{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,6]],"date-time":"2026-10-06T00:07:50Z","timestamp":1791245270114,"version":"4.1.0"},"reference-count":23,"publisher":"Wiley","issue":"12","license":[{"start":{"date-parts":[[2019,8,6]],"date-time":"2019-08-06T00:00:00Z","timestamp":1565049600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["obgyn.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Acta Obstet Gynecol Scand"],"published-print":{"date-parts":[[2019,12]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Introduction<\/jats:title>\n                    <jats:p>\n                      Approximately 100 million women currently use combined oral contraceptives. Combined oral contraceptives use is associated with increased risk of venous thromboembolic events and cardiovascular disease. Progestin\u2010only pills do not increase the risk of venous thromboembolic events, stroke and myocardial infarction but are associated with a poor cycle control. A novel estrogen\u2010free pill containing only drospirenone (\n                      <jats:styled-content style=\"fixed-case\">DRSP<\/jats:styled-content>\n                      ) was developed to improve bleeding pattern, tolerability and acceptance without increasing venous thromboembolic events risks in contraception.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Material and methods<\/jats:title>\n                    <jats:p>\n                      Two prospective, multicenter Phase\n                      <jats:styled-content style=\"fixed-case\">III<\/jats:styled-content>\n                      studies in healthy women aged 18\u201045\u00a0years were performed to demonstrate the efficacy and safety of a drospirenone\u2010only pill in a regimen of 24\u00a0days of 4\u00a0mg of drospirenone tablets followed by 4\u00a0days of placebo. A total of 1571 women (14\u00a0329 exposure cycles) were analyzed: 713 patients in the 13\u2010cycle study 1 with 7638 exposure cycles and 858 patients in the 9\u2010cycle study 2 with 6691 exposure cycles. The primary endpoint was the overall Pearl index, calculated for each study separately, and for both pooled. As main secondary efficacy endpoint, the \u201cmethod failure Pearl index\u201d including all pregnancies during \u201cperfect medication cycles\u201d was evaluated. Eudra\n                      <jats:styled-content style=\"fixed-case\">CT<\/jats:styled-content>\n                      registration numbers: 2010\u2010021787\u201015 &amp; 2011\u2010002396\u201042.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Calculations on pooled studies 1 and 2 with 1571 patients gave an overall Pearl index (based on 14\u00a0329 cycles) of 0.7258 (95% CI 0.3133 to 1.4301). No single case of deep vein thrombosis or pulmonary embolism and only one case of hyperkalemia were reported. Additional information such as laboratory parameters, body mass index, bodyweight, heart rate and blood pressure showed no statistically significant changes due to the treatment.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>This is the first report of a new drospirenone\u2010only oral contraceptive providing clinical efficacy similar to combined oral contraceptives, with a good safety profile, and favorable cycle control.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1111\/aogs.13688","type":"journal-article","created":{"date-parts":[[2019,7,19]],"date-time":"2019-07-19T01:19:11Z","timestamp":1563499151000},"page":"1549-1557","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":67,"title":["Multicenter, phase\n                    <scp>III<\/scp>\n                    trials on the contraceptive efficacy, tolerability and safety of a new drospirenone\u2010only pill"],"prefix":"10.1111","volume":"98","author":[{"given":"Santiago","family":"Palacios","sequence":"first","affiliation":[{"name":"Instituto Palacios Salud y Medicina de la Mujer Madrid Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Enrico","family":"Colli","sequence":"additional","affiliation":[{"name":"Exeltis HealthCare Madrid Madrid Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9551-2847","authenticated-orcid":false,"given":"Pedro\u2010Antonio","family":"Regidor","sequence":"additional","affiliation":[{"name":"Exeltis Europe Ismaning Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2019,8,6]]},"reference":[{"key":"e_1_2_10_2_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.maturitas.2008.11.013"},{"key":"e_1_2_10_3_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.maturitas.2003.09.016"},{"key":"e_1_2_10_4_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1111840"},{"key":"e_1_2_10_5_1","volume-title":"Medical Eligibility Criteria for Contraceptive Use","year":"2015"},{"key":"e_1_2_10_6_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.contraception.2015.07.014"},{"key":"e_1_2_10_7_1","doi-asserted-by":"publisher","DOI":"10.18632\/oncotarget.26015"},{"key":"e_1_2_10_8_1","doi-asserted-by":"publisher","DOI":"10.1093\/humrep\/14.4.982"},{"key":"e_1_2_10_9_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jbspin.2008.09.014"},{"key":"e_1_2_10_10_1","doi-asserted-by":"publisher","DOI":"10.1093\/oxfordjournals.humrep.a019245"},{"key":"e_1_2_10_11_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0010-7824(00)00133-5"},{"key":"e_1_2_10_12_1","doi-asserted-by":"publisher","DOI":"10.3109\/13625187.2015.1044082"},{"key":"e_1_2_10_13_1","unstructured":"MerkiGS.A study to evaluate the bioavailability of drospirenone in a new formulation of 4\u00a0mg drospirenone compared to a formulation containing 3\u00a0mg drospirenone and 0.02\u00a0mg ethinylestradiol. 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