Low dose mifepristone and two regimens of levonorgestrel for emergency contraception: A WHO multicentre randomised trial

Helena Von Hertzen, Gilda Piaggio, Juhong Ding, Junling Chen, Si Song, G. Bártfai, Ernest Ng, Kristina Gemzell-Danielsson, Amindavaa Oyunbileg, Shangchun Wu, Weiyu Cheng, Frank Lüdicke, Alenka Pretnar-Darovec, Rosemary Kirkman, Suneeta Mittal, Archil Khomassuridze, Dan Apter, Alexandre Peregoudov

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Abstract

Background: A single 10 mg dose of mifepristone, and two 0.75 mg doses of levonorgestrel 12 h apart, are effective for emergency contraception. Because no studies had compared the efficacies of both compounds, or investigated a single dose of 1.5 mg levonorgestrel, we undertook this three-arm trial. Methods: We did a randomised, double-blind trial in 15 family-planning clinics in 10 countries. We randomly assigned 4136 healthy women with regular menstrual cycles, who requested emergency contraception within 120 h of one unprotected coitus, to one of three regimens: 10 mg single-dose mifepristone; 1.5 mg single-dose levonorgestrel; or two doses of 0.75 mg levonorgestrel given 12 h apart. The primary outcome was unintended pregnancy; other outcomes were side-effects and timing of next menstruation. Analysis was by intention to treat, but we did exclude some patients from the final analyses. Findings: Of 4071 women with known outcome, pregnancy rates were 1.5% (21/1359) in those given mifepristone, 1.5% (20/1356) in those assigned single-dose levonorgestrel, and 1.8% (24/1356) in women assigned two-dose levonorgestrel. These proportions did not differ significantly (p=0.83). The relative risk of pregnancy for single-dose levonorgestrel compared with two-dose levonorgestrel was 0.83 (95% CI 0.46-1.50), and that for levonorgestrel (the two regimens combined) compared with mifepristone, 1.05 (0.63-1.76). Side-effects were mild and did not differ greatly between groups, and most women menstruated within 2 days of the expected date. Women who took levonorgestrel had earlier menses than did those who took mifepristone. Interpretation: The three regimens studied are very efficacious for emergency contraception and prevent a high proportion of pregnancies if taken within 5 days of unprotected coitus. Mifepristone and levonorgestrel do not differ in efficacy. A 1.5 mg single levonorgestrel dose can substitute two 0.75 mg doses 12 h apart.

Original languageEnglish
Pages (from-to)1803-1810
Number of pages8
JournalThe Lancet
Volume360
Issue number9348
DOIs
Publication statusPublished - Dec 7 2002

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Postcoital Contraception
Mifepristone
Levonorgestrel
Multicenter Studies
Menstruation
Coitus
Pregnancy
Intention to Treat Analysis
Family Planning Services
Pregnancy Rate
Menstrual Cycle

ASJC Scopus subject areas

  • Medicine(all)

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Low dose mifepristone and two regimens of levonorgestrel for emergency contraception : A WHO multicentre randomised trial. / Von Hertzen, Helena; Piaggio, Gilda; Ding, Juhong; Chen, Junling; Song, Si; Bártfai, G.; Ng, Ernest; Gemzell-Danielsson, Kristina; Oyunbileg, Amindavaa; Wu, Shangchun; Cheng, Weiyu; Lüdicke, Frank; Pretnar-Darovec, Alenka; Kirkman, Rosemary; Mittal, Suneeta; Khomassuridze, Archil; Apter, Dan; Peregoudov, Alexandre.

In: The Lancet, Vol. 360, No. 9348, 07.12.2002, p. 1803-1810.

