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Mifepristone 5 mg versus 10 mg for emergency contraception: double-blind randomized clinical trial

PURPOSE: To estimate the efficacy and safety of 5 mg and 10 mg mifepristone for emergency contraception up to 144 hours after unprotected coitus. METHODS: This double-blind randomized clinical trial was carried out at Eusebio Hernandez Hospital (Havana, Cuba). A total of 2,418 women who requested em...

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Autores principales: Carbonell, Josep Lluis, Garcia, Ramon, Gonzalez, Adriana, Breto, Andres, Sanchez, Carlos
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Dove Medical Press 2015
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4296957/
https://www.ncbi.nlm.nih.gov/pubmed/25624773
http://dx.doi.org/10.2147/IJWH.S65793
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author Carbonell, Josep Lluis
Garcia, Ramon
Gonzalez, Adriana
Breto, Andres
Sanchez, Carlos
author_facet Carbonell, Josep Lluis
Garcia, Ramon
Gonzalez, Adriana
Breto, Andres
Sanchez, Carlos
author_sort Carbonell, Josep Lluis
collection PubMed
description PURPOSE: To estimate the efficacy and safety of 5 mg and 10 mg mifepristone for emergency contraception up to 144 hours after unprotected coitus. METHODS: This double-blind randomized clinical trial was carried out at Eusebio Hernandez Hospital (Havana, Cuba). A total of 2,418 women who requested emergency contraception after unprotected coitus received either 5 mg or 10 mg mifepristone. The variables for assessing efficacy were the pregnancies that occurred and the fraction of pregnancies that were prevented. Other variables assessed were the side effects of mifepristone, vaginal bleeding, and changes in the date of the following menstruation. RESULTS: There were 15/1,206 (1.2%) and 9/1,212 (0.7%) pregnancies in the 5 mg and 10 mg group, respectively (P=0.107). There were 88% and 93% prevented pregnancies in the 5 mg and un ≥7 days was experienced by 4.9% and 11.0% of subjects in the 5 mg and 10 mg group, respectively (P=0.001). There was a significant high failure rate for women weighing >75 kg in the 5 mg group. CONCLUSION: It would be advisable to use the 10 mg dose of mifepristone for emergency contraception as there was a trend suggesting that the failure rate of the larger dose was lower.
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spelling pubmed-42969572015-01-26 Mifepristone 5 mg versus 10 mg for emergency contraception: double-blind randomized clinical trial Carbonell, Josep Lluis Garcia, Ramon Gonzalez, Adriana Breto, Andres Sanchez, Carlos Int J Womens Health Original Research PURPOSE: To estimate the efficacy and safety of 5 mg and 10 mg mifepristone for emergency contraception up to 144 hours after unprotected coitus. METHODS: This double-blind randomized clinical trial was carried out at Eusebio Hernandez Hospital (Havana, Cuba). A total of 2,418 women who requested emergency contraception after unprotected coitus received either 5 mg or 10 mg mifepristone. The variables for assessing efficacy were the pregnancies that occurred and the fraction of pregnancies that were prevented. Other variables assessed were the side effects of mifepristone, vaginal bleeding, and changes in the date of the following menstruation. RESULTS: There were 15/1,206 (1.2%) and 9/1,212 (0.7%) pregnancies in the 5 mg and 10 mg group, respectively (P=0.107). There were 88% and 93% prevented pregnancies in the 5 mg and un ≥7 days was experienced by 4.9% and 11.0% of subjects in the 5 mg and 10 mg group, respectively (P=0.001). There was a significant high failure rate for women weighing >75 kg in the 5 mg group. CONCLUSION: It would be advisable to use the 10 mg dose of mifepristone for emergency contraception as there was a trend suggesting that the failure rate of the larger dose was lower. Dove Medical Press 2015-01-12 /pmc/articles/PMC4296957/ /pubmed/25624773 http://dx.doi.org/10.2147/IJWH.S65793 Text en © 2015 Carbonell et al. This work is published by Dove Medical Press Limited, and licensed under Creative Commons Attribution – Non Commercial (unported, v3.0) License The full terms of the License are available at http://creativecommons.org/licenses/by-nc/3.0/. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed.
spellingShingle Original Research
Carbonell, Josep Lluis
Garcia, Ramon
Gonzalez, Adriana
Breto, Andres
Sanchez, Carlos
Mifepristone 5 mg versus 10 mg for emergency contraception: double-blind randomized clinical trial
title Mifepristone 5 mg versus 10 mg for emergency contraception: double-blind randomized clinical trial
title_full Mifepristone 5 mg versus 10 mg for emergency contraception: double-blind randomized clinical trial
title_fullStr Mifepristone 5 mg versus 10 mg for emergency contraception: double-blind randomized clinical trial
title_full_unstemmed Mifepristone 5 mg versus 10 mg for emergency contraception: double-blind randomized clinical trial
title_short Mifepristone 5 mg versus 10 mg for emergency contraception: double-blind randomized clinical trial
title_sort mifepristone 5 mg versus 10 mg for emergency contraception: double-blind randomized clinical trial
topic Original Research
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4296957/
https://www.ncbi.nlm.nih.gov/pubmed/25624773
http://dx.doi.org/10.2147/IJWH.S65793
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