Bleeding pattern and management of unexpected bleeding/spotting with an extended regimen of a combination of ethinylestradiol 20 mcg and drospirenone 3 mg

Detalhes bibliográficos
Autor(a) principal: Machado, Rogerio Bonassi
Data de Publicação: 2020
Outros Autores: Pompei, Luciano De Melo, Andrade, Rosires, Nahas, Eliana [UNESP], Guazzelli, Cristina, Wender, Maria Celeste, Cruz, Achilles Machado
Tipo de documento: Artigo
Idioma: eng
Título da fonte: Repositório Institucional da UNESP
Texto Completo: http://dx.doi.org/10.2147/IJWH.S238294
http://hdl.handle.net/11449/200341
Resumo: Objective: To compare the bleeding pattern in women using ethinylestradiol 20 mcg/ drospirenone 3 mg (EE 20 mcg/DRSP 3 mg) in a 24/4-day cyclic regimen with an extended regimen. Unexpected bleeding/spotting in the extended regimen group was managed by allowing a 4-day hormone-free interval (HFI). Methods: This was a randomized, prospective, open-label, multicenter study. Participants (N = 348) were randomized to receive EE 20 mcg/DRSP 3 mg in either an extended regimen (EE/DRSPes group) or a 24/4-day cyclic regimen (EE/DRSP24/4 group) and followed for 168 days. In the EE/DRSPes group, a 4-day HFI was allowed whenever unexpected bleeding/ spotting persisted for ≥7 consecutive days. The participants assessed their bleeding daily as “no bleeding,” “spotting,” or “light,” “moderate,” or “heavy” bleeding according to a predefined scale. Results: EE/DRSPes group experienced fewer days of bleeding than those using a 24/4 cyclic regimen (P < 0.001). After 168 days, 57.5% of women in the EE/DRSPes group achieved complete amenorrhea (i.e., neither bleeding nor spotting) and 73.9% achieved “no bleeding” (i.e., no bleeding with or without spotting) during the final 28-day interval of the study period. Women in the extended group who instituted the 4-day HFI experienced a 94.1% rate of successful management of unexpected bleeding/spotting. Conclusion: The use of EE 20 mcg/DRSP 3 mg in an extended regimen resulted in high rates of amenorrhea and “no bleeding”. Unexpected bleeding/spotting in the EE/DRSPes group could be managed effectively with a 4-day HFI. Clinical Trial Registration: International Standard Randomised Controlled Trial Number (ISRCTN57661673): http://www.controlled-trials.com/isrctn/pf/57661673.
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spelling Bleeding pattern and management of unexpected bleeding/spotting with an extended regimen of a combination of ethinylestradiol 20 mcg and drospirenone 3 mgBleeding profileCombined oral contraceptivesDrospirenoneExtended regimenLow dose oral contraceptiveObjective: To compare the bleeding pattern in women using ethinylestradiol 20 mcg/ drospirenone 3 mg (EE 20 mcg/DRSP 3 mg) in a 24/4-day cyclic regimen with an extended regimen. Unexpected bleeding/spotting in the extended regimen group was managed by allowing a 4-day hormone-free interval (HFI). Methods: This was a randomized, prospective, open-label, multicenter study. Participants (N = 348) were randomized to receive EE 20 mcg/DRSP 3 mg in either an extended regimen (EE/DRSPes group) or a 24/4-day cyclic regimen (EE/DRSP24/4 group) and followed for 168 days. In the EE/DRSPes group, a 4-day HFI was allowed whenever unexpected bleeding/ spotting persisted for ≥7 consecutive days. The participants assessed their bleeding daily as “no bleeding,” “spotting,” or “light,” “moderate,” or “heavy” bleeding according to a predefined scale. Results: EE/DRSPes group experienced fewer days of bleeding than those using a 24/4 cyclic regimen (P < 0.001). After 168 days, 57.5% of women in the EE/DRSPes group achieved complete amenorrhea (i.e., neither bleeding nor spotting) and 73.9% achieved “no bleeding” (i.e., no bleeding with or without spotting) during the final 28-day interval of the study period. Women in the extended group who instituted the 4-day