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A multicenter, uncontrolled clinical investigation of the contraceptive efficacy, cycle control, and safety of a new low dose oral contraceptive containing 20 micrograms ethinyl estradiol and 100 micrograms levonorgestrel over six treatment cycles.

The aim of the trial was to demonstrate the contraceptive efficacy of a new low dose oral contraceptive containing 20 micrograms ethinyl estradiol and 100 micrograms levonorgestrel and to observe cycle control and safety. Data from 805 treated women resulted in 4400 treatment cycles. One pregnancy occurred while on the trial medication as a result of method failure, resulting in a Pearl index of 0.29. Cycle control was good, and cycle length as well as duration and intensity of withdrawal bleeding were not significantly changed during the trial. Intermenstrual bleeding usually occurred as spotting and decreased considerably during the treatment phase. Spotting alone was reported in 12.4% of cycles, breakthrough bleeding alone in 4.5% of cycles, and breakthrough bleeding and spotting together in 1.4% of treatment cycles. The rate of absence of withdrawal bleeding declined throughout the trial to 2.4% in cycle 6. There were no serious adverse events related to treatment, and most adverse events were those commonly observed in clinical trials with oral contraceptives. Headache, breast tension, and nausea were reported by 17.3%, 11.0%, and 7.7% of the women, respectively. There were no clinically relevant changes in laboratory parameters, blood pressure, or weight. In this trial, the new low dose oral contraceptive containing 20 micrograms ethinyl estradiol and 100 micrograms levonorgestrel was shown to be effective, safe, and well tolerated. Cycle control was found to be good and there was a low incidence of adverse events.

Adolescent↗

[The benefit of the classification of oral contraceptives. Studies of 525 women taking oral contraceptives (author's transl)].

The multiplicity of oral contraceptives suggests a classification for clinical routine. From the dosage of estrogens and gestagens in oral contraceptives, aberration indices were calculated from consideration of proliferation and transformation aspects. According to these a classification of oral contraceptives into 3 "estrogen" groups and 4 "gestagen" groups was made. Such a classification was made in 525 women taking oral contraceptives which took into consideration the following parameters: age, length of time during which oral contraceptives had been taken, subjective side-effects, sexual medical and psychometric aspects.

Adult↗

Outcomes of adolescents using levonorgestrel implants vs oral contraceptives or other contraceptive methods.

OBJECTIVE: To compare outcomes among adolescents who use levonorgestrel implants, oral contraceptives, or other methods of birth control. DESIGN: Prospective, longitudinal study of 166 females who were followed up for 6 months. Fifty-four used implants, 64 used oral contraceptives, and 48 used condoms alone or with spermicide, or no contraceptive. Outcomes were measured by patient interview and medical chart review. SETTING: Inner-city, hospital-based adolescent and teenaged mother and baby clinic between April 1, 1992, and May 31, 1993. PARTICIPANTS: Sexually active 12- to 18-year-old females at least 1 year postmenarche who had no contraindications to use of hormonal contraceptives. MAIN OUTCOME MEASURES: Sexual activity, pregnancy rates, condom use, incidence of sexually transmitted disease, patient satisfaction continuation rates, and side effects. RESULTS: Despite similar reports of sexual activity, one subject who used the implant (2%) vs 13 subjects who used oral contraceptives (20%), and eight subjects who used other methods (17%) became pregnant (chi 2, P < .50). Condom use did not differ among groups (chi 2, P > .60). Overall, 30% of subjects contracted a new sexually transmitted disease; rates did not differ by method (chi 2, P = .92). Implant users were more likely than oral contraceptive users to continue their method (87% vs 50%; chi 2, P < .001) despite similar satisfaction scores (one-way analysis of variance, P = .52). Implant users were more likely to experience irregular menses, mood swings, acne, and hair loss (chi 2, P < .05). CONCLUSIONS: In this population, the levonorgestrel implant is an effective method of pregnancy prevention and is associated with high satisfaction and continuation rates at 6 months. Implant users are not at greater risk than others for sexually transmitted disease. Health care providers should continue to stress the use of barrier methods to all sexually active adolescents.

Adolescent↗

The intrauterine contraceptive device: an often-forgotten and maligned method of contraception.

