Levonorgestrel Emergency Contraception Research Articles

Use of serum evaluation of contraceptive and ovarian hormones to assess reduced risk of pregnancy among women presenting for emergency contraception in a multicenter clinical trial

ObjectiveTo evaluate ovulation risk among women enrolling in an emergency contraception (EC) study by measuring contraceptive steroids and ovarian hormones. Study DesignWe used standard chemoluminescent assays to evaluate endogenous hormones [estradiol (E2), progesterone (P4), FSH, LH] and liquid chromatography-tandem triple quadrupole mass spectrometry (LC-MS/MS) to simultaneously analyze concentrations of ethinylestradiol (EE), dienogest (DNG), norelgestromin (NGMN), norethindrone (NET), gestodene (GSD), levonorgestrel (LNG), etonogestrel (ENG), segesterone acetate (NES), medroxyprogesterone acetate (MPA), and drospirenone (DRSP), in serum samples obtained at the time of enrollment in a recent study comparing oral ulipristal acetate and LNG EC in women with weight ≥ 80kg reporting no recent use of hormonal contraception. ResultsWe enrolled 532 and obtained a valid baseline blood sample from 520 women. Of these, 117 (22.5%) had detectable concentrations of a progestin [MPA (n=58, 11.2%), LNG (50, 9.6%), ENG (11, 2.1%), NET (5, 0.96%), NGMN (3, 0.06%), or DRSP (1, 0.02%)]. LNG was co-detected in all three participants with samples containing NGMN. Multiple progestins were detected in 8 other women: ENG/MPA (1); ENG/LNG (2); MPA/LNG (5). Samples from 55 (10.6%) had concentrations of one or more progestin considered above the minimum level for contraceptive [MPA ≥ 0.1ng/mL, n = 19; NGMN/LNG ≥ 0.2ng/mL, n = 31; ENG ≥ 0.09 ng/mL, n = 8; NET ≥ 0.35 ng/mL, n = 4]. We detected concentrations of serum P4 ≥ 3ng/mL, indicative of luteal phase (post-ovulation) status, in an additional 194 (37.3%) samples. ConclusionsMore than one third of enrolled in our clinical trial of oral emergency contraception had evidence of prior ovulation at the time of enrollment. Additionally, about 23% had evidence of recent use of hormonal contraception recent use of hormonal contraception. This results would have decreased the expected risk of pregnancy in the study. ImplicationsMany participants in a recent clinical trial of oral emergency contraception did not appear to be at risk for pregnancy or would not have benefited from intervention due to cycle timing. Investigators should consider the effects of these findings on expected pregnancy rates when determining sample size in future EC clinical trials, particularly when using non-inferiority designs or historical controls.Keywords

Increases in retail sales of over-the-counter levonorgestrel emergency contraception in the United States, 2016–2022

ObjectivesTo understand patterns in demand for emergency contraception (EC), we characterize the sales of over-the-counter (OTC) levonorgestrel (LNG) EC in the United States from traditional retail outlets. Study designWe describe sales of OTC LNG EC using retail sales data aggregated from traditional retail channels, including grocery stores, drug stores, mass merchandisers, club stores, dollar stores, and military outlets. ResultsSales of OTC LNG EC doubled between 2016 and 2022 (approximately 7.2–14.8 million). ConclusionsIncreasing sales of EC are consistent with increased use and use frequency of EC by those at risk of pregnancy in the United States. ImplicationsOTC LNG EC sales since 2016 exceed what national survey usage estimates would suggest, indicating that national surveys underreport EC use, those using EC purchase it somewhat frequently, and/or individuals stockpile EC for later use. The role of EC in individual contraceptive strategies, particularly as access to reproductive healthcare is restricted, warrants further study.

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

ObjectiveTo 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 designThis 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. ResultsFrom 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. ConclusionsOvulation suppression of the etonogestrel implant alone exceeds threshold testing for future research while the implant + ulipristal acetate does not. ImplicationsData 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.

