Project description:Several options for emergency contraception are available in the United States. This article describes each method, including efficacy, mode of action, safety, side effect profile, and availability. The most effective emergency contraceptive is the copper intrauterine device (IUD), followed by ulipristal acetate and levonorgestrel pills. Levonorgestrel is available for sale without restrictions, whereas ulipristal acetate is available with prescription only, and the copper IUD must be inserted by a clinician. Although EC pills have not been shown to reduce pregnancy or abortion rates at the population level, they are an important option for individual women seeking to prevent pregnancy after sex.
Project description:BackgroundIn the United States, more intrauterine device (IUD) users select levonorgestrel IUDs than copper IUDs for long-term contraception. Currently, clinicians offer only copper IUDs for emergency contraception because data are lacking on the efficacy of the levonorgestrel IUD for this purpose.MethodsThis randomized noninferiority trial, in which participants were unaware of the group assignments, was conducted at six clinics in Utah and included women who sought emergency contraception after at least one episode of unprotected intercourse within 5 days before presentation and agreed to placement of an IUD. We randomly assigned participants in a 1:1 ratio to receive a levonorgestrel 52-mg IUD or a copper T380A IUD. The primary outcome was a positive urine pregnancy test 1 month after IUD insertion. When a 1-month urine pregnancy test was unavailable, we used survey and health record data to determine pregnancy status. The prespecified noninferiority margin was 2.5 percentage points.ResultsAmong the 355 participants randomly assigned to receive levonorgestrel IUDs and 356 assigned to receive copper IUDs, 317 and 321, respectively, received the interventions and provided 1-month outcome data. Of these, 290 in the levonorgestrel group and 300 in the copper IUD group had a 1-month urine pregnancy test. In the modified intention-to-treat and per-protocol analyses, pregnancy rates were 1 in 317 (0.3%; 95% confidence interval [CI], 0.01 to 1.7) in the levonorgestrel group and 0 in 321 (0%; 95% CI, 0 to 1.1) in the copper IUD group; the between-group absolute difference in both analyses was 0.3 percentage points (95% CI, -0.9 to 1.8), consistent with the noninferiority of the levonorgestrel IUD to the copper IUD. Adverse events resulting in participants seeking medical care in the first month after IUD placement occurred in 5.2% of participants in the levonorgestrel IUD group and 4.9% of those in the copper IUD group.ConclusionsThe levonorgestrel IUD was noninferior to the copper IUD for emergency contraception. (Supported by the Eunice Kennedy Shriver National Institute of Child Health and Human Development and others; ClinicalTrials.gov number, NCT02175030.).
Project description:Unwanted pregnancy is a global reproductive health problem. Emergency contraception is defined as the use of drug or device after unprotected or underprotected intercourse to prevent an unwanted pregnancy. 1.5 mg of levonorgestrel as a single dose or in two doses with 12 h apart taken within 72 h of unprotected intercourse is the current gold standard emergency contraception regimen. This method is only effective if used as soon as possible after sexual intercourse and before ovulation. A single dose of 30 mg ulipristal acetate, a novel selective progesterone receptor modulator, has recently been proposed for the emergency contraception use up to 120 h of unprotected intercourse with similar side effect profiles as levonorgestrel. Ulipristal acetate could possibly prevent pregnancy when administered in the advanced follicular phase, even if luteinizing hormone levels have already begun to rise, a time when levonorgestrel is no longer effective in inhibiting ovulation.
