Ulipristal Acetate For Emergency Contraception Research Articles

Double dosing ulipristal acetate emergency contraception for individuals with obesity: a randomised crossover trial

ObjectiveTo determine whether increasing the dose of ulipristal acetate (UPA)-containing emergency contraception (EC) improves pharmacodynamic outcomes in individuals with obesity.Study designWe enrolled healthy, regularly-cycling, confirmed ovulatory, reproductive-age individuals with body...

Emergency contraception in a historic southern city: Mystery caller study in Birmingham, Alabama

BackgroundAlabama's Human Life Protection Act (the Act) signed in 2019 became law in 2022, making provision of abortion a felony offense. ObjectiveIn 2020, we assessed the accessibility of emergency contraception (EC) pills in Birmingham, Alabama prior to the Act's enactment given the probable increased need for EC access due to abortion criminalization. Study designPharmacy staff were asked about availability, price, location, and identification requirements to obtain EC. ResultsOf 69 pharmacies, 59% had levonorgestrel EC and none had ulipristal acetate EC available. ConclusionThere are persistent barriers to EC accessibility that should be addressed as abortion is increasingly restricted.

Barriers and facilitators for pharmacists prescribing emergency contraception under statewide protocol

AbstractBackgroundPharmacists can prescribe levonorgestrel and ulipristal acetate emergency contraception (EC) under statewide protocol in California. The objective of this study was to determine barriers and facilitators for pharmacists prescribing EC.MethodsFor this qualitative study, we conducted semi‐structured individual interviews with 18 pharmacists and pharmacy technicians practicing in pharmacies across California. We operationalized the Practical, Robust Implementation and Sustainability Model (PRISM) implementation science framework to develop the interview guide and inform the thematic analysis. The interview questions explored barriers and facilitators to implementation of pharmacist prescribing of EC.ResultsSeveral themes emerged around barriers and facilitators to service implementation in the PRISM domains of Intervention, External Environment, Implementation and Sustainability Infrastructure, and Recipients. Though participants had experience with over‐the‐counter sales of levonorgestrel EC, they had limited experience prescribing EC and with ulipristal acetate. Reported barriers include difficulty incorporating an additional service into workload without payment or additional human resources, lack of patient demand possibly due to absence of public awareness, lack of physician prescribing of EC, management approval required, and being unaware of the protocol. Participating pharmacists reported being motivated to prescribe EC to benefit patients and provide clinical services. Other reported facilitators included support from their local communities, opportunities created by the statewide protocol, training opportunities, pharmacy team‐based care, and providing patient‐centered care.ConclusionsMultilevel contextual barriers and facilitators exist to implementing pharmacist prescribing of EC that could be addressed in a multicomponent implementation intervention. These findings may help guide implementation strategies, thus increasing patient access to EC.

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.

Regulatory standards and processes for over-the-counter availability of hormonal contraception and drugs for medical abortion in five countries in the Eastern Mediterranean Region

The World Health Organization 2019 WHO consolidated guideline on self-care interventions for health: sexual and reproductive health and rights includes recommendations on self-administration of injectable contraception, over-the-counter (OTC) oral contraception and self-management of medical abortion. A review of the regulatory status of these two self-care interventions can highlight processes required to ensure that the quality of the medicines and safety of individuals are safeguarded in the introduction and scale-up in countries. This review outlines the legal regulatory status of prescription-only medicine (POM) and OTC contraceptives, including emergency contraception, and drugs for medical abortion in Egypt, Jordan, Lebanon, Morocco and Tunisia using information obtained from internet searches, regulatory information databases and personal contacts. In addition, the review examines whether the national medicines regulatory authorities have documented procedures available to allow for a change in status from a POM to OTC to allow for increased accessibility, availability and uptake of self-care interventions recommended by WHO. Egypt, Jordan and Lebanon have a documented national OTC list available. The only contraceptive product mentioned in the OTC lists across all five countries is ellaOne (ulipristal acetate for emergency contraception), which is publicly registered in Lebanon. None of the five countries has an official documented procedure to apply for the change of POM to OTC. Informal procedures exist, such as the ability to apply to the national medicines regulatory authority for OTC status if the product has OTC status in the original country of manufacture. However, many of these procedures are not officially documented, highlighting the need for establishing sound, affordable and effective regulation of medical products as an important part of health system strengthening. From a public health perspective, it would be advantageous for licensed products to be available OTC. This is particularly the case for settings where the health system is under-resourced or over-stretched due to health emergencies. Readiness of national regulatory guidelines and OTC procedures could lead to increased access, availability and usage of essential self-care interventions for sexual and reproductive health and rights.

