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Breakage and acceptability of a polyurethane condom: a randomized, controlled study.

CONTEXT: Although the first commercial polyurethane condom was approved for use several years ago, no U.S. clinical trial has compared its performance to that of the latex condom. METHODS: In a masked crossover study, 360 couples were randomized to use three polyurethane condoms and three latex condoms. After each use, couples recorded condom breaks, condom slips and other aspects of performance. At completion of the study, couples compared the sensitivity, ease of use, fit and lubrication of the two types of condoms. RESULTS: The clinical breakage rate of the polyurethane condom was 7.2%, compared with 1.1% for the latex condom (relative risk of 6.6, 95% confidence interval of 3.5-12.3). The complete slippage rate (combining incidents during intercourse and withdrawal) of the polyurethane condom was 3.6%, compared with 0.6% for the latex condom (relative risk of 6.0, 95% confidence interval of 2.6-14.2). Most male users preferred the sensitivity provided by the polyurethane condom to that of the latex condom. CONCLUSIONS: The clinical breakage rate of the polyurethane condom is significantly higher than that of the latex condom. However, nearly half of the users preferred the polyurethane condom, which provides an option for couples who have rejected conventional condoms or who cannot use latex products.

Adolescent↗

Pharmacokinetics of gestodene and ethinylestradiol in 14 women during three months of treatment with a new tri-step combination oral contraceptive: serum protein binding of gestodene and influence of treatment on free and total testosterone levels in the serum.

The pharmacokinetics of gestodene (GEST) and ethinylestradiol (EE2) were determined in 14 healthy women (age 18 to 32 years) during a treatment period of three months with a new tri-step combination oral contraceptive (Milvane). Prior to this treatment period, the same women received a single administration of a coated tablet containing 0.1 mg GEST together with 0.03 mg EE2. There was a wash-out phase of one week between both treatments. Following single dose administration, a mean terminal half-life of 18 h was observed for GEST. The total clearance was 0.9 ml x min-1 x kg-1 and the volume of distribution was 84 l. During a treatment cycle, GEST levels in the serum accumulated by a factor of 8 as compared to single dose administration. Steady-state drug levels were reached during the second half of each cycle. As compared to single dose administration, the following changes were observed for GEST at the end of treatment cycles one and three: prolonged terminal half-life (20 to 22 h), reduced total (0.16 ml x min-1 x kg-1) and free clearance (ca. 27 ml x min-1 x kg-1), reduced volume of distribution (ca. 18 l). A concomitant EE2-induced increase in the SHBG concentrations by a factor of three as compared to pretreatment values was observed during a treatment cycle and appeared to be mainly responsible for the changes in the pharmacokinetics of GEST. Marked changes were also seen for the serum protein binding of GEST. After single dose administration, the free fraction of GEST was 1.3% and the fractions bound to SHBG and albumin were 69.4% and 29.3%, respectively. At the end of cycle one, the free fraction was only 0.6% and the fractions bound to SHBG and albumin were 81.4% and 18.0%, respectively. There was no difference in corresponding pharmacokinetic parameters and in the serum protein binding of GEST at the end of cycles one and three. On the last day of treatment cycles one and three, the AUC(0-4h) values of EE2 were 299.2 and 278.1 pg x ml-1 x h, respectively, which corresponds to an about 30% increase as compared to single dose administration, where an AUC(0-4h) value of 216.1 pg x ml-1 x h was found. Total and free testosterone concentrations decreased during treatment cycles one and three by about 36% and 60%, respectively, compared with the corresponding values measured prior to treatment. The fraction of unbound testosterone thus decreased from 0.5% to 0.3% during treatment.

Adolescent↗

Disposition of chlordiazepoxide: sex differences and effects of oral contraceptives.

