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PubMed2003

Extending the time limit for starting the Yuzpe regimen of emergency contraception to 120 hours.

OBJECTIVE: Current protocols state that the Yuzpe regimen of emergency contraception can be initiated up to 72 hours after unprotected intercourse. The purpose of this study was to determine whether the window for emergency hormonal contraception can be extended to 120 hours. METHODS: In an observational study, we tracked 111 women who requested emergency contraception between 72 and 120 hours after unprotected sex but refused postcoital copper intrauterine devices (IUDs), preferring instead the Yuzpe regimen. We compared failure rates for this group with rates among 675 otherwise similar women who started the same therapy within 72 hours. RESULTS: Both perfect use (1.9%) and typical use (3.6%) failure rates were low among women presenting between 72 and 120 hours after unprotected intercourse. These rates did not statistically differ from failure rates for the standard Yuzpe regimen (2.0% during perfect use and 2.5% during typical use). Our small sample size of 111, however, gave us just 25% power to detect a doubling in the failure rates (2% to 4%) and 59% power to detect a tripling in the failure rates (2% to 6%). CONCLUSION: The 72-hour cutoff for the Yuzpe regimen of emergency contraception appears needlessly restrictive. Women who request this therapy more than 72 hours after unprotected sex should be allowed to receive it, particularly if they decline postcoital insertion of a copper IUD and would otherwise have no options for reducing pregnancy risk.

Adolescent↗
PubMedDate not supplied

The fallibility of diagnostic tests for sexually transmitted diseases: the impact of behavioral and epidemiologic studies.

OBJECTIVES: Analysis of sexually transmitted disease (STD) data to identify specific behaviors and risk factors often fails to take into account the misclassification of disease by a less than perfect diagnostic test. The authors consider here how a diagnostic test's performance profile can introduce misclassification and thereby bias measures of association. METHODS: The authors used hypothetical data relating to diagnostic tests for Chlamydia trachomatis infections and oral contraceptive use to determine odds ratio estimates given a range of sensitivity, specificity, prevalence of infection, and sample size. RESULTS: Lower specificity in a diagnostic test can result in an underestimation of a risk factor's association with an infection. This bias is particularly severe in low prevalence populations. Use of a diagnostic test with low specificity also will increase the sample size needed to demonstrate the association and, thus, the cost of such surveys. CONCLUSIONS: Diagnostics tests for sexually transmitted diseases have less than perfect sensitivity and specificity, which affects the validity of analyses of factors associated with sexually transmitted diseases. Analyses done using low prevalence populations and/or small sample sizes may underestimate the magnitude of effect in retrospective studies and clinical trials of behavioral interventions aimed at reducing sexually transmitted disease risk.

Chlamydia Infections↗
PubMedDate not supplied

Contraceptive failure of the ovulation method of periodic abstinence.

Previously published estimates of probabilities of method and user failure for all contraceptive methods suffer from a serious methodological error and are biased downward, with the extent of bias unknown. Data from a World Health Organization clinical trial of the ovulation method of periodic abstinence were used to provide the first correctly calculated measures of method and user efficacy and to determine the characteristics that distinguish women who consciously take risks from those who do not. Probabilities of pregnancy during the first year are 3.1 percent during perfect use (method failure) and 86.4 percent during imperfect use (user failure). Thus, if used perfectly, the ovulation method is very effective. However, it is extremely unforgiving of imperfect use. Because perfect compliance is difficult for many couples who desire intercourse when it is forbidden by ovulation method rules, and because the risk of pregnancy during imperfect use is so great, the ovulation method cannot be considered an ideal contraceptive method for the typical couple, who are likely to be less compliant than couples who volunteer for a clinical trial. The probability of an accidental pregnancy is greatest when any of the three most serious rules--no intercourse during mucus days, within three days after the day of peak fecundity or during times of stress--are broken. Those who have a poor attitude toward the rules are more likely to take risks, including serious risks. Those who get away with taking a risk (i.e., do not get pregnant) are very likely to take risks again. Because breaking the most serious rules entails a 28 percent risk of pregnancy per cycle, those likely to take risks should be counseled about the probable consequences.

Adult↗
PubMed2005

A randomized trial of clinician-delivered interventions promoting barrier contraception for sexually transmitted disease prevention.

