{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,22]],"date-time":"2026-10-22T04:34:06Z","timestamp":1792643646454,"version":"4.5.0"},"reference-count":13,"publisher":"BMJ","issue":"2","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["J Fam Plann Reprod Health Care"],"accepted":{"date-parts":[[2012,2,6]]},"published-print":{"date-parts":[[2012,4]]},"abstract":"<jats:sec>\n                  <jats:title>Objectives<\/jats:title>\n                  <jats:p>The aim of this Phase III, multicentre, open-label, randomised study was to compare the efficacy and safety of ethinylestradiol (EE)\/drospirenone (DRSP) in a new flexible extended regimen that allowed the management of intracyclic (breakthrough) bleeding (MIB) with that of EE\/DRSP in a conventional 28-day regimen in women with moderate-to-severe primary dysmenorrhoea. <\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods<\/jats:title>\n                  <jats:p>Women (aged 18\u201340 years) with moderate-to-severe primary dysmenorrhoea-related pain received a flexible extended regimen with MIB (flexible<jats:sub>MIB<\/jats:sub>; minimum 24, maximum 120 days of continuous tablet intake for a flexible number of cycles to reach a treatment duration of at least 140 days with 4-day breaks between cycles) or a conventional 28-day regimen (24 active and four placebo tablets for five cycles) of EE\/DRSP. The primary outcome was the number of days with dysmenorrhoeic pain over 140 days. Secondary outcomes included other dysmenorrhoea-related pain outcomes, bleeding profile, satisfaction and safety.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>Overall, 223 patients received study medication. There were significantly fewer days with dysmenorrhoeic pain with the flexible<jats:sub>MIB<\/jats:sub> regimen than the conventional regimen (difference \u22124.2 days, 95% CI \u22126.5 to \u22122.0; <jats:italic>p<\/jats:italic>=0.0003), as well as considerably fewer days with at least moderate dysmenorrhoeic pain (difference \u22122.5 days, 95% CI \u22123.7 to \u22121.3), dysmenorrhoeic pain that interfered with daily activities (difference \u22122.2 days, 95% CI \u22124.2 to \u22120.1) and pelvic pain (difference \u22123.4 days, 95% CI \u22125.9 to \u22120.9). Adverse events were similar with both regimens.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusions<\/jats:title>\n                  <jats:p>Compared with the conventional regimen, the flexible extended regimen of EE\/DRSP with MIB was associated with a significantly greater reduction in days with dysmenorrhoeic pain in women with moderate-to-severe primary dysmenorrhoea. The flexible<jats:sub>MIB<\/jats:sub> regimen was also associated with greater improvements in dysmenorrhea according to the Clinical Global Impression rating scale and was generally well tolerated.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1136\/jfprhc-2011-100225","type":"journal-article","created":{"date-parts":[[2012,3,27]],"date-time":"2012-03-27T11:35:47Z","timestamp":1332848147000},"page":"94-101","source":"Crossref","is-referenced-by-count":32,"title":["Efficacy of ethinylestradiol 20 \u00b5g\/drospirenone 3 mg in a flexible extended regimen in women with moderate-to-severe primary dysmenorrhoea: an open-label, multicentre, randomised, controlled study"],"prefix":"10.1136","volume":"38","clinical-trial-number":[{"clinical-trial-number":"nct00569244","registry":"10.18810\/clinical-trials-gov"}],"author":[{"given":"Thomas","family":"Strowitzki","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bodo","family":"Kirsch","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"J\u00f6rg","family":"Elliesen","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"239","published-online":{"date-parts":[[2012,3,27]]},"reference":[{"key":"2025090512354903000_38.2.94.1","first-page":"489","article-title":"Primary