HFI experienced a 94.1% rate of successful management of unexpected bleeding/spotting. Conclusion: The use of EE 20 mcg/DRSP 3 mg in an extended regimen resulted in high rates of amenorrhea and “no bleeding”. Unexpected bleeding/spotting in the EE/DRSPes group could be managed effectively with a 4-day HFI. Clinical Trial Registration: International Standard Randomised Controlled Trial Number (ISRCTN57661673): http://www.controlled-trials.com/isrctn/pf/57661673.Department of Gynecology and Obstetrics Jundiaí School of MedicineDepartment of Gynecology and Obstetrics ABC School of MedicineDepartment of Gynecology and Obstetrics Federal University of ParanaDepartment of Gynecology and Obstetrics Botucatu Medical School (Unesp)Department of Obstetrics Federal University of Sao PauloDepartment of Gynecology and Obstetrics Federal University of Rio Grande do SulDepartment of Clinical Research Libbs Farmacêutica LtdaDepartment of Gynecology and Obstetrics Botucatu Medical School (Unesp)Jundiaí School of MedicineABC School of MedicineFederal University of ParanaUniversidade Estadual Paulista (Unesp)Universidade de São Paulo (USP)Federal University of Rio Grande do SulLibbs Farmacêutica LtdaMachado, Rogerio BonassiPompei, Luciano De MeloAndrade, RosiresNahas, Eliana [UNESP]Guazzelli, CristinaWender, Maria CelesteCruz, Achilles Machado2020-12-12T02:04:04Z2020-12-12T02:04:04Z2020-01-01info:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/article235-242http://dx.doi.org/10.2147/IJWH.S238294International Journal of Women's Health, v. 12, p. 235-242.1179-1411http://hdl.handle.net/11449/20034110.2147/IJWH.S2382942-s2.0-85083986836Scopusreponame:Repositório Institucional da UNESPinstname:Universidade Estadual Paulista (UNESP)instacron:UNESPengInternational Journal of Women's Healthinfo:eu-repo/semantics/openAccess2024-08-16T14:06:42Zoai:repositorio.unesp.br:11449/200341Repositório InstitucionalPUBhttp://repositorio.unesp.br/oai/requestopendoar:29462024-08-16T14:06:42Repositório Institucional da UNESP - Universidade Estadual Paulista (UNESP)false
dc.title.none.fl_str_mv Bleeding pattern and management of unexpected bleeding/spotting with an extended regimen of a combination of ethinylestradiol 20 mcg and drospirenone 3 mg
title Bleeding pattern and management of unexpected bleeding/spotting with an extended regimen of a combination of ethinylestradiol 20 mcg and drospirenone 3 mg
spellingShingle Bleeding pattern and management of unexpected bleeding/spotting with an extended regimen of a combination of ethinylestradiol 20 mcg and drospirenone 3 mg
Machado, Rogerio Bonassi
Bleeding profile
Combined oral contraceptives
Drospirenone
Extended regimen
Low dose oral contraceptive
title_short Bleeding pattern and management of unexpected bleeding/spotting with an extended regimen of a combination of ethinylestradiol 20 mcg and drospirenone 3 mg
title_full Bleeding pattern and management of unexpected bleeding/spotting with an extended regimen of a combination of ethinylestradiol 20 mcg and drospirenone 3 mg
title_fullStr Bleeding pattern and management of unexpected bleeding/spotting with an extended regimen of a combination of ethinylestradiol 20 mcg and drospirenone 3 mg
title_full_unstemmed Bleeding pattern and management of unexpected bleeding/spotting with an extended regimen of a combination of ethinylestradiol 20 mcg and drospirenone 3 mg
title_sort Bleeding pattern and management of unexpected bleeding/spotting with an extended regimen of a combination of ethinylestradiol 20 mcg and drospirenone 3 mg
author Machado, Rogerio Bonassi
author_facet Machado, Rogerio Bonassi
Pompei, Luciano De Melo
Andrade, Rosires
Nahas, Eliana [UNESP]
Guazzelli, Cristina
Wender, Maria Celeste
Cruz, Achilles Machado
author_role author
author2 Pompei, Luciano De Melo
Andrade, Rosires
Nahas, Eliana [UNESP]
Guazzelli, Cristina
Wender, Maria Celeste
