Pharmacodynamic evaluation of the etonogestrel contraceptive implant initiated midcycle with and without ulipristal acetate: An exploratory study.

OBJECTIVE: To estimate the incidence of ovulation suppression within five days of etonogestrel 68 mg implant insertion in the presence of a dominant follicle with and without same-day ulipristal acetate. STUDY DESIGN: This single site non-masked, exploratory randomized trial recruited people age 18-35 years with regular menstrual cycles, no pregnancy risk, and confirmed ovulatory function. We initiated transvaginal ultrasound examinations on menstrual day 7-9 and randomized participants 1:1 to etonogestrel implant alone or with concomitant ulipristal acetate 30 mg oral when a dominant follicle reached ≥14 mm in diameter. We completed daily sonography and serum hormone levels for up to seven days or transitioned to labs alone if sonographic follicular rupture occurred. We defined ovulation as follicular rupture followed by progesterone >3 ng/mL. We calculated point estimates, risk ratios and 95% confidence intervals for ovulation for each group. Ovulation suppression of ≥44% in either group (the follicular rupture suppression rate with oral levonorgestrel emergency contraception), would prompt future method testing. RESULTS: From October 2020 to October 2022, we enrolled 40 people and 39 completed primary outcome assessments: 20 with etonogestrel implant alone (mean follicular size at randomization: 15.2 mm ± 0.9 mm) and 19 with etonogestrel implant + ulipristal acetate (mean follicular size at randomization: 15.4 mm ± 1.2 mm, p = 0.6). Ovulation suppression occurred in 13 (65%) of etonogestrel implant-alone participants (Risk ratio 0.6 (95% CI: 0.3, 1.1), p = 0.08) and seven (37%) of implant + ulipristal acetate participants. CONCLUSIONS: Ovulation suppression of the etonogestrel implant alone exceeds threshold testing for future research while the implant + ulipristal acetate does not. IMPLICATIONS: Data are lacking on midcycle ovulation suppression for the etonogestrel implant with and without oral ulipristal acetate. In this exploratory study, ovulation suppression occurred in 65% of implant participants and 37% of implant + ulipristal acetate participants. Ovulation suppression of the implant alone exceeds threshold testing for future emergency contraception research.

Efficacy of oral levonorgestrel emergency contraception with same day etonogestrel contraceptive implant: A prospective observational study.

OBJECTIVE: To determine a 1-month pregnancy rate point estimate and 95% confidence interval for guideline-supported, same-day initiation of an etonogestrel implant plus oral levonorgestrel emergency contraception. STUDY DESIGN: In this single-arm, prospective observational study, all emergency contraception clients who presented to four Planned Parenthood Association of Utah clinics from February 2021 to March 2023 received information about oral levonorgestrel with same-day etonogestrel implant insertion. Participants were ≤35 years and reported unprotected intercourse within 5 days with negative pregnancy testing. The primary outcome measure was a 1-month home pregnancy test. We calculated the efficacy using a test of proportions with Yates continuity correction. RESULTS: A total of 160 emergency contraception clients (7.6% of 2106 approached) enrolled and 153 had 1-month pregnancy outcomes. A positive pregnancy test occurred in 2 participants resulting in an overall pregnancy rate of 1.32% (95% confidence interval 0.23%-5.19%). Ultrasound gestational dating assigned conception of the first pregnancy to 8 days before enrollment. For the second pregnancy, ultrasound dating designated conception at 5 days prior to enrollment. Limiting the efficacy rate to the single pregnancy that occurred within 5 days of unprotected intercourse, we report a pregnancy rate of 0.66% (95% confidence interval 0.03%-4.19%). CONCLUSIONS: In this observational study of emergency contraception clients selecting oral levonorgestrel with same-day etonogestrel implant, we identified a pregnancy rate within the established range of oral emergency contraception methods alone. IMPLICATIONS: Clients presenting for emergency contraception may also desire ongoing highly-effective contraception, yet current clinical guidelines serve as a barrier to same-day method initiation for the etonogestrel implant and other hormonal methods. Improving access to contraceptive method initiation will reduce the ongoing risk of unwanted pregnancy for this population. CLINICAL TRIAL REGISTRATION: Clinicaltrials.gov NCT04678817; registered 12/16/20.