dysmenorrhea","volume":"60","author":"Coco","year":"1999","journal-title":"Am Fam Physician"},{"key":"2025090512354903000_38.2.94.2","first-page":"285","article-title":"Dysmenorrhea","volume":"71","author":"French","year":"2005","journal-title":"Am Fam Physician"},{"key":"2025090512354903000_38.2.94.3","doi-asserted-by":"publisher","DOI":"10.1097\/01.AOG.0000230214.26638.0c"},{"key":"2025090512354903000_38.2.94.4","doi-asserted-by":"publisher","DOI":"10.1016\/S1083-3188(00)00076-0"},{"key":"2025090512354903000_38.2.94.5","doi-asserted-by":"publisher","DOI":"10.1016\/S0002-9343(99)00362-9"},{"key":"2025090512354903000_38.2.94.6","doi-asserted-by":"crossref","unstructured":"Wong CL Farquhar C Roberts H . Oral contraceptive pill for primary dysmenorrhoea. Cochrane Database Syst Rev 2009;4:CD002120.","DOI":"10.1002\/14651858.CD002120.pub2"},{"key":"2025090512354903000_38.2.94.7","doi-asserted-by":"crossref","unstructured":"Edelman AB Gallo MF Jensen JT . Continuous or extended cycle vs cyclic use of combined oral contraceptives for contraception. Cochrane Database Syst Rev 2005;3:CD004695.","DOI":"10.1002\/14651858.CD004695.pub2"},{"key":"2025090512354903000_38.2.94.8","doi-asserted-by":"crossref","first-page":"655","DOI":"10.1016\/0002-9378(82)90433-1","article-title":"An epidemiologic study of young women with dysmenorrhea","volume":"144","author":"Andersch","year":"1982","journal-title":"Am J Obstet Gynecol"},{"key":"2025090512354903000_38.2.94.9","doi-asserted-by":"publisher","DOI":"10.1016\/S0029-7844(96)00488-7"},{"key":"2025090512354903000_38.2.94.10","doi-asserted-by":"crossref","first-page":"215","DOI":"10.1016\/j.contraception.2009.10.010","article-title":"Bleeding patterns and menstrual-related symptoms with the continuous use of a contraceptive combination of ethinylestradiol and drospirenone: a randomized study","volume":"81","author":"Machado","year":"2010","journal-title":"Contraception"},{"key":"2025090512354903000_38.2.94.11","first-page":"400","article-title":"A prospective follow-up of two 21\/7 cycles followed by two extended regimen 84\/7 cycles with contraceptive pills containing ethinyl estradiol and drospirenone","volume":"12","author":"Seidman","year":"2010","journal-title":"Isr Med Assoc J"},{"key":"2025090512354903000_38.2.94.12","doi-asserted-by":"publisher","DOI":"10.1016\/S0010-7824(02)00445-6"},{"key":"2025090512354903000_38.2.94.13","doi-asserted-by":"crossref","first-page":"269","DOI":"10.2165\/11586720-000000000-00000","article-title":"Extended cycles with the combined oral contraceptive chlormadinone acetate 2 mg\/ethinylestradiol 0.03 mg: pooled analysis of data from three large-scale, non-interventional, observational studies","volume":"31","author":"G\u00f6retzlehner","year":"2011","journal-title":"Clin Drug Investig"}],"container-title":["Journal of Family Planning and Reproductive Health Care"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/syndication.highwire.org\/content\/doi\/10.1136\/jfprhc-2011-100225","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,9,5]],"date-time":"2025-09-05T19:36:07Z","timestamp":1757100967000},"score":1,"resource":{"primary":{"URL":"https:\/\/jfprhc.bmj.com\/lookup\/doi\/10.1136\/jfprhc-2011-100225"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2012,3,27]]},"references-count":13,"journal-issue":{"issue":"2","published-online":{"date-parts":[[2012,3,27]]},"published-print":{"date-parts":[[2012,4]]}},"alternative-id":["10.1136\/jfprhc-2011-100225"],"URL":"https:\/\/doi.org\/10.1136\/jfprhc-2011-100225","relation":{},"ISSN":["1471-1893","2045-2098"],"issn-type":[{"value":"1471-1893","type":"print"},{"value":"2045-2098","type":"electronic"}],"subject":[],"published":{"date-parts":[[2012,3,27]]}}}