Pharmacy availability of emergency contraception in southwestern Pennsylvania: A simulated patient study

ObjectiveTo assess the availability of oral emergency contraception in southwestern Pennsylvania pharmacies. Study designWe conducted a simulated patient study to assess on-the-shelf availability of levonorgestrel emergency contraception and immediate availability of ulipristal acetate emergency contraception. ResultsOnly 44% of pharmacies stocked levonorgestrel on-the-shelf and only 5% of pharmacies had ulipristal acetate immediately available. ConclusionsWe found significant barriers to obtaining timely oral emergency contraception in southwestern Pennsylvania. Implications statementTimely access to emergency contraception is important for people's ability to determine if, when, how, and under what circumstances to have children. Pharmacies in southwestern Pennsylvania need to expand access to oral emergency contraception.

Common questions on emergency and postcoital contraception

There are a number of key questions that must be asked when considering the method of emergency or postcoital contraception to use. Alison J Vaughan examines these when choosing from the three treatments available in the UK Copper IUD (CU-IUD), Levonorgestrel (LNG-EC), Ulipristal Acetate Emergency Contraception (UPA-EC) are the three methods of emergency contraception (EC) available in the UK. CU-IUD is the most effective method and must be offered to all women requesting emergency contraception and that offer documented in the record. UPA is more effective than LNG but the efficacy of UPA can be affected by on-going contraception, so is not always the ideal method for all women (see Figure 1 ). A consultation for EC offers the opportunity to discuss on going contraception and sexual health. Comprehensive evidence-led guidance can be found in the EC clinical guideline, published by the Clinical Effectiveness Committee of Faculty of Sexual and Reproductive Healthcare (FSRH) in 2017.

Availability of Ulipristal Acetate and the Impact of a Brief Educational Intervention at Retail Pharmacies [07I

INTRODUCTION: A Colorado study in 2014 determined levonorgestrel (LNG) emergency contraception (EC) to be completely accessible in 23% of pharmacies. No study has evaluated the availability of ulipristal acetate (UPA), which is a more effective form of EC, available by prescription in Denver. The goal was to assess availability of UPA EC, ability of pharmacy staff to answer questions about it, and determine if the American Society of Emergency Contraception (ASEC) educational tool was perceived as useful. METHODS: 134 retail pharmacies within 10-mile radius of the state capitol were included: one-half were randomized to receive the ASEC handout. Three pharmacies subsequently merged. (N=131) All pharmacies received a standard mystery call two weeks after the intervention mailing. The pharmacies receiving the handout received additional calls one and 9 weeks after the original call, to assess handout usefulness and were asked about the intervention tool. RESULTS: UPA EC was reportedly available in only 24, or 18.3%, of pharmacies. 36.4% of pharmacy staff members counseled that there was no difference between UPA and LNG EC. Only 18.6% of pharmacy staff seemed aware of the higher efficacy of UPA. Few pharmacy staff recalled seeing the ASEC handout: 13/65 (20%) at one week and 3/65 (4.6%) at nine weeks. One site reported that the handout was posted. CONCLUSION: Although UPA is available by prescription (therefore covered under the Affordable Care Act) and has a higher efficacy than LNG EC, it is not readily available. A single educational intervention did not have lasting value to pharmacists.

Does ulipristal acetate emergency contraception (ella®) interfere with implantation?