There is considerable interspecies and interdrug variability in the effect of sex differences and oral contraceptive (OC) steroids on hepatic drug elimination. Their influence on the disposition of chlordiazepoxide has been studied in 11 healthy young men (29 +/- 5 yr), 11 healthy young women (28 +/- 5 yr), and 7 healthy women receiving OC steroids (27 +/- 2 yr) for more than 6 months. The elimination half-life (t1/2(beta)) was longer (from 14.8 +/- 5.9 hr to 8.9 +/- 2.5 hr) and protein binding less (95.5 +/- 1.4% and 97.0 +/- 1.2%) in women than in men. Weight-normalized plasma clearances of total drug did not differ, but the clearance of unbound drug was significantly less in women (8.7 +/- 5.0 ml/min/kg) than in men (15.6 +/- 5.3 ml/min/kg). Women on OC steroids had a lower plasma binding (from 93.6 +/- 1.5% to 95.5 +/- 1.4%) and a higher volume of distribution (from 0.62 +-/ 0.23 l/kg to 0.40 +/- 0.14 l/kg) than women not on OC steroids. The elimination t1/2 was longer (from 24.3 +/- 12 hr to 14.8 +/- 5.9 hr) and the clearance of unbound drug lower (from 5.7 +/- 3.0 ml/min/kg to 8.7 +/- 5.0 ml/min/kg) in women on OC steroids than in those not using them, but these differences were not statistically significant.

Adolescent↗

Condom use and sexual behaviors among individuals procuring free male condoms in South Africa: a prospective study.

BACKGROUND: Although the South African government has increased the number of male condoms distributed free to the public, there is no understanding of whether these are being used effectively to prevent the spread of sexually transmitted diseases, including HIV infection. GOAL: The study goal was to determine sexual behaviors and barriers to condom use among individuals procuring condoms distributed free to the public sector. STUDY DESIGN: In a prospective study, individuals who procured condoms from 12 public health facilities across South Africa were recruited and observed for the next 5 weeks. RESULTS: The 384 successfully observed subjects reported 3262 sexual contacts, of which 2637 (81%) involved protection with a condom. In multivariate analysis, alcohol consumption and use of other contraceptives were associated with unprotected sexual intercourse. CONCLUSION: The levels of condom use are relatively high in this population, but these data highlight several important barriers to condom use that may be targeted by future interventions.

Adult↗

Oral contraceptives and thrombotic diseases: impact of new epidemiological studies.

Oral contraceptives (OCs) are, or perhaps more correctly, were, until recently, being taken by approximately 65 million women worldwide, which corresponds to approximately 6% of all women of reproductive age. OCs have been available since the early 1960s, and there is substantial evidence to suggest that no single medication has had such a profound impact on our reproductive and social life than the pill. In the Scandinavian countries, 30-50% of young women have been reported to be using OCs. Its widespread use throughout the world for several decades indicates that women and their doctors have considered that the benefits of OCs outweigh potential side effects. On October 18, 1995, the Committee on Safety of Medicines in the United Kingdom sent a warning to all British doctors and pharmacists about OCs containing desogestrel or gestodene. A similar warning was subsequently distributed by the German and Norwegian health authorities. As these OC types dominate the market in Northern Europe, many gynaecologists, general practitioners, women of reproductive age, different national bodies on drug safety, and people in general have been asking: * What was the background for these actions? * How do we interpret the new studies? * What do we do now concerning prescription of OCs? * What is the moral of this story?

Contraceptives, Oral↗

Teenage pregnancies and abortions in Finland in the 1990s.

AIMS: This study analyses trends and regional variation in teenage pregnancy, abortion, and fertility rates in Finland in the 1990s, by single-year age group. METHODS: Individual-level data from Finnish abortion and birth registers maintained by the National Research and Development Centre for Welfare and Health (STAKES) were used to calculate the rates and the abortion ratio. The abortion ratio was also calculated using conception as the time reference. RESULTS: Teenage pregnancy rates and abortion rates reverted from decrease to increase in the mid-1990s. This was accompanied by an increase in the share of teenage pregnancies that ended in an abortion. The increase in abortions started first among older teenagers, and spread gradually to younger girls. Regional variation in the rates remained the same throughout the study period. CONCLUSIONS: The observed trends reflect a change towards less effective use of contraceptive methods among teenagers. There is also evidence of the earlier start of teenage sexual activity at the end of the 1990s. The possible explanations for less effective contraceptive use include cutbacks in healthcare and family planning services in the first half of the 1990s and the reduction of sex education in schools.

Abortion, Induced↗

A review of family planning services by general practitioners in a health board region.