Society of Family Planning Clinical Recommendation: Emergency contraception.

Emergency contraception (EC) refers to several contraceptive options that can be used within a few days after unprotected or under protected intercourse or sexual assault to reduce the risk of pregnancy. Current EC options available in the United States include the copper intrauterine device (IUD), levonorgestrel (LNG) 52 mg IUD, oral LNG (such as Plan B One-Step, My Way, Take Action), and oral ulipristal acetate (UPA) (ella). These clinical recommendations review the indications, effectiveness, safety, and side effects of emergency contraceptive methods; considerations for the use of EC by specific patient populations and in specific clinical circumstances and current barriers to emergency contraceptive access. Further research is needed to evaluate the effectiveness of LNG IUDs for emergency contraceptive use; address the effects of repeated use of UPA at different times in the same menstrual cycle; assess the impact on ovulation of initiating or reinitiating different regimens of regular hormonal contraception following UPA use; and elucidate effective emergency contraceptive pill options by body mass indices or weight.

Free access to emergency oral contraceptives (EOCs) in the European Union: A regulatory vacuum to be filled.

BACKGROUND: According to the World Health Organization (WHO), any woman in childbearing age who have decided not to take permanently an oral contraceptive but who are sexually active has the right to access emergency contraception (EC). Despite this, in many European countries there are no specific laws governing the criteria for access to emergency oral contraceptives (EOCs) for girls under 18, especially about the need for third party consent. This normative vacuum is dangerous as it risks creating confusion and entrusting the management of the fundamental right of self-determination to the discretion of others. Moreover, in European Union (EU) countries, there is an inequality in terms of access to contraceptive supplies, reimbursement criteria and the availability of information online. OBJECTIVE: Our article compares the criteria for access to EOCs (Ulipristal Acetate-UPA and Levonorgestrel-LNG) in the various EU countries to highlight possible disparities and consequent inequalities. METHODS: Government and ministerial websites, European agencies websites, and Contraceptive Use by Method 2019 (WHO) have been consulted. RESULTS: There are some differences between the various European countries that could configure inequality in EU countries. CONCLUSIONS: It would be appropriate a definitive levelling of the legislation of the European Union on emergency contraception associated with massive information and awareness campaigns.

Evidence-Based Contraception: Common Questions and Answers.

Primary care clinicians are uniquely situated to reduce unintended pregnancy in the context of a patient's medical comorbidities, social circumstance, and gender identity. New evidence regarding contraception use has emerged in recent years. The copper intrauterine device is the most effective option for emergency contraception, with similar effectiveness found for the levonorgestrel-releasing intrauterine system, 52 mg, and both offer extended future contraception. Ulipristal given within 120 hours after unprotected intercourse is the most effective oral emergency contraceptive. Oral levonorgestrel, 1.5 mg, is slightly less effective than ulipristal, and is less effective in patients with a body mass index of more than 30 kg per m2 and if administered after 72 hours. The Yuzpe method, which uses a combination of oral contraceptives, is less effective than ulipristal or oral levonorgestrel, 1.5 mg, and has high risk of nausea and vomiting. Contraception methods based on fertility awareness are safe and have similar effectiveness as condom use and the withdrawal method. Patients who have migraine with aura have a higher risk of ischemic stroke, and combined oral contraceptives appear to increase this risk. Therefore, the Centers for Disease Control and Prevention recommends avoiding their use in these patients. Studies support the extended use of the levonorgestrel-releasing intrauterine system, 52 mg, for seven years, the copper intrauterine device for 12 years, and the etonogestrel subdermal contraceptive implant for five years. One levonorgestrel-releasing intrauterine device, 52 mg, (Mirena) was recently approved by the U.S. Food and Drug Administration (FDA) for seven years of use to prevent pregnancy. However, the intervals for the copper intrauterine device and the etonogestrel subdermal contraceptive implant are longer than approved by the FDA, and patient-clinician shared decision-making should be used. Subcutaneous depot medroxyprogesterone acetate, 104 mg, a newer formulation with prefilled syringes, can be safely self-administered every 13 weeks. Because bone density loss appears to be reversible, the American College of Obstetricians and Gynecologists recommends considering use of depot medroxyprogesterone acetate beyond two years despite an FDA boxed warning about increased fracture risk. Testosterone does not prevent pregnancy but is safe to use with hormonal contraception; thus, transgender and gender-diverse patients with a uterus can be offered the full range of contraceptive options.

