{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,24]],"date-time":"2026-09-24T04:12:03Z","timestamp":1790223123837,"version":"4.1.0"},"reference-count":22,"publisher":"BMJ","issue":"2","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["J Fam Plann Reprod Health Care"],"accepted":{"date-parts":[[2012,2,10]]},"published-print":{"date-parts":[[2012,4]]},"abstract":"<jats:sec>\n                  <jats:title>Background<\/jats:title>\n                  <jats:p>The contraceptive efficacy and tolerability of a new flexible extended regimen of ethinylestradiol (EE) 20 \u03bcg\/drospirenone (DRSP) 3 mg to extend the menstrual cycle and enable management of intracyclic (breakthrough) bleeding (flexible<jats:sub>MIB<\/jats:sub>) was investigated and the bleeding pattern compared with a conventional 28-day regimen and a fixed extended 124-day regimen. <\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Study design<\/jats:title>\n                  <jats:p>This Phase III, 2-year, multicentre, open-label study randomly (4:1:1) allocated women (aged 18\u201335 years) to the following regimens: flexible<jats:sub>MIB<\/jats:sub> (24\u2013120 days' active hormonal intake with 4-day tablet-free intervals); conventional (24 days' active hormonal intake followed by a 4-day hormone-free interval); or fixed extended (120 days' uninterrupted active hormonal intake followed by a 4-day tablet-free interval). Primary outcomes included the number of bleeding\/spotting days during Year 1 (all regimens) and the number of observed unintended pregnancies over 2 years (flexible<jats:sub>MIB<\/jats:sub> only).<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>Results were analysed in 1067 women (full analysis set). The mean number of bleeding\/spotting days was lower with the flexible<jats:sub>MIB<\/jats:sub> vs the conventional regimen [41.0\u00b129.1 (95% CI 38.8\u201343.3) vs 65.8\u00b127.0 (95% CI 62.2\u201369.4) days, <jats:italic>p<\/jats:italic>&lt;0.0001; treatment difference \u221224.8 (95% CI \u221229.2 to \u221220.3) days]. The corresponding value for the fixed extended regimen was 60.9\u00b151.1 (95% CI 53.9\u201367.9) days. The Pearl Index for the flexible<jats:sub>MIB<\/jats:sub> regimen was 0.64 (95% CI 0.28\u20131.26). All regimens had comparable tolerability profiles.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusions<\/jats:title>\n                  <jats:p>EE 20 \u03bcg\/DRSP 3 mg administered as a flexible extended regimen with MIB is effective, well tolerated and is associated with statistically significantly fewer bleeding\/spotting days and fewer withdrawal bleeding episodes vs EE\/DRSP in a conventional 28-day regimen. The flexible<jats:sub>MIB<\/jats:sub> also provided statistically significantly fewer spotting days vs EE\/DRSP in a fixed extended 124-day regimen (<jats:italic>post hoc<\/jats:italic> evaluation). The flexible<jats:sub>MIB<\/jats:sub> regimen allows women to extend their menstrual cycle and manage their intracyclic (breakthrough) bleeding.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1136\/jfprhc-2011-100213","type":"journal-article","created":{"date-parts":[[2012,3,27]],"date-time":"2012-03-27T11:35:47Z","timestamp":1332848147000},"page":"73-83","source":"Crossref","is-referenced-by-count":36,"title":["Contraceptive efficacy and tolerability of ethinylestradiol 20 \u00b5g\/drospirenone 3 mg in a flexible extended regimen: an open-label, multicentre, randomised, controlled study"],"prefix":"10.1136","volume":"38","clinical-trial-number":[{"clinical-trial-number":"nct00266032","registry":"10.18810\/clinical-trials-gov"}],"author":[{"given":"Christine","family":"Klipping","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ingrid","family":"Duijkers","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michel 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