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Mario P. Valeria Bahamondes, Nathalie Kapp, A prospective, open-label, single arm, multicentre study to evaluate efficacy, safety and acceptability of pericoital oral contraception using levonorgestrel 1. Will the use of levonorgestrel LNG 1.
Typical use of LNG 1. LNG 1. Some users take it repeatedly, as their means of regular contraception. This was a prospective, open-label, single-arm, multicentre Phase III trial study with women who have infrequent coitus on up to 6 days a month. Each woman had a follow-up visit at 2. The study was conducted between 10 January and 15 November A total of healthy fertile women aged 18—45 years at risk of pregnancy who reported sexual intercourse on up to 6 days a month, were recruited from four university centres located in Bangkok, Thailand; Campinas, Brazil; Singapore and Szeged, Hungary to use LNG 1.
The participants were instructed to take one tablet every day she had sex, without taking more than one tablet in any h period, and to maintain a paper diary for recording date and time for every coital act and ingestion of the study tablet, use of other contraceptive methods and vaginal bleeding patterns.
Anaemia was assessed by haemoglobin evaluation.
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Pregnancy tests were performed monthly and pregnancies occurring during product use were assessed by ultrasound. At the 2.
There were women included in the evaluable population which includes all eligible women enrolledwith There were three reported severe adverse events and other mild adverse events most common were headache, nausea, abdominal and pelvic painwith high recovery rate. The vaginal bleeding patterns showed a slight decrease in volume of bleeding and the of bleeding-free days increased over time.
There was only one case of severe anaemia, found at the final visit 0. This was a single-arm study with small sample size, without a control group, deed as a proof of concept study to explore the feasibility of this type of contraception. A larger clinical study evaluating pericoital contraception with LNG is feasible and our data show that this method would be acceptable to many women.
The other authors declare no conflicts of interest. Recent survey data and anecdotal information from sources in Africa, Latin America, Europe, and the USA suggested that many women are interested in an oral contraceptive pill OCP that is deed to be used only at the time of sexual intercourse Arowojolu and Adekunle, ; Lerkiatbundit and Reanmongkol, ; Gilliam et al. Such a method may have numerous advantages over daily OCP for women who have infrequent sex. For some women, taking an OCP only when needed may seem more intuitive than taking one every day even when sex has not occurred.
Users may find compliance easier with a coital-dependent pill regimen because pill-taking is triggered by a defined event and does not necessitate advance planning or routine intake. For most women, a coital-dependent pill regimen would require fewer doses than a daily pill regimen and would be more convenient. Furthermore, unlike other coital-dependent methods, such as condoms, diaphragms and spermicides, a contraceptive pill taken orally has the potential to be used without the cooperation or the knowledge of the male partner.
Levonorgestrel LNG when taken post-coitally has been studied extensively as a method of emergency contraception EC and the principal mechanism of action is to arrest or delay ovulation Croxatto et al. When used very near to ovulation, LNG is much less effective than when used earlier in the follicular phase, contributing to lower efficacy estimates of post-coital use during this time frame.
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Precoital use of LNG is likely to be more effective at preventing pregnancy than post-coital use as it may simultaneously affect both cervical mucus and delay or arrest ovulation Halpern et al. A recent Cochrane review of repeated pericoital hormonal contraceptive use identified 12 clinical trials conducted in the s and s, including a total of 12 women who used the prescribed method for a total of about woman-years W-Y Halpern et al. These women represented a broad cross section of the female population in terms of age and reproductive history.
In each of these trials, women were instructed to take 0. In most trials, the observed coital frequency was a mean of about four times a month. The efficacy of the method did not seem to be consistently related to any particular characteristic of the study population or to coital frequency.
Overall, these data suggest that the efficacy of pericoital LNG was in the range of that of other coital-dependent contraceptives like the condom Trussell, The main side effects of pericoital use of 0. The incidence of these side effects was not clearly related to the frequency of tablet intake.
Most subjects were satisfied with the method Halpern et al. Consequently, the objectives of this proof of concept study were to evaluate the efficacy and safety of LNG 1. This was a prospective, open-label, single-arm, multicentre Phase III trial study with women who have infrequent coitus up to 6 days a month.