Emergency Contraception: Access and Challenges at Times of Uncertainty.

BACKGROUND: The UN Commission on Life-Saving Commodities for Women and Children identified emergency contraceptive pills as 1 of the 13 essential underused, low-cost, and high-impact commodities that could save the lives of millions of women and children worldwide. In the US, 2 emergency contraceptive regimens are currently approved, and their most plausible mechanism of action involves delaying and/or inhibiting ovulation. AREAS OF UNCERTAINTY: Abortion and contraception are recognized as essential components of reproductive health care. In the US, in the wake of the Dobbs v. Jackson Women's Health Organization Supreme Court decision on June 24, 2022, 26 states began to or are expected to severely restrict abortion. It is anticipated that these restrictions will increase the demand for emergency contraception (EC). Several obstacles to EC access have been described, and these include cost, hurdles to over-the-counter purchase, low awareness, myths about their mechanisms of action, widespread misinformation, and barriers that special populations face in accessing them. The politicization of EC is a major factor limiting access. Improving sex education and health literacy, along with eHealth literacy, are important initiatives to improve EC uptake and access. DATA SOURCES: PubMed, The Guttmacher Institute, Society of Family Planning, American College of Obstetricians and Gynecologists, the World Health Organization, The United Nations. THERAPEUTIC ADVANCES: A randomized noninferiority trial showed that the 52 mg levonorgestrel intrauterine device was noninferior to the copper intrauterine device when used as an EC method in the first 5 days after unprotected intercourse. This is a promising and highly effective emergency contraceptive option, particularly for overweight and obese patients, and a contraceptive option with a different bleeding profile than the copper intrauterine device. CONCLUSIONS: EC represents an important facet of medicine and public health. The 2 medical regimens currently approved in the US are very effective, have virtually no medical contraindications, and novel formulations are actively being investigated to make them more convenient and effective for all patient populations. Barriers to accessing EC, including the widespread presence of contraception deserts , threaten to broaden and accentuate the already existing inequities and disparities in society, at a time when they have reached the dimensions of a public health crisis.

Knowledge and counseling preferences of the public and pharmacy staff on emergency contraception: Results of a cross-sectional study in Belgium.

OBJECTIVE: To assess the knowledge and counseling preferences of the public ('individuals') and pharmacy staff ('professionals') in Belgium on emergency contraceptive pills (ECPs). STUDY DESIGN: Cross-sectional study using 2 different anonymous, online surveys (one addressing the public and one professionals). RESULTS: Overall, 1518 individuals and 1118 professionals participated, obtaining a mean knowledge score of 6.3(±1.8)/10 and 5.0(±1.6)/10, respectively. For the public, a lower level of knowledge was found among men, nonhealthcare workers, and low educated individuals with no prior ECP use/purchase. For professionals, a lower level of knowledge was observed among pharmacy-technicians, French-speaking persons, and professionals with ≥5 years of experience and poorly involved in continuous education. CONCLUSIONS: Limited knowledge on ECPs was observed among the public and pharmacy staff in Belgium, underscoring educational and counseling opportunities on ECPs.

Oral Emergency Contraception Provision in the Veterans Health Administration: a Retrospective Cohort Study.