OBJECTIVE: The objective of this study was to compare 2 interventions promoting condoms and vaginal microbicides to prevent sexually transmitted disease (STD). STUDY: Women (N = 427) attending an STD clinic were randomly assigned to 2 clinician-delivered interventions and followed up monthly to assess condom/microbicide use and incidence of gonorrhea, chlamydia, and syphilis. RESULTS: During follow up, condom use rates were 69% (enhanced) and 49% (basic) and microbicide use rates were 44% and 29%, respectively. STD rates did not significantly differ between intervention groups. Perfect condom use (regardless of intervention arm) was associated with a 3-fold decrease in STD rates (relative risk [RR], 0.3; 95% confidence interval [CI], 0.1-0.8). Using a vaginal microbicide during > or =50% of the acts of intercourse was associated with reduced STD rates (RR, 0.5; 95% CI, 0.3-1.0) across intervention groups and condom use categories. CONCLUSIONS: The enhanced intervention increased use of condoms and vaginal microbicide; however, STD rates did not decrease because a protective effect was seen only among perfect barrier users, and the enhanced intervention only modestly increased perfect use.

Administration, Intravaginal↗
PubMedDate not supplied

Oral contraceptives: an update on health benefits and risks.

OBJECTIVE: To review the health benefits and risks of oral contraceptives, with an emphasis on emerging noncontraceptive benefits and the pharmacist's role in promoting safe and effective use of these widely prescribed medications. DATA SOURCES: Published articles identified through MEDLINE (1995-2001) using the search terms oral contraception, neoplasms, cardiovascular disease, menstrual cycle, and other pertinent subject headings. Additional articles and books were identified from the bibliographies of the retrieved articles. DATA SYNTHESIS: Combined oral contraceptives (COCs), which contain synthetic estrogen and progestin, are the second most common form of birth control for women after sterilization. When taken properly, COCs are highly effective, with a pregnancy rate of 0.1% among perfect users. Also, a growing body of evidence points to multiple noncontraceptive benefits of COCs, including protection from several types of cancer and a variety of gynecologic benefits, such as reduced menstrual bleeding irregularities and fewer ectopic pregnancies. COCs are one of the most studied classes of medications, and they have been found to have an excellent safety profile in nonsmoking healthy women. They may be used continuously until menopause. For women with coexisting medical conditions or other special circumstances, the risks and benefits of COCs must be carefully evaluated before use. CONCLUSION: More than 40 years after their introduction, COCs remain the leading form of hormonal contraception. By assessing patients' contraceptive needs, evaluating their risk factors, and providing sensitive and thorough counseling, pharmacists can help ensure the safe and effective use of these medications.

Adult↗
PubMed2001

Optimal management of endometrial hyperplasia.

The optimal management of endometrial hyperplasia is the subject of considerable debate. In this chapter the development of our current classification of endometrial hyperplasias is outlined in some detail in order to give an understanding of the complexity of the problem of determining the malignant potential of the hyperplasia which is the central issue in determining optimal treatment. While hysterectomy is still the definitive treatment for older women with hyperplasia, conservative therapy is perfectly acceptable in a defined group of younger women who are closely monitored.

Contraceptives, Oral, Combined↗
PubMed1993

Oestrogen receptor message in premalignant and normal cervical cells: a methodological study.

Normal and abnormal biopsies of the uterine cervix, to a total of 124 samples, have been analysed for the detection of oestrogen receptor (ER) mRNA. The tough fibrous nature of the cervix proved very resistant to disaggregation in the first instance and subsequently, it was difficult to extract good high molecular weight message. This necessitated a systematic study of methodological technique, including two methods of tissue disaggregation and five techniques of extraction of ER mRNA, which in total involved the use of 124 cervical biopsies. The most successful method involved chopping the tissue, then digesting the cells with proteinase K and extracting the nucleic acids in salt and sodium dodecyl sulphate. Using the perfected technique, 16 cervical biopsies obtained at serial intervals from four women did not show any differences in ER mRNA in cervical biopsies either in the presence of oral contraception or histological abnormality. The successful method described will prove valuable for the detection of ER message in human tumours and other tissues of similar nature.

Cervix Uteri↗
PubMed1999

Activated protein C resistance: automated detection of the factor V Leiden mutation by mismatch hybridization.