BackgroundUlipristal acetate (UPA) 30 mg (ella®, HRA-Pharma, Paris, France) acts as an emergency contraceptive (EC) by delaying ovulation. Because it is a selective progesterone receptor modulator, an additional effect on interfering with implantation has been suggested. ObjectiveThis review discusses the evidence for, and against, an anti-implantation effect of UPA-EC. Sources of evidencePrimary research on the effect of UPA, at a relevant dose, on endometrium, implantation, efficacy and pregnancy outcome. ResultsUPA-EC does not appear to have a direct effect on the embryo. Changes in endometrial histology are small and not consistent, varying among studies. While UPA-EC affects the profile of gene expression in human endometrium, the findings vary between studies, and it is not clear that these changes affect endometrial receptivity or prevent implantation. UPA at pharmacological concentrations does not appear to have any inhibitory effect on embryo attachment in in vitro systems of human endometrium. UPA-EC is not more effective at preventing pregnancy than chance alone if used after ovulation and does not increase miscarriage rates. ConclusionsAn anti-implantation effect of UPA is highly unlikely at the dose used for EC. Maintaining the warning on the FDA-approved label that “it may also work by preventing implantation to the uterus” might deter some women from using EC, leaving them no option to prevent unwanted pregnancy after unprotected sexual intercourse.

“My BMI is too high for Plan B.” A changing population of women seeking ulipristal acetate emergency contraception online

ABSTRACTEmergency contraceptive (EC) pills may be less effective for women with higher body mass index (BMI), but little is known about public response to the fact that EC may lose efficacy as weight increases. In November 2013, European authorities changed the label for a levonorgestrel EC product to warn of a reduction in effectiveness for women with higher BMI, garnering significant media coverage in the United States. Ulipristal acetate (UPA) EC may be more effective than levonorgestrel for women with BMI levels designated as obese. Among 8,019 women who received UPA from the online pharmacy KwikMed from 2011 to 2015 and self-reported their height, weight and reasons for seeking UPA online, we analyzed changes in the proportion of women in different BMI categories before and after the label change. For the 25 month-period after the label change, the proportion of women in the obese category rose by 26.7 percentage points relative to the 35 months before (B = 0.2665, p < .01). Mean BMI (25.5 versus 29.4, p < .001) and average weight (148.6 pounds versus 175.5 pounds, p < .001) of users were higher after the label change. Some women appear to have acted on the information that EC efficacy may be associated with body weight.

Pregnancy Outcomes Following Ulipristal Acetate Emergency Contraception Failure: A Report of Five Cases

ABSTRACTIntroduction: The emergency contraceptive ulipristal acetate (UPA) 30 mg is increasingly used by women, but there is no published data on UPA exposure in pregnancy. Case report: Here we describe five cases of unintended pregnancies following the use of UPA for emergency contraception. Of five pregnant women exposed to UPA, one decided to terminate the pregnancy for personal reasons. Two of them experienced premature rupture of membranes and the babies were born large for gestational age (LGA). The other two women experienced gestational diabetes, and one of them also delivered a LGA baby. The blood glucose levels of the mothers were normal after delivery and at six weeks postpartum. No birth defects and no growth or developmental abnormalities for the infants were reported during 6 months follow-up. Conclusion: Pregnant women inadvertently exposed to UPA should be monitored carefully, unless further data are available.

Pharmacokinetics of levonorgestrel and ulipristal acetate emergency contraception in women with normal and obese body mass index

ObjectiveThis study compares the pharmacokinetics (PK) of levonorgestrel (LNG) emergency contraceptive (EC) and ulipristal acetate (UPA)-EC between normal-body mass index (BMI) and obese-BMI women. Study designThis prospective, randomized crossover study evaluates the PK of women after single doses of LNG-EC (1.5mg) and UPA-EC (30mg). Study procedures took place during clinical research unit admissions, where participants received a standardized meal and each study drug, in random order, during two separate 24-h admissions. Study staff collected 14 blood specimens (0, 0.5, 1.0, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 24 and 48h). We evaluated serum concentrations of LNG and UPA using liquid chromatography–tandem mass spectroscopy and estimated the PK parameters of both drugs using noncompartmental analysis. The main outcome of this study was a comparison of between-group differences in AUC0–24. ResultsThirty-two women completed the study (16 in each group). Among normal-BMI and obese-BMI participants, the mean BMIs were 22.0 (range 18.8–24.6) and 34.3 (range 30.6–39.9), respectively. After LNG-EC, mean AUC0–24 and maximum concentration (Cmax) were 50% lower among obese-BMI women than among normal-BMI women (AUC0–24 100.8 vs. 208.5ng*h/mL, IQRobese-BMI 35.8, IQRnormal-BMI 74.2, p≤.01; Cmax 10.8 vs. 18.2ng/mL, p=.01). After UPA-EC, AUC0–24 and Cmax were similar between obese-BMI and normal-BMI women (AUC0–24 362.5 vs. 293.5ng*h/mL, IQRobese-BMI 263.2, IQRnormal-BMI 112.5, p=.15; Cmax 95.6 vs. 89.3ng/mL, p=.70). ConclusionAfter a single dose of EC, obese-BMI women are exposed to lower concentrations of LNG and similar concentrations of UPA, when compared to normal-BMI women. ImplicationsDifferences in LNG-EC PK by BMI group may underlie and account for the lower LNG-EC efficacy reported among obese-BMI women, but modest differences in UPA-EC PK by BMI group provide less support for variable efficacy. A pharmacodynamic study may be able to clarify whether these PK differences account for observed differences in LNG-EC and UPA-EC efficacy.

