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PubMed2004

The impact of improved compliance with a weekly contraceptive transdermal system (Ortho Evra) on contraceptive efficacy.

OBJECTIVE: The contraceptive efficacy of perfect dosing cycles and imperfect dosing cycles has not been described previously. Method compliance determines the proportion of perfect and imperfect dosing cycles, and together can form the basis for evaluating differences in efficacy based on differences in compliance. MATERIALS AND METHODS: The transdermal contraceptive delivery system (Ortho Evra) has been studied in a North American randomized trial vs. an oral contraceptive (OC) and in total has been evaluated in 3319 women in contraceptive clinical trials. This article explores the impact of perfect vs. imperfect compliance with the contraceptive method on contraceptive efficacy. Previously published data for a transdermal system (Patch, n = 812) and OC (Triphasil, n = 605) users from the North American comparative study were reanalyzed to determine the effect of imperfect use on the contraceptive efficacy of the different methods. RESULTS: Contraceptive efficacy was significantly better (p = 0.007) in cycles with perfect dosing (Pearl Index = 0.83) compared to those with imperfect dosing (Pearl Index = 6.32) for both methods. This difference is homogeneous (p = 0.62) across the Patch and OC groups. Pooled data for all Patch users confirm that perfect dosing cycles are associated with significantly better efficacy than imperfect dosing cycles (p = 0.047). In addition, compliance did not vary by age in the pooled Patch data, which are in agreement with the previously published Patch data from the comparative study. In the comparative study, the percentage of cycles with perfect dosing was significantly higher with the Patch than with the OC (88.7% vs. 79.2%, p < 0.001), and was consistently high in all age groups (range, 89.6-91.8%). By contrast, among OC users, the percentage of cycles with perfect dosing increased with increasing age (p < 0.001) from 67.7% in users aged 18-20 years to more than 80% in those aged 30 years and older. CONCLUSION: In conclusion, deviations from perfect use (whether corrected or not) of a transdermal contraceptive system and of an OC increase contraceptive failures by approximately 5-10-fold when compared to perfect use. The weekly change schedule of the transdermal contraceptive delivery system is associated with a significantly greater proportion of cycles in which there is perfect dosing compared to an OC.

Administration, Cutaneous↗
PubMedDate not supplied

Correlates of unintended pregnancy in Beheira governorate, Egypt.

This study looked at the frequency and determinants of unplanned births among women in Beheira governorate, Egypt, and the effects on antenatal and postnatal care sought by the mother for herself and her child. Unintended births comprised 23.6%; 13.8% were unwanted and 9.8% were mistimed. Contraceptive failure accounted for 28.8% of unintended pregnancies; 47.1% of women who reported unintended pregnancy were not using [corrected] contraception. Age, education and parity were predictors of unwanted pregnancy. Contraceptive use and maternal employment status predicted mistimed pregnancy. Unintended pregnancy was a barrier to antenatal care, but not to child care. Our findings suggest that family planning programmes should help women of reproductive age achieve spacing and fertility limits.

Adolescent↗
PubMed1997

Traditional fertility regulation methods among the Yoruba of southwestern Nigeria. II. A prospective study of use-effectiveness.

This study investigated the effectiveness of traditional contraceptives commonly used by Yoruba women, and the attitudes of users and non-users towards family planning services and contraceptives in Nigeria. One hundred forty-two married women aged 19 to 40 years were followed for 18 months. Seventy-two of the women were identified as current users of four types of traditional contraceptives (ring, incision, soup, and waistband types), and 70 women did not use any type of contraceptive. The users and non-users were matched on socio-demographic characteristics. Attitudes of the users and non-users towards fertility regulation were investigated using focus group discussions. The study found that 5.6 percent of the users and 34.5 percent of the non-users became pregnant during the follow-up period. Contraceptive failure was experienced by users of the waistband and ring methods. The main barriers to the use of modern contraceptives as described by women were the negative attitudes of men and the fear of side effects.

Adolescent↗
PubMed1996

A follow-up study of first trimester induced abortions at hospitals and family planning clinics in Sichuan province, China.

Four-thousand women aged 18-40 underwent an early induced abortion at hospitals and family planning clinics in six counties in Sichuan province, China, between 1 July 1990 and 30 June 1991. The subjects were followed-up three times, on days 15, 90 and 180 after the operation. Information was obtained about their age, parity, contraceptive use, social behaviors, and gynecological and psychological characteristics before and after the abortion. The results indicate that induced abortion is safe when provided by medically trained personnel in health facilities such as hospitals or clinics. Depressive symptomatology was assessed by the CES-D and SCL-90 scales. The depressive symptoms declined over time. A substantial proportion of the abortions were to unmarried women or resulted from non-use of contraception or contraceptive failure, implying that the incidence of unintended pregnancies and induced abortions could be reduced by more effective and accessible contraception.