Maximizing the effectiveness of 1.5 mg levonorgestrel for emergency contraception: The case for precoital use

ObjectivesU.S. and World Health Organization Selected Practice Recommendations for Contraceptive Use state people may have an advanced supply of emergency contraception (EC) to minimize treatment delays. We sought to characterize the potential improvement in effectiveness of 1.5 mg levonorgestrel (LNG-EC) if it were taken up to a few hours before unprotected sex. Study designWe expanded on an existing mathematical model for the maximum attainable effectiveness of LNG-EC, assuming it exclusively works to disrupt ovulation, and compared results with point estimates from nine studies when it was taken up to 72 hours after sex. We then modelled how effectiveness might have improved if subjects had taken LNG-EC up to 3 hours before sex. ResultsTaking LNG-EC immediately after sex could potentially reduce the risk of unintended pregnancy by 91%. However, population-average maximum attainable effectiveness levels ranged from just 49% to 67% when accounting for the distributions of postcoital treatment delays in the example studies. If half the subjects had taken it 3 hours before sex, then maximum effectiveness levels would have ranged from 70% to 81%. ConclusionsAt the individual level, taking LNG-EC a few hours before sex is a logical extension of Selected Practice Recommendations regarding an advanced supply of EC and, based on our modeling, should be advocated for people who can reasonably anticipate an unprotected sex act. In the absence of more clinical data, however, people should not routinely rely on precoital use of LNG-EC to prevent pregnancy unless modern, effective contraceptives are inaccessible to them. ImplicationsBased on mathematical modeling, individuals who anticipate needing to take LNG-EC for an impending unprotected act of sex could further reduce their chance of an undesired pregnancy by taking it a few hours in advance.

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.

Retail demand for emergency contraception in United States following New Year holiday: time series study.

To estimate the increase in sales of emergency contraception following the New Year's Eve/New Year's Day holiday. Time series analysis using autoregressive integrated moving average (ARIMA) model. Traditional (that is, "bricks and mortar") retail outlets-grocery stores, drug stores, mass merchandisers, club stores, dollar stores, and military outlets-in the United States from 2016 to 2022. Marketing data on weekly aggregated sales of items classified as emergency contraception gathered between 2016 and 2022 (n=362). On the basis of dates, weeks were classified as following the New Year holiday (n=6) or not (n=356). Weekly sales of levonorgestrel emergency contraception per 1000 women of reproductive age in the US population. Sales of levonorgestrel emergency contraception significantly increased after the New Year holiday (0.63 (95% confidence interval 0.58 to 0.69) unit increase per 1000 women aged 15-44). Holidays that share some aspects of the elevated risks of unprotected sexual intercourse with the New Year holiday (Valentine's Day, St Patrick's Day, US Independence Day) were associated with increased sales, albeit to a lesser degree, with respective sales increases per 1000 women aged 15-44 of 0.31 (0.25 to 0.38), 0.14 (0.06 to 0.23), and 0.20 (0.11 to 0.29). Holidays without these expectations (Easter, Mother's Day, Father's Day) were not significantly associated with sales of levonorgestrel emergency contraception. Increased sales of emergency contraception following the New Year's holiday suggest that this period is associated with increased risks of unprotected vaginal intercourse compared with other holidays. Targeting behavioral risks, prevention strategies to mitigate sexual violence, and improving access to contraception around holidays may limit the risks associated with unprotected vaginal intercourse.

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

ObjectiveTo 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 designIn 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. ResultsA 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%). ConclusionsIn 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. ImplicationsClients 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 RegistrationClinicaltrials.gov NCT04678817; registered 12/16/20

Levonorgestrel Emergency Contraception Information Accuracy From West Virginia Community Pharmacies: A Mystery Caller Approach.