“I don’t know what I would have done.” Women's experiences acquiring ulipristal acetate emergency contraception online from 2011 to 2015

ObjectivesThis study describes women's reasons for seeking ulipristal acetate (UPA) for emergency contraception (EC) through the only authorized online retailer for UPA EC in the US. Study designWomen aged 14 to 59 years, living in states that allow prescription medications to be shipped from out-of-state, accessed the KwikMed online pharmacy between January 2011 and December 2015. After completing a medical eligibility screener, women answered optional multiple-choice questions. To obtain UPA through KwikMed, individuals must be female, 50 years of age or younger, not currently pregnant or breastfeeding and not attempting to order UPA more than once within 30 days or more than four times per year. ResultsOver the 5-year period, KwikMed provided 8019 prescriptions for UPA, and the number of women using this service more than tripled over time. Among women who responded to the survey questions (n=7133; response rate = 89%), most sought EC because of a condom failure (45.3%) or because they did not use regular contraception (41.2%). More than half (53.5%) of women reported that they chose UPA because of its effectiveness compared to levonorgestrel EC pills, and 58.9% preferred ordering UPA online because they found it easier than getting it from a doctor, clinic or pharmacy. ConclusionsThis study documents the importance of providing confidential services for acquiring EC online. Benefits of online access include convenience, less embarrassment, avoiding situations in which a provider might refuse to provide EC because of their own ideological belief and more reliable availability for this time-sensitive contraceptive. ImplicationsThough physical, logistical and societal barriers can restrict women's access to EC, this study demonstrates that providing access to UPA online empowers women to obtain EC when they need it.

Mechanism of Action of Ulipristal Acetate for Emergency Contraception: A Systematic Review.

Ulipristal acetate (UPA) is now recommended as first choice hormonal emergency contraception (EC), due to its higher efficacy and similar safety compared to Levonorgestrel – EC. Even though all trials demonstrated that the first mechanism of action is inhibition of ovulation, some authors still postulate that a post fertilization effect is also possible, raising the alert on medication and fostering the ethical debate. A Medline database search was performed in order to find recent articles related to UPA’s effects on ovulation, on fallopian tube and on endometrium. We also analyzed the effects on sperm function and pregnancy. All studies conclude that UPA is effective in inhibition of ovulation even when administered shortly before LH peak. The effects on fallopian tube are unclear: according to some authors UPA inhibits ciliar beat through an agonistic effect on progesterone receptors, according to others it antagonizes the progesterone-induced ciliar beat decrease. Concerning the action on endometrium and on embryo implantation most of the studies concluded that low dose UPA used for EC has no significant effect on the decrease of endometrial thickness and on embryo’s attachment, but these results are still matter of debate. Finally recent evidence suggests that UPA modulates human sperm functions while it has no effect on established pregnancy. To date the majority of the evidence concurs in excluding a post-fertilization effect of UPA, even though more studies are needed to clarify its mechanism of action.

Canadian Contraception Consensus (Part 2 of 4).

