Levonorgestrel Emergency Research Articles

Assessment of Family Planning Services at Community Pharmacies in San Diego, California

Levonorgestrel emergency contraception and other contraceptive methods are available over-the-counter (OTC); however youth continue to face a number of barriers in accessing healthcare services, including lack of knowledge of the method, fear of loss of privacy, difficulties in finding a provider, and cost. A descriptive, nonexperimental, cross-sectional study of a sample of 112 community pharmacies in San Diego, California was conducted between December 2009 and January 2010 to assess community pharmacy practices related to the availability and accessibility of family planning health pharmacy services and products, particularly to youth. A majority (n = 79/112, 70.5%) of the pharmacies carried a wide selection of male condoms; however, the other OTC nonhormonal contraceptive products were either not available or available with limited selection. A majority of the pharmacies sold emergency contraception (n = 88/111, 78.6%). Most patient counseling areas consisted of either a public or a semi-private area. A majority of the pharmacy sites did not provide materials or services targeting youth. Significant gaps exist in providing family planning products and services in the majority of community pharmacies in San Diego, California. Education and outreach efforts are needed to promote provision of products and services, particularly to the adolescent population.

Plan B and the German Catholic Bishops

Germany's Catholic bishops recently ruled that levonorgestrel emergency contraception (EC) was acceptable for prevention of pregnancy in the case of rape. The ruling represents a significant change in Catholic doctrine that has been opposed to most forms of birth control. In their ruling the bishops cited a lack of evidence that levonorgestrel EC acts as an abortifacient. This case serves as a reminder of the need for bioethics to be based on current scientific literature as well as articles of faith and morals.

Expressions of candidate molecules in the human fallopian tube and chorionic villi of tubal pregnancy exposed to levonorgestrel emergency contraception

BackgroundCases of ectopic pregnancy (EP) following levonorgestrel (LNG) emergency contraception (EC) failure were reported, however, the effects of LNG on tubal microenvironment or chorionic villi in EP have not yet been documented.MethodsFifty-five women with tubal pregnancy were divided into two groups according to whether LNG-EC was administrated during the cycle of conception. The serum concentrations of beta-hCG, E2 and P were measured. The mRNA and protein expressions of estrogen and progesterone receptors, leukemia inhibitory factor, vascular endothelial growth factor, inducible nitric oxide synthase, and endocannabinoid receptor - CB1 in the ectopic implantation site and chorionic villi were examined.ResultsCompared to those unexposed to LNG-EC, women with tubal pregnancy exposed to LNG-EC during the cycle of conception had no statistically significances in the serum concentrations of beta-hCG, E2 P, nor in the pathological types of tubal pregnancy or the expressions of ER-alpha, PR, LIF, VEGF, iNOS and CB1.ConclusionsThe expressions of candidate molecules in the fallopian tube and chorionic villi were not altered by exposure to LNG-EC. A routine therapy with no additional intervention might thus be applied to tubal pregnancy exposed to LNG-EC.

Access to Levonorgestrel Emergency Contraception: Science versus Federal Politics

Past US FDA decisions about emergency contraception (EC) have been subject to undue political influence, and last year's barring of over-the-counter access to Plan B One-Step(®) for those under the age of 17 years is no exception. The US Department of Health and Human Services cited insufficient data on EC use for females aged 11-12 years. These youngest adolescents, however, rarely need EC: data from California (USA) show that in 2009, fewer than one in 10,000 females under the age of 13 years received EC. Maintaining barriers to safe and effective EC is not medically necessary and conflicts with national goals to decrease teenage and unintended pregnancies.

Over‐the‐Counter Access to Emergency Contraception without Age Restriction: An Opinion of the Women's Health Practice and Research Network of the American College of Clinical Pharmacy

Family planning remains a high priority area for the United States, with goals to increase the proportion of pregnancies that are intended, reduce pregnancy rates among adolescents, and increase contraceptive use prioritized in the Healthy People 2020 objectives. Contraception intended for use after unprotected intercourse, known as emergency contraception, remains underutilized. Levonorgestrel is one method of oral emergency contraception, which prevents fertilization and does not disrupt an already established pregnancy; thus, timing of administration is critical. Despite data demonstrating safety and efficacy, evidence‐based decision making has been overshadowed by politically charged actions involving levonorgestrel emergency contraception for over a decade. The Women's Health Practice and Research Network of the American College of Clinical Pharmacy supports expanded access to levonorgestrel emergency contraception and removal of barriers such as age restrictions on the nonprescription drug product. Pharmacists remain a key provider of emergency contraceptive services and can help ensure timely access. In states where direct pharmacy access to emergency contraception is available, pharmacists are encouraged to participate. Education, research, and advocacy are other important responsibilities for pharmacists in this arena.