Although 90% of women at risk for unintended pregnancy in the United States use contraception, <1% of these women use the intrauterine contraceptive device. The mechanism of action of intrauterine contraceptive devices has been controversial, but several studies suggest that interference with sperm migration or function and with fertilization may be the most likely mechanisms. More important, there is lack of compelling evidence that the intrauterine contraceptive device acts as an abortifacient. The risk for pelvic inflammatory disease among users now appears to be extremely low, primarily as a result of better selection of candidates. A levonorgestrel-releasing intrauterine contraceptive device may offer some new therapeutic approaches for the treatment of certain gynecologic disorders. Although women who are not at risk for pelvic inflammatory disease or sexually transmitted diseases are appropriate candidates for the intrauterine contraceptive device, it appears that use can be expanded to selected nulliparous women and women with certain medical conditions.

Contraceptive Agents, Female↗

Resistance against contraception or medical contraceptive methods: a qualitative study on women and men in Istanbul.

OBJECTIVES: This research was carried out to reveal the attitudes of men and women about contraception in the Umraniye district of Istanbul. METHODS: Focus group discussions were used for data collection. Data from 20 groups of married people (ten groups of men and ten of women) living in Umraniye were analyzed. RESULTS: Most people attending the focus groups in the study were against having 'too many' children. Economic constraints appear to be a leading influencing factor for limiting the number of children. Urbanization also seems to have a strong influence on people's knowledge and attitudes about contraception. Culture and religious beliefs were not found to be major barriers to contraception in general, but they would influence the selection of the type of a certain contraceptive method. More specifically, culture and religious beliefs were barriers to use of medical methods, and they were the main reasons for use of the withdrawal method, which is the most common method used in Turkey. CONCLUSIONS: Men and women are not resistant to contraception, but they are reluctant to use medical methods. The provision of contraceptive services, with special attention to cultural and religious beliefs and values, and the inclusion of appropriate counseling and education sessions during service delivery, may give clients new options and increase the use of medical methods.

Contraception Behavior↗

Combined oral contraceptives and risk of cervical carcinoma in situ. WHO Collaborative Study of Neoplasia and Steroid Contraceptives.

BACKGROUND: Although the possible influence of oral contraceptives on risk of cervical carcinoma in situ has been the subject of multiple prior investigations, the results have been inconsistent. METHODS: Data from a multinational, collaborative case-control study were analysed to investigate further this possible relationship. To assess potential screening bias, some statistical analyses were restricted to subgroups of cases with and without symptoms at the time of their diagnosis. RESULTS: Relative risk estimates in relation to various features of oral contraceptive use tended to be highest for asymptomatic disease, lowest for disease presenting with vaginal bleeding, and intermediate for disease presenting with other symptoms, suggesting the presence of a screening bias. In women with vaginal bleeding, who are least likely to have been detected by routine screening, no elevated risk of cervical carcinoma in situ was observed in relation to ever having used combined oral contraceptives, but there was an increased risk in users of over 60 months' duration. An increasing trend in risk with duration of use was most pronounced in these women who first used oral contraceptives in the past 5-10 years; and in women who used oral contraceptives for more than 60 months, risk declined with time since last use. CONCLUSION: These findings could reflect a reversible effect of long-term use of oral contraceptives at an intermediate stage in the carcinogenic process, or a non-causal relationship due to unidentified sources of bias or confounding.

Adult↗

Oral contraceptives and invasive adenocarcinomas and adenosquamous carcinomas of the uterine cervix. The World Health Organization Collaborative Study of Neoplasia and Steroid Contraceptives.

Data from a hospital-based case-control study collected between 1979 and 1988 in 10 participating hospitals in eight countries were analyzed to determine whether use of combined oral contraceptives alters the risks of invasive adenocarcinomas and adenosquamous carcinomas of the uterine cervix. Information on prior use of oral contraceptives, suspected risk factors for cervical cancer, and history of cytologic screening was ascertained from interviews with 271 women with adenocarcinomas, 106 with adenosquamous carcinomas, and a large pool of hospitalized controls, from which 2,887 were matched to the cases included in this report. History of smoking and anogenital warts and blood specimens for measurement of herpes simplex and cytomegalovirus antibodies were obtained from subsets of these women, as was a sexual history from a subset of their husbands. The epidemiologic features and associations with oral contraceptives were similar for adenocarcinoma and adenosquamous carcinoma. For both types combined, risk increased with duration of oral contraceptive use, was highest in recent and current users, and declined with time since cessation of use. These trends in risk were strongest for cancers that occurred in women under age 35 years, and the association with risk was somewhat stronger for high compared with low progestin potency products. The strength of the observed relation with oral contraceptives was about the same as has been observed for invasive squamous cell cervical carcinomas. Women who have used oral contraceptives should be considered at increased risk of adenomatous cervical carcinomas.