Abstract Objective To provide guidelines for health care providers on the use of contraceptive methods to prevent pregnancy and on the promotion of healthy sexuality. Outcomes Guidance for Canadian practitioners on overall effectiveness, mechanism of action, indications, contraindications, non-contraceptive benefits, side effects and risks, and initiation of cited contraceptive methods; family planning in the context of sexual health and general wellbeing; contraceptive counselling methods; and access to, and availability of, cited contraceptive methods in Canada Evidence Published literature was retrieved through searches of Medline and The Cochrane Database from January 1994 to January 2015 using appropriate controlled vocabulary (e g , contraception, sexuality, sexual health) and key words (e g , contraception, family planning, hormonal contraception, emergency contraception) Results were restricted to systematic reviews, randomized control trials/controlled clinical trials, and observational studies published in English from January 1994 to January 2015. Searches were updated on a regular basis and incorporated in the guideline to June 2015. Grey (unpublished) literature was identified through searching the websites of health technology assessment and health technology-related agencies, clinical practice guideline collections, clinical trial registries, and national and international medical specialty societies Values The quality of the evidence in this document was rated using the criteria described in the Report of the Canadian Task Force on Preventive Health Care (Table).Key to evidence statements and grading of recommendations, using the ranking of the Canadian Task Force on Preventive Health CareQuality of evidence assessment*Classification of recommendations † I:Evidence obtained from at least one properly randomized controlled trial II-1:Evidence from well-designed controlled trials without randomization II-2:Evidence from well-designed cohort (prospective or retrospective) or case-control studies, preferably from more than one centre or research group II-3:Evidence obtained from comparisons between times or places with or without the intervention. Dramatic results in uncontrolled experiments (such as the results of treatment with penicillin in the 1940s) could also be included in this category III:Opinions of respected authorities, based on clinical experience, descriptive studies, or reports of expert committees A.There is good evidence to recommend the clinical preventive action B.There is fair evidence to recommend the clinical preventive action C.The existing evidence is conflicting and does not allow to make a recommendation for or against use of the clinical preventive action; however, other factors may influence decision-making D.There is fair evidence to recommend against the clinical preventive action E.There is good evidence to recommend against the clinical preventive action L.There is insufficient evidence (in quantity or quality) to make a recommendation; however, other factors may influence decision-making Wbolf SH, Battista RN, Angerson GM, Logan AG, Eel W. Canadian Task Force on Preventive Health Care. New grades for recommendations from the Canadian Task Force on Preventive Health Care. CMAJ 2003;169:207-8.*The quality of evidence reported in these guidelines has been adapted from The Evaluation of Evidence criteria described in the Canadian Task Force on Preventive Health Care.†Recommendations included in these guidelines have been adapted from the Classification of Recommendations criteria described in the Canadian Task Force on Preventive Health Care

A prospective, randomized, pharmacodynamic study of quick-starting a desogestrel progestin-only pill following ulipristal acetate for emergency contraception.

Is there a pharmacodynamic interaction between ulipristal acetate (UPA) 30 mg for emergency contraception and a daily progestin-only contraceptive pill, desogestrel (DSG) 0.75 mg, when initiated the next day? In this study, DSG impaired the ability of UPA to delay ovulation, but UPA had little impact on the onset of contraceptive effects due to DSG. UPA is a progesterone receptor modulator used for emergency contraceptive (EC) at the dose of 30 mg. UPA delays ovulation by at least 5 days when administered in the mid to late follicular phase. In theory, potent progestins could reactivate progesterone signaling that leads to follicle rupture, thereby impacting the effectiveness of UPA as EC. In addition, UPA could alter the onset of the contraceptive effect of progestin-containing contraceptives started immediately after UPA. A single-blind (for observer), placebo-controlled, partial crossover study was conducted in two sites [Dominican Republic (DR) and the Netherlands (NDL)] over 11 months from October 2012 to September 2013. Healthy female volunteers participated in two of the three treatment cycles separated by a washout cycle. Treatment combinations studied were as follows: (i) a single 30 mg dose of UPA followed by 75 µg per day DSG for 20 days, (ii) a single 30 mg dose of UPA followed by 20 days of placebo matching that of DSG (PLB2) or (iii) one tablet of placebo-matching UPA (PLB1) followed by 75 µg per day DSG for 20 days. Participants were randomized to one of the three treatment sequences (UPA + DSG/UPA + PLB2, PLB1 + DSG/UPA + DSG and UPA + PLB2/PLB1 + DSG) when a lead follicle was ≥ 14 to <16 mm diameter on transvaginal ultrasound imaging (TVU). A total of 71 women were included, and 49 were randomized to a first treatment combination of the three period sequences (20 in the DR and 29 in the NDL); 41 of the 49 continued and completed two treatment combinations (20 in the DR and 21 in the NDL). Initiating DSG treatment the day after UPA significantly reduced the ovulation delaying effect of UPA (P = 0.0054). While ovulation occurred in only one of the 29 UPA-only cycles (3%) in the first 5 days, it occurred in 13 of the 29 (45%) UPA + DSG cycles. This was a small, descriptive, pharmacodynamic study in which some findings differed by study site. Distinguishing between a cystic corpus luteum and a luteinized unruptured follicle (LUF) by TVU was difficult in some cases; however, the investigators reached consensus, when the study was still blinded, regarding ovulation based on hormone levels and careful review of daily TVU images. Initiating the use of a DSG progestin-only pill (POP) immediately after UPA reduces the ability of UPA to delay ovulation and thus may decrease its efficacy as EC. If starting a DSG POP after using UPA for EC, and possibly any progestin-only method, consideration should be given to delaying for at least 5 days after UPA intake in order to preserve the ovulation delaying effects of UPA.

