Natural family planning. Effective only if used perfectly.
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Contraception Behavior↗
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Transdermal ethinylestradiol/norelgestromin: a review of its use in hormonal contraception.
UNLABELLED: Ethinylestradiol 20 microg/day plus norelgestromin 150 microg/day have been formulated into a transdermal patch for hormonal contraception. The predominant mechanism of action for transdermal ethinylestradiol/norelgestromin (Ortho Evra, Evra) is inhibition of ovulation by suppression of gonadotropins. It suppresses follicular development, induces changes to the endometrium that reduce the probability of implantation, and increases the viscosity of cervical mucus, which may prevent sperm penetration into the uterus. Two large randomized, nonblind efficacy studies demonstrated that transdermal ethinylestradiol/norelgestromin was as efficacious in preventing pregnancy as oral triphasic ethinylestradiol/levonorgestrel or oral ethinylestradiol/desogestrel. A large, noncomparative study also showed transdermal ethinylestradiol/norelgestromin to have good contraceptive efficacy. Moreover, in the two comparative trials, women using transdermal ethinylestradiol/norelgestromin had higher rates of perfect compliance than women using oral contraception. Age did not affect the rate of perfect compliance in women using the transdermal ethinylestradiol/norelgestromin patch, whereas the rate of compliance reduced with younger age in oral contraceptive users. Pooled results from three efficacy studies found that 1.8% of patches were replaced as a result of complete detachment and 2.9% because of partial detachment. Physical exercise, water immersion, and living in a humid climate did not affect patch adhesion. Transdermal ethinylestradiol/norelgestromin was generally well tolerated in clinical trials. The most common menstrual disturbances were breakthrough bleeding/spotting and dysmenorrhea. The incidence of discontinuation of treatment because of an adverse event was < or = 3.2%, with the most common reason being application-site reactions. CONCLUSIONS: Transdermal ethinylestradiol/norelgestromin offers a well tolerated, effective, reversible, and easy-to-use method of hormonal contraception with an increased likelihood of compliance relative to oral contraceptives.
Administration, Cutaneous↗
Contraceptive failure in the United States.
This review provides an update of previous estimates of first-year probabilities of contraceptive failure for all methods of contraception available in the United States. Estimates are provided of probabilities of failure during typical use (which includes both incorrect and inconsistent use) and during perfect use (correct and consistent use). The difference between these two probabilities reveals the consequences of imperfect use; it depends both on how unforgiving of imperfect use a method is and on how hard it is to use that method perfectly. These revisions reflect new research on contraceptive failure both during perfect use and during typical use.
Amenorrhea↗
Assessment of compliance with a weekly contraceptive patch (Ortho Evra/Evra) among North American women.
OBJECTIVE: To determine compliance with the contraceptive patch (Ortho Evra/Evra) overall and by age among women in North America and to compare rates of perfect use with those of an established oral contraceptive. DESIGN: Data were pooled for three contraceptive studies in which women participated for up to 13 cycles; the subset of centers in North America was used in this analysis. SETTING: 76 North American centers. PATIENT(S): Healthy women 18-45 years of age. INTERVENTION(S): In all studies, the patch regimen was three consecutive 7-day patches (21 days) followed by 1 patch-free week per cycle. MAIN OUTCOME MEASURE(S): Perfect use for the patch or oral contraceptive, defined as 21 consecutive days of drug-taking followed by a 7-day drug-free period; for contraceptive patch users, no patch could be worn for more than 7 days. Oral contraceptives were used according to package labeling. RESULTS: For all contraceptive patch users in North America (n = 1,785), perfect use was consistent across age groups. The percentage of cycles with perfect use of the patch ranged within age groups from 88.1% to 91.0%. In the comparative study conducted only in North America, perfect use was also consistent across age groups for the patch (n = 812), but rates of perfect use for the oral contraceptive (n = 605) differed significantly by age. CONCLUSION(S): Age did not affect compliance with the patch among all North American women studied. In a comparative study of women at North American centers, compliance with the weekly contraceptive patch was significantly better than with an established oral contraceptive. The contraceptive patch is uniformly easy to use across all ages.
Administration, Cutaneous↗
New Product Review (September 2003). Norelgestromin/ethinyl oestradiol transdermal contraceptive system (Evra).
