Bleeding patterns and menstrual-related symptoms with the continuous use of a contraceptive combination of ethinylestradiol and drospirenone: a randomized study

Machado, Rogério Bonassi; Melo, Nilson Roberto de; Maia, Hugo

doi:10.1016/j.contraception.2009.10.010

Cited by 36 publications

(21 citation statements)

References 19 publications

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“…The effects of the flexible extended regimen on bleeding patterns observed in this study are consistent with those previously reported, that is, fewer withdrawal bleeding episodes but a small increase in the number of days of intra-cyclic bleeding 13,14,18. Based on these data, one can predict that women receiving ethinylestradiol/drospirenone as a flexible extended regimen would have 6–7 withdrawal bleeding episodes per year, whereas those receiving ethinylestradiol/drospirenone as a 28-day cyclic regimen would have 10–11 episodes, suggesting 3–5 fewer withdrawal bleeding episodes with the flexible extended regimen.…”

Section: Discussionsupporting

confidence: 92%

Efficacy and safety of a flexible extended regimen of ethinylestradiol/drospirenone for the treatment of dysmenorrhea: a multicenter, randomized, open-label, active-controlled study

Momoeda

Kondo

Elliesen

et al. 2017

IJWH

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BackgroundDysmenorrhea is a common condition in women, which is characterized by menstrual pain. Low-dose estrogen/progestin combined oral contraceptives have been shown to reduce the severity of dysmenorrhea symptoms, and a 28-day cyclic regimen of ethinylestradiol/drospirenone (28d regimen) is approved for this indication in Japan.AimThe aim of this study was to assess the safety and efficacy of a flexible extended regimen of ethinylestradiol/drospirenone (flexible regimen) in Japanese women with dysmenorrhea.MethodsThis multicenter, open-label study was performed in Japanese women with dysmenorrhea who, after a baseline observational phase, were randomized to receive ethinylestradiol 20 μg/drospirenone 3 mg in a flexible regimen (one tablet each day for 24–120 days followed by a 4-day tablet-free interval) or in the standard 28d regimen (one tablet each day for 24 days, followed by 4 days of placebo tablets for six cycles). The primary endpoint was the number of days with dysmenorrhea of at least mild intensity over a 140-day evaluation period. Dysmenorrhea scores, bleeding patterns, and other pain-related parameters were also assessed.ResultsA total of 216 women (mean age 29.7 years) were randomized to the flexible regimen (n=108) or 28d regimen (n=108) and 212 were included in the full analysis sets (flexible regimen, n=105; 28d regimen, n=107). Women in the flexible-regimen group reported a mean of 3.4 fewer days with dysmenorrheic pain than women in the 28d-regimen group, with similar decreases in disease severity reported in both treatment groups. According to the investigators, 64.8% and 59.4% of women in the flexible-regimen and 28d-regimen treatment groups had “very much improved” or “much improved” disease, while 54.3% and 50.9% of patients reported being “very much satisfied” or “much satisfied” with their treatment, respectively.ConclusionIn Japanese women with dysmenorrhea, a flexible extended regimen of ethinylestradiol/drospirenone decreased the number of days with dysmenorrheic pain versus the traditional 28d regimen.

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Section: Discussionsupporting

confidence: 92%

Efficacy and safety of a flexible extended regimen of ethinylestradiol/drospirenone for the treatment of dysmenorrhea: a multicenter, randomized, open-label, active-controlled study

Momoeda

Kondo

Elliesen

et al. 2017

IJWH

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“…Miller (14) reported a significant difference of 27.2 bleeding days per year for the continuous users and 53.3 bleeding days for cyclic users. Bleeding intensity was less for the continuous users (17).…”

Section: Resultsmentioning

confidence: 99%

Continuous use of oral contraceptives: an overview of effects and side‐effects

Hee

Kettner

Vejtorp

2012

Acta Obstet Gynecol Scand

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“…Actualmente, el uso de la forma extendida de anticoncepción hormonal combinada ha sido motivo de especial preocupación científica, como lo avalan las recientes publicaciones detallando tanto las distintas experiencias clínicas con diferentes formulas (6,7,8,9,20), así como las consecuencias metabóli-cas en las usuarias después de 12 meses de uso (10,11). Innegables aparecen las ventajas de esta forma especial de uso de anticoncepción hormonal, en los grupos de usuarias afectas al denominado síndrome de tensión y/o disfórico premenstrual, así como en todas aquellas con el sostenido deseo de espaciar sus periodos menstruales.…”