Project description:BACKGROUND:The copper intrauterine device is the most effective form of emergency contraception and can also provide long-term contraception. The levonorgestrel intrauterine device has also been studied in combination with oral levonorgestrel for women seeking emergency contraception. However, intrauterine devices have higher up-front costs than oral methods, such as ulipristal acetate and levonorgestrel. Health care payers and decision makers (eg, health care insurers, government programs) with financial constraints must determine if the increased effectiveness of intrauterine device emergency contraception methods are worth the additional costs. OBJECTIVE:We sought to compare the cost-effectiveness of 4 emergency contraception strategies-ulipristal acetate, oral levonorgestrel, copper intrauterine device, and oral levonorgestrel plus same-day levonorgestrel intrauterine device-over 1 year from a US payer perspective. STUDY DESIGN:Costs (2017 US dollars) and pregnancies were estimated over 1 year using a Markov model of 1000 women seeking emergency contraception. Every 28-day cycle, the model estimated the predicted number of pregnancy outcomes (ie, live birth, ectopic pregnancy, spontaneous abortion, or induced abortion) resulting from emergency contraception failure and subsequent contraception use. Model inputs were derived from published literature and national sources. An emergency contraception strategy was considered cost-effective if the incremental cost-effectiveness ratio (ie, the cost to prevent 1 additional pregnancy) was less than the weighted average cost of pregnancy outcomes in the United States ($5167). The incremental cost-effectiveness ratios and probability of being the most cost-effective emergency contraception strategy were calculated from 1000 probabilistic model iterations. One-way sensitivity analyses were used to examine uncertainty in the cost of emergency contraception, subsequent contraception, and pregnancy outcomes as well as the model probabilities. RESULTS:In 1000 women seeking emergency contraception, the model estimated direct medical costs of $1,228,000 and 137 unintended pregnancies with ulipristal acetate, compared to $1,279,000 and 150 unintended pregnancies with oral levonorgestrel, $1,376,000 and 61 unintended pregnancies with copper intrauterine devices, and $1,558,000 and 63 unintended pregnancies with oral levonorgestrel plus same-day levonorgestrel intrauterine device. The copper intrauterine device was the most cost-effective emergency contraception strategy in the majority (63.9%) of model iterations and, compared to ulipristal acetate, cost $1957 per additional pregnancy prevented. Model estimates were most sensitive to changes in the cost of the copper intrauterine device (with higher copper intrauterine device costs, oral levonorgestrel plus same-day levonorgestrel intrauterine device became the most cost-effective option) and the cost of a live birth (with lower-cost births, ulipristal acetate became the most cost-effective option). When the proportion of obese women in the population increased, the copper intrauterine device became even more most cost-effective. CONCLUSION:Over 1 year, the copper intrauterine device is currently the most cost-effective emergency contraception option. Policy makers and health care insurance companies should consider the potential for long-term savings when women seeking emergency contraception can promptly obtain whatever contraceptive best meets their personal preferences and needs; this will require removing barriers and promoting access to intrauterine devices at emergency contraception visits.
Project description:Compare the efficacy and adverse effects of CDB-2914, a new progesterone receptor modulator, to levonorgestrel for emergency contraception.We performed a randomized, double-blinded noninferiority trial, enrolling healthy women seeking emergency contraception within 72 hours of unprotected intercourse. Participants were randomly assigned to receive a single dose of 50 mg of CDB-2914, plus a placebo 12 hours later or two doses of 0.75 mg of levonorgestrel taken 12 hours apart. Follow-up was scheduled 5 to 7 days after the expected onset of the next menstrual period. Posttreatment pregnancy was established by a positive urine test at follow-up and confirmed by quantitative serum beta-hCG. Daily diaries were used from the time of emergency contraception use until next menses to record adverse effects and sexual activity.Product efficacy was evaluable in 775 of CDB-2914 users and 774 of levonorgestrel users. Pregnancies occurred in 7 (0.9%, 95% confidence interval 0.2-1.6%) and 13 (1.7%, 95% confidence interval 0.8-2.6%) women, respectively. Based on the estimated cycle day of unprotected intercourse, 85% and 69% of anticipated pregnancies, respectively, were averted. Nausea was reported by a somewhat greater percentage of CDB-2914 than levonorgestrel users (29% compared with 24%, P=.03), but the distribution of other adverse effects was similar in both groups. Women in both groups experienced considerable variation in menstrual cycle length as compared with their reported individual normal cycle lengths.CDB-2914 is at least as effective as levonorgestrel in preventing pregnancies after unprotected intercourse and has a similar side effect profile.I.