Emergency Contraception

ObjectiveTo review current knowledge about emergency contraception (EC), including available options, their modes of action, efficacy, safety, and the effective provision of EC within a practice setting. OptionsThe combined estradiol-levonorgestrel (Yuzpe regimen) and the levonorgestrel-only regimen, as well as post-coital use of copper intrauterine devices, are reviewed. OutcomesEfficacy in terms of reduction in risk of pregnancy, safety, and side effects of methods for EC and the effect of the means of access to EC on its appropriate use and the use of consistent contraception. EvidenceStudies published in English between January 1998 and March 2010 were retrieved though searches of Medline and the Cochrane Database, using appropriate key words (emergency contraception, post-coital contraception, emergency contraceptive pills, post-coital copper IUD). Clinical guidelines and position papers developed by health or family planning organizations were also reviewed. ValuesThe studies reviewed were classified according to criteria described by the Canadian Task Force on Preventive Health Care, and the recommendations for practice were ranked according to this classification (Table 1). Benefits, Harms, and CostsThese guidelines are intended to help reduce unintended pregnancies by increasing awareness and appropriate use of EC. SponsorThe Society of Obstetricians and Gynaecologists of Canada. Summary Statements1.Hormonal emergency contraception may be effective if used up to 5 days after unprotected intercourse. (II-2)2.The earlier hormonal emergency contraception is used, the more effective it is. (II-2)3.A copper IUD can be effective emergency contraception if used within 7 days after intercourse. (II-2)4.Levonorgestrel emergency contraception regimens are more effective and cause fewer side effects than the Yuzpe regimen. (I)5.Levonorgestrel emergency contraception single dose (1.5 mg) and the 2-dose levonorgestrel regimen (0.75 mg 12 hours apart) have similar efficacy with no difference in side effects. (I)6.Of the hormonal emergency contraception regimens available in Canada, levonorgestrel-only is the drug of choice. (I)7.A pregnancy that results from failure of emergency contraception need not be terminated (I) Recommendations1.Emergency contraception should be used as soon as possible after unprotected sexual intercourse. (II-2A)2.Emergency contraception should be offered to women if unprotected intercourse has occurred within the time it is known to be effective (5 days for hormonal methods and up to 7 days for a copper IUD). (II-2B)3.Women should be evaluated for pregnancy if menses have not begun within 21 days following emergency contraception treatment. (III-A)4.During physician visits for periodic health examinations or reproductive health concerns, any woman in the reproductive age group who has not been sterilized may be counselled about emergency contraception in advance with detailed information about how and when to use it. (III-C)

Use of Levonorgestrel Emergency Contraception In Utah: Is It More than “Plan B”?

It is important to understand why some women use levonorgestrel emergency contraceptive pills repeatedly, because the method is not intended for repeated use, and current evidence suggests that it is approximately 77% effective at preventing pregnancy. An anonymous patient survey of 1,040 women aged 18-29 purchasing levonorgestrel at Planned Parenthood clinics in Utah was conducted during a 4-6-week period in 2007. Chi-square tests and analyses of variance were used to examine associations between selected characteristics and level of levonorgestrel use. Logistic regression was used to assess characteristics independently associated with repeated use. Twenty-nine percent of participants had used levonorgestrel more than twice in the prior year. Fifty-eight percent believed that levonorgestrel is at least 90% effective in protecting against pregnancy; 16% believed that it is 100% effective. In univariate analyses, lifetime number of partners, currently having multiple partners, substance use at last intercourse and perceived effectiveness of levonorgestrel were positively associated with repeated levonorgestrel use in the previous year. The measure most strongly associated with repeated levonorgestrel use in multivariate analyses was perceived effectiveness: Women who believed that the method is 90-99% or 100% effective in preventing pregnancy had greater odds of repeated use than those who believed it is 75-89% effective (odds ratios, 1.8 each). Women who repeatedly use levonorgestrel may have an inflated perception of its effectiveness. Future research, including qualitative research, may help clarify factors that lead to inflated perceptions of effectiveness.

Emergency Contraception Access Curtailed Yet Again

In 2003, an FDA advisory committee endorsed over-the-counter (OTC) access to levonorgestrel emergency contraception (EC). Nonetheless, under federal pressure, the FDA instead placed this medication “behind the counter,” which required women who sought EC to obtain prescriptions or to prove that they were at least 18. In 2009, a federal judge ruled that this policy did not reflect scientific evidence and required that, at minimum, EC must be made available without prescription to all women who could prove they were …

Science, Politics, and Over-the-Counter Emergency Contraception

This article focuses on levonorgestrel emergency contraception known as Plan B One-Step and the decision to make it available over-the-counter for all women of childbearing age. It describes the emergency contraceptive how it works and the politics involved in the decision to make it available as a nonprescription drug.