This new transdermal contraceptive system (contraceptive patch), Evra (Janssen-Cilag), received a UK product licence in 2003. In clinical trials: Consistent doses of norelgestromin and ethinyl oestradiol are released into the systemic circulation daily. Pharmacokinetic data suggest that levels are sufficient to inhibit ovulation for at least 7 days. The overall Pearl index for the contraceptive patch (1.24; 95% CI 0.19-2.33) was similar to that of a triphasic combined oral contraceptive (COC) pill (2.18; 95% CI 0.57-3.8). Self-reported "perfect" compliance was significantly better with the contraceptive patch (88.2%) than with a combined contraceptive pill (77.7%). Patch detachment, requiring replacement with a new patch, with normal daily activity is uncommon (4.6%). Breakthrough bleeding and spotting were significantly more common with the contraceptive patch than with combined oral contraception in the first two cycles but differences were not significant by cycle three. In general, reported side effects were not significantly different with contraceptive patch or combined pill use. However, breast tenderness in the first two treatment cycles was more common with patch use. Symptoms were mild to moderate in 85% of women and were rarely treatment limiting. Currently, there are limited data regarding risk of venous thromboembolism, and cervical or breast cancer with the contraceptive patch. No clinically significant alterations in metabolic or haemostatic parameters were identified with contraceptive patch use. A month's supply of the contraceptive patch costs 7.74 UK pounds. Combined oral contraception prices range from approximately 0.80 to 5.00 UK pounds and hormone replacement therapy patches range from 10.00 to 13.00 UK pounds. The contraceptive patch offers additional choice for women who wish to use a combined hormonal method of contraception.
Administration, Cutaneous↗
Cost-effectiveness and contraceptive effectiveness of the transdermal contraceptive patch.
OBJECTIVE: The purpose of this study was to examine implications of increased perfect use on the cost-effectiveness of the contraceptive patch compared with combination oral contraceptives (COCs). STUDY DESIGN: This study compared the patch with low-estrogen-dose COCs. It assumes that the risks of developing a medical condition during use are the same for both the patch and COCs. Differences in net cost and pregnancies avoided during use were modeled. With the use of a pharmacoeconomic model, both methods were compared with a hypothetical reference case of contraception nonuse. The base-case model considered women, ages 15 to 50, in average health in a long-term, mutually monogamous, heterosexual relationship. RESULTS: The base-case analysis showed that use of the patch resulted in a savings of 249 US dollars and 0.03 pregnancies per woman over 2 years compared with COCs. CONCLUSION: This analysis demonstrated that patch use would be cost saving compared with COC use, resulting in a net avoidance of pregnancy for this population. The cost savings are attributed to reduced costs of pregnancy.
Administration, Cutaneous↗
Are there unmet family planning needs in Europe?
CONTEXT: The measurement of unmet need for family planning--the discrepancy between individuals' sexual and contraceptive behavior and their stated fertility preferences--has generally focused on developing countries. There has so far been little effort to measure how low unmet family planning needs can go in more developed countries, where contraceptive practice is supposedly (nearly) perfect. METHODS: Data were taken from Fertility and Family Surveys (FFS) conducted in recent years in selected member states of the United Nations Economic Commission for Europe, and minimum and maximum estimates of unmet need were calculated for 10 countries with the requisite data. RESULTS: The proportion of individuals with an unmet need for family planning (i.e., who have a current unwanted pregnancy or who are fecund, are sexually active, want no more births but are not using contraceptives) is as low as 3% in two European countries and below 10% in most. However, levels of unmet need in countries with economies in transition (13% in Latvia and Lithuania and 23% in Bulgaria) surpass some of the lowest levels observed for developing countries. Considerable within-country variations are seen. For instance, unmet need is more prominent among men than among women in seven of the nine countries for which there are data. Moreover, unmet need increases with family size and with age, suggesting an unmet need for limiting rather than for spacing births. In all of the countries except Hungary, unmet need is higher among those in marital unions than among those in less formal relationships. Level of education is another important dimension of unmet need, with less-educated respondents having the highest level of unmet need in nine of the 10 countries. Multivariate analyses confirm most of these results. Moreover, there is a clear association between unmet need and abortion ratios: Where levels of unmet need are high, the number of abortions per 100 live births is also relatively high. CONCLUSIONS: Data on unmet need, supplemented with information on induced abortion and related issues, could provide countries in Europe with useful inputs for formulating and implementing responsive reproductive health policies and programs.
Contraception Behavior↗
Contraceptive failure in the United States: an update.
This report provides an update of the authors' previous estimates of first-year probabilities of contraceptive failure for all methods of contraception. Estimates are provided of failure during typical use (which includes both incorrect and inconsistent use) and during perfect use (correct use at every act of intercourse). The difference between these two probabilities provides a measure of how forgiving of imperfect use each method is. These revisions are prompted by recent studies that provide the first estimates of failure during perfect use for periodic abstinence and the cervical cap, by more complete evaluations of implants, and by the appearance of the Copper T 380A and disappearance of other IUDs from the US market. Also provided is a more complete explanation of how the previous estimate of the probability of becoming pregnant while relying solely on chance should be interpreted, and this estimate is revised slightly downward.
Clinical Trials as Topic↗
Failure rates among perfect users and during perfect use: a distinction that matters.
