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

Chen, Q.-J.; Xiang, Wenpei; Zhang, D.-K.; Wang, R.-P.; Luo, Yongwei; Kang, Jia-wei; Liu, Cheng

doi:10.1093/humrep/der181

Cited by 10 publications

(3 citation statements)

References 20 publications

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“…Globally, emergency contraception pills (ECPs) are widely used by women after unprotected intercourse to prevent unwanted pregnancies [1]. In many countries including Kenya; most pharmacies stock Levonorgestrel-only pills for emergency contraception (LNG-EC) and sell them over-the-counter form [2-5]. LNG-EC can prevent unwanted pregnancies with an efficacy of 52-94% when used within 12 hours of unprotected intercourse [5, 6].…”

Section: Introductionmentioning

confidence: 99%

Levonorgestrel only emergency contraceptive use and risk of ectopic pregnancy in Eldoret Kenya: a case-control study

Shurie¹,

Were²,

Orang’o³

et al. 2018

Pan Afr Med J

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Introduction ectopic pregnancy is one of the causes of maternal morbidity and mortality in sub-Saharan Africa. Levonorgestrel (LNG) only emergency contraceptive pill is a well-established emergency contraceptive pill that is administered within 72 hours after unprotected intercourse. This study aimed at determining whether or not there is a significant association between levonorgestrel emergency contraceptive use and the occurrence of ectopic pregnancy. Methods case-control (1:3) study among 79 women with ectopic pregnancy (cases) matched against 237 women without (controls) at Moi Teaching and Referral Hospital in Eldoret, Kenya; Sociodemographic and clinical data were collected using a questionnaire. Association between ectopic pregnancy and LNG-EC was assessed using Pearson chi-square test. The relationship between outcome and exposure (while adjusting for confounders) was assessed using logistic regression model. Results The mean age was 27.15 years. Both cases and controls were similar by age (p = 0.990), educational level (p = 0.850), marital status (p = 0.559), employment status (p = 0.186) and parity (p = 0.999). Seventy-eight (24.7%) participants had a history of miscarriage. A higher proportion of the cases had history of using LNG-EC compared to the controls (32.9% vs. 7.2%, p < 0.001). The use of LNG-EC portended more than nine times increased odds of ectopic pregnancy compared to other contraceptive methods {OR = 9.34 (95% CI: 3.9 - 16.0)}. Conclusion levonorgestrel only emergency contraceptive use was associated with ectopic pregnancy. One of the limitations of this study is that we could not control for all confounders of ectopic pregnancy.

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Section: Introductionmentioning

confidence: 99%

Levonorgestrel only emergency contraceptive use and risk of ectopic pregnancy in Eldoret Kenya: a case-control study

Shurie¹,

Were²,

Orang’o³

et al. 2018

Pan Afr Med J

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“…The 12-month postinsertion continuation rate was 94.0 per 100 woman-years 14 . An enteric-coated levonorgestrel emergency contraceptive pill (E-LNG-ECP) is an improved formulation, in terms of side effects, which is both dissolved and absorbed in the intestine 15 .…”

Section: Types Of Emergency Contraceptive Pills (Ecps)mentioning

confidence: 99%

Emergency Contraception—Rational Use for Women's Health

Mittal¹

2013

Clinical Progress in Obstetrics and Gynecology

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Emergency contraception (EC) is a safe and effective method which is used to prevent unwanted pregnancy after unprotected sexual intercourse. Many of the unwanted pregnancies end in unsafe abortions. The search for an ideal contraceptive, which does not interfere with spontaneity or pleasure of the sexual act, yet effectively controls the fertility, is still continuing. Numerous contraceptive techniques are available, yet contraceptive coverage continues to be poor in India. Thus, even when not planning for a pregnancy, exposure to unprotected sex takes place often, necessitating the use of emergency contraception. This need may also arise due to failure of contraceptive method being used (condom rupture, diaphragm slippage, forgotten oral pills) or following sexual assault. Emergency contraception is an intervention that can prevent a large number of unwanted pregnancies resulting from failure of regular contraception or unplanned sexual activity, which in turn helps in reducing the maternal mortality and morbidity due to unsafe abortions. However, a concern has been expressed regarding repeated and indiscriminate usage of e-pill, currently the rational use of emergency contraception is being promoted as it is expected to make a significant dent in reducing the number of unwanted pregnancies and unsafe abortions. In fact, since the introduction of emergency contraception, the contribution of unsafe abortion towards maternal mortality has declined from 13 to 8 per cent.

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“…In a large‐scale study, the World Health Organization reported that the levonorgestrel regimen (0.75 mg, repeated 12 h later) was better tolerated, more effective, and caused fewer side effects, such as nausea and vomiting than the Yuzpe regimen (ethinylestradiol 100 μg plus levonorgestrel 0.5 mg, repeated 12 h later) . Levonorgestrel (two 0.75 mg doses 12 h apart) prescription was approved as an emergency contraceptive method in the United States in 1999 and has been marketed in many countries, and the same regimen was subsequently approved as an over‐the‐counter drug in 2006. It was shown in 2002 that a single 1.5 mg oral levonorgestrel dose within 72 h of sexual intercourse could substitute for two 0.75 mg doses 12 h apart, and this new regimen was approved as an over‐the‐counter treatment in the United States in 2013.…”

Section: Introductionmentioning

confidence: 99%

Pregnancy rate after emergency contraception with single‐dose oral levonorgestrel in Japanese women

Sakurai¹

2019

J of Obstet and Gynaecol

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Aim To evaluate the pregnancy rate in Japanese women treated with levonorgestrel for emergency contraception. Methods This retrospective record‐based medical study included 1000 women who visited our clinic for emergency contraceptive treatment with 1.5 mg single‐dose oral levonorgestrel, followed by 50 μg hormonal oral contraceptive from May 2011 to December 2017. The outcomes of the emergency contraceptive treatment were recorded at a follow‐up visit, and descriptive statistics were obtained. Results The number of women treated with levonorgestrel at the clinic increased from 2011 to 2015, but there was no subsequent increase thereafter. Most women were in their 20s (57.4%), followed by their 30s (19.3%) and teens (18.3%). Of the 1000 women treated with levonorgestrel, 659 were followed up. Among the 659 women with follow‐up data, 16 were pregnant (2.4%), of whom 11 underwent abortions, three had miscarriages, and two delivered at term. The timing of unprotected sexual intercourse relative to the estimated ovulation date among the pregnant women ranged from −3 to 23 days. The most commonly used contraceptive method before the emergency contraceptive visit was condoms (89.3%, 887/993). No new safety concerns were identified throughout the study period. Conclusion The pregnancy rate after levonorgestrel treatment in Japanese women was low, and similar to that reported in previous studies. Information on contraceptive methods and emergency contraception with levonorgestrel needs to be better disseminated among women of childbearing age.

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

Cited by 10 publications

References 20 publications

Levonorgestrel only emergency contraceptive use and risk of ectopic pregnancy in Eldoret Kenya: a case-control study

Levonorgestrel only emergency contraceptive use and risk of ectopic pregnancy in Eldoret Kenya: a case-control study

Emergency Contraception—Rational Use for Women's Health

Pregnancy rate after emergency contraception with single‐dose oral levonorgestrel in Japanese women

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