BACKGROUND: In the USA, oral emergency contraception (EC) use to prevent unintended pregnancy is increasing. Oral EC methods include levonorgestrel (LNG) and ulipristal acetate (UPA), with increased UPA efficacy over LNG in high BMI users and those beyond 3 days post intercourse. The Veterans Health Administration (VHA) provides oral EC at low or no cost, yet prescription-level Veteran data are lacking. OBJECTIVE: To describe oral EC provision in VHA, including method type and Veteran user and prescriber characteristics. DESIGN: A retrospective cohort study using VHA administrative data. PARTICIPANTS: All VHA oral EC prescriptions from January 1, 2016, to December 31, 2020. MAIN MEASURES: We linked Veteran-level sociodemographic and military characteristics and provider-level data with each prescription to identify variables associated with oral EC method. KEY RESULTS: A total of 4280 EC prescriptions (85% LNG) occurred for 3120 unique Veterans over 5 years. While prescriptions remained low annually, the proportion of UPA prescriptions increased from 12 to 19%. Compared to LNG users, UPA users were older (34% vs 25% over age 35 years, p <0.001); more likely to identify as white (57% vs 46%) and non-Hispanic (84% vs 79%) (p <0.001); and more likely to have a BMI ≥ 25 (76% vs 67%, p <0.001). UPA prescriptions originated most frequently from VA Medical Centers (87%) and women's health clinics (76%) compared to community-based or other clinic types. In multivariable regression models, race, ethnicity, BMI ≥30, and prescriber facility type of a VA Medical Center or a women's clinic location were predictive of UPA prescription. CONCLUSIONS: Oral EC provision in VHA remains low, but UPA use is increasing. LNG prescription occurs frequently in high BMI Veterans who would benefit from increased efficacy of UPA. Interventions to expand oral EC access in VHA are essential to ensure Veterans' ability to avert unwanted pregnancies.

Effect of levonorgestrel emergency contraception on implantation and fertility: A review.

PURPOSE: Levonorgestrel-only emergency contraception (EC) inhibits ovulation to prevent fertilization. Misconceptions regarding its mechanism of action contribute to low use in some settings. We aimed to review the mechanism of action of Levonorgestrel EC and assess the evidence for a postovulatory effect on viable pregnancy development in the exposed and subsequent cycles. BASIC PROCEDURES: We searched Pubmed, Embase, Web of Science, clinicaltrials.gov, the Cochrane database, and the US FDA Adverse Event Reporting System. We included studies reporting on the effect of Levonorgestrel EC exposure on (1) ovulation, (2) conception, (3) implantation, (4) ectopic pregnancy, (5) pregnancy viability, and (6) fertility in subsequent cycles. Data were extracted and tabulated from included studies by two researchers. The results were analyzed and summarized in narrative form. MAIN FINDINGS: We included 33 studies. Women exposed to Levonorgestrel EC at or after the LH (luteinizing hormone) surge had similar rates of inhibited ovulation (3 studies) and conception rates (2 studies) as controls. Nine out of ten studies found no difference in endometrial receptivity to implantation after exposure to Levonorgestrel EC compared to controls. The evidence for an association between Levonorgestrel EC and reduced fallopian tube motility or ectopic pregnancy was conflicting. We found no evidence of increased miscarriage or teratogenicity (3 studies) or disrupted menstrual cycle (3 studies) after Levonorgestrel EC exposure compared to controls. PRINCIPAL CONCLUSIONS: This review supports that Levonorgestrel EC taken after ovulation does not affect implantation and results in similar conception rates compared to placebo. There is no evidence that exposure to Levonorgestrel EC affects fetal development, miscarriage, stillbirth, or subsequent menstruations.

Effect of ulipristal acetate on gene expression profile in endometrial cells in culture and in vivo upon post-ovulatory administration in fertile women.

PURPOSE: To analyse the effect of ulipristal acetate (UPA) as emergency contraception (EC) on the gene expression of human endometrial cell line (HEC-1A) and endometrium from fertile women treated with UPA after ovulation. MATERIALS AND METHODS: HEC-1A cells were treated with UPA, and endometrial tissue from four healthy women was collected in cycles before, during and 2 months after post-ovulation pill intake. Ovulation and luteal phase were monitored, and endometrial biopsies were obtained at day LH + 7 in each cycle. In all cases, we analysed the expression profile of 192 genes associated to endometrial receptivity. RESULTS: We observed a significant change in total transcriptomic activity of UPA-treated HEC-1A cells compared to controls. In vivo, we also observed a trend to down-regulation of genes in the UPA-treated cycle that was partially restored in the post-treatment cycle. Altogether, our results supported a partially reversible effect of UPA in gene expression associated with uterine receptivity. CONCLUSIONS: When UPA was administered after ovulation, it seems to induce a down-regulation of the main genes involved in conditioning the endometrium for implantation. This effect is partially restored two months after pill intake. The action of UPA on the endometrium for users of EC should be further investigated.