Section: Discussionunclassified

“…El 60% de las mujeres italianas prefieren tener sangrados menos de una vez al mes, no necesariamente por razones médicas, sino por conveniencias prácticas, lo cual concuerda con datos provenientes de otros países europeos (5). Respondiendo a la creciente aceptabilidad por parte de determinadas usuarias de este uso extendido de AOC siguen apareciendo publicaciones con el uso de esta forma de anticoncepción, usando ya sea distintas fórmulas hormonales combinadas orales, considerando aspectos tanto clínicos (6,7,8,9) como variaciones metabólicas (10,11) o en la forma de anillos vaginales (12,13).…”

Section: Introductionunclassified

Experiencia piloto con el uso extendido de un anticonceptivo oral combinado de baja dosis de estrógeno

2011

Rev. chil. obstet. ginecol.

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RESUMENObjetivo: Evaluar en una experiencia piloto la aceptabilidad y bienestar de la usuaria, después de un periodo de 12 meses de un anticonceptivo hormonal combinado oral de baja dosis estrogénica, con modalidad de uso extendido de 84 píldoras activas consecutivas, seguidas de 7 días de placebo. Método: Se incorporan 25 mujeres voluntarias que usan una combinación de 20 ug de etinilestradiol + 3 mg de drospirenona, con un tiempo de uso de 12 meses. En calendario de registro diario se consignan los días de sangrado o goteo genital así como todo tipo de fármaco ingerido. Al término de los 12 meses se efectúa una encuesta respecto al grado de satisfacción con la posología recibida. Resultados: 13 usuarias (52%) cumplen los 12 meses de uso. Todas ellas manifiestan un alto grado de conformidad, destacando las ventajas de presentar periodos menstruales ocasionales, mejoría marcada en la sintomatología compatible con el síndrome de tensión premenstrual con el consiguiente incremento del bienestar general. Siete usuarias (28%) no terminan el estudio por razones médicas, siendo 6 de estas por alteraciones de los flujos rojos y en 5 casos (20%) se producen retiros no médicos. Conclusión: Esta experiencia, que es la primera con la formulación descrita, confirma en un porcentaje de usuarias las bondades adicionales reportadas en las experiencias previas con otros productos similares, respecto al uso extendido de anticoncepción hormonal oral en un grupo de mujeres que deseaban espaciar sus periodos menstruales.PALABRAS CLAVE: Anticoncepción hormonal de uso extendido, drospirenona, síndrome tensión premenstrual SUMMARYObjetives: A pilot study designed in order to know about the acceptability of an oral combined contraceptive pill, with low estrogen dose used in an extended way of 84 consecutive days, followed by 7 days of no pills ingestion during a scheduled follow up of 1 year. Methods: 25 volunteers women were recruited among those which wants to use oral combined contraceptive pills and who accepted this extended way of use. Combined contraceptive pills contains each 20 ug of ethinylestradiol plus 3 mg of drosperinone. At admission women were provided with menstrual diary cards in order to check all bleeding days plus any extra pharmaceutical compound received. At the end of the 12 months follow up an interview was done in order to know women experiences and acceptability of this extended way of use. Results: 52% of women end the study at the scheduled 12 months use. All of them feel that the main advantages of these extended way of use were to have few menstrual periods and improving premenstrual symtomatology with better quality of life. 7 women (28%) did not finish the study because of medical reasons being due in 6 of these for bleeding disturbances. Conclusions: This report is pioneer with the use this hormone combination in this extended

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Bleeding patterns and menstrual-related symptoms with the continuous use of a contraceptive combination of ethinylestradiol and drospirenone: a randomized study

Cited by 36 publications

References 19 publications

Efficacy and safety of a flexible extended regimen of ethinylestradiol/drospirenone for the treatment of dysmenorrhea: a multicenter, randomized, open-label, active-controlled study

Efficacy and safety of a flexible extended regimen of ethinylestradiol/drospirenone for the treatment of dysmenorrhea: a multicenter, randomized, open-label, active-controlled study

Continuous use of oral contraceptives: an overview of effects and side‐effects

Experiencia piloto con el uso extendido de un anticonceptivo oral combinado de baja dosis de estrógeno

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