Research output: Contribution to journalArticle

Von Hertzen, H, Piaggio, G, Ding, J, Chen, J, Song, S, Bártfai, G, Ng, E, Gemzell-Danielsson, K, Oyunbileg, A, Wu, S, Cheng, W, Lüdicke, F, Pretnar-Darovec, A, Kirkman, R, Mittal, S, Khomassuridze, A, Apter, D & Peregoudov, A 2002, 'Low dose mifepristone and two regimens of levonorgestrel for emergency contraception: A WHO multicentre randomised trial', The Lancet, vol. 360, no. 9348, pp. 1803-1810. https://doi.org/10.1016/S0140-6736(02)11767-3
Von Hertzen, Helena ; Piaggio, Gilda ; Ding, Juhong ; Chen, Junling ; Song, Si ; Bártfai, G. ; Ng, Ernest ; Gemzell-Danielsson, Kristina ; Oyunbileg, Amindavaa ; Wu, Shangchun ; Cheng, Weiyu ; Lüdicke, Frank ; Pretnar-Darovec, Alenka ; Kirkman, Rosemary ; Mittal, Suneeta ; Khomassuridze, Archil ; Apter, Dan ; Peregoudov, Alexandre. / Low dose mifepristone and two regimens of levonorgestrel for emergency contraception : A WHO multicentre randomised trial. In: The Lancet. 2002 ; Vol. 360, No. 9348. pp. 1803-1810.
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T1 - Low dose mifepristone and two regimens of levonorgestrel for emergency contraception

T2 - A WHO multicentre randomised trial

AU - Von Hertzen, Helena

AU - Piaggio, Gilda

AU - Ding, Juhong

AU - Chen, Junling

AU - Song, Si

AU - Bártfai, G.

AU - Ng, Ernest

AU - Gemzell-Danielsson, Kristina

AU - Oyunbileg, Amindavaa

AU - Wu, Shangchun

AU - Cheng, Weiyu

AU - Lüdicke, Frank

AU - Pretnar-Darovec, Alenka

AU - Kirkman, Rosemary

AU - Mittal, Suneeta

AU - Khomassuridze, Archil

AU - Apter, Dan

AU - Peregoudov, Alexandre

PY - 2002/12/7

Y1 - 2002/12/7

N2 - Background: A single 10 mg dose of mifepristone, and two 0.75 mg doses of levonorgestrel 12 h apart, are effective for emergency contraception. Because no studies had compared the efficacies of both compounds, or investigated a single dose of 1.5 mg levonorgestrel, we undertook this three-arm trial. Methods: We did a randomised, double-blind trial in 15 family-planning clinics in 10 countries. We randomly assigned 4136 healthy women with regular menstrual cycles, who requested emergency contraception within 120 h of one unprotected coitus, to one of three regimens: 10 mg single-dose mifepristone; 1.5 mg single-dose levonorgestrel; or two doses of 0.75 mg levonorgestrel given 12 h apart. The primary outcome was unintended pregnancy; other outcomes were side-effects and timing of next menstruation. Analysis was by intention to treat, but we did exclude some patients from the final analyses. Findings: Of 4071 women with known outcome, pregnancy rates were 1.5% (21/1359) in those given mifepristone, 1.5% (20/1356) in those assigned single-dose levonorgestrel, and 1.8% (24/1356) in women assigned two-dose levonorgestrel. These proportions did not differ significantly (p=0.83). The relative risk of pregnancy for single-dose levonorgestrel compared with two-dose levonorgestrel was 0.83 (95% CI 0.46-1.50), and that for levonorgestrel (the two regimens combined) compared with mifepristone, 1.05 (0.63-1.76). Side-effects were mild and did not differ greatly between groups, and most women menstruated within 2 days of the expected date. Women who took levonorgestrel had earlier menses than did those who took mifepristone. Interpretation: The three regimens studied are very efficacious for emergency contraception and prevent a high proportion of pregnancies if taken within 5 days of unprotected coitus. Mifepristone and levonorgestrel do not differ in efficacy. A 1.5 mg single levonorgestrel dose can substitute two 0.75 mg doses 12 h apart.

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