NOMAC-E2 shows a better contraceptive effectiveness than LNG combined oral contraceptives in women under 25: real-world PRO-E2 study

Objective: To investigate unintended pregnancy and changes in mood, acne, and weight in NOMAC-E2 vs levonorgestrel-containing COC (COCLNG) users under 25 years.Methods: In this large, observational study, new users (first-ever users of an eligible COC or restarting with the same or a new eligible CO...

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Autores: von Stockum S., Bauerfeind A., Becker K., Franke C., Fruzzetti F., Calaf J., Keck C., Heinemann K.
Formato: artículo
Estado:Versión publicada
Fecha de publicación:2023
País:España
Recursos:Institut d’Investigació Biomèdica Sant Pau (IIB Sant Pau)
Repositorio:r-IIB SANT PAU. Repositorio Institucional de Producción Científica del Instituto de Investigación Biomédica Sant Pau
OAI Identifier:oai:iibsantpau.fundanetsuite.com:p15449
Acesso em linha:https://iibsantpau.fundanetsuite.com/Publicaciones/ProdCientif/PublicacionFrw.aspx?id=15449
https://www.scopus.com/inward/record.uri?eid=2-s2.0-85146654375&doi=10.1080%2f09513590.2022.2162036&partnerID=40&md5=fb42e1453efacc7f7f8e479cd0ecf070
Access Level:acceso abierto
Palavra-chave:NOMAC-E2
nomegestrol acetate
estradiol
levonorgestrel
unintended pregnancy
contraceptive failure
contraceptive effectiveness
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spelling NOMAC-E2 shows a better contraceptive effectiveness than LNG combined oral contraceptives in women under 25: real-world PRO-E2 studyvon Stockum S.Bauerfeind A.Becker K.Franke C.Fruzzetti F.Calaf J.Keck C.Heinemann K.NOMAC-E2nomegestrol acetateestradiollevonorgestrelunintended pregnancycontraceptive failurecontraceptive effectivenessObjective: To investigate unintended pregnancy and changes in mood, acne, and weight in NOMAC-E2 vs levonorgestrel-containing COC (COCLNG) users under 25 years.Methods: In this large, observational study, new users (first-ever users of an eligible COC or restarting with the same or a new eligible COC after a break of at least 2 months) of NOMAC-E2 and COCLNG were recruited in 12 countries in Europe, Australia, and Latin America and followed up via questionnaires for up to 2 years. Unintended pregnancy was expressed by the Pearl Index (PI; contraceptive failures/100 women-years). Crude (HRcrude) and adjusted hazard ratios (HRadj) were calculated. Mood and acne changes were defined as change of score from baseline. Weight change was defined as percent change of body weight.Results: Overall, 12,829 NOMAC-E2 users and 17,095 COCLNG users under 25 were followed-up. The risk of unintended pregnancy was statistically significantly lower in the NOMAC-E2 cohort; confirmed events: 30 NOMAC-E2 (PI 0.24; 95% CI, 0.16-0.35) vs 94 COCLNG (PI 0.51; 95% CI, 0.41-0.62). The HRcrude for unintended pregnancy comparing NOMAC-E2 to COCLNG was 0.47 (95% CI, 0.31-0.71) and the HRadj was 0.52 (95% CI, 0.34-0.78). No differential effect on acne, mood, and weight was observed between cohorts.Conclusions: NOMAC-E2 shows a significantly better contraceptive effectiveness in young women and has no differential effect on acne, mood, and weight compared to COCLNG.TAYLOR & FRANCIS LTD2023info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionhttps://iibsantpau.fundanetsuite.com/Publicaciones/ProdCientif/PublicacionFrw.aspx?id=15449https://www.scopus.com/inward/record.uri?eid=2-s2.0-85146654375&doi=10.1080%2f09513590.2022.2162036&partnerID=40&md5=fb42e1453efacc7f7f8e479cd0ecf070GYNECOLOGICAL ENDOCRINOLOGYISSN: 09513590ISSNe: 14730766reponame:r-IIB SANT PAU. Repositorio Institucional de Producción Científica del Instituto de Investigación Biomédica Sant Pauinstname:Institut d’Investigació Biomèdica Sant Pau (IIB Sant Pau)Inglésinfo:eu-repo/semantics/openAccessoai:iibsantpau.fundanetsuite.com:p154492026-06-14T12:41:47Z
dc.title.none.fl_str_mv NOMAC-E2 shows a better contraceptive effectiveness than LNG combined oral contraceptives in women under 25: real-world PRO-E2 study
title NOMAC-E2 shows a better contraceptive effectiveness than LNG combined oral contraceptives in women under 25: real-world PRO-E2 study
spellingShingle NOMAC-E2 shows a better contraceptive effectiveness than LNG combined oral contraceptives in women under 25: real-world PRO-E2 study
von Stockum S.