In 1994 the North Eastern Health Board published a study, which ascertained the range of family planning services provided by General Practitioners (GPs) in the area. This study highlighted some service and training needs, which have since been addressed. This study has been repeated to evaluate service developments. All GPs on the NEHB mailing list were sent a pre-piloted questionnaire about the range of family planning services they provide, their referral patterns should they not provide the service themselves and their comments on how the health board could assist in the enhancement of family planning services. The data were analysed using the software package JMP and statistical analysis was carried out using either the Chi-square test or Fishers exact test. There was a response rate of sixty six percent. There has been a decrease in the number of GPs in single-handed practices (24% vs 50% in 1994) and an increase in the number of practices who employ a practice nurse. Almost one third of GPs providing family planning services are women (18% in 1994) and over half of GPs hold a family planning certificate (33% in 1994). The range of services provided has increased and more GPs are now fitting intrauterine contraceptive devices (19% vs 14%). This study highlights significant developments in the family planning service and indicates that general practice is capable of providing a fully comprehensive service.

Adult↗

The IARC commitment to cancer prevention: the example of papillomavirus and cervical cancer.

Every year approximately half a million women worldwide develop cervical cancer (CC) of whom 80% live in poor countries where population-based screening programmes are virtually non-existent. The role of sexually transmitted agents in the aetiology of cervical cancer has been suspected for more than a century, but knowledge in this field has rapidly expanded only in the last 20 years, after major improvements were made in detection methods for human papillomavirus (HPV). A dozen types of HPV have been identified in 99% of biopsy specimens from CC worldwide and the relative risk estimates for HPV in case-control studies of CC are in the 50 to 100 range. A meta-analysis done at the International Agency for Research on Cancer (IARC) included a total of 10,058 CC cases from 85 published studies. The most common HPV types identified in CC were, in order of decreasing prevalence, HPV 16, 18, 45, 31, 33, 58, 52, 35, 59, 56, 6, 51, 68, 39, 82, 73, 66 and 70. Over two-thirds of CC cases were associated with an infection of either HPV 16 (51.0%) or HPV 18 (16.2%). Despite the overwhelming importance of HPV, other factors contribute to the rare occurrence of CC after HPV infection. Nine case-control studies from the IARC have confirmed the adverse effect of long-term use of oral contraceptives, high parity, smoking and sexually transmitted infections (i.e. Chlamydia trachomatis and herpes simplex virus-2) after adjustment for, or stratification by, HPV infection. Ten surveys of HPV infection in population-based samples of approximately 15,000 women in four continents have shown that: (1) the prevalence of HPV infection varies greatly (between 2% and nearly 30%); and (2) the age distribution also varies widely, pointing to cohort effects. There is no effective medical treatment for HPV, but a prophylactic vaccine, based on late (L) 1 HPV 16 proteins, has been shown to be safe, highly immunogenic and efficacious in preventing persistent HPV infections. A multivalent vaccine against the most common oncogenic HPV types may thus ultimately represent the most effective way to prevent CC worldwide either alone, or in combination with screening. It may, however, take several years before this approach becomes a reality. Thus, early detection of CC precursor lesions by screening, and their treatment, will remain the most important measures for the control of CC for the foreseeable future.

Female↗

Factors associated with Hispanic women's HIV-related communication and condom use with male partners.

To determine factors influencing Hispanic women's HIV-related communication and condom use with their primary male partner, 189 Dominican, Puerto Rican, and Mexican women were interviewed regarding sexual behaviour and condom use, relationship characteristics, perceived risk for HIV, and HIV-related communication with the primary male partner. Level of HIV-related communication with the primary male partner was associated with the woman's perceived risk for HIV and her rating of the openness with which she could communicate with her primary partner. Mexican women were less likely than Puerto Rican or Dominican women and women with multiple partners were less likely than those with one partner to communicate about HIV-related issues with their primary partner. Women reporting more condom use with their primary partner were younger, had discussed HIV-related issues more with the primary partner, and were less likely to expect negative reactions to requests for condom use than those reporting less condom use. These results suggest that prevention programmes that increase both general and HIV-specific communication between members of a couple may facilitate safer sex practices by the couple. Prevention programmes that encourage women to insist on condom use should consider the woman's expectations about her partner's reaction as a potential barrier to the initiation of safer sex practices.

Acculturation↗

Gonadotropin-releasing hormone receptors.