To make an informed decision when choosing a contraceptive, women and couples need to know how effective different methods are when used perfectly, where perfect use is defined as following the directions for use. In this article, we show that unbiased estimates of pregnancy rates during perfect use can be guaranteed only if information on consistency and correctness of use is available for each menstrual cycle. The estimated probability of pregnancy during a year of perfect use among the subset of women who always used a method perfectly will be biased upward.
Contraception Behavior↗
Further analysis of contraceptive failure of the ovulation method.
Reanalysis of data on the ovulation method of natural family planning collected by the World Health Organization yields the following conclusions. The method is effective during perfect (correct and consistent) use, with a first-year probability of failure of 3.4%. However, it is extremely unforgiving of imperfect use, with a first-year probability of failure of 84.2% if the method is not used correctly. During the initial year, 87% of the cycles were characterized by perfect use. Nevertheless, the 13% of cycles characterized by imperfect use had a tremendous impact on the overall failure rate. During the first year of typical use 22.5% of the women in the clinical trial became accidentally pregnant.
Adult↗
[A prospective study of the provision of emergency contraception in French family planning centers].
OBJECTIVES: To describe emergency contraception provision, including the efficacy of the method, in family planning centers in suburban Paris two years after the method became available without a prescription. PATIENTS AND METHODS: A prospective study involving two questionnaires was conducted between September 2001 and July 2002 in 27 family planning centers in the Val-de-Marne region. The first questionnaire was completed at the time emergency contraception was dispensed and the second one upon a follow-up visit. Efficacy was calculated for both perfect use (only one act of unprotected intercourse in the current menstrual cycle, emergency contraception treatment initiated within 72 hours) and typical use (including multiple acts of unprotected intercourse in the cycle and/or treatment initiated after 72 hours). RESULTS: A total of 519 requests for emergency contraception was recorded, resulting in the provision of 518 treatments. The women requesting emergency contraception were young (96% under the age of 25) and cited unprotected intercourse and problems with condom use as the main reasons for the request. Information regarding the outcome of emergency contraception treatment was available in 77% of the cases, and a failure rate of 1.9% was observed with perfect use and 2.7% with typical use. DISCUSSION AND CONCLUSIONS: This prospective study of emergency contraception prescription in family planning centers confirms data on the efficacy and safety of the method observed in similar environments. The failure rate associated with typical use is higher than that observed with perfect use.
Adult↗
Transdermal application of steroid hormones for contraception.
The concept of transdermal delivery (TD) for steroid application has nowadays been largely accepted for hormone replacement therapy in the menopause. It is only recently that the same concept has been envisaged for contraception. The skin can be penetrated by both estrogens and progestins, provided they are delivered in an appropriate solvent. About 10% of the total dose applied topically is actually absorbed. The transdermal delivery systems (TDS) presently available are either of the reservoir type (membrane-moderated system) or of the matrix dispersion type where the drug is dispersed into a polymer matrix. Estradiol (E2) is the most appropriate steroid for TD and can be combined with progestins to ensure a contraceptive effect. Only potent progestins should be used to achieve effective plasma levels with low doses in order to maintain an acceptable small surface of TDS. TDS changed weekly and delivering both E2 and levonorgestrel (L-NG) at daily dosages of 38.4 (+/- 7.5) and 28.8 (+/- 7.2) micrograms/10 cm2 per day respectively, showed ovulation suppression. Another progestin derived from norprogesterone (ST 1435) has been shown to penetrate the skin when suspended in acetylated lanolin or dissolved in a hydroalcoholic gel and to ensure ovulation suppression at a dose of 2 mg per day in a small number of cycles. These preliminary data demonstrate the feasibility of suppressing ovulation in women by transdermal absorption of steroids. Using TDS for contraception implies that such systems should be perfectly adhesive, well tolerated locally and achieve nearly 100% efficacy. These targets are very challenging, however, the potential advantages are so high that the concept deserves further development.
Absorption↗
Mortality and fertility control.
The authors present a continuation of the thesis suggesting that the most rational procedure for regulating fertility is a perfectly safe, even though not completely effective, contraceptive method combined with safe methods for terminating pregnancy when the contraceptive fails. This analysis demonstrates that, compared with the risk of death from pregnancy and childbirth, major reversible methods of fertility control--the pill, IUDs, condoms, and diaphragms--and abortion are associated with very low levels of mortality. The exception to this statement is pill use after age 40 by women who smoke. This analysis also confirms the very low mortality associated with using the condom and diaphragm with early induced abortion as a backup to terminate pregnancies resulting from contraceptive failures.
Abortion, Induced↗
[Unintended effects of oral contraceptives. I.Estrogen-related effects].