To ensure access to effective levonorgestrel (LNG) emergency contraception (EC), pharmacies must keep medication in stock or available for quick delivery, and pharmacists must be knowledgeable about sales restrictions and the therapeutic window for EC. We conducted a mystery caller study to assess LNG EC availability and information accuracy provided by staff in West Virginia community pharmacies. A female research team member posed as a 16-year-old caller to ask pharmacy staff questions about whether LNG EC was in stock, the requirements for purchase, and when it should be taken for effectiveness. Data were analyzed with SPSS using the Pearson's χ2 test to determine if there was a relationship between pharmacy type and response accuracy to our questions about point-of-sale requirements and timing for effectiveness for LNG EC. Of the 506 pharmacies in the sample, 275 (54.3%) were chain pharmacies and 231 (45.7%) were independent. Overall, chain pharmacies provided significantly more accurate answers than independent pharmacies on all point-of-sale requirements. Regarding timing for effectiveness, 49.2% of all pharmacies provided an accurate response (62.9% for chain pharmacies vs. 32.9% for independent pharmacies). Overall, availability and accuracy regarding LNG EC were poor in West Virginia pharmacies. Pharmacists, particularly those at independent pharmacies serving rural communities, are in a critical and powerful position to influence community health by providing accurate and timely information and access to all contraceptive options, including LNG EC.

Oral emergency contraception with levonorgestrel plus piroxicam: a randomised double-blind placebo-controlled trial

Levonorgestrel, a standard drug for emergency contraception (EC), is not effective if administered post-ovulation. A cyclo-oxygenase inhibitor could contribute synergistic effects. We investigated whether a single 40 mg oral dose of piroxicam as co-treatment with levonorgestrel improved emergency contraceptive efficacy. This was a randomised double-blind placebo-controlled trial carried out in a major community sexual and reproductive health service in Hong Kong. Women who required levonorgestrel EC within 72 h of unprotected sexual intercourse were recruited and block-randomised in a 1:1 ratio to receive a single supervised dose of levonorgestrel 1·5 mg plus either piroxicam 40 mg or placebo orally. Group assignment was concealed in opaque envelopes and masked to the women, clinicians, and investigators. At follow-up 1-2 weeks after the next expected period, the pregnancy status was noted by history or pregnancy test. The primary efficacy outcome was the proportion of pregnancies prevented out of those expected based on an established model. All women randomised to receive the study drug and who completed the follow-up were analysed. The trial was registered with ClinicalTrials.gov, NCT03614494. 860 women (430 in each group) were recruited between Aug 20, 2018, and Aug 30, 2022. One (0·2%) of 418 efficacy-eligible women in the piroxicam group were pregnant, compared with seven (1·7%) of 418 in the placebo group (odds ratio 0·20 [95% CI 0·02-0·91]; p=0·036). Levonorgestrel plus piroxicam prevented 94·7% of expected pregnancies compared with 63·4% for levonorgestrel plus placebo. We noted no significant difference between the two groups in the proportion of women with advancement or delay of their next period, or in the adverse event profile. Oral piroxicam 40 mg co-administered with levonorgestrel improved efficacy of EC in our study. Piroxicam co-administration could be considered clinically where levonorgestrel EC is the option of choice. None.

Pharmacogenetic interactions of efavirenz or rifampin and isoniazid with levonorgestrel emergency contraception during treatment of HIV or tuberculosis.

In AIDS Clinical Trials Group study A5375, a pharmacokinetic trial of levonorgestrel emergency contraception, double-dose levonorgestrel (3 mg, versus standard dose 1.5 mg) offset the induction effects of efavirenz or rifampin on plasma levonorgestrel exposure over 8 h post-dose (AUC 0-8h ). We characterized the pharmacogenetics of these interactions. Cisgender women receiving efavirenz- or dolutegravir-based HIV therapy, or on isoniazid-rifampin for tuberculosis, were followed after a single oral dose of levonorgestrel. Linear regression models, adjusted for BMI and age, characterized associations of CYP2B6 and NAT2 genotypes (which affect plasma efavirenz and isoniazid exposure, respectively) with levonorgestrel pharmacokinetic parameters. Of 118 evaluable participants, 17 received efavirenz/levonorgestrel 1.5 mg, 35 efavirenz/levonorgestrel 3 mg, 34 isoniazid-rifampin/levonorgestrel 3 mg, and 32 (control group) dolutegravir/levonorgestrel 1.5 mg. There were 73 Black and 33 Asian participants. Regardless of genotype, women on efavirenz and isoniazid-rifampin had higher levonorgestrel clearance. In the efavirenz/levonorgestrel 3 mg group, CYP2B6 normal/intermediate metabolizers had levonorgestrel AUC 0-8h values similar to controls, while CYP2B6 poor metabolizers had AUC 0-8h values of 40% lower than controls. In the isoniazid-rifampin group, NAT2 rapid/intermediate acetylators had levonorgestrel AUC 0-8h values similar to controls, while NAT2 slow acetylators had AUC 0-8h values 36% higher than controls. CYP2B6 poor metabolizer genotypes exacerbate the efavirenz-levonorgestrel interaction, likely by increased CYP3A induction with higher efavirenz exposure, making the interaction more difficult to overcome. NAT2 slow acetylator genotypes attenuate the rifampin-levonorgestrel interaction, likely by increased CYP3A inhibition with higher isoniazid exposure.