Abortion, Induced↗
PubMed1997

The use of behavioral methods of contraception in women seeking abortion.

AIMS: To determine the extent to which behavioural methods, used alone or with other methods of contraception, contribute to contraceptive failure in women seeking termination of pregnancy. METHOD: A clinical audit was conducted of the use of behavioural methods of contraception, in 1342 women attending the Parkview Clinic for termination of pregnancy, over a four year period 1992-6. The information was obtained through standard interview and patient records. RESULTS: The women seen were representative of New Zealand women undergoing termination of pregnancy. Approximately one third of women (34.9%) used one or more behavioural methods in the month prior to conception. The two most common methods were periodic abstinence and coitus interruptus, both used by approximately 17%. Other methods used less frequently and not solely for contraceptive purposes, were cleansing of the vagina and breastfeeding. Pacific Island and Asian women were more likely to use behavioural methods than European and Maori women. Many women (45.6%) using behavioural methods also used other methods of contraception, especially the condom. CONCLUSIONS: Behavioural methods were found more commonly than previously reported. Greater understanding of the use of behavioural methods will assist in the implementation of preventive programmes to reduce the number of terminations.

Abortion, Legal↗
PubMed1978

Menstrual regulation in Ibadan, Nigeria.

Menstrual regulation (MR) (i.e., vacuum aspiration of the uterus with a small diameter, flexible cannula before pregnancy can be determined by a conventional pregnancy test) has been proven safe and effective in many clinics around the world. The present study, which we believe is the first such study of MR in Subsaharan Africa, shows that, for women in an urban African setting, MR is an acceptable backup for other contraceptive methods. Data on 507 MR patients treated at the University College Hospital in Ibadan, Nigeria, between January 1974 and April 1976, showed that the procedure was both safe and effective for 93.4% of the study subjects: there was an overall complication rate of 3.4% and MR failed in seven cases (3.2%). Data also showed that MR is an effective method of recruiting new contraceptive acceptors, as well as an effective back-up procedure in case of contraceptive failure.

Adult↗
PubMed1998

Emergency contraception: the user profile.

UNLABELLED: Emergency contraception (EC) has recently become available, accepted and widely used in Sweden but little is known about the characteristics and background factors of women requesting EC. METHODS: During a four-month period, consecutive women (n = 762) visiting family planning clinics to request emergency contraception filled out a questionnaire about their current need for EC. RESULTS: The user of emergency contraception was typically a nulligravid young woman (83%) but 13% had a previous history of at least one induced abortion and 41% had given birth in the past. One out of four had used EC before, and of these 20% more than once. Condom breakage was the major reason for the current need for EC but as many as 37% had not discussed the need for contraception prior to intercourse. Friends were the most important source of knowledge about EC. CONCLUSION: Women requesting emergency contraception could be anyone and emergency contraception is used to compensate for contraceptive failure in order to prevent unwanted pregnancies.

Adolescent↗
PubMed2003

Sterilization failure, sterilization reversal, and pregnancy after sterilization reversal in Quebec.

OBJECTIVE: 1). To determine the likelihood of sterilization reversal and of subsequent sterilization after sterilization reversal among men and women and 2). to examine the likelihood of pregnancy after sterilization (contraceptive failure) and of pregnancy after sterilization reversal. METHODS: Payment data from the Quebec provincial health insurance system were obtained for each person undergoing vasectomy or female sterilization from January 1, 1980 to December 31, 1999 and linked through a unique identifying number for each person. Using standard techniques of survival analysis, we computed the cumulative probability of experiencing each of six events. RESULTS: Among women, 0.9% (of 311960) experienced a pregnancy after sterilization, 1.8% (of 321929) obtained a reversal after sterilization, 61% (of 4369) achieved a pregnancy after sterilization reversal and 48% achieved a delivery; 23% (of 4677) obtained a subsequent sterilization after reversal. Among men, 2.4% (of 310827) obtained a reversal after vasectomy and 18% (of 6694) obtained a subsequent vasectomy after reversal. All of these risks were much higher among those in the youngest age groups. CONCLUSION: Sterilization reversal and pregnancy after sterilization are not rare. Relatively high rates of reversal among the youngest age groups suggest a need for better counseling about alternative contraceptive strategies.

