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Progesterone receptor modulator for emergency contraception: a randomized controlled trial.

OBJECTIVE: Compare the efficacy and adverse effects of CDB-2914, a new progesterone receptor modulator, to levonorgestrel for emergency contraception. METHODS: We performed a randomized, double-blinded noninferiority trial, enrolling healthy women seeking emergency contraception within 72 hours of unprotected intercourse. Participants were randomly assigned to receive a single dose of 50 mg of CDB-2914, plus a placebo 12 hours later or two doses of 0.75 mg of levonorgestrel taken 12 hours apart. Follow-up was scheduled 5 to 7 days after the expected onset of the next menstrual period. Posttreatment pregnancy was established by a positive urine test at follow-up and confirmed by quantitative serum beta-hCG. Daily diaries were used from the time of emergency contraception use until next menses to record adverse effects and sexual activity. RESULTS: Product efficacy was evaluable in 775 of CDB-2914 users and 774 of levonorgestrel users. Pregnancies occurred in 7 (0.9%, 95% confidence interval 0.2-1.6%) and 13 (1.7%, 95% confidence interval 0.8-2.6%) women, respectively. Based on the estimated cycle day of unprotected intercourse, 85% and 69% of anticipated pregnancies, respectively, were averted. Nausea was reported by a somewhat greater percentage of CDB-2914 than levonorgestrel users (29% compared with 24%, P=.03), but the distribution of other adverse effects was similar in both groups. Women in both groups experienced considerable variation in menstrual cycle length as compared with their reported individual normal cycle lengths. CONCLUSION: CDB-2914 is at least as effective as levonorgestrel in preventing pregnancies after unprotected intercourse and has a similar side effect profile. LEVEL OF EVIDENCE: I.

Adolescent↗

Lorazepam and oxazepam kinetics in women on low-dose oral contraceptives.

Women on low-dose estrogen oral contraceptives (OC) and drug-free control women matched for age, weight, and cigarette smoking habits, received single 2-mg IV doses of lorazepam or single 30-mg oral doses of oxazepam, two benzodiazepines metabolized by glucuronide conjugation. Kinetics were determined from multiple plasma concentrations measured during 48 hr after dosing. Mean kinetic variables for lorazepam in control and OC groups (n = 15 in each group) were: volume of distribution (Vd), 1.33 and 1.45 l/kg; elimination t1/2, 13.1 and 12.2 hr; total clearance, 1.25 and 1.50 ml/min/kg; free fraction in plasma, 10.3% and 10.3% unbound. For oxazepam, kinetic variables in the two groups (n = 14 and 17) were: Vd, 1.05 and 1.19 l/kg; t1/2, 7.6 and 7.2 hr; total clearance, 1.60 and 2.03 ml/min/kg; free fraction, 4.6% and 4.9% unbound. None of these differences were significant. Thus, metabolic clearance by glucuronidation of lorazepam and oxazepam is not significantly affected by OC, in contrast with the highly significant reduction in clearance of the oxidized benzodiazepine diazepam.

Adult↗

HIV/AIDS in women: an expanding epidemic.

More than 20 years into the human immunodeficiency virus-type 1 (HIV-1) epidemic, women account for nearly half of the 40 million people living with HIV-1 worldwide, with an even higher proportion existing in developing countries. Social determinants of female vulnerability to HIV-1 include gender disparities, poverty, cultural and sexual norms, lack of education, and violence. Women are also more susceptible to HIV-1 because of hormonal changes, vaginal microbial ecology and physiology, and a higher prevalence of sexually transmitted diseases. Prevention strategies must address the wide range of gender inequalities that promote the dissemination of HIV-1.

Acquired Immunodeficiency Syndrome↗

The relationship between change in educational attainment and fertility rates in Taiwan.

Using vital statistics data for 1966 on age-education-specific marital fertility rates and comparable data drawn from a sample of Taiwanese women in 1971, the author computes the separate effects of changes in marital fertility, proportions married, age distribution, and educational distribution on changes in the crude birth rate and the fertility rate between 1966 and 1971. The changing educational distribution appears to have been fairly important, accounting for 24 percent of the 1966-1971 change in crude birth rate, holding other factors constant. For young women, the closely related factors of education and age at marriage seem to dominate fertility over the period, probably reflecting the widespread adoption of contraceptive practice by the lower educational strata. The effects of organized family planning program efforts are probably felt here.