Updates in Hormonal Emergency Contraception

In recent years, there have been many updates in hormonal emergency contraception. Levonorgestrel emergency contraception has been available for several years to prevent pregnancy when used within 72 hours after unprotected intercourse or contraceptive failure, and it was recently approved for nonprescription status for patients aged 17 years or older. Current research suggests that the primary mechanism of action is delaying ovulation. Ulipristal is the newest emergency contraception, available by prescription only, approved for use up to 120 hours after unprotected intercourse or contraceptive failure. The primary mechanism of action is delaying ovulation. When compared with levonorgestrel emergency contraception, ulipristal was proven noninferior in preventing pregnancy. Evidence suggests that ulipristal does not lose efficacy from 72-120 hours; however, more studies are warranted to support this claim. Many misconceptions and controversies about hormonal emergency contraception still exist. Research does not support that increased access to emergency contraception increases sexual risk-taking behavior. Several studies suggest that health care providers, including pharmacists, could benefit from increased education about emergency contraception. It is important for pharmacists to remain up-to-date on the most recent hormonal emergency contraception products and information, as pharmacists remain a major point of access to emergency contraception.

Efficacy and safety of a levonorgestrel enteric-coated tablet as an over-the-counter drug for emergency contraception: a Phase IV clinical trial

BACKGROUNDAn enteric-coated levonorgestrel emergency contraceptive pill (E-LNG-ECP) is an improved formulation, in terms of side effects, which both dissolves and is absorbed in the intestine. Our aim was to evaluate the efficacy and safety of E-LNG-ECP as an over-the-counter (OTC) drug for emergency contraception (EC) in Chinese women.METHODSA Phase IV clinical trial was conducted in five family planning clinics in China. Women seeking EC within 72 h after unprotected sexual intercourse or contraceptive failure who met the inclusion criteria were recruited. The efficacy of contraception (primary end-point was pregnancy rate), side effects (i.e. safety) and the value of E-LNG-ECP for EC were investigated.RESULTSOf 2445 women (aged 15–48 years) who took E-LNG-ECP with follow-up to determine pregnancy, only five pregnancies (0.2%) occurred. The efficacy of contraception was 95.3%. In total, 6.5% of women reported at least one adverse event after taking E-LNG-ECP, and no serious adverse events were reported. Only four subjects (0.16%) reported vomiting. The incidence of menstrual cycle disturbance was 20.1% after taking E-LNG-ECP. Subjects who had previously taken ECPs (54.4% of these women) rated the acceptability of E-LNG-ECP at 9.36 (on a 10-point scale) higher (P<0.05) than the rating of other LNG-EC pills taken previously.CONCLUSIONSThe study found that E-LNG-ECP was effective, safe and well tolerated as an OTC drug. However, an randomized controlled trial should be performed to compare standard LNG tablets with E-LNG-ECP.

Ectopic pregnancy after levonorgestrel emergency contraception

Background Although the possibility of ectopic pregnancy after intake of levonorgestrel (LNG) as an emergency contraceptive (EE) pill is well-known, the causality has not been well established. Case A 27-year-old nulliparous woman with regular menstrual periods took 1.5-mg LNG EE midcyclic 5 h after an unprotected intercourse. She had prolonged vaginal bleeding at the expected time. She consulted the general practitioner because of continuous vaginal bleeding for 4 weeks and lower abdominal pain. The pregnancy test was positive, and her symptoms and clinical findings suggested an ectopic pregnancy. At emergency surgery, she was found to have a left tubal pregnancy. Conclusion The possible role of 1.5-mg LNG EE in causing ectopic pregnancy is discussed. A high serum LNG concentration decreases ciliary activity and tube motility, but further epidemiological studies are necessary to establish the risk of ectopic pregnancy following intake of LNG EE.

Ectopic pregnancy following levonorgestrel emergency contraception: a case report

Hormonal contraceptive pills containing 750 microgram levonorgestrel are the most commonly used postcoital contraceptive method because of their high efficacy and fewer side effects. Emergency contraceptive pills containing levonorgestrel present their effects by several mechanisms, including delayed tubal transport of the ovum. A delay of tubal transportation of an ovum is also one of the possible etiologic factors of tubal ectopic pregnancies. There are limited data on the risk of ectopic pregnancy following levonorgestrel treatment as an emergency contraception. Here, a case of tubal pregnancy associated with the use of levonorgestrel containing emergency contraceptive pills has been presented along with discussion of the relevant literature.