Adolescent↗
PubMedDate not supplied

Postcoital contraception.

The evolution of postcoital contraception has led to the development of emergency measures to be used following a single unprotected act of intercourse and to ongoing methods, such as the administration of a contraceptive steroid agent following every coital exposure. In emergency situations, the most commonly employed hormonal steroids are the synthetic, conjugated and natural estrogens, administered in large doses for five days. Recently, a combination of an estrogen and a progestin has been employed for the same purpose. A copper-bearing intrauterine device (IUD), inserted within seven days of coitus, has also been utilized with success. Progestins alone have been utilized as an ongoing method of postcoital contraception. Failure rates have been found to vary with the dosage, the specific progestin employed and the frequency of intercourse. The major role of postcoital contraception in the developed world appears to be as an emergency measure. Ease of availability, a high degree of efficacy and a low incidence of side effects are essential for patient and physician acceptance.

Animals↗
PubMed1995

A pilot program of contraceptive continuation in six school-based clinics.

PURPOSE: Few school-based health centers (SBHC) in the United States dispense contraceptives on-site and little is known about contraceptive continuation in these health centers. METHODS: An 11-month contraceptive continuation pilot project offering monthly reproductive health assessment and counseling to students enrolled in Baltimore school clinics was evaluated. One hundred-forty-three women voluntarily enrolled in the study over a seven month period. A monthly contraceptive calendar was developed to collect data on contraceptive use, pregnancy and STD risk, sexual behavior and parental support for contraceptive use. Physical assessment was provided as needed to assess the presence of STD's or pregnancy. Data were analyzed for the month prior to enrollment in the program and eleven months after entry into the program. RESULTS: Both contraceptive (OCP) use and abstinence increased over the course of the program. Condom use remained at approximately 30% with frequent use of OCP's and condoms, condoms or abstinence. Program drop-out was common. Thirteen students became pregnant while enrolled in the program and 35% of the students were diagnosed with one or more sexually transmitted diseases. Partner-switching was common, although two or more partners within any one month was rare. CONCLUSIONS: Monthly follow-up provided through SBHCs can improve contraceptive use although dropout rate and contraceptive failure remain high.

Adolescent↗
PubMed1977

Target fertility, contraception, and aggregate rates: toward a formal synthesis.

This paper develops a stock adjustment model relating total expected births to conventional aggregate fertility rated for married women over 25. Each year, cohorts bear about 20 percent of their additional expected births. Aggregate U.S. rates have been consistent with expectations as expressed in surveys between 1955 and 1975; indeed, total expected births may be inferred from aggregate fertility behavior. A peculiar empirical finding is that the additional expected fertility of nonterminators has not changed since 1955, despite the dramatic decline in total expected and actual fertility. The model leads to a dynamic expression for the duration pattern of current and cumulative fertility and for the proportion of couples who have terminated childbearing. The model is also used to analyze the effects of changing contraceptive failure rates on fertility patterns. For example, a decline in "timing" failure rates increases duration-specific fertility five years later.

Adult↗
PubMed2001

A competing risk approach to the analysis of trials of alternative intra-uterine devices (IUDs) for fertility regulation.

The methods of survival analysis have had a profound influence on the way that studies concerned with the safety and efficacy of intra-uterine devices (IUDs) for fertility control have been designed, conducted, analysed and reported. For example, the Kaplan-Meier technique has been used to summarize the results of controlled clinical trials of alternative devices and the logrank test used to make any comparisons. A particular feature of IUD studies is the large number of possible causes of failure (reasons for discontinuation of the device). These lead to considerations of competing risks, where in this framework, the discontinuations are considered as competing causes of contraceptive failure. In this context, we compare the net and crude probability estimates of discontinuation rates using continuous time and argue for the routine use of the latter. We use data from a randomized multi-centre trialon the long-term safety and efficacy of two IUDs, TCu220C and TCu380A, for illustration.

Contraception↗
PubMed2000

The acceptability of a novel oral contraceptive containing drospirenone and its effect on well-being.