Adolescent↗

Adolescent women's contraceptive decision making.

A modified rational decision model incorporating salient events and social influences (particularly from sexual partners) is used to analyze adolescent women's consistent use of oral contraceptives (OCs) over a six-month period. Data are taken from a panel study of 308 clients of an inner-city family planning clinic. Expected OC use was computed for each subject on the basis of subjective expected utility (SEU) theory, and is found in multivariate analyses to be a significant predictor of actual OC use. In addition, variables representing baseline and follow-up partner influences, the salience of pregnancy for the subject, and positive side effects of OCs during the first months of use are found to predict OC use. Partner's support of OC use during follow-up and positive side effects of OCs are found to predict OC use among subjects for whom OC use was not the expected decision according to baseline SEU. Implications of the findings for models of adolescents' contraceptive behavior and for clinicians are discussed.

Adolescent↗

[Effect of low doses of estrogens in menopausal women].

The effect of hormonal therapy in serum glucose, lipoproteins and the hemostatic system was studied in menopausal women, who were distributed in three groups: Group I (15 patients) received placebo in cycles of 21 days, followed by 7 days of rest; Group II (16 patients), received natural estrogens conjugated with progesterone in a sequential way, also in cycles of 21 days: Group III (16 patients), was treated with triphasic oral contraceptives in the same cyclical fashion. The patients completed 6, 12 or 18 cycles of the treatment. The results were as follows: The glucose levels were decreased by the 18th cycle in group II (P < 0.01). The HDL-cholesterol levels and the cholesterol/HDL cholesterol index were unchanged, however the basal levels of LDL-cholesterol in group III were high, but normal after 12 cycles of treatment. The coagulation factors did not changed significantly with the hormonal treatment, however fibrinogen was increased after 18 cycles under placebo. The von Willebrand factor and antithrombin III remained stable. Platelet aggregation with ADP increased after 12 cycles in group III (p < 0.05), and no changes were found with collagen. The above results suggest that the hormonal treatment in menopausal women, either with natural estrogens and progesterone or with triphasic oral contraceptives, has little effect in the lipidic concentrations of sera in these patients, however it can increase platelet activity, specially with prolonged treatment with semisynthetic estrogens.

Blood Coagulation Factors↗

[Sexuality and psychopathology: aspects of prevention. Cognitive investigation of the sexual information of high school students in Avezzano (AQ)].

Here are reported the final data to out of the analysis of the answers given in a questionnaire distributed to more than a thousand students of the secondary schools of Avezzano before the beginning of a course of sexual information. The questions covered general information (including an opinion on the idea and on the way of treating a course of sexual information at school) such as knowledge of contraceptive methods, the illnesses that are transmitted with sexual acts, the most important rules for the prevention of tumoral pathologies in women and the knowledge of the family's advisory bureau. With a very careful analysis of the answers we have been able to get out very important data about the knowledge that the young people have of sexual arguments (arguments that have guided the successive course of information), and interesting aspects of boys' and girls' psychology with regard to sexual arguments.

Adolescent↗

The association between substance use, condom use and sexual risk among low-income women.

Substance use is frequently assumed to be associated with higher levels of sexual risk-taking and lower levels of condom use. An analysis of 668 black, Hispanic and white low-income women at public health and public assistance facilities in Miami show that 19% engaged in risky sexual behavior over the preceding six months, 24% in substance use and 31% in condom use. Overall, substance users are nearly four and one-half times more likely to take sexual risks than nonusers, but are about half as likely to have relied on condoms. When the probability of condom use is considered in the context of both substance use and sexual risk, substance users who take sexual risks appear just as likely to rely on condoms as are nonusers who take sexual risks and those who do not (odds of 0.43-0.49). However, substance users who do not take sexual risks are much less likely to use condoms (odds of 0.15). This pattern holds among black, Hispanic and white women, and suggests that perceptions of risk and the risks that partners bring to sexual encounters may be more important determinants of condom use than substance use per se.

Adolescent↗

The effect of age and menstrual cycle upon proliferative activity of the normal human breast.