GnRH and its analogs are used extensively for the treatment of hormone-dependent diseases and assisted reproductive techniques. They also have potential as novel contraceptives in men and women. A thorough delineation of the molecular mechanisms involved in ligand binding, receptor activation, and intracellular signal transduction is kernel to understanding disease processes and the development of specific interventions. Twenty-three structural variants of GnRH have been identified in protochordates and vertebrates. In many vertebrates, three GnRHs and three cognate receptors have been identified with distinct distributions and functions. In man, the hypothalamic GnRH regulates gonadotropin secretion through the pituitary GnRH type I receptor via activation of G(q). In-depth studies have identified amino acid residues in both the ligand and receptor involved in binding, receptor activation, and translation into intracellular signal transduction. Although the predominant coupling of the type I GnRH receptor in the gonadotrope is through productive G(q) stimulation, signal transduction can occur via other G proteins and potentially by G protein-independent means. The eventual selection of intracellular signaling may be specifically directed by variations in ligand structure. A second form of GnRH, GnRH II, conserved in all higher vertebrates, including man, is present in extrahypothalamic brain and many reproductive tissues. Its cognate receptor has been cloned from various vertebrate species, including New and Old World primates. The human gene homolog of this receptor, however, has a frame-shift and stop codon, and it appears that GnRH II signaling occurs through the type I GnRH receptor. There has been considerable plasticity in the use of different GnRHs, receptors, and signaling pathways for diverse functions. Delineation of the structural elements in GnRH and the receptor, which facilitate differential signaling, will contribute to the development of novel interventive GnRH analogs.

Amino Acid Sequence↗

Knowledge about sexually transmitted diseases in rural and periurban communities of the Asaro Valley of Eastern Highlands Province: the health education component of an STD study.

Community health education played a major role in a study of sexually transmitted diseases (STDs) and other reproductive tract infections which we conducted in rural and periurban communities of the Asaro Valley near Goroka in the Eastern Highlands Province of Papua New Guinea. We found that most women had little knowledge about STDs, which they often did not realize were sexually transmitted. Even major signs and symptoms were thought to be normal and many women had not sought treatment until irreversible damage was done. Knowledge of the complications of STDs, such as infertility and stillbirth, was also slight in these women. It is apparent that there is a desperate need for more reproductive health education at the community level. In developing our health education methods, we found that simple line drawings of male and female reproductive organs and of people with different signs of STDs proved useful. These were quick and easy to produce from readily available materials. It was important to separate men and women into different groups with educators of the same sex, and to create a very informal atmosphere, encouraging free-ranging discussion. Following health education and sensitive interviewing, almost all the women selected for the community-based study of the prevalence of reproductive tract infections consented to vaginal examination, even if they were asymptomatic. Additionally, many nonselected women requested examination.

Adolescent↗

Pharmacokinetics of oral contraceptive steroids in Egyptian women: studies with Ovral, Nordette and Norminest.

Plasma concentration profiles and pharmacokinetic parameters have been obtained following single dose administration of three commonly used oral contraceptive steroid preparations, Ovral, Nordette and Norminest to Egyptian women. The constituents of the preparations are as follows: Ovral (50 micrograms ethinyloestradiol, EE2 and 500 micrograms levonorgestrel, LNG); Nordette (30 micrograms EE2 and 150 micrograms LNG); and Norminest (35 micrograms EE2 and 500 micrograms norethisterone, NOR). Peak plasma concentrations of EE2 ranged between 116-160 pg ml-1 for Ovral, 55-78 pg ml-1 for Norminest and 30-70 pg ml-1 for Nordette. There was no significant difference in half-life (t1/2), oral clearance (CL) or apparent volume of distribution (Vd). The relative values of the area under the plasma concentration-time curve (AUC) reflected well the different amounts of oestrogen in each preparation. There was no significant difference in t1/2, CL or Vd for LNG in the 2 preparations containing this progestogen. The mean AUC following Nordette (150 micrograms LNG) was 40% of that following Ovral (500 micrograms LNG; p less than 0.001). Comparing pharmacokinetic parameters for the same dose of LNG (Ovral) and NOR (Norminest) showed the AUC to be decreased and CL and Vd increased in the latter group. The study indicates that the kinetic profile of the OCS in healthy Egyptian women are similar to other ethnic populations.

Adult↗

Intra-uterine contraception and the risk of endometrial cancer.