BACKGROUND: A single point mutation in the factor V gene has been demonstrated to be the cause of factor Va resistance to proteolytic cleavage by activated protein C. Knowledge of the patient's genetic disposition is of great importance in situations such as pregnancy, surgery, use of oral contraceptives, and immobilization. METHODS: We have developed a rapid, automated test for the detection of the factor V mutation that makes use of differences in thermal stability between perfect-match and non-perfect-match hybrids. A DNA fragment spanning the mutation is amplified with a biotin-labeled primer. Ruthenium-labeled oligonucleotides, perfectly matching either the biotinylated wild-type strand or the biotinylated mutation strand, are added. Heating to 95 degrees C and subsequent cooling lead to the formation of double-stranded DNA. Under the conditions chosen, ruthenium-labeled oligonucleotides form stable, double-stranded DNA with the biotinylated strand only if both strands perfectly match each other. The ruthenium signal is measured on a modified Elecsys 1010 system (Roche Diagnostics). RESULTS: The ratio between the signals obtained with perfectly matching and non-perfectly matching oligonucleotides reflects the genetic status. Analyzed samples can be divided into three nonoverlapping groups based on these ratios. We confirmed the reliability of the method by analyzing several samples of known genetic status; the results were identical in every single instance. CONCLUSIONS: The test discriminates unambiguously between the heterozygous and the homozygous states. Because of its low costs and easy handling, the assay is suitable for use in routine laboratories of clinical chemistry.

Autoanalysis↗
PubMed2001

Efficacy and safety of a transdermal contraceptive system.

OBJECTIVES: To evaluate the efficacy, cycle control, compliance, and safety of a transdermal contraceptive system that delivers norelgestromin 150 microg and ethinyl estradiol 20 microg daily. METHODS: In this open-label, 73-center study, 1672 healthy, ovulatory, sexually active women received ORTHO EVRA/EVRA for six (n = 1171) or 13 cycles (n = 501). The treatment regimen for each cycle was three consecutive 7-day patches (21 days) followed by 1 patch-free week. RESULTS: The overall and method-failure probabilities of pregnancy through 13 cycles were 0.7% and 0.4%, respectively. The incidence of breakthrough bleeding was low throughout the study. Perfect compliance (21 consecutive days of dosing, followed by a 7-day drug-free interval; no patch could be worn for more than 7 days) was achieved in 90% of subject cycles; only 1.9% of patches detached completely. Adverse events were typical of hormonal contraception, and most were mild-to-moderate in severity and not treatment limiting. The most common adverse events resulting in discontinuation were application site reactions (1.9%), nausea (1.8%), emotional lability (1.5%), headache (1.1%), and breast discomfort (1.0%). CONCLUSIONS: The transdermal contraceptive patch provides effective contraception and cycle control, and is well tolerated. The weekly change schedule for the contraceptive patch is associated with excellent compliance and wearability characteristics.

Administration, Cutaneous↗
PubMedDate not supplied

Hormonal contraception without estrogens.

The long-term clinical effects of ethinyl estradiol and the impact on environmental safety of the alkylated estrogen components used in combined contraceptive pills remain the subject of debate. The development of improved methods for the use of progestogen-only contraception would represent a viable and desirable option. Several progestogen compounds are not alkylated, and these can be delivered through a variety of routes. Some of the progestogen-only methods are well established in clinical use. Estimates for both perfect and typical effectiveness are less than one pregnancy per 100 woman-years with oral, injectable, implantable and intrauterine methods. In practice, with the oral progestogen-only method, perfect and typical effectiveness range from three to five pregnancies per 100 woman-years. The main side effect with all progestogen-only methods is unpredictable vaginal bleeding during the first months of use, and this may lead to discontinuation. Nevertheless, continuation of use is more frequent if patients are well informed of this side effect before treatment begins. No cardiovascular- and cancer-related side effects have been proven.

Contraception↗
PubMed1999

[Contraception with levonorgestrel (Norplant) subcutaneous implants. African experience in Burkina Faso].

The subcutaneous implants from the levonorgestrel (Norplant) has been introduced in Burkina Faso in September 1992 within the context of a project assisted by a non-governmental organization (the Population Council). The aim was to reinforce the family planning programme in Burkina Faso by increasing the number of family planning methods available for the clients. 4 years after its introduction, we propose to make a report of our experience in terms of the contraception through subcutaneous implants in order to better set up an IEC campaign on this method. Within 4 years, 1,660 users benefitted from that contraceptive method. They were housewives in 65% of the cases. The age-group of 30-34 years old most used this method with 28.6%. Multipares most benefitted from this method with 64.3%. In 72% of the cases, the insertion was made during the premenstrual period. On the whole, 247 withdrawals have been made before the fourth years for various reasons. Among those reasons are cycle disorders (60 withdrawals), medical reasons (53 withdrawals), personal conveniences (47 withdrawals), weight gaining (14 withdrawals), failures (2 withdrawals). Regarding the side effects, they were mainly represented by the menstrual cycle disorders such as amenorrhoea, spotting, hypermenorrhoea in 51% of the cases. A good information and sensitization campaign should reduce the number of implants withdrawals before the fourth year of use. Moreover, a perfect knowledge of contraindications is indispensable before any prescription.

