All of them remained infertile, and without developing hypokalemia and irreversible azoospermia. The fertility and the inducing abnormal histone-to-protamine replacement reaction as well as alteration of nuclear basic proteins could be recovered 10 weeks after withdrawal of drug treatment. These results provide a new approach for using the new regimen in clinical trial and a new prospect of gossypol as a potential male contraceptive.

Animals↗
PubMedDate not supplied

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↗
PubMed2003

[Venous thromboembolism and combined oral contraceptives. Reported adverse reactions indicate at least similar risk with the most recent contraceptive pills].

Rare adverse drug reactions (ADRs) to combined oral contraceptives (COCs), such as venous thromboembolism (VTE), are seldom disclosed until a COC has been on the market for some time. Two new COCs, Yasmin and Cilest have recently been launched in several European countries with expectations of being safer than older COCs. Utilising data from spontaneous reporting of ADRs to the Medical Products Agency in Sweden and sales data, VTE incidence for Yasmin and Cilest was estimated and compared with VTE incidence for a second (Follimin) and a third generation (Desolett) COC. The reported VTE incidence for Yasmin and Cilest was higher 4.6, and 3.7 per 10,000 users per year, respectively than the corresponding VTE incidences for Follimin and Desolett of 1.9 and 2.9 per 10,000 users per year, respectively. The differences were, however, not statistically significant. We conclude that the risk of VTE associated with the most recent COCs is at least similar to that of older COCs.

Adverse Drug Reaction Reporting Systems↗
PubMed1991

[Time course of inhibition of caffeine elimination in response to the oral depot contraceptive agent Deposiston. Hormonal contraceptives and caffeine elimination].

In the course of six months, the influence of the oral depot contraceptive, Deposiston (3 mg ethinylestradiol sulphonate and 10 mg norethisterone acetate per menstrual cycle) on the pharmacokinetics of caffeine as a model substance was studied in seven women in intraindividual comparison. The first examination began prior to administration of Deposition. The women were subjected to little challenge as saliva was used as the measuring compartment. Deposiston was found markedly delay the elimination half-life life of caffeine (p less than 0.05): t1/2 prior to therapy 4.9 +/- 2.6 h and, after as little as 2 mg ethinylestradiol sulphonate 8.0 +/- 3.5 h. In contrast to the effect observed for preparations containing less estrogen, these longer half-lives persisted throughout the trial. As expected, the AUC values were slightly elevated during this period, whereas clearance values were reduced.

Adult↗
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

The prevalence of abnormal cervical cytology in a group of New Zealand women using contraception: a preliminary report. The New Zealand Contraception and Health Study Group.

Between 1980 and 1986, cervical smears were obtained from 9430 women throughout New Zealand to determine their eligibility to enter the New Zealand contraception and health study. Excluded were 128 women in whom the smear was unsatisfactory or the cytological diagnosis was inconclusive. The prevalence of mild dysplasia or worse was 4.3% and of carcinoma in situ/invasive carcinoma was 0.5%. Risk factors that were identified were age at first intercourse, number of sexual partners, age and smoking. Over the age range studied (essentially 20-39), the prevalence of dysplasia decreased slightly with increasing age but the prevalence of carcinoma in situ/invasive cancer increased from 0.18% at ages 20-24 to 0.74% at ages 35-39.

Adolescent↗
PubMed1995

Venous thromboembolic disease and combined oral contraceptives: results of international multicentre case-control study. World Health Organization Collaborative Study of Cardiovascular Disease and Steroid Hormone Contraception.

The composition and use of oral contraceptives (OCs) have changed since their cardiovascular side-effects were established 20 years ago. This report describes the risk of idiopathic venous thromboembolic (VTE) events (deep vein thrombosis [DVT] and/or pulmonary embolism [PE]) in association with current use of combined OCs among 1143 cases aged 20-44 and 2998 age-matched controls, as evaluated in a hospital-based, case-control study in 21 centres in Africa, Asia, Europe, and Latin America. OC use was associated with an increased risk of VTE in Europe (odds ratio 4.15 [95% CI 3.09-5.57]) and in non-European ("developing") countries (3.25 [2.59-4.08]). Risk estimates were generally higher for DVT than for PE but no consistent trend by certainty of diagnosis (definite, probable, possible) was found. Increased risk was apparent within 4 months of starting OCs, was unaffected by duration of current episode of OC use, and had disappeared within 3 months of stopping OCs. Relative risk estimates of VTE associated with OC use were unaffected by age of user, by history of hypertension (excluding hypertension in pregnancy), or in any consistent way by smoking. However, in both groups of countries increased body mass index (BMI) was an independent risk factor for VTE, and OC-associated odds ratios were higher among those with a BMI above 25 kg/m2 than among those with smaller BMIs. OC-associated risk estimates were high among women in Europe with a history of hypertension in pregnancy. Odds ratios associated with the use of OCs containing a third-generation progestagen were higher than those observed with progestagens of the first (norethindrone type) and second (norgestrel group) generation. Odds ratios associated with first and second generation progestagens tended to be lower, though not significantly, when used in combination with low (< 50 micrograms oestrogen) rather than higher oestrogen doses. This study confirms an association between OC use and VTE in Europe and the developing countries, although overall risk estimates associated with use were lower than demonstrated in most previous studies of non-fatal idiopathic VTE.

Adult↗
PubMed1995

Effect of different progestagens in low oestrogen oral contraceptives on venous thromboembolic disease. World Health Organization Collaborative Study of Cardiovascular Disease and Steroid Hormone Contraception.