Levonorgestrel Emergency Contraception Availability in Louisiana Independent and Chain Pharmacies Post-Dobbs v Jackson Women’s Health Organization [ID: 1376654

INTRODUCTION: Following recent legal changes, there is increased confusion regarding availability of medications for reproductive health, including emergency contraception (EC). We aimed to quantify over-the-counter (OTC) access to levonorgestrel EC in three metropolitan Louisiana parishes (counties) among chain and independent pharmacies. METHODS: This cross-sectional study took place during August and September 2022. Secret shoppers surveyed all retail pharmacies in Jefferson, Orleans, and Terrebonne parishes. Pharmacies were classified as independent or chain based on affiliation with supermarket or drug store chains. Odds ratios (ORs) with 95% CIs were used to compare availability of OTC EC. RESULTS: Among 212 retail pharmacies, 55% (n=117) were large chain pharmacies and 45% were independent stores. Only 67% (n=141) had EC in stock. Chain pharmacies were more likely to offer EC than independent pharmacies (92% versus 35%, OR 22.6, 95% CI [10.1, 50.2]). Independent pharmacies were more likely to keep OTC EC behind the counter (91% versus 11%, OR 80.0, 95% CI [21.2, 302.5]), require identification (45% versus 4%, OR 21.7, 95% CI [6.5, 72.7]), and carry no EC less than $50 (24% versus 2%, OR 17.0, 95% CI [3.4, 84.8]). Among pharmacies without EC available, no chain pharmacies described recent changes in EC stock, while 5 out of 28 (18%) respondent independent pharmacies attributed loss of EC stock to recent legislation. CONCLUSION: Independent pharmacies were less likely to carry OTC EC and more likely to enforce multiple barriers to purchase. Recent legislation has disproportionately further reduced EC availability at these pharmacies.

454 - Cross sectional evaluation of availability of levonorgestrel emergency contraception in new orleans metropolitan pharmacies

454 - Cross sectional evaluation of availability of levonorgestrel emergency contraception in new orleans metropolitan pharmacies

Pharmacokinetics of dose-adjusted levonorgestrel emergency contraception combined with efavirenz-based antiretroviral therapy or rifampicin-containing tuberculosis regimens

To determine if double-dose levonorgestrel emergency contraception (EC) in combination with efavirenz or rifampicin, 2 drugs known to decrease levonorgestrel exposure, resulted in similar pharmacokinetics compared to standard-dose levonorgestrel EC without drug-drug interactions. We conducted a phase 2, open-label, multicenter, partially randomized, 4 parallel group trial in pre-menopausal females ≥16 years old without an indication for EC and not on hormonal contraception. Participants on dolutegravir-based antiretroviral therapy (ART) received levonorgestrel 1.5 mg (control group); those on rifampicin-containing tuberculosis therapy received levonorgestrel 3 mg; those on efavirenz-based ART were randomized 1:2 to levonorgestrel 1.5 mg or 3 mg. Plasma was collected through 48 hours post-dose to assess levonorgestrel pharmacokinetics. Area under the concentration-time curve (AUC) over 8 hours was the primary outcome. Levonorgestrel pharmacokinetic parameters were compared between groups using geometric mean ratios (GMR) with 90% confidence intervals. The median (Q1, Q3) age for all participants (n=118) was 34 (27, 41) years and BMI was 23.2 (20, 26.3) kg/m2. Participants receiving levonorgestrel 1.5mg plus efavirenz (n=17) had 50% lower AUC0-8h compared to the control group (n=32) [0.50 (0.40, 0.62)]. Participants receiving levonorgestrel 3 mg had a similar AUC0-8h when receiving either efavirenz (n=35) [0.99 (0.81, 1.20)] or rifampicin (n=34) [1.16 (0.99, 1.36)] compared to control. Levonorgestrel 3 mg resulted in similar or higher maximum concentration with either efavirenz [1.17 (0.96, 1.41)] or rifampicin [1.27 (1.09, 1.49)] compared to the control group. Doubling the dose of levonorgestrel EC successfully increased levonorgestrel exposure over the first 8 hours in participants receiving either efavirenz-based ART or rifampicin-containing tuberculosis therapy. Adjusting levonorgestrel emergency contraception from 1.5 mg to 3 mg improves levonorgestrel pharmacokinetic exposure in participants receiving either efavirenz-based antiretroviral regimens or rifampicin-containing tuberculosis therapy. These data support guideline recommendations to double the dose of levonorgestrel emergency contraception in persons on medications that decrease levonorgestrel exposure by inducing levonorgestrel metabolism.