Adenocarcinoma↗

Impact of a school-based comprehensive program for pregnant teens on their contraceptive use, future contraceptive intention, and desire for more children.

In response to multiple problems faced by pregnant or parenting teens, or both, many alternative school-based comprehensive programs have been established to provide the teens with multiple services. However, few of these programs have been evaluated to assess their impact on the teens. In this study, we have made a systematic evaluation of such a school-based comprehensive program-the Paquin School Program in Baltimore City-to assess its impact on contraceptive use, future contraceptive intention, and desire for more children. We used data collected from a sample of 371 pregnant and parenting teens who attended the Paquin School Program between 1999 and 2001, and from a sample of 506 comparable teens, who did not attend the Program. Our findings showed that the percentages of the Paquin School enrollees who were using contraceptives or who expressed intention to use contraceptives in the future were higher than those of their counterpart nonenrollees from the comparison schools. The findings also showed that the use of Depo-Provera and desire for no more children were higher among the Paquin School enrollees than among the enrollees from the comparison schools. Because the Paquin School enrollees self-selected into its program, some unobserved differences between them and their counterpart nonenrollees might have affected the outcomes of this article. However, the consistent patterns of positive outcomes for the Paquin School enrollees with regard to contraceptive use, future intention to use contraceptives, and desire for no more children, compared to those from the comparison schools, seem to suggest that the Paquin School's alternative comprehensive program has been successful in its effort to promote family planning. One possible reason for this success of the effort to promote family planning is its integration with the multiple services of the comprehensive program of the Paquin School that enables its teens to plan their fertility.

Adolescent↗

Epithelial ovarian cancer and combined oral contraceptives. The WHO Collaborative Study of Neoplasia and Steroid Contraceptives.

The relationship between use of combined oral contraceptives and risk of epithelial ovarian cancer was investigated in a hospital-based case-control study conducted from 1979-1986 in seven countries. Three hundred and sixty-eight women with histologically confirmed epithelial ovarian cancer were compared to 2397 hospital controls matched for age, study centre, hospital and year of interview. The relative risk (RR) in women who ever used combined oral contraceptives, controlling for the confounding effect of number of pregnancies, was 0.75 (95% confidence interval (Cl) 0.56, 1.01). The relative risk decreased with increasing duration of oral contraceptive use and with increasing time since cessation of use. Except for mucinous tumours, oral contraceptive use was associated with lower risk of all histological subtypes of epithelial ovarian cancer. While the reduced risk associated with oral contraceptive use was present in parous women (RR = 0.85), it was most pronounced in nulliparous women (RR = 0.16). The magnitude of the negative association between oral contraceptives and ovarian cancer in five developing countries (RR = 0.77) was similar to that reported in developed countries.

Adult↗

[Our experience in using the triphasic contraceptive trisiston for contraception].

The authors carried out studies on 80 women, using Trisistone, a preparation of Germed, Jenapharm, DDR, in the course of 250 cycles, taking into consideration the advantages of triphasic contraceptive preparations as well as the fact that till this moment there were not applied in our country. A good contraceptive efficiency was established. No case with conception was recorded. The side effects were mild and and their frequency varies between 2.4 and 9.7% Irregular bleedings were the only disadvantage of Trisistone, which caused refusal for its usage. It is proposed that Trisistone should be used as an initial contraceptive preparation like the preparations with "mini" doses. In cases with good tolerance women should continue to use it, but they should take another contraceptive preparation, when bleeding occurs.

Contraceptive Agents↗

Acceptability and satisfaction using Quick Start with the contraceptive vaginal ring versus an oral contraceptive.

BACKGROUND: Many women discontinue their use of hormonal contraception, and even those who continue so may have difficulty using oral contraceptive pills consistently. New delivery systems, including the vaginal ring, may be easier to use, but user acceptability and satisfaction with these new methods may be affected by women's experience with their bodies. MATERIALS AND METHODS: Data for this study were collected as part of a randomized clinical trial on 201 women comparing immediate start of vaginal ring use with immediate start of low-dose oral contraceptive use. We assessed user satisfaction and method continuation 3 months after ring or pill initiation. RESULTS: At 3 months, 174 of 201 subjects (87%) had follow-up interviews. Among the 174 study participants with follow-up data, 61% of ring subjects and 34% of pill subjects were very satisfied with their methods (p=.003). For posttrial contraception, 79% of ring subjects chose to continue with the ring whereas 59% of pill subjects chose to continue with the pill (p<.001). Women who reported greater comfort in touching their genitals, greater frequency of masturbation, more comfort with intercourse and past use of vaginal contraceptives and products were not more likely than others to be satisfied with the ring or to continue using it for birth control. CONCLUSION: Women who were allocated to vaginal ring use, regardless of their baseline characteristics or behavior, were likely to be highly satisfied with the method and to continue its use.