The aim of this study was to determine the proliferative activity within the epithelial cells of the normal human breast in 122 patients (6 reduction mammoplasties and 116 fibroadenoma excisions) in relation to age and the phase of the menstrual cycle. Thirty three of the patients were on oral contraceptives and 33 were parous. Thin tissue slices were incubated with tritiated thymidine and processed for autoradiography. Other samples were fixed directly and prepared for histology. The labelling, mitotic and apoptotic indices (LI, MI and AI) were determined and all illustrated considerable variability. The labelling indices are significantly (P less than 0.05) influenced by both patient age and stage during the menstrual cycle and ranged from 0-11.5%. Maximum LI values were obtained on the 20.8th day of the cycle. A square root transformation of the data was used to reduce the skewness of the data to a more normal distribution. The square root of the LI declined by 0.22 per decade. The mitotic data showed similar significant (P less than 0.05) correlations against age and day of cycle with a peak on the 21.5th day of the cycle, a decline by 0.072 per decade and a range from 0-0.6%. The data for apoptotic cells were less clearly influenced by the stage of the menstrual cycle but showed a significant (P less than 0.5) decline with age. The AI in parous patients was significantly higher than that in non-parous patients. There was no significant effect of oral contraceptives on any of the parameters measured when age and stage of cycle were taken into account. The considerable variability in the data could not be fully accounted for by either technical factors, the age of the patients, or the day of the cycle. We conclude that proliferation is negatively related to age and is influenced by the menstrual cycle but that additional as yet unknown factors must account for a large part of the variability seen in the data.

Adolescent↗

Effect of chronic oral contraceptive steroids on theophylline disposition.

The effect of chronic oral contraceptive (OC) usage on the disposition of theophylline was examined. Aminophylline solution (4 mg/kg) was given orally to 8 healthy female non-OC users and to 8 healthy women who were chronic (greater than 6 months) OC users. The OC user group had a significantly lower total plasma clearance of theophylline than women not using OC (35.1 +/- 5.6 vs. 53.1 +/- 14.5 ml/h/kg). The t1/2 was also significantly prolonged in the OC group (9.79 +/- 1.43 vs. 7.34 +/- 1.75 h) while the volume of distribution was similar between the 2 groups. The serum ethinylestradiol (EE) concentrations after oral OC administration were measured simultaneously. The apparent clearance of EE was about 30% lower in the OC users. A significant positive correlation was found between the apparent clearance of EE and the plasma clearance of theophylline. The effects of OC are predominantly due to chronic use with decreased elimination of both theophylline and EE.

Adult↗

Cervical carcinoma in Algiers, Algeria: human papillomavirus and lifestyle risk factors.

We conducted a hospital-based case-control study in Algiers, Algeria. A total of 198 cervical carcinoma (CC) cases (including 15 adeno- and adenosquamous carcinomas) and 202 age-matched control women were included. Human papillomavirus (HPV) DNA in cervical cells was evaluated using a PCR assay. Odds ratios and corresponding confidence intervals were computed by means of unconditional multiple logistic regression models. HPV infection was detected in 97.7% of CC cases and 12.4% of control women (OR = 635). Nineteen different HPV types were found. HPV 16 was the most common type in both CC cases and control women, followed by HPV 18 and 45. Twelve types (HPV 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 66 and 73) were found as single infections in CC cases. Multiple HPV infections did not show a higher odds ratio for CC than single infections. In addition to HPV infection, husband's extramarital sexual relationships with other women (OR = 4.8) or prostitutes (OR = 3.2), residing in a rural environment for most of one's life (OR = 4.9) and indicators of poor sanitation or poor hygiene were the strongest risk factors for CC. Oral contraceptive use was unrelated to CC risk, while multiparity emerged as a significant risk factor after adjustment for sexual habits. Intrauterine device users showed a lower CC risk than nonusers. The role of major risk factors, except inside toilet, was confirmed in the analysis restricted to HPV-positive women. The distribution of HPV types in CC cases and control women in Algeria is more similar to the one found in Europe than the one in sub-Saharan Africa, where HPV 16 is less prevalent. A vaccine against HPV 16 and 18 may be effective in more than 3/4 of CCs in Algeria.