Cruz, Achilles Machado
author2_role author
author
author
author
author
author
dc.contributor.none.fl_str_mv Jundiaí School of Medicine
ABC School of Medicine
Federal University of Parana
Universidade Estadual Paulista (Unesp)
Universidade de São Paulo (USP)
Federal University of Rio Grande do Sul
Libbs Farmacêutica Ltda
dc.contributor.author.fl_str_mv Machado, Rogerio Bonassi
Pompei, Luciano De Melo
Andrade, Rosires
Nahas, Eliana [UNESP]
Guazzelli, Cristina
Wender, Maria Celeste
Cruz, Achilles Machado
dc.subject.por.fl_str_mv Bleeding profile
Combined oral contraceptives
Drospirenone
Extended regimen
Low dose oral contraceptive
topic Bleeding profile
Combined oral contraceptives
Drospirenone
Extended regimen
Low dose oral contraceptive
description Objective: To compare the bleeding pattern in women using ethinylestradiol 20 mcg/ drospirenone 3 mg (EE 20 mcg/DRSP 3 mg) in a 24/4-day cyclic regimen with an extended regimen. Unexpected bleeding/spotting in the extended regimen group was managed by allowing a 4-day hormone-free interval (HFI). Methods: This was a randomized, prospective, open-label, multicenter study. Participants (N = 348) were randomized to receive EE 20 mcg/DRSP 3 mg in either an extended regimen (EE/DRSPes group) or a 24/4-day cyclic regimen (EE/DRSP24/4 group) and followed for 168 days. In the EE/DRSPes group, a 4-day HFI was allowed whenever unexpected bleeding/ spotting persisted for ≥7 consecutive days. The participants assessed their bleeding daily as “no bleeding,” “spotting,” or “light,” “moderate,” or “heavy” bleeding according to a predefined scale. Results: EE/DRSPes group experienced fewer days of bleeding than those using a 24/4 cyclic regimen (P < 0.001). After 168 days, 57.5% of women in the EE/DRSPes group achieved complete amenorrhea (i.e., neither bleeding nor spotting) and 73.9% achieved “no bleeding” (i.e., no bleeding with or without spotting) during the final 28-day interval of the study period. Women in the extended group who instituted the 4-day HFI experienced a 94.1% rate of successful management of unexpected bleeding/spotting. Conclusion: The use of EE 20 mcg/DRSP 3 mg in an extended regimen resulted in high rates of amenorrhea and “no bleeding”. Unexpected bleeding/spotting in the EE/DRSPes group could be managed effectively with a 4-day HFI. Clinical Trial Registration: International Standard Randomised Controlled Trial Number (ISRCTN57661673): http://www.controlled-trials.com/isrctn/pf/57661673.
publishDate 2020
dc.date.none.fl_str_mv 2020-12-12T02:04:04Z
2020-12-12T02:04:04Z
2020-01-01
dc.type.status.fl_str_mv info:eu-repo/semantics/publishedVersion
dc.type.driver.fl_str_mv info:eu-repo/semantics/article
format article
status_str publishedVersion
dc.identifier.uri.fl_str_mv http://dx.doi.org/10.2147/IJWH.S238294
International Journal of Women's Health, v. 12, p. 235-242.
1179-1411
http://hdl.handle.net/11449/200341
10.2147/IJWH.S238294
2-s2.0-85083986836
url http://dx.doi.org/10.2147/IJWH.S238294
http://hdl.handle.net/11449/200341
identifier_str_mv International Journal of Women's Health, v. 12, p. 235-242.
1179-1411
10.2147/IJWH.S238294
2-s2.0-85083986836
dc.language.iso.fl_str_mv eng
language eng
dc.relation.none.fl_str_mv International Journal of Women's Health
dc.rights.driver.fl_str_mv info:eu-repo/semantics/openAccess
eu_rights_str_mv openAccess
dc.format.none.fl_str_mv 235-242
dc.source.none.fl_str_mv Scopus
reponame:Repositório Institucional da UNESP
instname:Universidade Estadual Paulista (UNESP)
instacron:UNESP
instname_str Universidade Estadual Paulista (UNESP)
instacron_str UNESP
institution UNESP
reponame_str Repositório Institucional da UNESP
collection Repositório Institucional da UNESP
repository.name.fl_str_mv Repositório Institucional da UNESP - Universidade Estadual Paulista (UNESP)
repository.mail.fl_str_mv
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