Adult↗

Contraceptive failures and determinants of emergency contraception use.

OBJECTIVES: Two years after emergency contraceptive pills (ECPs) were made available without prescription in France, we investigated the determinants of ECP use in a representative sample of women at risk for unintended pregnancy. STUDY DESIGN: This study is based on data collected from a population-based cohort exploring contraceptive practices and abortion (N=2863). RESULTS: Among the 706 women at risk for unintended pregnancy during the first year of follow-up (2001), only 11.1% used ECPs. Women in stable relationships or using the same contraceptive method during the year were less likely to use ECPs than other women. The study also demonstrates that detailed knowledge of ECPs increases the probability of its subsequent use. CONCLUSIONS: Given the low frequency of ECP use in cases of unintended pregnancy risk, these results suggest that information campaigns should be targeted not only at women with irregular contraceptive practices but also at women who experience errors in the use of their regular contraceptive method.

Adolescent↗

Contraceptive knowledge, contraceptive use, and pregnancy risk experience among young Manawatu women.

The contraceptive knowledge, use, and desire for information of never-married Manawatu women aged 16-19 years were examined, distinguishing between respondents with and without pregnancy risk (coital) experience. Overall, 45.7% of the women had ever been at risk, the percentage varying positively with age. Awareness of contraceptive methods (especially the pill and condom) was widespread, particularly among the sexually experienced, a higher percentage of whom had also ever wanted and sought contraceptive information. Women who had never been at risk were less knowledgeable, fewer had ever wanted information (19.3%) and about one-third knew of no source of contraceptive information. Few (7.9%) of the sexually experienced had never used any contraceptive methods but others (19.9%) had not yet employed an effective female method. These results, akin to previous studies, indicate a need for school-based sex education.

Adolescent↗

Randomised controlled trial of levonorgestrel versus the Yuzpe regimen of combined oral contraceptives for emergency contraception. Task Force on Postovulatory Methods of Fertility Regulation.

BACKGROUND: A previous randomised study suggested that the progestagen, levonorgestrel, given alone in two separate doses each of 0.75 mg caused nausea and vomiting in fewer women and might be more effective than the Yuzpe regimen of combined oral contraceptives for emergency contraception, although the difference was not significant. We compared these two regimens when started within 72 h of unprotected coitus. METHODS: We enrolled in the double-blind, randomised trial 1998 women at 21 centres worldwide. Women with regular menses, not using hormonal contraception, and requesting emergency contraception after one unprotected coitus, received levonorgestrel (0.75 mg, repeated 12 h later) or the Yuzpe regimen (ethinyloestradiol 100 microg plus levonorgestrel 0.5 mg, repeated 12 h later). FINDINGS: Outcome was unknown for 43 women (25 assigned levonorgestrel, 18 assigned Yuzpe regimen). Among the remaining 1955 women, the crude pregnancy rate was 1.1% (11/976) in the levonorgestrel group compared with 3.2% (31/979) in the Yuzpe regimen group. The crude relative risk of pregnancy for levonorgestrel compared with the Yuzpe regimen was 0.36 (95% CI 0.18-0.70). The proportion of pregnancies prevented (compared with the expected number without treatment) was 85% (74-93) with the levonorgestrel regimen and 57% (39-71) with the Yuzpe regimen. Nausea (23.1 vs 50.5%) and vomiting (5.6 vs 18.8%) were significantly less frequent with the levonorgestrel regimen than with the Yuzpe regimen (p<0.01). The efficacy of both treatments declined with increasing time since unprotected coitus (p=0.01). INTERPRETATION: The levonorgestrel regimen was better tolerated and more effective than the current standard in hormonal emergency contraception. With either regimen, the earlier the treatment is given, the more effective it seems to be.

Adult↗

Levonorgestrel-releasing intrauterine device-wearing women express contraceptive glycodelin A in endometrium during midcycle: another contraceptive mechanism?

