{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,5,14]],"date-time":"2025-05-14T00:44:26Z","timestamp":1747183466436,"version":"3.40.5"},"reference-count":25,"publisher":"Wiley","issue":"3","license":[{"start":{"date-parts":[[2020,7,24]],"date-time":"2020-07-24T00:00:00Z","timestamp":1595548800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"funder":[{"DOI":"10.13039\/100004326","name":"Bayer","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100004326","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Brit J Clinical Pharma"],"published-print":{"date-parts":[[2021,3]]},"abstract":"<jats:sec><jats:title>Aims<\/jats:title><jats:p>The primary objective was to explore whether the suppression of ovarian activity induced by a combined oral contraceptive (COC) is influenced by the simultaneous intake of the selective progesterone receptor modulator (SPRM) vilaprisan (VPR).<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>In this exploratory randomized, double\u2010blind, parallel\u2010group study, 71 healthy premenopausal women were randomized (1:1) to receive either 2 mg\/d VPR or placebo for 3 months. Concomitantly, a COC (0.15 mg levonorgestrel, 0.03 mg ethinyloestradiol) was administered in a cyclic regimen. Ovarian activity (Hoogland score based on follicle size and hormone concentrations), cervical function (Insler score), bleeding pattern and endometrial thickness\/histology were assessed before treatment, in treatment cycle 3 and during follow\u2010up.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>The known COC\u2010driven suppression of ovarian activity was mildly affected by VPR. COC+VPR group: 22, 0 and 6% of the subjects had Hoogland scores of 4 (active follicle\u2010like structures), 5 or 6 (ovulation). COC+placebo group: 14% of the subjects had a score of 4 and none a score of 5 or 6 (Bayesian analysis for Hoogland score = 4, median difference in response rate: 7.5%; 90% credible interval [\u22128.5; 23.5%]). COC effects on cervical function were moderately affected (mucus more sperm permeable under COC+VPR). COC withdrawal bleeding, in contrast, was absent in 81% of the subjects receiving COC+VPR <jats:italic>vs<\/jats:italic> 0% receiving COC+placebo.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>The SPRM VPR interfered with the pharmacodynamic effects of the COC. Therefore, full contraceptive effectiveness cannot be assumed without final judgement by a Pearl index study. Women on SPRMs should be advised to use nonhormonal contraception methods.<\/jats:p><\/jats:sec>","DOI":"10.1111\/bcp.14443","type":"journal-article","created":{"date-parts":[[2020,6,27]],"date-time":"2020-06-27T17:24:36Z","timestamp":1593278676000},"page":"925-936","source":"Crossref","is-referenced-by-count":2,"title":["The effects of vilaprisan on the pharmacodynamics and pharmacokinetics of a combined oral contraceptive\u2014A randomized controlled trial"],"prefix":"10.1111","volume":"87","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-4424-6339","authenticated-orcid":false,"given":"Marcus\u2010Hillert","family":"Schultze\u2010Mosgau","sequence":"first","affiliation":[{"name":"Department of Clinical Pharmacology, Research &amp; Development, Pharmaceuticals Bayer AG  Berlin Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Barbara","family":"Sch\u00fctt","sequence":"additional","affiliation":[{"name":"Department of Clinical Pharmacology, Research &amp; Development, Pharmaceuticals Bayer AG  Berlin Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Corinna","family":"Draeger","sequence":"additional","affiliation":[{"name":"dinox GmbH, Female Health Research  Berlin Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Manuela","family":"Casjens","sequence":"additional","affiliation":[{"name":"CRS Clinical Research Services Berlin GmbH  Berlin Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Stephanie","family":"Loewen","sequence":"additional","affiliation":[{"name":"Early Development Statistics Chrestos Concept GmbH &amp; Co. KG  Essen Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Torsten","family":"Zimmermann","sequence":"additional","affiliation":[{"name":"Department of Clinical Pharmacology, Research &amp; Development, Pharmaceuticals Bayer AG  Berlin Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Beate","family":"Rohde","sequence":"additional","affiliation":[{"name":"Department of Clinical Pharmacology, Research &amp; Development, Pharmaceuticals Bayer AG  Berlin Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2020,7,24]]},"reference":[{"doi-asserted-by":"publisher","key":"e_1_2_10_2_1","DOI":"10.1155\/2012\/436174"},{"doi-asserted-by":"publisher","key":"e_1_2_10_3_1","DOI":"10.1080\/14728222.2016.1180368"},{"issue":"4","key":"e_1_2_10_4_1","first-page":"1","article-title":"Selective progesterone receptor modulators (SPRMs) for uterine fibroids","author":"Murji A","year":"2017","journal-title":"Cochrane Database Syst Rev"},{"doi-asserted-by":"publisher","key":"e_1_2_10_5_1","DOI":"10.1210\/jc.2006-2816"},{"doi-asserted-by":"publisher","key":"e_1_2_10_6_1","DOI":"10.1002\/jcph.998"},{"doi-asserted-by":"publisher","key":"e_1_2_10_7_1","DOI":"10.1016\/j.jsbmb.2004.02.003"},{"doi-asserted-by":"publisher","key":"e_1_2_10_8_1","DOI":"10.1093\/humrep\/det247"},{"doi-asserted-by":"publisher","key":"e_1_2_10_9_1","DOI":"10.1093\/humrep\/dew140"},{"doi-asserted-by":"publisher","key":"e_1_2_10_10_1","DOI":"10.5414\/CP202756"},{"doi-asserted-by":"publisher","key":"e_1_2_10_11_1","DOI":"10.1016\/j.cct.2017.02.002"},{"doi-asserted-by":"publisher","key":"e_1_2_10_12_1","DOI":"10.1007\/s40262-017-0607-4"},{"doi-asserted-by":"publisher","key":"e_1_2_10_13_1","DOI":"10.1016\/j.fertnstert.2018.10.012"},{"doi-asserted-by":"publisher","key":"e_1_2_10_14_1","DOI":"10.1002\/cpt.1848"},{"doi-asserted-by":"publisher","key":"e_1_2_10_15_1","DOI":"10.1016\/0010-7824(93)90025-3"},{"doi-asserted-by":"publisher","key":"e_1_2_10_16_1","DOI":"10.1002\/j.1879-3479.1972.tb00857.x"},{"doi-asserted-by":"publisher","key":"e_1_2_10_17_1","DOI":"10.1007\/978-1-4419-0489-8"},{"doi-asserted-by":"publisher","key":"e_1_2_10_18_1","DOI":"10.1038\/modpathol.2008.19"},{"unstructured":"European Medicines Agency (EMA).Committee for Medicinal Products for human use (CHMP): guideline on bioanalytical method validation. 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