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

TitleLow dose mifepristone and two regimens of levonorgestrel for emergency contraception: A WHO multicentre randomised trial
Authors
Issue Date2002
PublisherThe Lancet Publishing Group. The Journal's web site is located at http://www.elsevier.com/locate/lancet
Citation
Lancet, 2002, v. 360 n. 9348, p. 1803-1810 How to Cite?
AbstractBackground: 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.
Persistent Identifierhttp://hdl.handle.net/10722/173265
ISSN
2015 Impact Factor: 44.002
2015 SCImago Journal Rankings: 14.638
ISI Accession Number ID
References

 

DC FieldValueLanguage
dc.contributor.authorVon Hertzen, Hen_US
dc.contributor.authorPiaggio, Gen_US
dc.contributor.authorDing, Jen_US
dc.contributor.authorChen, Jen_US
dc.contributor.authorSong, Sen_US
dc.contributor.authorBártfai, Gen_US
dc.contributor.authorNg, Een_US
dc.contributor.authorGemzellDanielsson, Ken_US
dc.contributor.authorOyunbileg, Aen_US
dc.contributor.authorWu, Sen_US
dc.contributor.authorCheng, Wen_US
dc.contributor.authorLüdicke, Fen_US
dc.contributor.authorPretnarDarovec, Aen_US
dc.contributor.authorKirkman, Ren_US
dc.contributor.authorMittal, Sen_US
dc.contributor.authorKhomassuridze, Aen_US
dc.contributor.authorApter, Den_US
dc.contributor.authorPeregoudov, Aen_US
dc.date.accessioned2012-10-30T06:28:55Z-
dc.date.available2012-10-30T06:28:55Z-
dc.date.issued2002en_US
dc.identifier.citationLancet, 2002, v. 360 n. 9348, p. 1803-1810en_US
dc.identifier.issn0140-6736en_US
dc.identifier.urihttp://hdl.handle.net/10722/173265-
dc.description.abstractBackground: 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.en_US
dc.languageengen_US
dc.publisherThe Lancet Publishing Group. The Journal's web site is located at http://www.elsevier.com/locate/lanceten_US
dc.relation.ispartofLanceten_US
dc.subject.meshAdulten_US
dc.subject.meshContraceptives, Oral, Synthetic - Administration & Dosageen_US
dc.subject.meshContraceptives, Postcoital, Synthetic - Administration & Dosageen_US
dc.subject.meshDouble-Blind Methoden_US
dc.subject.meshDrug Administration Scheduleen_US
dc.subject.meshEmergenciesen_US
dc.subject.meshFemaleen_US
dc.subject.meshHumansen_US
dc.subject.meshLevonorgestrel - Administration & Dosageen_US
dc.subject.meshMifepristone - Administration & Dosageen_US
dc.subject.meshWorld Health Organizationen_US
dc.titleLow dose mifepristone and two regimens of levonorgestrel for emergency contraception: A WHO multicentre randomised trialen_US
dc.typeArticleen_US
dc.identifier.emailNg, E:nghye@hkucc.hku.hken_US
dc.identifier.authorityNg, E=rp00426en_US
dc.description.naturelink_to_subscribed_fulltexten_US
dc.identifier.doi10.1016/S0140-6736(02)11767-3en_US
dc.identifier.pmid12480356-
dc.identifier.scopuseid_2-s2.0-0037038859en_US
dc.relation.referenceshttp://www.scopus.com/mlt/select.url?eid=2-s2.0-0037038859&selection=ref&src=s&origin=recordpageen_US
dc.identifier.volume360en_US
dc.identifier.issue9348en_US
dc.identifier.spage1803en_US
dc.identifier.epage1810en_US
dc.identifier.isiWOS:000179706100006-
dc.publisher.placeUnited Kingdomen_US
dc.identifier.scopusauthoridVon Hertzen, H=7004390324en_US
dc.identifier.scopusauthoridPiaggio, G=7005979371en_US
dc.identifier.scopusauthoridDing, J=7402608672en_US
dc.identifier.scopusauthoridChen, J=8397398400en_US
dc.identifier.scopusauthoridSong, S=8959016300en_US
dc.identifier.scopusauthoridBártfai, G=7006286090en_US
dc.identifier.scopusauthoridNg, E=35238184300en_US
dc.identifier.scopusauthoridGemzellDanielsson, K=7003551602en_US
dc.identifier.scopusauthoridOyunbileg, A=6503957421en_US
dc.identifier.scopusauthoridWu, S=24381095800en_US
dc.identifier.scopusauthoridCheng, W=7402169516en_US
dc.identifier.scopusauthoridLüdicke, F=6603675362en_US
dc.identifier.scopusauthoridPretnarDarovec, A=6602910640en_US
dc.identifier.scopusauthoridKirkman, R=7006208117en_US
dc.identifier.scopusauthoridMittal, S=16444643600en_US
dc.identifier.scopusauthoridKhomassuridze, A=6603094731en_US
dc.identifier.scopusauthoridApter, D=7005792721en_US
dc.identifier.scopusauthoridPeregoudov, A=6603256918en_US

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