Intrauterine devices (IUDs) exert contraceptive action by interfering with sperm transport, ovum development, fertilization and implantation. Glycodelin A (GdA) is a uterine glycoprotein that has local contraceptive activity by inhibiting sperm-egg binding. GdA is normally absent from endometrium during the fertile midcycle and it is not expressed until the fifth postovulatory day. The phase of menstrual cycle addressed in this study covers the phase when conception is most likely to follow an unprotected intercourse and when GdA is normally absent. We present here evidence that levonorgestrel-releasing IUD (LNg-IUD) is accompanied by 'inappropriate' expression of GdA in endometrium between days 7 and 16 of the menstrual cycle (six out of six cases). The same was also found in copper-releasing IUD (Cu-IUD)-wearing women, but less frequently (four out of 11 cases, P < 0.0345, Fisher's exact test). In-situ hybridization localized GdA mRNA into endometrial glands in the midcycle endometrium, confirming the cellular site of synthesis. Based on the potent inhibitory activity of GdA on sperm-egg binding, the presence of GdA in uterine glands of IUD wearers may lead to prior exposure of sperm to contraceptive GdA, thus contributing to the contraceptive activity of the IUD.

Contraception↗

Oral contraceptive use and breast cancer risk: a meta-analysis of variations with age at diagnosis, parity and total duration of oral contraceptive use.

OBJECTIVE: To review published reports of risk of breast cancer with oral contraceptive use. DESIGN: Meta-analysis of study results, using regression techniques to explore the inter-study heterogeneity. SETTING: Twenty-seven epidemiological studies of breast cancer risk and oral contraceptive use published 1980-1989. MAIN OUTCOME MEASURES: Relative risk of breast cancer with oral contraceptive use; variations by age at diagnosis, parity, and total duration of use, and with study design characteristics. RESULTS: The overall relative risk estimate was 1.16 (95% CI 1.07-1.25) for the less than 45 years group, 1.21 (95% CI 0.99-1.47) for the nulliparous subgroup, and 1.27 (95% CI 1.12-1.44) for durations of use of more than 8 years. Source of subjects, their marital status, the type of study, data collection methods, matching for geographical area, the number of adjustment factors used in the study analysis, the country of study and the calendar period in which the study ended were all important explanatory factors for inter-study variation, but a substantial proportion of inter-study variation remained unexplained. CONCLUSIONS: These meta-analyses suggest that risk of breast cancer may be raised by around 20% in younger, nulliparous and long use duration subgroups of oral contraceptive users. Risk estimates appear to be influenced by several study design factors, which should be considered carefully in designing and reviewing future studies.

Age Factors↗

Atherosclerosis and oral contraceptive use. Serum from oral contraceptive users stimulates growth of arterial smooth muscle cells.

Pooled serum from women taking a combined estrogen-progestin oral contraceptive preparation caused significantly greater cell proliferation and incorporation of 3H-thymidine into DNA in both human arterial smooth muscle cells and dermal fibroblasts in tissue culture than did serum from controls. A portion of this mitogenic effect appears to be related to the presence of a factor(s) that is heat stable, nondialyzable, and contained in the lipoprotein-deficient serum fraction. In vitro addition of varying concentrations of mestranol and norethindrone, the two constituents of the oral contraceptive preparation taken by participants in the study, to control serum did not enhance its mitogenicity, suggesting that the effect observed with intact serum was due either to a metabolite of these compounds or to the production of other growth-promoting substances during oral contraceptive treatment. Since smooth muscle cell proliferation is an integral feature of all atherosclerotic lesions, these findings provide some insights applicable to understanding the pathogenesis of vascular disease associated with oral contraceptive use.

Adult↗

GyneFIX. The frameless intrauterine contraceptive implant--an update for interval, emergency and postabortal contraception.

This article reviews the clinical experience with the GyneFix intrauterine implant system for interval, emergency and post-abortal contraception. The relatively high rate of unintended pregnancies and abortions in the world signifies that greater access to contraception is necessary. Unwanted pregnancies and abortions could be avoided by widening the range of effective and acceptable contraceptive methods for use in situations where current methods are far from optimal. High effectiveness, protection against sexual transmitted infections, long duration of action, reversibility and safety are some of the most important attributes of contraceptives valued by women. The development of the frameless intrauterine device is a response to the need to develop contraceptives with high user continuation rate. GyneFix has the lowest failure rate of all copper IUDs currently available. Its performance is further optimised by the atraumatic frameless design which minimises the side effects and discomfort experienced with conventional IUDs. GyneFix could, therefore, be a useful new contraceptive option in looking at ways to reduce the number of unwanted pregnacies and induced abortions.

Abortion, Induced↗