NOMAC-E2 compares to LNG combined oral contraceptives in women over forty

To investigate safety and effectiveness of NOMAC-E2 and levonorgestrel-containing COCs (COC) in users over 40. In this large, observational study, new users of NOMAC-E2 and COC were recruited in Europe, Australia, and Latin America and followed-up via questionnaires. Incidence of venous thromboembol...

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Autores: von Stockum, Sophia, Becker, Kerstin, Bauerfeind, Anja, Franke, Christian, Fruzzetti, Franca|||0000-0001-8273-0258, Calaf Alsina, Joaquim|||0000-0002-2407-7884, Keck, Christoph, Heinemann, Klaas
Tipo de recurso: artículo
Fecha de publicación:2023
País:España
Institución:Universitat Autònoma de Barcelona
Repositorio:Dipòsit Digital de Documents de la UAB
Idioma:inglés
OAI Identifier:oai:ddd.uab.cat:296626
Acceso en línea:https://ddd.uab.cat/record/296626
https://dx.doi.org/urn:doi:10.1080/09513590.2023.2166032
Access Level:acceso abierto
Palabra clave:NOMAC-E2
Estradiol
Levonorgestrel
Nomegestrol acetate
Perimenopause
Unintended pregnancy
Venous thromboembolism
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network_name_str España
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spelling NOMAC-E2 compares to LNG combined oral contraceptives in women over fortyreal-world PRO-E2 studyvon Stockum, SophiaBecker, KerstinBauerfeind, AnjaFranke, ChristianFruzzetti, Franca|||0000-0001-8273-0258Calaf Alsina, Joaquim|||0000-0002-2407-7884Keck, ChristophHeinemann, KlaasNOMAC-E2EstradiolLevonorgestrelNomegestrol acetatePerimenopauseUnintended pregnancyVenous thromboembolismTo investigate safety and effectiveness of NOMAC-E2 and levonorgestrel-containing COCs (COC) in users over 40. In this large, observational study, new users of NOMAC-E2 and COC were recruited in Europe, Australia, and Latin America and followed-up via questionnaires. Incidence of venous thromboembolism (VTE) was expressed as incidence rate (IR; events/10 women-years [WY]). Unintended pregnancy was expressed by the Pearl Index (PI; contraceptive failures/100 WY). Mood and weight changes were defined as mean changes in mood score and percentage of body weight. Overall, 7,762 NOMAC-E2 and 6,059 COC users over 40 were followed-up. NOMAC-E2 showed no increased VTE risk compared to COC; confirmed events: 5 NOMAC-E2 (IR 5.9; 95% CI, 1.9-13.7) vs 4 COC (IR 5.9; 95% CI, 1.6-15.1). Unintended pregnancy did not differ substantially between cohorts; confirmed events: 4 NOMAC-E2 (PI 0.05; 95% CI, 0.01-0.13) vs 5 COC (PI 0.08; 95% CI, 0.03-0.18). No differential effect on mood and weight was observed between cohorts. NOMAC-E2 can be considered a valid alternative to COC in perimenopausal women.Universitat Autònoma de Barcelona 22023-01-0120232023-01-01Articlehttp://purl.org/coar/resource_type/c_6501VoRhttp://purl.org/coar/version/c_970fb48d4fbd8a85info:eu-repo/semantics/articleapplication/pdfhttps://ddd.uab.cat/record/296626https://dx.doi.org/urn:doi:10.1080/09513590.2023.2166032reponame:Dipòsit Digital de Documents de la UABinstname:Universitat Autònoma de BarcelonaInglésengopen accesshttp://purl.org/coar/access_right/c_abf2Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, la comunicació pública de l'obra i la creació d'obres derivades, fins i tot amb finalitats comercials, sempre i quan es reconegui l'autoria de l'obra original.https://creativecommons.org/licenses/by/4.0/info:eu-repo/semantics/openAccessoai:ddd.uab.cat:2966262026-06-06T12:50:31Z
dc.title.none.fl_str_mv NOMAC-E2 compares to LNG combined oral contraceptives in women over forty
real-world PRO-E2 study
title NOMAC-E2 compares to LNG combined oral contraceptives in women over forty
spellingShingle NOMAC-E2 compares to LNG combined oral contraceptives in women over forty
von Stockum, Sophia
NOMAC-E2
Estradiol
Levonorgestrel
Nomegestrol acetate
Perimenopause
Unintended pregnancy