Project description:ObjectiveWe studied whether increased emergency contraception availability for women over age 18 was associated with a higher probability of risky sexual practices.DataA total of 34,030 individual/year observations on 3,786 women aged 18 and older were extracted from the National Longitudinal Survey of Youth, 1997 from October 1999 through November 2009.Study designWe modeled three binary outcome variables: any sexual activity; sexual activity with more than one partner; and any sex without a condom for women with multiple partners for women in states with state-level policy changes (prior to the 2006 FDA ruling) and for women in states subject to only the national policy change both jointly and separately.FindingsWe found different results when estimating the state and federal changes separately. The national change was associated with a reduction in the probability of sexual activity, a reduction in the likelihood of reporting multiple partnerships, and there was no relationship between the national policy change and unprotected sexual activity. There was no relationship between the probability of sexual activity or multiple partnerships for women in states with their own policy changes, but we did find that women in these states were more likely to report unprotected sex.
Project description:Estimated use of emergency contraception (EC) remains low, and one reason is measurement challenges. The study aims to compare EC use estimates using five approaches. Data come from Performance Monitoring and Accountability 2020 surveys from 10 countries, representative sample surveys of women aged 15 to 49 years. We explore EC use employing the five definitions and calculate absolute differences between a reference definition (percentage of women currently using EC as the most effective method) and each of the subsequent four, including the most inclusive (percentage of women having used EC in the past year). Across the 17 geographies, estimated use varies greatly by definition and EC use employing the most inclusive definition is statistically significantly higher than the reference estimate. Impact of using various definitions is most pronounced among unmarried sexually active women. The conventional definition of EC use likely underestimates the magnitude of EC use, which has unique programmatic implications.
Project description:Since the United States Food and Drug Administration's approval of over-the-counter levonorgestrel emergency contraception, access to this time-sensitive medication has improved. However, multiple barriers, including the cost of the medication and pharmacy availability, still exist. The objective of this study was to determine the over-the-counter availability of levonorgestrel emergency contraception in pharmacies on Oahu, Hawaii. We conducted a cross-sectional population-based study using in-person simulated patient encounters at all pharmacies on Oahu. Out of 109 chain pharmacies and 13 independent pharmacies, 102 (84%) pharmacies had levonorgestrel emergency contraception available over the counter. Of pharmacies in which it was available, 12.7% required an employee to unlock the medication, 37.3% required the medication to be unlocked at the register, 29.4% were packaged in a large plastic box, and 3.9% were packaged in a blister pack. Levonorgestrel emergency contraception is widely available as an over-the-counter medication in pharmacies on Oahu, yet there are packaging and display practices that make it less accessible. Many of these practices could be improved with pharmacy education or changes in store policies. Systems-based interventions are needed to improve the access to levonorgestrel emergency contraception as an over-the-counter medication.
Project description:BACKGROUND:Unprotected intercourse is common, especially among teens and young women. Access to intrauterine device (IUD) as emergency contraception (EC) can help interested patients more effectively prevent unintended pregnancy and can also offer ongoing contraception. This study evaluated young women's awareness of IUD as EC and interest in case of need. STUDY DESIGN:We conducted a secondary analysis of data from young women aged 18-25?years, not desiring pregnancy within 12?months, and receiving contraceptive counseling within a cluster-randomized trial in 40?US Planned Parenthood health centers in 2011-2013 (n=1500). Heath centers were randomized to receive enhanced training on contraceptive counseling and IUD placement, or to provide standard care. The intervention did not focus specifically on IUD as EC. We assessed awareness of IUD as EC, desire to learn more about EC and most trusted source of information of EC among women in both intervention and control groups completing baseline and 3- or 6-month follow-up questionnaires (n=1138). RESULTS:At follow-up, very few young women overall (7.5%) visiting health centers had heard of IUD as EC. However, if they needed EC, most (68%) reported that they would want to learn about IUDs in addition to EC pills, especially those who would be very unhappy to become pregnant (adjusted odds ratio [aOR], 1.3; 95% confidence interval, 1.0-1.6, p<.05). Most (91%) reported a doctor or nurse as their most trusted source of EC information, over Internet (6%) or friends (2%), highlighting providers' essential role. CONCLUSION:Most young women at risk of unintended pregnancy are not aware of IUD as EC and look to their providers for trusted information. Contraceptive education should explicitly address IUD as EC. IMPLICATIONS:Few young women know that the IUD can be used for EC or about its effectiveness. However, if they needed EC, most reported that they would want to learn about IUDs in addition to EC pills, especially those very unhappy to become pregnant. Contraceptive education should explicitly address IUD as EC.