NOMAC-E2
nomegestrol acetate
estradiol
levonorgestrel
unintended pregnancy
contraceptive failure
contraceptive effectiveness
title_short NOMAC-E2 shows a better contraceptive effectiveness than LNG combined oral contraceptives in women under 25: real-world PRO-E2 study
title_full NOMAC-E2 shows a better contraceptive effectiveness than LNG combined oral contraceptives in women under 25: real-world PRO-E2 study
title_fullStr NOMAC-E2 shows a better contraceptive effectiveness than LNG combined oral contraceptives in women under 25: real-world PRO-E2 study
title_full_unstemmed NOMAC-E2 shows a better contraceptive effectiveness than LNG combined oral contraceptives in women under 25: real-world PRO-E2 study
title_sort NOMAC-E2 shows a better contraceptive effectiveness than LNG combined oral contraceptives in women under 25: real-world PRO-E2 study
dc.creator.none.fl_str_mv von Stockum S.
Bauerfeind A.
Becker K.
Franke C.
Fruzzetti F.
Calaf J.
Keck C.
Heinemann K.
author von Stockum S.
author_facet von Stockum S.
Bauerfeind A.
Becker K.
Franke C.
Fruzzetti F.
Calaf J.
Keck C.
Heinemann K.
author_role author
author2 Bauerfeind A.
Becker K.
Franke C.
Fruzzetti F.
Calaf J.
Keck C.
Heinemann K.
author2_role author
author
author
author
author
author
author
dc.subject.none.fl_str_mv NOMAC-E2
nomegestrol acetate
estradiol
levonorgestrel
unintended pregnancy
contraceptive failure
contraceptive effectiveness
topic NOMAC-E2
nomegestrol acetate
estradiol
levonorgestrel
unintended pregnancy
contraceptive failure
contraceptive effectiveness
description Objective: To investigate unintended pregnancy and changes in mood, acne, and weight in NOMAC-E2 vs levonorgestrel-containing COC (COCLNG) users under 25 years.Methods: In this large, observational study, new users (first-ever users of an eligible COC or restarting with the same or a new eligible COC after a break of at least 2 months) of NOMAC-E2 and COCLNG were recruited in 12 countries in Europe, Australia, and Latin America and followed up via questionnaires for up to 2 years. Unintended pregnancy was expressed by the Pearl Index (PI; contraceptive failures/100 women-years). Crude (HRcrude) and adjusted hazard ratios (HRadj) were calculated. Mood and acne changes were defined as change of score from baseline. Weight change was defined as percent change of body weight.Results: Overall, 12,829 NOMAC-E2 users and 17,095 COCLNG users under 25 were followed-up. The risk of unintended pregnancy was statistically significantly lower in the NOMAC-E2 cohort; confirmed events: 30 NOMAC-E2 (PI 0.24; 95% CI, 0.16-0.35) vs 94 COCLNG (PI 0.51; 95% CI, 0.41-0.62). The HRcrude for unintended pregnancy comparing NOMAC-E2 to COCLNG was 0.47 (95% CI, 0.31-0.71) and the HRadj was 0.52 (95% CI, 0.34-0.78). No differential effect on acne, mood, and weight was observed between cohorts.Conclusions: NOMAC-E2 shows a significantly better contraceptive effectiveness in young women and has no differential effect on acne, mood, and weight compared to COCLNG.
publishDate 2023
dc.date.none.fl_str_mv 2023
dc.type.none.fl_str_mv info:eu-repo/semantics/article
info:eu-repo/semantics/publishedVersion
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dc.identifier.none.fl_str_mv https://iibsantpau.fundanetsuite.com/Publicaciones/ProdCientif/PublicacionFrw.aspx?id=15449
https://www.scopus.com/inward/record.uri?eid=2-s2.0-85146654375&doi=10.1080%2f09513590.2022.2162036&partnerID=40&md5=fb42e1453efacc7f7f8e479cd0ecf070
url https://iibsantpau.fundanetsuite.com/Publicaciones/ProdCientif/PublicacionFrw.aspx?id=15449
https://www.scopus.com/inward/record.uri?eid=2-s2.0-85146654375&doi=10.1080%2f09513590.2022.2162036&partnerID=40&md5=fb42e1453efacc7f7f8e479cd0ecf070
dc.language.none.fl_str_mv Inglés
language_invalid_str_mv Inglés
dc.rights.none.fl_str_mv info:eu-repo/semantics/openAccess
eu_rights_str_mv openAccess
dc.publisher.none.fl_str_mv TAYLOR & FRANCIS LTD
publisher.none.fl_str_mv TAYLOR & FRANCIS LTD
dc.source.none.fl_str_mv GYNECOLOGICAL ENDOCRINOLOGY
ISSN: 09513590
ISSNe: 14730766
reponame:r-IIB SANT PAU. Repositorio Institucional de Producción Científica del Instituto de Investigación Biomédica Sant Pau
instname:Institut d’Investigació Biomèdica Sant Pau (IIB Sant Pau)
instname_str Institut d’Investigació Biomèdica Sant Pau (IIB Sant Pau)
reponame_str r-IIB SANT PAU. Repositorio Institucional de Producción Científica del Instituto de Investigación Biomédica Sant Pau
collection r-IIB SANT PAU. Repositorio Institucional de Producción Científica del Instituto de Investigación Biomédica Sant Pau
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