The study enrolled non-pregnant healthy fertile women of reproductive age 18—45 years who had sex on between 1 and 6 days a month, were at low risk for sexually transmitted infections STIswere willing to use LNG 1. The exclusion criteria included being not at risk of pregnancy currently pregnant, breastfeeding, recently post-partum, using an intrauterine device or had female or male sterilization ; having a breast mass; or with contraindications to hormonal contraceptive use, and participation in the study or any other current medical research.
You have up to 24 h before or after sex to take the tablet. The women were counselled to take a second tablet if she vomited within 1 h after taking a study tablet. If she failed to follow the instructions missed an indicated tabletshe was asked to contact the study site for advice about using EC pills.
Tablets were provided in blister packages of 7 provided by Delpharm Lille S. S; Lys-lez-Lannoy Cedex, France. Women were advised to use condoms if needed to protect against STI or human immunodeficiency virus. Furthermore, the women were instructed to maintain a paper diary, on which she recorded date and time for every coital act and ingestion of the study tablet, use of other contraceptive methods such as condoms, and occurrence of vaginal bleeding or spotting.
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Participants were instructed to bring the diary with them during follow-up visits. Each subject had an enrolment visit and three follow-up visits at 2. After assessment of eligibility, baseline data including weight, blood pressure [BP] and haemoglobin [Hb] level were collected, and each participant was provided with the study medication and instructions on use.
At each follow-up visit, data about use of the study product and other contraceptives, vaginal bleeding, and adverse events AE were collected and a BP check and urine pregnancy test was performed. At the final visit, weight and Hb levels were rechecked. The site investigator team contacted each subject by telephone between follow-up visits to ascertain the result of the home pregnancy test performed each month where there was no in-clinic visitto ask about continued use of the product, and to ensure that the subject had sufficient supply to last until the next scheduled visit.
The site investigator team entered data into an electronic database and transmitted it electronically to the WHO for analysis. Pregnancies were ascertained by urine pregnancy tests at each visit, by home pregnancy tests between visits, and by subject self-report.
Those with a positive urine pregnancy test had an ultrasound to confirm the pregnancy usually at 5—8 weeks gestation. Data collection forms were reviewed for accuracy and completeness by study staff in-country. Validation checks and regular review of missing values, outliers, inconsistencies, and other errors were conducted. All statistical analyses were performed using the SAS system for Windows. Release 9. As a proof-of-concept study, the protocol established to enrol women into the study. This analysis would censor each subject's data on the date when she stopped considering the study product to be her primary contraceptive method and would exclude months in which a woman used any other method of contraception such as condoms.
Additionally, efficacy analyses estimated the PI during typical and perfect use of the product, and life-table analysis of pregnancy rates through 6 months of sole, typical and perfect use of the study product. Perfect use analysis excluded months during which the study product was not used according to instructions and typical use analysis included study months in which a subject used any other method of contraception in addition to the study pill. Safety analyses estimated the proportion of all subjects, including those over 35 years old, who had various safety outcomes of interest, including changes in vaginal bleeding parameters from baseline and other adverse events.
Bleeding patterns were analysed according to the terminology proposed by the WHO Belsey et al. Bleeding patterns and adherence were summarized according to the information captured in the diaries. The diary information was checked by staff in the presence of the woman against the relevant info in the follow-up form.
Acceptability analyses from all subjects included calculations of discontinuation rate by reason, as well as summaries of responses to the acceptability questions. Future contraceptive desires were assessed during 2. The of women assessed for eligibility, the enrolled and the different analyses performed are shown in Fig.
Baseline socio-demographic characteristics of the participants are shown in Table I. Selected baseline characteristics of the participants in a study to evaluate the efficacy, safety and acceptability of pericoital oral contraception using levonorgestrel 1. Participant flowchart for the study.
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Ten confirmed pregnancies occurred among the evaluable population during In the primary evaluable population less than 35 years old wherein there were nine pregnancies, the rate was The lost to follow-up was only 1. The distribution of the pill intake by month of follow-up ranged from a mean of 4. The pill intake during the other months of observation was within the same range. Furthermore, no relationship was observed between the pregnancy rate and the frequency of pill intake per month of observation. Participant used study pill as the primary method for up to at least days or became pregnant during product use before days.