Low-dose combined oral contraceptives are generally well tolerated and represent an excellent reversible form of contraception that is suitable for most women. Certain aspects of the clinical profile of combined oral contraceptives, such as intermenstrual bleeding and a tendency to weight gain, are, however, known to have an adverse effect on compliance, which may in a few women lead to contraceptive failure or pill discontinuation. Conversely, factors that have a positive effect, such as relief from the symptoms of premenstrual syndrome, can enhance compliance. An oral contraceptive that minimizes the adverse and enhances the positive effects would, therefore, be likely to improve compliance. Recently, a new combined oral contraceptive containing 30 microg ethinylestradiol and 3 mg drospirenone (Yasmin, EE/DRSP) has been developed. The pharmacological profile of drospirenone is very similar to that of natural progesterone; in particular, it has antimineralocorticoid activity. This counteracts estrogen-mediated fluid retention, resulting in stable or slightly lowered body weight. In addition, drospirenone has antiandrogenic activity and therefore a positive effect on skin conditions. Present data also indicate that EE/DRSP has a favorable effect on the symptoms of premenstrual syndrome. In order to evaluate whether the positive effects of drospirenone on body weight, skin and the symptoms of premenstrual syndrome are also observed on well-being, a survey was carried out. This asked women who had been involved in two major clinical trials how they felt after these trials had ended, in comparison with the study periods when they were taking EE/DRSP or a combined oral contraceptive containing 30 microg ethinylestradiol/150 microg desogestrel (Marvelon, EE/DSG). The returned questionnaires demonstrated that, with respect to their disposition before and during menses, women who had taken EE/DRSP felt worse after the trial had ended and they had returned to taking a conventional preparation. This was also evident on the basis of their body weights and the condition of their skin and hair. These results from clinical trials with EE/DRSP indicate that it is a well-tolerated combined oral contraceptive that has a positive effect on body weight, skin and the symptoms of premenstrual syndrome. Overall, the combination of 30 microg ethinylestradiol/3 mg drospirenone appears to improve specific aspects associated with feelings of well-being, which may result in better compliance.

Adolescent↗
PubMed2001

Evaluation of interaction between fluconazole and an oral contraceptive in healthy women.

OBJECTIVE: To evaluate the potential pharmacokinetic interaction between 2 x 150 mg fluconazole administered once weekly and an oral contraceptive (OC) containing ethinyl estradiol and norethindrone. METHODS: A placebo-controlled, double-masked, randomized, two-way crossover study was used to investigate the pharmacokinetic interaction between 300 mg fluconazole once weekly and the OC Ortho Novum 7/7/7 (Ortho-McNeil Pharmaceutical, Inc., Raritan, NJ) in 26 healthy women, 18-36 years old. In the first cycle (28 days), subjects received OC only. In the second cycle, subjects were assigned randomly to receive OC-fluconazole or OC-placebo. In the third cycle, subjects were crossed over to the opposite treatment. RESULTS: Data for 21 subjects who completed the study were included in the pharmacokinetic analysis; data for all 26 subjects were included in the safety analysis (26 OC only; 24 OC-fluconazole; 23 OC-placebo). Treatment with OC-fluconazole resulted in small but statistically significant increases in 0-24 hour area under the plasma concentration-time curve (AUC(0-24)) for both ethinyl estradiol (mean 24%, 95% confidence interval [CI] 18%, 31%) and norethindrone (mean 13%, 95% CI 8%, 18%) as compared with treatment with OC-placebo. Ethinyl estradiol maximum plasma concentration (C(max)) was slightly (mean 8%, 95% CI 2%, 15%) though statistically significantly higher for OC-fluconazole treatment as compared with OC-placebo treatment. Norethindrone C(max) was not different (95% CI -6%, 11%) between the two treatment groups. No adverse events related to treatment were seen in the fluconazole treatment group. CONCLUSION: The concomitant administration of 300 mg fluconazole once weekly, twice the recommended dose for vaginal candidiasis, to women using OCs results in a slight increase in OC concentrations. Therefore, it appears that there is no threat of contraceptive failure because of concomitant fluconazole administration.

Adolescent↗
PubMed1986

Drug interactions with oral contraceptives.