Adult↗
PubMedDate not supplied

Contraceptive efficacy of the diaphragm, the sponge and the cervical cap.

A reanalysis of data from two clinical studies--in which 1,439 women were randomly assigned to use either the contraceptive sponge or the diaphragm and 1,394 women were randomly assigned to use either the cervical cap or the diaphragm--found first-year probabilities of failure during typical use of 17% for the sponge, 18% for the cervical cap and 13-17% for the diaphragm. The first-year probabilities of failure during perfect use are 11-12% for the sponge, 10-13% for the cervical cap and 4-8% for the diaphragm. The probability of failure during perfect use is significantly higher among women who have given birth than among those who have not for users of the sponge (19-21% vs. 9-10%) and users of the cervical cap (26-27% vs. 8-10%), but not for users of the diaphragm.

Contraceptive Devices, Female↗
PubMed2006

[Contraceptive efficacy of bioadhesive benzalkonium chloride gel in comparison with nonoxynol-9 gel].

OBJECTIVE: To compare the contraceptive efficacy of a new spermicide, bioadhesive benzalkonium chloride (BZK) gel, with the traditional nonoxynol (NP-9) gel. METHODS: A total of 240 child-bearing age women volunteers were randomly divided into two groups: 120 using the BZK gel for contraception, and the other 120 using the NP-9 gel. Using life table method and log-rank test, we compared the pregnancy rates and discontinuation rates after follow-up for 6 months in two groups. RESULTS: No abnormal findings of cervical smears were detected before and after this clinical trial in all 240 women. The follow-up rates at 6 months were 100.0% and 99.2% in the BZK group and the NP-9 group, respectively. The 6-month gross cumulative pregnancy rates of typical use were 1.72 and 0.91 per 100 women (P > 0.05), respectively. If we excluded the 2 pregnant women (1 in each group), who did not correctly or consistently use the spermicides for every intercourse, the cumulative pregnancy rates at 6 months in perfect use would be 0.87 and 0 per 100 women (P > 0.05). And the gross cumulative discontinuation rates due to allergy or other adverse reactions at 6 months in typical use were 0 and 2.68 per 100 women (P > 0.05), respectively. CONCLUSION: The contraceptive efficacy of bioadhesive BZK gel is the same as that of the NP-9 gel, and it is more acceptable in clinical use.

Adult↗
PubMed2006

Fertility regulation and reproductive health in the Millennium Development Goals: the search for a perfect indicator.

Although several key elements of sexual and reproductive health are included in the United Nations Millennium Development Goals, a measure of women's capacity to regulate their fertility safely and effectively is missing. We considered the usefulness of 3 pairs of indicators in monitoring this component of reproductive health: contraceptive prevalence and total fertility; unmet need for contraception and unplanned births; and unsafe abortion and abortion mortality. A single measure of contraceptive use is insufficient. The risks women face from unplanned births and unsafe abortion should also be incorporated into the monitoring process, either directly within the Millennium Development Goals framework or as a parallel effort by reporting governments and other agencies.

Abortion, Induced↗
PubMed2003

[Contraceptive efficacy of bioadhesive nonoxynol-9 Gel: comparison with nonoxynol-9 suppository].

OBJECTIVE: To compare the contraceptive efficacy of a new spermicide, bioadhesive nonoxynol (N-9) gel, with a traditional N-9 suppository. METHODS: A total of 240 child-bearing aged woman volunteers were randomly divided into two groups: 120 cases using the gel for contraception, and another 120 using the suppository. Using lifetable method and log rank test, we compared the pregnancy rates and other discontinuation rates after follow-up for 6 months in two groups. RESULTS: No abnormal findings of cervical smears were detected before and after this clinical trial in all 240 women. The follow-up rates at 6 months were 100.0% and 97.5% in the gel group and the suppository group, respectively. The 6-month gross cumulative pregnancy rates of typical use were 6.39 and 2.95 per 100 women (P > 0.05), respectively. If we eliminated the 5 pregnancy women (3 in the gel group, and 2 in the suppository one), who did not consistently use the spermisides for every intercourse, the cumulative pregnancy rates at 6 month in perfect use would be 3.71 and 2.03 (P > 0.05). And the discontinuation rates due to allergy or other side effects at 6 months in typical use were 3.45 and 4.57 (P > 0.05), respectively. All of the results observed between two groups in this study were not statistically significant. CONCLUSION: The contraceptive efficacy of bioadhesive N-9 gel is as same as that of the N-9 suppository, and its clinical use is quite safe.