Atendimento de urgência de mulheres grávidas em decorrência de violência sexual: características e tendências observadas em 20 anos / Emergency care for women due to sexual assault: characteristics and tendency observed for 20 years

Objetivo: O atendimento médico de urgência (AMU) é fundamental na prevenção e na redução de agravos da violência sexual (VS), como o uso de anticoncepção de emergência (AE). O objetivo deste estudo é analisar 20 anos de AMU após VS entre gestantes decorrente de estupro. Métodos: Estudo transversal com 2.816 mulheres entre 1999 e 2018. Considerou-se buscar ou não o AMU após a VS e dados sociodemográficos. Analisou-se por dispersão de dados e curva exponencial de tendência. Resultados: O AMU ocorreu em 188 casos (6,7%). Neste grupo, não se prescreveu AE em 31 (16,5%) mulheres. Não houve diferença significativa nos dados sociodemográficos. Os extremos de variação dos percentuais para quem buscou AMU foram de 16,1%, em 1999, e de 2%, em 2010, com queda da linha de tendência exponencial (R2 = 0,4667). Conclusão: Não houve associação com características sociodemográficas e a queda expressiva dos percentuais de gestações sugere, indiretamente, melhora da eficácia dos serviços de saúde em prover a AE.(AU)

Objective: Emergency medical care (EMC) is essential in the prevention and reduction of sexual assault (SA), including the use of emergency contraception (EC). The aim of this study is to analyze 20 years of EMC after SA in pregnant women due to rape. Methods: Cross-sectional study with 2,816 women between 1999 and 2018. It was considered to seek or not EMC after SA and sociodemographic data. Statistical analysis was performed by data dispersion and exponential trend curve. Results: EMC occurred in 188 cases (6.7%). In this group, EC was not prescribed in 31 (16.5%). There was no significant difference in sociodemographic data. The extremes of percentage variation for those seeking EMC were 16.1% in 1999, and 2% in 2010, with a drop in the exponential trend line (R2 = 0.4667). Conclusion: There was no association with sociodemographic characteristics and the significant drop in the percentage of pregnancies indirectly suggests an improvement in the effectiveness of health services in providing EC.(AU)

Dispositivos intrauterinos na contracepção de emergência: novas perspectivas para o uso do sistema intrauterino liberador de levonorgestrel / Intrauterine devices in emergency contraception: new perspectives for the use of the levonorgestrelreleasing intrauterine system

Pouco sabe-se a respeito do sistema intrauterino liberador de levonorgestrel (SIU-LNG) 52 mg em contracepção de emergência (CE). Foi realizada uma busca não sistemática em bases eletrônicas para avaliar o papel do SIU-LNG na CE e, até o momento, apenas um único trabalho que avaliou o uso isolado do SIU-LNG para uso em CE foi encontrado. Esse estudo demonstrou a não inferioridade do SIU-LNG em relação ao dispositivo intrauterino de cobre em CE. Análises secundárias desse trabalho evidenciaram baixas chances de gestação em pacientes que fizeram uso de SIU-LNG como CE, independentemente da frequência das relações sexuais desprotegidas ou do tempo em que ocorreram (até 14 dias prévios à inserção ou 7 dias após). Torna-se evidente que o SIU-LNG poderá ser uma opção viável para uso em contracepção emergencial, porém mais estudos devem ser realizados, possibilitando a validação desse método.(AU)

Little is known about the 52-mg levonorgestrel-releasing intrauterine system (LNG- -IUS) in emergency contraception (EC). A non-systematic search was carried out in electronic databases to assess the role of the LNG-IUS in EC and, to date, only a single study that evaluated the isolated use of the LNG-IUS for EC use was found. This study demonstrated the non-inferiority of the LNG-IUS in relation to the copper intrauterine device in EC. Secondary analyzes of this study showed low chances of pregnancy in patients who used LNG-IUS as EC, regardless of the frequency of unprotected sexual intercourse or the time it took place (up to 14 days prior to insertion or 7 days after). It is evident that the LNG-IUS may be a viable option for use in emergency contraception, however, more studies must be carried out, enabling the validation of this method.(AU)

Dispensing and practice use patterns, facilitators and barriers for uptake of ulipristal acetate emergency contraception in British Columbia: a mixed-methods study.