Oral contraceptives are almost optimally effective but not yet perfectly safe. They can cause favourable or adverse unintended effects which cannot always be attributed to either the estrogen or the progestagen; however, in many instances a fair differentiation is possible. Type, intensity and frequency of side effects depend on dosage, duration of administration and on the structure of the substance. Some favourable side effects of estrogens are used for therapeutic purposes. Adverse side effects of estrogens are either subjectively disturbing only, or medically important, but few are life threatening. Dose dependence has been established, a structure relationship is unlikely.
Body Weight↗
Breastfeeding, lactational, infecundity, contraception and the spacing of births: implications of the Bellagio consensus statement.
While the nutritional, immunological and anti-bacterial benefits of breast milk are incontestable, the contraceptive effect of breastfeeding is more apparent in the aggregate than at the level of the individual. Nevertheless, it has recently been recommended that lactating women not consider adopting contraception until the earliest of their first post-partum menstruation, the introduction of supplementary feeding or their child's reaching six months of age. This article employs microsimulation to quantify the implications of this recommendation for the spacing of births and, in particular, for the proportion of birth intervals that are unacceptably short. The findings are not encouraging. The implementation of this protocol would not produce better birth spacing than a simpler strategy of initiating contraception early in the post-partum period and, unless implemented perfectly, the outcomes would be considerably worse. Breastfeeding should be viewed not as a method of birth control but as the best form of infant nourishment. Efficient contraception is the best way to ensure that children in modernizing societies can reap the benefits of breastfeeding, without being endangered by being weaned too early because of a new pregnancy.
Amenorrhea↗
Measuring contraceptive effectiveness: a conceptual framework.
We present a conceptual model that outlines the four measures of how well a contraceptive method works: 1) efficacy, 2) effectiveness, 3) perfect-use pregnancy rate, and 4) typical-use pregnancy rate. Moreover, we illustrate how four variables influence these measures: 1) capacity to conceive, 2) frequency and timing of intercourse, 3) degree of compliance, and 4) inherent protection of the method. Because of inter-individual as well as intra-individual variability of the first three variables, generalizing results from a contraceptive clinical trial to other populations is problematic. There is a hierarchy of generalizability of the four outcome measures, with the typical-use pregnancy rate the least generalizable but the easiest to measure, and efficacy the most generalizable but the most difficult to measure. These four variables should be considered in the design and analysis of future contraceptive clinical trials. Finally, this article illustrates why the terms "pregnancy rate" and "failure rate" are not synonymous and why we recommend that the latter term not be used.
Clinical Trials as Topic↗
Comparative contraceptive efficacy of the female condom and other barrier methods.
Because the research design for the clinical trial establishing the contraceptive efficacy of the female condom--a six-month life-table probability of failure of 15% (12% in the United States vs. 22% in Latin America)--did not include randomization with another method of contraception, no definite conclusion about its comparative efficacy is possible. Comparisons using other female barrier methods as historical controls, however, provide evidence that, among women in the United States, the contraceptive efficacy of the female condom during typical use is not significantly different from that of the diaphragm, the sponge or the cervical cap. The six-month probability of failure during perfect use of the female condom is 2.6% among U.S. women, similar to rates for the diaphragm and the cervical cap but significantly lower than that for the sponge. Meaningful comparisons with the male condom are not possible because of the lack of data from carefully controlled prospective clinical trials. Extrapolations from the results on contraceptive efficacy suggest that perfect use of the female condom may reduce the annual risk of acquiring the human immunodeficiency virus by more than 90% among women who have intercourse twice weekly with an infected male.
Clinical Trials as Topic↗
Child consent and the law: an insight and discussion into the law relating to consent and competence.
BACKGROUND: The law governing consent for children is not very clear. A child can consent to treatment but usually in practice is unable to refuse it. Even if both the child and parents refuse treatment, courts are reluctant to accept this, particularly if it is in the best interest of the child. DISCUSSION: In order to consent to treatment, a child must be competent enough to do so, and this competence is judged usually by a doctor. Children can even consent to contraceptives and abortion if 'competent' to do so. This concept perfectly lacks moral, ethical and emotional competence, and judgement of competence is carried out usually purely scientifically by pure science-orientated objective professionals like doctors. A broad discussion about the issues of children refusing treatment is conducted from the legal, ethical and philosophical point of view. Life-saving treatment and various other cases are also discussed. CONCLUSION: There is no right answer to the question. A more holistic approach is needed, and not only doctors but also sociologists, care specialists and even clergymen should be asked to judge competence in a multidisciplinary environment, particularly for contraceptives and abortion. This multidisciplinary working can be extended to other areas in medical law as well particularly in light of changes in medicine. Experience in life should be valued in a decision-making environment for judging competence. The law in relation to child consent is unclear and requires changes in order to clarify what is perceived as the child's best interest.
Child↗