Venous thromboembolism
title_short NOMAC-E2 compares to LNG combined oral contraceptives in women over forty
title_full NOMAC-E2 compares to LNG combined oral contraceptives in women over forty
title_fullStr NOMAC-E2 compares to LNG combined oral contraceptives in women over forty
title_full_unstemmed NOMAC-E2 compares to LNG combined oral contraceptives in women over forty
title_sort NOMAC-E2 compares to LNG combined oral contraceptives in women over forty
dc.creator.none.fl_str_mv von Stockum, Sophia
Becker, Kerstin
Bauerfeind, Anja
Franke, Christian
Fruzzetti, Franca|||0000-0001-8273-0258
Calaf Alsina, Joaquim|||0000-0002-2407-7884
Keck, Christoph
Heinemann, Klaas
author von Stockum, Sophia
author_facet von Stockum, Sophia
Becker, Kerstin
Bauerfeind, Anja
Franke, Christian
Fruzzetti, Franca|||0000-0001-8273-0258
Calaf Alsina, Joaquim|||0000-0002-2407-7884
Keck, Christoph
Heinemann, Klaas
author_role author
author2 Becker, Kerstin
Bauerfeind, Anja
Franke, Christian
Fruzzetti, Franca|||0000-0001-8273-0258
Calaf Alsina, Joaquim|||0000-0002-2407-7884
Keck, Christoph
Heinemann, Klaas
author2_role author
author
author
author
author
author
author
dc.contributor.none.fl_str_mv Universitat Autònoma de Barcelona
dc.subject.none.fl_str_mv NOMAC-E2
Estradiol
Levonorgestrel
Nomegestrol acetate
Perimenopause
Unintended pregnancy
Venous thromboembolism
topic NOMAC-E2
Estradiol
Levonorgestrel
Nomegestrol acetate
Perimenopause
Unintended pregnancy
Venous thromboembolism
description To investigate safety and effectiveness of NOMAC-E2 and levonorgestrel-containing COCs (COC) in users over 40. In this large, observational study, new users of NOMAC-E2 and COC were recruited in Europe, Australia, and Latin America and followed-up via questionnaires. Incidence of venous thromboembolism (VTE) was expressed as incidence rate (IR; events/10 women-years [WY]). Unintended pregnancy was expressed by the Pearl Index (PI; contraceptive failures/100 WY). Mood and weight changes were defined as mean changes in mood score and percentage of body weight. Overall, 7,762 NOMAC-E2 and 6,059 COC users over 40 were followed-up. NOMAC-E2 showed no increased VTE risk compared to COC; confirmed events: 5 NOMAC-E2 (IR 5.9; 95% CI, 1.9-13.7) vs 4 COC (IR 5.9; 95% CI, 1.6-15.1). Unintended pregnancy did not differ substantially between cohorts; confirmed events: 4 NOMAC-E2 (PI 0.05; 95% CI, 0.01-0.13) vs 5 COC (PI 0.08; 95% CI, 0.03-0.18). No differential effect on mood and weight was observed between cohorts. NOMAC-E2 can be considered a valid alternative to COC in perimenopausal women.
publishDate 2023
dc.date.none.fl_str_mv 2
2023-01-01
2023
2023-01-01
dc.type.none.fl_str_mv Article
http://purl.org/coar/resource_type/c_6501
VoR
http://purl.org/coar/version/c_970fb48d4fbd8a85
dc.type.openaire.fl_str_mv info:eu-repo/semantics/article
format article
dc.identifier.none.fl_str_mv https://ddd.uab.cat/record/296626
https://dx.doi.org/urn:doi:10.1080/09513590.2023.2166032
url https://ddd.uab.cat/record/296626
https://dx.doi.org/urn:doi:10.1080/09513590.2023.2166032
dc.language.none.fl_str_mv Inglés
eng
language_invalid_str_mv Inglés
language eng
dc.rights.none.fl_str_mv open access
http://purl.org/coar/access_right/c_abf2
https://creativecommons.org/licenses/by/4.0/
dc.rights.openaire.fl_str_mv info:eu-repo/semantics/openAccess
rights_invalid_str_mv open access
http://purl.org/coar/access_right/c_abf2
https://creativecommons.org/licenses/by/4.0/
eu_rights_str_mv openAccess
dc.format.none.fl_str_mv application/pdf
dc.source.none.fl_str_mv reponame:Dipòsit Digital de Documents de la UAB
instname:Universitat Autònoma de Barcelona
instname_str Universitat Autònoma de Barcelona
reponame_str Dipòsit Digital de Documents de la UAB
collection Dipòsit Digital de Documents de la UAB
repository.name.fl_str_mv
repository.mail.fl_str_mv
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