BACKGROUND: Ulipristal acetate 30 mg became available as prescription-only emergency contraception in British Columbia, Canada, in September 2015, as an addition to over-the-counter levonorgestrel emergency contraception. In this study, we determined dispensing and practice use patterns for ulipristal acetate, as well as facilitators of and barriers to emergency contraception for physicians, pharmacists and patients in BC. METHODS: In the quantitative component of this mixed-methods study, we examined ulipristal acetate use from September 2015 to December 2018 using a database that captures all outpatient prescription dispensations in BC (PharmaNet) and another capturing market sales numbers for all oral emergency contraception in BC (IQVIA). We analyzed the quantitative data descriptively. We conducted semistructured interviews from August to November 2019, exploring barriers and facilitators affecting the use of ulipristal acetate. We performed iterative qualitative data collection and thematic analysis guided by Michie's Theoretical Domains Framework. RESULTS: Over the 3-year study period, 318 patients filled 368 prescriptions for ulipristal acetate. Use of this agent increased between 2015 and 2018. However, levonorgestrel use by sales (range 118 897-129 478 units/yr) was substantially higher than use of ulipristal acetate (range 128-389 units/yr). In the 39 interviews we conducted, from the perspectives of 12 patients, 12 community pharmacists, and 15 prescribers, we identified the following themes and respective theoretical domains as barriers to access: low awareness of ulipristal acetate (knowledge), beliefs and experiences related to shame and stigma (beliefs about consequences), and multiple health system barriers (reinforcement). INTERPRETATION: Use of ulipristal acetate in BC was low compared with use of levonorgestrel emergency contraception; lack of knowledge, beliefs about consequences and health system barriers may be important impediments to expanding use of ulipristal acetate. These findings illuminate potential factors to explain low use of this agent and point to the need for additional strategies to support implementation.

An evaluation of the quality of online information on emergency contraception.

OBJECTIVES: The increasing availability of health information online combined with reduced access to health care providers due to the coronavirus pandemic means that more people are using the internet for health information. However, with no standardised regulation of the internet, the population is vulnerable to misinformation regarding important health information. This review aimed to evaluate the quality and readability of the online information available on emergency contraception (EC) options. STUDY DESIGN: In this descriptive study, a Google search was performed using the term 'emergency contraception options' on 13 April 2020 yielding 232 results. Seventy-one results were excluded (34 inaccessible, 37 contained no medical information). The remaining 161 results were categorised by typology and assessed for credibility (JAMA criteria and HONcode), reliability (DISCERN tool) and readability (Flesch-Kincaid Grade Level and Simple Measure of Gobbledygook). RESULTS: Of all webpages evaluated, the most common typology was governmental. Credibility of web pages was poor (average JAMA score of 1.47 out of 4). Only 10.6% of webpages were HONcode certified. The most common DISCERN category was Fair (29.81%), closely followed by Poor (27.95%) reliability. On average, readability levels were above the recommended grade level for health information. The intrauterine device was discussed least frequently (86.96%) of all the EC options. CONCLUSION: Online information was of low credibility, reliability and written above the recommended reading level. Clinicians should be aware of the poor quality of online information on EC options, and actively educate patients on what makes a source credible.

Levonorgestrel vs. Copper Intrauterine Devices for Emergency Contraception.

BACKGROUND: In 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. METHODS: This 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. RESULTS: Among 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. CONCLUSIONS: The 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.).

Emergency contraception from the pharmacy 20 years on: a mystery shopper study.

BACKGROUND: Emergency contraception (EC) was approved in the UK as a pharmacy medicine for purchase without prescription in 2001. Twenty years later we conducted a study to characterise routine practice pharmacy provision of EC. STUDY DESIGN: Mystery shopper study of 30 pharmacies in Edinburgh, Dundee and London participating in a clinical trial of contraception after EC. METHODS: Mystery shoppers, aged ≥16 years, followed a standard scenario requesting EC. After the pharmacy visit, they completed a proforma recording the duration of the consultation, where it took place, and whether advice was given to them about the importance of ongoing contraception after EC. RESULTS: Fifty-five mystery shopper visits were conducted. The median reported duration of the consultation with the pharmacist was 6 (range 1-18) min. Consultations took place in a private room in 34 cases (62%) and at the shop counter in the remainder. In 27 cases (49%) women received advice about ongoing contraception. Eleven women (20%) left the pharmacy without EC due to lack of supplies or of a trained pharmacist. Most women were generally positive about the consultation. CONCLUSIONS: While availability of EC from UK pharmacies has undoubtedly improved access, the necessity to have a consultation, however helpful, with a pharmacist introduces delays and around one in five of our mystery shoppers left without getting EC. Consultations in private are not always possible and little advice is given about ongoing contraception. It is time to make EC available without a pharmacy consultation.