Levonorgestrel Emergency Contraception Works Before and Not After Fertilization

Emergency contraception (EC) with levonorgestrel (LNG) is hypothesized to work by preventing fertilization and, therefore, to be ineffective once an

Effects of oral and vaginal administration of levonorgestrel emergency contraception on markers of endometrial receptivity

The standard regimen of the levonorgestrel-only pill (1.5 mg either in a single dose or in a dose of 0.75 mg twice, 12 h apart) administered orally for emergency contraception (EC) has been shown to have no effect on endometrial development and markers of endometrial receptivity. We aimed to explore whether repeated oral and single vaginal administration of levonorgestrel affect the endometrium and thus potentially increase the EC efficacy, compared with the standard regimen. Endometrial biopsies were taken from non-smoking, healthy women with proven fertility on cycle days LH + 6 to LH + 8 in control and levonorgestrel treatment cycles (each woman serving as her own control). Levonorgestrel was administered either orally (0.75 mg x 4, at 24 h intervals on LH + 1 to LH + 4; n = 8) or vaginally (a single dose of 1.5 mg on LH + 2; n = 7). Immunohistochemistry and real-time RT-PCR was performed to compare the levels of protein and mRNA for sex steroid receptors, interleukin-1beta, leukaemia inhibitory factor (LIF), vascular endothelial growth factor, cyclooxygenase-2, tumour necrosis factor-alpha, integrin alpha(v)beta(3) and mucin 1 in endometrial cells. Following the repeated oral treatment, the immunoreactivity of both progesterone receptor (PR)-A and PR-B declined in glandular epithelium (P = 0.03 and P = 0.02, respectively), whereas stromal immunoreactivity and mRNA expression of LIF increased compared with control (P < 0.001 and P = 0.03, respectively). However, vaginal levonorgestrel did not cause any significant endometrial changes. The two regimens of levonorgestrel caused either only minor or no alterations in markers of endometrial receptivity. New agents targeting the endometrial development should be explored in order to increase EC efficacy.

Widening Availability of Plan B Emergency Contraception

Since 2006, Plan B (levonorgestrel) emergency contraception (EC) has been available without prescription for women who are 18 or older. Now, the FDA

Emergency contraception: Patterns of use in community sexual health clinics

SummaryThe reported uptake of the intrauterine device (IUD) as emergency contraception is very low despite its superior efficacy when compared with levonorgestrel emergency contraception. A prospective study was conducted to investigate the methods of emergency contraception offered to and accepted by women attending South Staffordshire Sexual Health Clinics. A total of 240 women attended the clinic for emergency contraception during the 2-month study period. The IUD as a method of emergency contraception was not offered to the majority of women presenting within 72 h of an episode of unprotected intercourse. Nulliparous women presenting before 72 h were significantly less likely to be offered an IUD compared with parous women, p < 0.01. This study shows that the IUD is not offered to the majority of patients, in particular nulliparous women, attending for emergency contraception. Also, the low rate of the uptake of the emergency IUD is related, at least in part, to the counselling patients receive from clinicians.

Ectopic pregnancy following levonorgestrel emergency contraception: a case report

Use of levonorgestrel as emergency contraception is a safe and effective measure to prevent unwanted pregnancy. However, ectopic gestation in case of failure is a known risk. Access to levonorgestrel without a prescription in many countries has made it impossible to estimate the exact incidence of this potential adverse event. Thus, spontaneous reporting of cases serves to alert physicians to this possibility. We present a case of ectopic pregnancy following use of levonorgestrel emergency contraception. To our knowledge, this is the first case report from India following introduction of levonorgestrel emergency contraception in 2001.

Emergency Contraception: A Reasonable Personal Choice or a Destructive Societal Influence?

A 2003 petition to the US Food and Drug Administration by the manufacturer to move levonorgestrel emergency contraception from prescription status to over-the-counter sale embroiled the Agency in politics and remains controversial in some circles. This essay addresses the current remaining main points of contoversy about the medication and the Agency's decision.

Levonorgestrel emergency contraception: a joint analysis of effectiveness and mechanism of action

To model the effectiveness that can be obtained if levonorgestrel-only emergency contraception (EC) acts only through disrupting ovulation, in relation to other effects that may occur before or after fertilization and accounting for delays in administration. We modeled follicular growth as a function of follicular size, using known day-specific probabilities of conception and known disruption of ovulation by levonorgestrel-only EC, to estimate the expected effectiveness of EC. Combined data from multiple clinical studies. Simulation models. Disruption of ovulation. Effectiveness in the form of proportion of pregnancies prevented. With disruption of ovulation alone, the potential effectiveness of levonorgestrel EC ranged from 49% (no delay) to 8% (72-hour delay). With complete inhibition of fertilization before the day of ovulation, the potential effectiveness of levonorgestrel EC ranged from 90% (no delay) to 16% (72-hour delay). The gap between effectiveness of levonorgestrel EC estimated from clinical studies and what can be attributed to disruption of ovulation may be explained by overestimation of actual effectiveness and supplementary mechanisms of action, including postfertilization effects. Additional data with follicular ultrasound and precise measures of delay between intercourse and EC administration would yield greater insight into effectiveness and mechanisms of action.