Despite the increasing world-wide popularity of contraceptive intra-uterine devices (IUDs), their potential long-term effects on the risk of developing endometrial carcinoma have been poorly studied. This paper reports on the relationship between intra-uterine contraception and endometrial cancer by analyzing epidemiological data from a large, multicenter, population-based, case-control study of epithelial endometrial cancer. Cases were 437 women, 20 to 54 years of age, with histologically confirmed epithelial endometrial cancer ascertained through 6 population-based cancer registries in the United States. Controls were 3200 women selected at random from the populations of these areas. The age- and parity-adjusted odds ratio (OR) for the association between ever having used intra-uterine contraception and endometrial cancer was 0.51 (95% confidence interval (CI) 0.3-0.8). Although the protective effect increased with duration of use, a dose-response relationship among users was not statistically demonstrable. The association did not vary significantly with age at first or last IUD use or with time elapsed since first or last IUD use. Years of education significantly modified the effect of intra-uterine contraception. Thus, intra-uterine contraception appeared to be strongly protective for women with at least 13 years of education (OR = 0.29, 95% CI, 0.15-0.6). It is proposed that intra-uterine contraception exerts its protective effect through local structural and biochemical changes in the endometrium that may alter endometrial sensitivity and response to circulating estrogen and progesterone.

Adult↗

Validation studies of drug exposures in pregnant women.

The aim of these studies was to check the quality of data collection concerning drug use during pregnancy in the Hungarian Case-Control Surveillance of Congenital Abnormalities from four different aspects. (a) The parents of non-respondent cases were visited at home to collect data, but the Ethics Committee did not allow collection of comparable data from non-respondent control women. Thus only 200 selected non-respondent controls were visited at home and questioned about drug use as part of a validation study. There was no difference in the distribution and occurrence of frequently used drugs between the respondent and non-respondent control groups. (b) Data collection was compared between the usual method of the Case-Control Surveillance and personal interview in case with congenital limb deficiencies. In general, the two methods produced similar results with respect to drug use, but the personal interview revealed a higher use of unintended contraceptive pills while the use of antenatal care logbooks in the Case-Control Surveillance showed a higher use of drugs to prevent threatened abortion and preterm delivery. (c) A check of source and completeness of drug exposure showed that about one-quarter of the drugs used during pregnancy were not recorded in the Case-Control Surveillance, and the proportion of lack of recall was about 23%. A small group of women (2.4%) did not use prescribed drugs due to the suspected teratogenic risk. (d) The teratogenic labelling of drugs deters pregnant patients from the use of prescribed drugs, or at least shortens the duration of drug intake. Thus the evaluation of drug use on the basis of medically recorded prescribed drugs and/or usual recommendations produces a bias thus it is necessary to complete it with information from the patients.

Adolescent↗

Anthropometrical measurements and androgen levels in males, females, and hormonally untreated female-to-male transsexuals.

To elucidate the relationship between body build, androgens, and transsexual gender identity, anthropometric measurements were assessed in 15 hormonally untreated female-to-male-transsexuals (FMT). Nineteen healthy women (CF) (X = 22 years; 2 months), and 21 healthy men (CM) (X = 23; 7) were enrolled as controls. Baseline levels of testosterone (T; ng/dl), androstenedione (A4; ng/dl), dehydroepiandrosterone sulfate (DHEAS; ng/ml), and sex-hormone binding globulin (SHBG; microgram/ml) were assessed in 12 FMT, 15 CF, and in all CM. No control was under hormonal medication (including contraceptives). Absolute measurements in FMT were in accordance with their biological sex: they showed only small differences from the CF. However, FMT differed from CF in 7 of 14 sex-dimorphic indices of masculinity/femininity in body build. Of these 14 indices, 9 did not show a difference between FMT and CM. Hence, FMT presented a more masculine body build, particularly in fat distribution and bone proportions. Levels of T and A4 were significantly higher in FMT than in CF (T: 54.0 +/- 13.8 vs. 41.1 +/- 12.8; A4: 244.8 +/- 73.0 vs. 190.5 +/- 49.3), while DHEAS was higher in CM (3335 +/- 951) than in CF (2333 +/- 793) and in FMT (2679 +/- 1089). Altogether, 83.3% of FMT and 33.3% of CF were above normal values for at least one measured androgen. SHBG in FMT (1.21 +/- 0.70) and CF (1.87 +/- 0.91) was higher than in CM (0.49 +/- 0.18) and tended to be higher in CF than in FMT. Unbound T (T/SHBG ratio) was higher in FMT (72.0 +/- 67.6) than in CF (26.4 +/- 15.1) and correlated positively with manly body shape. Findings are discussed in relation to etiology of transsexualism.

Adult↗