Contraceptive Agents, Female↗
PubMed2003

Modifying the Yuzpe regimen of emergency contraception: a multicenter randomized controlled trial.

OBJECTIVE: Emergency contraceptives can prevent unintended pregnancy after unprotected intercourse. The best-studied regimen ("Yuzpe") consists of ordinary combined oral contraceptives containing levonorgestrel and ethinyl estradiol. Women traditionally take one dose within 72 hours after unprotected intercourse, and a second dose 12 hours later. Historically, half experience nausea and a fifth vomit. The purpose of this study was to determine whether 1). women could use combined oral contraceptives other than those containing levonorgestrel and 2). eliminating the second dose improves comfort and convenience. METHODS: Women presenting within 72 hours after unprotected intercourse were randomized to receive 1). standard two-dose Yuzpe, 2). a variant of Yuzpe substituting norethindrone for levonorgestrel, or 3). only the first dose of Yuzpe, followed 12 hours later by a placebo. RESULTS: Perfect-use failure rates were low in all groups and did not differ in a statistically significant way (standard Yuzpe 2.0% [n = 589], norethindrone-ethinyl estradiol 2.7% [n = 547], single dose of Yuzpe 2.9% [n = 546]). Typical-use failure rates were slightly higher but similarly did not differ significantly. Side effects were similar across groups, except that women taking the single dose reported half the vomiting. Taking the pills with food did not seem to reduce nausea or vomiting, and the pills were not more effective when started sooner after unprotected intercourse. CONCLUSION: Oral contraceptives containing norethindrone-ethinyl estradiol work approximately as well for emergency contraception as levonorgestrel-ethinyl estradiol formulations and should be offered when first-line therapies are not available.

Adolescent↗
PubMed2001

Condom effectiveness in reducing heterosexual HIV transmission.

BACKGROUND: The amount of protection that condoms provide for HIV and other sexually transmitted diseases is unknown. Cohort studies of sexually active HIV serodiscordant couples with follow-up of the seronegative partner, provide a situation in which a seronegative partner has known exposure to the disease and disease incidence can be estimated. When some individuals use condoms and some do not, namely some individuals use condoms 100% of the time and some never use (0%) condoms, condom effectiveness can be estimated by comparing the two incidence rates. Condom effectiveness is the proportionate reduction in disease due to the use of condoms. OBJECTIVES: The objective of this review is to estimate condom effectiveness in reducing heterosexual transmission of HIV. SEARCH STRATEGY: Studies were located using electronic databases (AIDSLINE, CINAHL, Embase, and MEDLINE) and handsearched reference lists. SELECTION CRITERIA: For inclusion, studies had to have: (1) data concerning sexually active HIV serodiscordant heterosexual couples, (2) a longitudinal study design, (3) HIV status determined by serology, and (4) contain condom usage information on a cohort of always (100%) or never (0%) condom users. DATA COLLECTION AND ANALYSIS: Studies identified through the above search strategy that met the inclusion criteria were reviewed for inclusion in the analysis. Sample sizes, number of seroconversions, and the person-years of disease-free exposure time were recorded for each cohort. If available, the direction of transmission in the cohort (male-to-female, female-to-male), date of study enrollment, source of infection in the index case, and the presence of STDs was recorded. Duplicate reports on the same cohort and studies with incomplete or nonsepecific information were excluded. HIV incidence was estimated from the cohorts of "always" users and for the cohorts of "never" users. Effectiveness was estimated from these two incidence estimates. MAIN RESULTS: Of the 4709 references that were initially identified, 14 were included in the final analysis. There were 13 cohorts of "always" users that yielded an homogeneous HIV incidence estimate of 1.14 [95% C.I.:.56, 2.04] per 100 person-years. There were 10 cohorts of "never" users that appeared to be heterogeneous. The studies with the longest follow-up time, consisting mainly of studies of partners of hemophiliac and transfusion patients, yielded an HIV incidence estimate of 5.75 [95% C.I.: 3.16, 9.66] per 100 person-years. Overall effectiveness, the proportionate reduction in HIV seroconversion with condom use, is approximately 80%. REVIEWER'S CONCLUSIONS: This review indicates that consistent use of condoms results in 80% reduction in HIV incidence. Consistent use is defined as using a condom for all acts of penetrative vaginal intercourse. Because the studies used in this review did not report on the "correctness" of use, namely whether condoms were used correctly and perfectly for each and every act of intercourse, effectiveness and not efficacy is estimated. Also, this estimate refers in general to the male condom and not specifically to the latex condom, since studies also tended not to specify the type of condom that was used. Thus, condom effectiveness is similar to, although lower than, that for contraception.

Cohort Studies↗