The impact of caller characteristics on levonorgestrel emergency contraception access in West Virginia community pharmacies

ObjectiveAccess to levonorgestrel (LNG) emergency contraception (EC) has increased since the FDA removed age restrictions on over-the-counter (OTC) LNG EC in 2013, but availability is highly variable and numerous barriers to access remain. The purpose of this study was to assess availability and accessibility of LNG EC at community pharmacies in West Virginia (WV). MethodsA mystery caller cross-sectional study was conducted to assess availability and accessibility of LNG EC. Inquiries were made by identified ‘research’ staff and by staff presenting as a 16 y/o. ResultsNearly half of community pharmacies reported having LNG EC in stock. Pharmacy staff were significantly more likely to tell research callers LNG EC was in stock (53%) and more likely to report willingness to order it (50%) than ‘teen’ callers (45% and 34%, respectively). There was no significant difference between caller types on the five barriers assessed. ConclusionLack of availability may contribute to teen and unintended pregnancies.

Conscientious Objection to Emergency Contraception

Conscientious Objection to Emergency Contraception

Ectopic Pregnancy Following Levonorgestrel Emergency Contraception: Report of Two Cases

Abstract
 Ectopic pregnancy (EP) is likely to occur as an unwanted complication after unprotected intercourse in spite of levonorgestrel emergency contraception (LNG-EC). Its incidence has been increasing recently.
 We present 2 cases of tubal EP after the oral use of levonorgestrel, treated by laparoscopy.The first unruptured EP with unclear ultrasound findings, because of uterine ventrofixation after the caesarean section (CS) . The second case is a ruptured EP after LNG –EC on day 24 of the period with mild haemoperitoneum with severe peritoneal irritation.
 The fundamental question is whether levonorgestrel participates in the etiology of EP.
 The etiology of EP involves many factors. Levonorgestrel mechanisms of action give us grounds to believe theoretically that it increases the risk of EP and participates as an etiological factor.

Surveying the persistence of age- and gender-based restrictions on over-the-counter emergency contraception across pharmacies in Los Angeles County, CA

BackgroundOver-the-counter levonorgestrel emergency contraception (OTC EC) is safe and effective but underutilized for postcoital pregnancy prevention. Unnecessary restrictions imposed by pharmacies and pharmacy workers may impede EC uptake. ObjectiveTo assess the persistence of age- and gender-based barriers to OTC EC access among pharmacists and pharmacy staff across Los Angeles, CA. MethodsWe conducted a cross-sectional survey of registered community pharmacies randomly chosen from regions with the highest unintended pregnancy rates in Los Angeles County. Using an adaptation of the 2017 American Society for Emergency Contraception EC Access and Price Survey, we interviewed pharmacy staff about their attitudes and practices related to OTC EC, with attention to age- and gender-based barriers. ResultsWe surveyed 139 staff members (45% pharmacists, 20% technicians, 26% retail) from 93 publicly accessible pharmacies. Thirteen pharmacies did not stock EC. Half of respondents cited age-based restrictions; only 4% noted gender-based restrictions. More than 75% reported being asked for EC by a man; 7% reported refusing to sell to a man. Nearly 40% reported that men never or rarely purchased EC. Pharmacists were more likely than technicians or retail staff to believe men rarely purchased EC (P = 0.01). The most frequently cited concern about selling to men was inability to confirm the female partner’s age. ConclusionAlthough gender-based restrictions to EC are rare, more than half of pharmacy staff continue to report age-based restrictions. Inability to verify the female partner’s age may underlie cases where men are unable to purchase OTC EC.