Adenocarcinoma↗

Infertility after acute salpingitis with special reference to Chlamydia trachomatis.

Of 552 women with laparoscopically verified acute salpingitis (AS), 299 were reviewed 2.5 to 7.5 years later. Cervical secretions from these women had been cultured for the presence of Chlamydia trachomatis and Neisseria gonorrhoeae. For 49 of 82 women with visually normal pelvic organs, such cultures were also performed; these women served as control subjects. In women exposing themselves to pregnancy, 50 (23.3%) of 197 AS patients and 2 (6.7%) of 30 control women were infertile for at least 1 year (P less than 0.02). After one episode of AS, women harboring chlamydiae, gonococci, both, or neither of these microorganisms in the cervix on admission seemed to have the same fertility prognosis. Infertility was correlated with the number of AS episodes, the erythrocyte sedimentation rate (millimeters per hour) at admission, and the severity of the inflammatory reactions of the tubes. The use of oral contraceptives at admission was found to be a positive prognostic factor regarding fertility. Oral contraceptives might protect the patient from severe tubal inflammatory reactions.

Adolescent↗

Changes in the incidence and prevalence of rheumatoid arthritis in Kamitonda, Wakayama, Japan, 1965-1996.

OBJECTIVE: To evaluate secular trends in the incidence and prevalence of rheumatoid arthritis (RA) in Japan. METHODS: The incidence and prevalence of RA were determined in a longitudinal population based study in the Kamitonda district, Wakayama, Japan, from 1965 to 1996. RESULTS: In the study area consisting of about 3000 inhabitants, 16 incident cases, satisfying definite RA by the Rome criteria were detected during the study period. The age and sex adjusted incidence in both men and women combined and the age adjusted incidence in women significantly decreased (p<0.025 and p<0. 01, respectively). The age and sex adjusted prevalence in all inhabitants tended to decrease (p<0.1), and the age adjusted prevalence in women significantly declined (p<0.025). In men, however, neither incidence nor prevalence showed significant change. CONCLUSIONS: The decline of incidence and prevalence of female RA may be reducible to some environmental changes preferentially occurring more obviously in Japanese women than in men. Because the use of oral contraceptives has been extremely low in Japan, the decline should be explained by other factors.

Adolescent↗

Cholestasis of pregnancy. Clinical and laboratory studies.

A prospective study was made of clinical symptoms, liver function and pregnancy prognosis in women with cholestasis of pregnancy (CP). We used several positive and negative criteria to allow a clinical definition of CP as itching limited to time of pregnancy with or without laboratory evidence of liver dysfunction. The incidence during 1971-74 was 1.5% (100/6798 women) and lower during 1980-82 (52/5441 = 1.0%). One hundred consecutive pregnant women without itching were used as clinical controls. The incidence of CP showed a distinct seasonal variation, culminating in November. Women with CP had often had itching during previous pregnancies and during use of contraceptive pills and described anamnestically itching in mother and sisters. Laboratory data in CP were compared with reference intervals for healthy pregnant women. Serum enzyme levels were significantly increased for serum alkaline phosphatase, 5-nucleotidase, aspartate aminotransferase and alanine aminotransferase in the second and especially in the third trimester. The enzyme distribution was often markedly skewed to the right, i.e. some patients reacted more than others. Most patients with cholestasis only had itching without pronounced abnormalities in laboratory data. This mild form of CP was associated with a good prognosis for both mother and child.

Adult↗

[Epidemiology of tumors of the renal parenchyma].

Renal cell carcinoma is responsible for about 2% of all cancer deaths in developed countries and represents 80-85% of all tumors of the kidney. Its etiology is still largely undefined. Its incidence varies among countries, with the highest rates in North Americans and Scandinavians. Its incidence is steadily rising in the last ten years. The location of the tumor suppressor gene on chromosome 3p has contributed to the understanding of tumor pathogenesis. Renal cell carcinoma occurs nearly twice as often in men as in women. Patients are generally more than 40 years old at diagnosis, usually in the fifth to seventh decade of life. This tumor is more common among urban than rural residents, but it was not a consistent association with education or socio-economic status. Recently large epidemiologic studies showed an increased risk of renal-cell cancer in relation to tobacco smoking, with a relative risk of about 2 for current smokers. Other established risk factors are elevated body mass index (mainly in women) and a family history of the disease. Occupational exposure to chemicals appears to have little significance, although associations with specific products, such as asbestos fibres, have been reported. Some relationship has been observed between renal-cell cancer and hypertension, use of anti-hypertensives and kidney diseases, although this issue remains open to discussion. Data are inconsistent on the role of nutrition, mainly for fats and proteins, while vegetable and fruit consumption seems to convey some protection on renal-cell cancer risk. The risk of renal-cell cancer was not materially elevated in relation to coffee, tea and alcohol intake and, in women, oral contraceptive use, hormone replacement therapy, and menstrual factors.