Accessing emergency contraception pills from pharmacies: the experience of young women in London.

INTRODUCTION: Over-the-counter provision of emergency contraception pills (ECP) has increased since deregulation of progestogen-only formulations and is now the most common public health service provided by UK pharmacists. Important questions relate to women's perceptions of their experience of receiving ECPs from pharmacists. METHODS: Qualitative study: in-depth interviews with young women reporting ECP use, recruited from clinic (10); pharmacy (6) and community settings (5) in London. RESULTS: Key advantages of pharmacy provision were ease and speed of access and convenience. Disadvantages included a less personal service, inadequate attention to information needs and to prevention of recurrence of ECP need, and unsupportive attitudes of pharmacy staff. Suggested service improvements included increasing privacy, providing more contraceptive advice, adopting a more empathetic approach and signposting follow-up services. CONCLUSION: Pharmacies are important in the choice of settings from which ECPs can be obtained and many aspects of pharmacy provision are appreciated by young women. There is scope to further enhance pharmacists' role.

Use of effective contraception following provision of the progestogen-only pill for women presenting to community pharmacies for emergency contraception (Bridge-It): a pragmatic cluster-randomised crossover trial.

BACKGROUND: Unless women start effective contraception after oral emergency contraception, they remain at risk of unintended pregnancy. Most women in the UK obtain emergency contraception from community pharmacies. We hypothesised that pharmacist provision of the progestogen-only pill as a bridging interim method of contraception with emergency contraception plus an invitation to a sexual and reproductive health clinic, in which all methods of contraception are available, would result in increased subsequent use of effective contraception. METHODS: We did a pragmatic cluster-randomised crossover trial in 29 UK pharmacies among women receiving levonorgestrel emergency contraception. Women aged 16 years or older, not already using hormonal contraception, not on medication that could interfere with the progestogen-only pill, and willing to give contact details for follow-up were invited to participate. In the intervention group, women received a 3-month supply of the progestogen-only pill (75 µg desogestrel) plus a rapid access card to a participating sexual and reproductive health clinic. In the control group, pharmacists advised women to attend their usual contraceptive provider. The order in which each pharmacy provided the intervention or control was randomly assigned using a computer software algorithm. The primary outcome was the use of effective contraception (hormonal or intrauterine) at 4 months. This study is registered, ISRCTN70616901 (complete). FINDINGS: Between Dec 19, 2017, and June 26, 2019, 636 women were recruited to the intervention group (316 [49·6%], mean age 22·7 years [SD 5·7]) or the control group (320 [50·3%], 22·6 years [5·1]). Three women (one in the intervention group and two in the control group) were excluded after randomisation. 4-month follow-up data were available for 406 (64%) participants, 25 were lost to follow-up, and two participants no longer wanted to participate in the study. The proportion of women using effective contraception was 20·1% greater (95% CI 5·2-35·0) in the intervention group (mean 58·4%, 48·6-68·2), than in the control group (mean 40·5%, 29·7-51·3 [adjusted for recruitment period, treatment group, and centre]; p=0·011).The difference remained significant after adjusting for age, current sexual relationship, and history of effective contraception use, and was robust to the effect of missing data (assuming missingness at random). No serious adverse events occurred. INTERPRETATION: Provision of a supply of the progestogen-only pill with emergency contraception from a community pharmacist, along with an invitation to a sexual and reproductive health clinic, results in a clinically meaningful increase in subsequent use of effective contraception. Widely implemented, this practice could prevent unintended pregnancies after use of emergency contraception. FUNDING: National Institute for Health Research (Health Technology Assessment Programme project 15/113/01).