A multinational hospital-based case-control study of the risk of venous thromboembolic disease associated with combined oral contraceptives (OCs) done in 1989-93 prompted a separate inquiry comparing the risk of venous thromboembolism (VTE) associated with low oestrogen (< 35 micrograms ethinyloestradiol) OCs containing levonorgestrel with risks in low oestrogen preparations containing the third-generation progestagens desogestrel or gestodene. This analysis of data from 9 countries, involved 769 cases and 1979 age matched hospital controls and, in one centre, 246 community controls matched on age and general practice. 137 cases and 203 controls were current users of levonorgestrel (odds ratio [OR with 95% confidence interval] 3.5 [2.6-4.7]), with non-users as the reference; 35 cases and 28 controls were current users of desogestrel (9.1 [4.9-17.0]), and 36 cases and 28 controls were current users of gestodene (9.1 [4.9-16.7]). The ratios of these risks, compared with levonorgestrel, were 2.6 (1.4-4.8) for both products separately. Risk estimates adjusted for body mass index (BMI) were 3.4, 7.3, and 10.2 for levonorgestrel, desogestrel, and gestodene, respectively, compared with non-users, and 2.2 and 3.0 for desogestrel and gestodene, respectively, compared with levonorgestrel. 48 (68%) cases and 48 (86%) controls exposed to desogestrel or gestodene were from the UK (Oxford region). In this centre risk estimates compared with non-users, adjusted for BMI, were 2.6, 5.3, and 5.7 for levonorgestrel, desogestrel, and gestodene, respectively. Current users of low oestrogen dose combined OCs containing desogestrel or gestodene appear to be at higher risk of VTE than users of combined OCs containing levonorgestrel. The possibility that these unexpected results on a secondary study objective are due to chance, bias, or residual confounding cannot be excluded entirely and the results need to be confirmed by independent studies. They are at variance with the apparently more favourable metabolic effects of the newer progestagens. Whether the new progestagens are associated with lower risk of arterial disease (stroke and myocardial infarction) must be evaluated further.

Adult↗
PubMed1995

An attempt to estimate the incidence of cervical dysplasia in a group of New Zealand women using contraception. The New Zealand Contraception and Health Study Group.

We attempted to estimate incidence rates of cervical dysplasia and carcinoma in a cohort of 7,199 New Zealand women using contraception. The cohort was followed prospectively with periodic cervical smears, intended to be annual, over a 6-year period. The principal outcome investigated was a diagnosis of cervical dysplasia of any degree, from mild to severe dysplasia and including carcinoma in situ or invasive carcinoma, made cytologically by a central study laboratory and confirmed by histology or deoxyribonucleic acid (DNA) evaluation. These diagnoses are jointly referred to as "dysplasia." Two successive negative (nondysplastic) smears were required before a woman was considered eligible for the analysis of incidence. Even after these two negative smears, the estimated "incidence" of dysplasia declined markedly in each of the 5 years of the study, particularly among women who provided negative smears in each prior year. This suggests that prevalent cases were being diagnosed even after five or more negative smears. Assuming that nearly all of the prevalent cases were removed after five negative smears, our estimate of the annual incidence of cervical dysplasia in this population during this time period would be of the order of 5 per 1,000 per year. We conclude that the sensitivity of cervical testing for identifying cervical dysplasia is quite low in this population but is consistent with values reported from some other populations. Age at first intercourse, age at first pregnancy, number of sex partners, and current cigarette smoking were strongly associated with risk of dysplasia. Our data are equivocal on the question of whether age at first intercourse is a risk factor independently of the closely associated variable, number of sex partners.

Adult↗
PubMed1994

[School children's knowledge of, need for and use of contraception before and after the AIDS campaigns. Sexual activity and contraception habits].

The purpose of the present investigation was to evaluate changes in contraceptional habits or sexual activity among adolescents as a consequence of the AIDS-campaigns. In 1986 and 1993 all pupils in their ninth school year in the municipality of Viborg answered an identical questionnaire concerning the mentioned subjects. Both in 1986 and 1993 one third had had sexual intercourse, and one seventh had had their sexual debut before the age of 15. There were significantly more condom users at the first coitus in 1993 and fewer pill users. The proportion of unprotected intercourse did not differ. More pupils had had experience using condoms in 1993, but, as in 1986, nearly half of the girls had used coitus interruptus or safe periods. The proportion of girls who had had intercourse within a week of answering the questionnaire increased from 26% to 42%, indicating a more sexually active population of girls. It is concluded that the increased sexual activity, the fewer pill users and the persisting large proportion of un- or low-protected intercourse may result in more unintended pregnancies. The coincident use of pill and condom should be encouraged.

Acquired Immunodeficiency Syndrome↗
PubMed1996

[Levonorgestrel contraceptive implants. Facts and controversies of a current contraceptive method].

Research in the world of birth control technology advance daily. In México we now count with one of the best and most advanced contraceptive methods levonorgestrel implants. Even though it is far from being the ideal anticonceptive. It is in advantage over those known today in this country, because it does not content estrogens, it lasts up to 5 years, its reversible and it can be easily installed in a doctor's office. Some mexican doctors do not recognize yet this product or have been the victims of bad taste advertising. Learning about the method, its indications, contraindications, side effects, correct application and removal technics you can easily end the wrong ideas of it as a problematic device. The objective of the present work is to inform to the medical field of an excellent birth control alternative.

Contraceptive Agents, Female↗