Age Factors↗

Interpreting the beta geometric in comparative fecundability studies.

The beta distribution has often been used to describe variation in fecundability between couples when modelling the number of menstrual cycles required for a couple to achieve pregnancy. Groups are often compared for a condition or factor that could affect conception rates. However, when heterogeneity is present in each group, comparing group-specific parameters is not very informative on what any differences might imply for the individual couples. We present a quantile ratio that provides an individual level interpretation of any between-group differences in the beta distribution. Our results are illustrated on the two examples of Ridout and Morgan (1991, Biometrics 47, 1423-1433). The quantile ratio suggests a simplification in one of the examples.

Biometry↗

Family communication about sex: what are parents saying and are their adolescents listening?

CONTEXT: Communication between parents and adolescents about sex, particularly in minority families, has been understudied; more information is needed both on which sex-related topics are discussed and on how their content is transmitted. METHODS: Parent-adolescent communication about 10 sex-related topics was examined in a sample of 907 Hispanic and black 14-16-year-olds. Chi-square analyses were performed to test for significant differences across the 10 topics in discussions reported by the adolescents (with either parent) and by the mothers. The openness of communication, parent-adolescent agreement about communication of topics and differences by gender and ethnicity were also examined. RESULTS: Significantly higher proportions of mothers and adolescents reported discussions of HIV or AIDS (92% by mothers and 71% by adolescents, respectively) and STDs (85% and 70%, respectively) than of issues surrounding sexual behavior, contraceptive use and physical development (27-74% for these other eight topics as reported by mothers vs. 15-66% as reported by adolescents). The gender of the adolescent and of the parent holding the discussion, but not the family's ethnicity, significantly influenced findings, with adolescents of both sexes more likely to report discussions with mothers than with fathers, and with parents more likely to discuss any of the 10 topics with an adolescent of the same gender than of the opposite gender. The likelihood of a topic being discussed and of mother-adolescent agreement that a topic was discussed both increased with an increasing degree of openness in the communication process. CONCLUSIONS: Consistent with research among white samples, mothers of black and Hispanic adolescents are the primary parental communicators about sexual topics. To facilitate communication, educational programs for parents should cover not only what is discussed, but how the information is conveyed.

Adolescent↗

[Abortion-related mortality in Brazil: decrease in spatial inequality].

Abortion is not only a major cause of obstetric hospitalization in poor countries, but it also represents the failure of the public health system to provide enough information about contraceptive methods and thus prevent pregnancies. In Brazil, the high utilization rates of health facilities due to abortions reflect the ongoing difficulties with family planning and contraception. In addition, mortality resulting from abortions serves as an indicator of the quality of abortion procedures, an important point in a country where the practice is illegal and therefore done clandestinely. In this study, we analyzed the rates of mortality resulting from abortions among women 10 to 54 years old, including women who died from spontaneous and induced abortion, from 1980 to 1995, for the various regions of the country. The information we used came from the mortality data bank of the public health system of the Ministry of Health. Population data were obtained from the Brazilian Institute for Geography and Statistics. We studied 2,602 deaths, 15% of which were due to missed abortion, spontaneous abortion, or legally permitted induced abortion. The other 85% of the deaths were due to illegal induced abortions or to nonspecified abortions. The mortality rates from abortion-related causes have steadily decreased in all the regions of Brazil, but this improvement has been unevenly distributed in the country. The region with the smallest decrease in this rate (38% over 15 years) was the Northeast. The age of women dying from abortions progressively declined over the period studied.

Abortion, Induced↗