Opportunities for improving provision of emergency contraception in California

ObjectivesTo assess emergency contraception (EC) service provision by California's family planning clinics. Study DesignWe made 2 scripted calls to a random sample of 309 family planning clinics. ResultsWe reached one hundred ninety-four clinics on 2 occasions, although only 183 (59%) could be reached with the information provided online by California's office of family planning. Of these 194 clinics, 27% responded that the clinic did not provide EC and 43% offered only levonorgestrel EC. Only 1 clinic asked about recent sexual assault and one other about their weight. ConclusionsPrompt access to effective EC remains challenging in California. Clinic staff responding to requests for EC should provide trauma-informed care.

97. Misinformation About Levonorgestrel Emergency Contraception in West Virginia Community Pharmacies

Levonorgestrel (LNG) emergency contraception (EC)—commonly known as Plan B®--became available in the United States (US) without a prescription in 2013, but barriers to access remain. One barrier is misinformation about the medication and who can obtain it. To assess the accuracy of information provided by community pharmacies in West Virginia (WV), a state with particularly low LNG EC access and high teen pregnancy rate, we conducted a mystery caller study to ask pharmacies questions about the requirements for purchasing LNG EC and when it should be taken for maximum effectiveness.

Ulipristal Acetate (UPA) in Emergency Contraception: The Mechanism of Action, Toxicity and Perspectives

After recalling that Levonorgestrel Emergency Contraceptive Pills never delay or suppress ovulation, but impair the luteal body functions, and, consequently, the embryo-implantation, we focus on the mechanism of action (MOA) of ellaOne®: micronized UPA (Ulipristal Acetate) 30mg and on UPA- toxicity. EMA and, after it, the National Drug Regulatory Institutions and the most renowned International Gynecological Societies present ellaOne® as an anti-ovulatory drug which is safe even in repeated assumption, also during the same menstrual cycle. We’ll try to understand whether this dogma is supported by experimental data in literature. As to the MOA, EMA reports (EMEA-261787-2009) that Ulipristal blocks the synthesis of the proteins necessary to begin and maintain pregnancy, and that Ulipristal and mifepristone were approximately equipotent as to their ability to terminate pregnancy. Besides, EMA further evidences (EMA/73099/2015) that it is unknown whether it is possible to use ellaOne® for abortion. Data in Literature evidence that ellaOne® can delay ovulation only when is taken in the very first fertile days of the cycle. In the pre-ovulatory, most fertile, days - when most intercourses do occur and over 70% fertilizations ensue - it never prevents ovulation, like placebo. On the contrary, whenever it is taken in the cycle, it consistently impairs the endometrium that becomes an inhospitable ground for the embryo: endometrial gene expression is completely subverted compared with that of the normal luteal phase. Recently, an UPA-based drug used for uterine fibroids-treatment (Esmya®) was withdrawn from the market because it caused fulminant hepatitis requiring transplantation (EMA/455818/2020). It was prescribed by the hospital for 3-6 months and carefully followed-up. The strict post-marketing surveillance allowed to link UPA-administration and tissue-accumulation to liver-failure. Surprisingly EMA, while revoking Esmya®, warranted for the safety of ellaOne®, though it is taken by millions of women unaware of the risk, repeatedly without prescription, without medical supervision and any possibility of post-marketing surveillance, in UPA-cumulating doses even greater than with Esmya®. Finally, we criticize the attempt to propose UPA in daily contraceptive pills, at doses even double than in Esmya® and for much longer periods, to fertile women aiming at preserving their fertility and health.