In the very rare cases where a pregnancy occurs during oral contraceptive use, the blame is usually laid against the patient for having forgotten to take the pill. Evidence has started to accumulate to suggest that neither the patient nor the pill is at fault in some contraceptive failures. It may be because the patient is taking other medicines and these may be preventing the pill from suppressing ovulation. Most drug interactions reducing or negating contraceptive activity are due to concomitant use of drugs having microsomal enzyme-inducing activity (e.g., some antibiotics, especially rifampicin, and anticonvulsants, including phenobarbital, phenytoin, and primidone. Other antibiotics (e.g., tetracycline) may also interact by interruption of the enterohepatic circulation of contraceptive steroids. Less well appreciated, oral contraceptive steroids may themselves modify the metabolism and pharmacological activity of various other drugs (e.g., anticoagulants, benzodiazepines, beta-blockers, caffeine, corticosteroids, and tricyclic antidepressants); in this respect the oral contraceptives are acting as enzyme inhibitors. Contraceptive steroids may also interact with drugs that cause enzyme inhibition and this delays the metabolism of the hormonal agents. Interactions of this type would be expected to potentiate the action of the contraceptive steroids. It is suggested that the effects of such interaction might be presented in terms of increased incidence of side effects, including water retention, diabetogenic effects, hypertension, and an increased risk of thromboembolic disorders. The spectrum of interactions with oral contraceptives is presented in three tables.

Binding, Competitive↗
PubMed1996

The social costs of inadequate contraception.

This study examines, on a per-case basis, the social costs associated with contraceptive failures and resulting term pregnancies. To combat unintended pregnancy and escalating health care costs, the public sector needs to provide greater access to highly effective methods of contraception.

Contraception↗
PubMed1998

Emergency contraception: a global overview.

Emergency contraception, sometimes referred to as "morning after" or postcoital contraception, provides a second chance for women who experience contraceptive failure or do not use a method, as well as for women who experience unplanned intercourse, including coerced sex or rape. The two primary methods of emergency contraception are postcoital use of a higher dose of oral contraceptive pills and insertion of an intrauterine device (IUD). Both can significantly reduce a woman's chance of becoming pregnant (75% and 99% respectively). Knowledge of emergency contraception is crucial, since women must know they can prevent pregnancy after intercourse in order to seek out treatment. While rates of unwanted pregnancy vary in different countries and among population groups, the need for emergency contraception is critical worldwide, However, the availability of emergency contraception differs widely. It is most extensively used in Europe, but is still a new method in other countries, including the United States.

Contraceptives, Postcoital↗
PubMed1998

Aryl phosphate derivatives of bromo-methoxy-azidothymidine are dual-function spermicides with potent anti-human immunodeficiency virus.

Detergent-based vaginal microbicides, in addition to their high contraceptive failure rates, cause mucosal erosion and local inflammation that might increase the risk of heterosexual human immunodeficiency virus (HIV) transmission. In a systematic effort to identify a microbicide contraceptive potentially capable of preventing the sexual transmission of HIV as well as providing fertility control, a series of novel aryl phosphate derivatives of 5-bromo-6-methoxy-3'-azido-3'-deoxythymidine (AZT; zidovudine) were synthesized and examined for dual anti-HIV and sperm-immobilizing activity (SIA). Whereas AZT displayed potent anti-HIV activity (IC50 = 0.006 microM) but lacked SIA (EC50 > 300 microM), two 5-bromo-6-methoxy-aryl phosphate derivatives of AZT, compounds WHI-05 and WHI-07, exhibited potent anti-HIV activity as well as SIA. The IC50 (HIV) and EC50 (SIA) values for WHI-07 were 439-fold and 13.5-fold lower, respectively, than those for the detergent-based virucidal spermicide, nonoxynol-9 (N-9). Sperm motion kinematics using computer-assisted sperm motion analysis combined with confocal laser scanning microscopy, high-resolution low-voltage scanning, and transmission electron microscopy demonstrated that both WHI-05 and WHI-07 cause a complete and irreversible loss of sperm motility in a concentration- and time-dependent fashion without concomitantly affecting the sperm acrosomal membrane integrity. In experiments designed to assess the fertilizing capacity of treated sperm, preincubation of sperm with either compound resulted in a concentration-dependent loss of the ability to adhere to and penetrate zona-free hamster eggs as well as inhibition of binding to human zona. WHI-07 applied intravaginally prior to artificial insemination of epididymal sperm drastically reduced fertility in hormonally primed CD-1 mice. Unlike the intravaginal application of N-9, repetitive intravaginal application of WHI-07 did not damage the vaginal epithelium or cause local inflammation. Structure-function relationship analyses showed that the addition of bromo-methoxy functional groups to AZT was essential for, and the aryl phosphate derivatization contributory to, the SIA of both compounds. Compounds WHI-05 and WHI-07 may be useful as dual-function vaginal contraceptives for women who are at high risk for acquiring HIV/acquired immunodeficiency virus syndrome by heterosexual vaginal transmission.

Animals↗