Pharmacy availability of ulipristal acetate emergency contraception: an audit study

Objectives: The potential of emergency contraception (EC) to reduce unplanned pregnancy has not yet been realized. Ulipristal acetate EC has equal or greater efficacy than levonorgestrel EC and is effective for a longer window of time, yet is not prescribed nearly as often. Additionally, pharmacists vary in both their training on EC and their comfort in discussing its use. We performed a cross-sectional audit study to examine pharmacy availability and staff knowledge of both forms of EC in western Massachusetts pharmacies.

Ulipristal acetate for emergency contraception: postmarketing experience after use by more than 1 million women

ObjectiveTo describe the safety of ulipristal acetate in emergency contraception. Study designPostmarketing pharmacovigilance data collection. ResultsA total of 553 women experienced 1049 adverse drug reactions. The most frequent (n,%) were pregnancies (282, 6.8%); nausea, abdominal pain and vomiting (139, 13.3%); headache, dizziness (67, 6.4%); and metrorrhagia, menses delay and breast symptoms (84, 8.0%). Including data from clinical trials, 376 pregnancies have been reported in total, 232 (62%) with a known outcome: 28 live births (29 newborns), 34 miscarriages, 151 induced abortions, 4 ectopics and 15 which are ongoing. ConclusionsNo safety concern emerges from a sizable database of reported adverse reactions following ulipristal acetate exposure among varying ethnicities and regions. Postapproval data confirm the safety profile described during the clinical trials. ImplicationsUse of ulipristal acetate for emergency contraception in a variety of settings and among diverse populations indicate that it is safe and without unexpected or serious adverse events.

Results from pooled Phase III studies of ulipristal acetate for emergency contraception

BackgroundUlipristal acetate (UPA) is a new effective option to prevent unintended pregnancies up to 5 days after unprotected intercourse. We used pooled data from two Phase III studies to refine our understanding of the efficacy of UPA by time from unprotected intercourse and the effects of other factors on pregnancy rates. Study DesignData from two Phase III studies were pooled to create a larger analysis population. Analyses were performed on the first participation of 2183 women. ResultsA total of 41 women became pregnant despite the use of UPA, yielding an overall proportion pregnant of 1.9% (1.3%–2.5%). Proportions of pregnant women were higher among those with further acts of unprotected intercourse in the same cycle and among obese women. These varied from 1.3% (0.9%–2.0%) among nonobese women who had no further acts of unprotected intercourse (n=1704) to 8.3% (0.2%–38.5%) among obese women who had subsequent unprotected intercourse (n=12). ConclusionsUPA is effective and safe in preventing pregnancy after unprotected intercourse. Its effectiveness is lower among women who have subsequent unprotected intercourse and among obese women.

Results from pooled phase III studies of ulipristal acetate for emergency contraception

The objective was to refine our understanding of the efficacy of the emergency contraceptive pill ulipristal acetate (UPA) by time from unprotected intercourse and the effects of other factors on pregnancy rates and the incidence of adverse events.