{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,4]],"date-time":"2026-05-04T17:39:41Z","timestamp":1777916381514,"version":"3.51.4"},"reference-count":37,"publisher":"SAGE Publications","issue":"1","license":[{"start":{"date-parts":[[2018,1,1]],"date-time":"2018-01-01T00:00:00Z","timestamp":1514764800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"},{"start":{"date-parts":[[2018,1,1]],"date-time":"2018-01-01T00:00:00Z","timestamp":1514764800000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["Journal of Women's Health"],"published-print":{"date-parts":[[2018,1]]},"abstract":"<jats:sec>\n                    <jats:title>Objective:<\/jats:title>\n                    <jats:p>To evaluate the safety of daily oral ospemifene 60\u2009mg, estrogen agonist\/antagonist, used to treat moderate-to-severe dyspareunia due to postmenopausal vulvovaginal atrophy, which is part of genitourinary syndrome of menopause.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods:<\/jats:title>\n                    <jats:p>\n                      <jats:italic toggle=\"yes\">Post hoc<\/jats:italic>\n                      analysis of safety data (treatment-emergent adverse events [TEAEs]) pooled from six phase 2 and 3 randomized, double-blind, multicenter placebo-controlled studies, evaluating the effects of ospemifene 60\u2009mg on the breast, cardiovascular system, and bone in postmenopausal women.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results:<\/jats:title>\n                    <jats:p>At least one TEAE was reported by 67.6% (840\/1242) and 54.1% (518\/958) of women taking ospemifene 60\u2009mg and placebo, respectively. Most TEAEs were mild or moderate and occurred within 4 to 12 weeks. The most commonly reported TEAEs with ospemifene were hot flush (8.5% vs. 3.3% for placebo) and urinary tract infection (6.5% vs. 4.8%). Discontinuation due to TEAEs was 7.6% with ospemifene and 3.8% with placebo. Most women discontinued treatment due to adverse events (AEs): hot flushes, muscle spasms, headache, and vaginal discharge. Serious AEs occurred infrequently (ospemifene, 2.6%; placebo, 1.8%); most were not considered related to treatment. Breast cancer and other breast-related TEAE incidences were comparable between ospemifene (2.5%) and placebo (2.2%), and cardiovascular TEAE incidence, including deep vein thrombosis, was low with ospemifene (0.3%) and placebo (0.1%).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion:<\/jats:title>\n                    <jats:p>No unexpected safety signals were reported, and discontinuation due to TEAEs was low, with use of ospemifene 60\u2009mg versus placebo in six phase 2 and 3 trials, suggesting a lack of detrimental effects on the breast, bone, and cardiovascular health of postmenopausal women when ospemifene is used to effectively treat moderate-to-severe postmenopausal dyspareunia.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1089\/jwh.2017.6385","type":"journal-article","created":{"date-parts":[[2017,10,24]],"date-time":"2017-10-24T11:45:17Z","timestamp":1508845517000},"page":"14-23","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":50,"title":["Overall Safety of Ospemifene in Postmenopausal Women from Placebo-Controlled Phase 2 and 3 Trials"],"prefix":"10.1177","volume":"27","author":[{"given":"James A.","family":"Simon","sequence":"first","affiliation":[{"name":"Women's Health and Research Consultants, Washington, District of Columbia."}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Corrado","family":"Altomare","sequence":"additional","affiliation":[{"name":"Shionogi, Inc."}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Susannah","family":"Cort","sequence":"additional","affiliation":[{"name":"Shionogi, Inc."}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Wei","family":"Jiang","sequence":"additional","affiliation":[{"name":"Shionogi, Inc."}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"JoAnn V.","family":"Pinkerton","sequence":"additional","affiliation":[{"name":"University of Virginia"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"179","published-online":{"date-parts":[[2018,1,1]]},"reference":[{"key":"e_1_3_3_2_2","doi-asserted-by":"publisher","DOI":"10.1111\/j.1743-6109.2009.01335.x"},{"key":"e_1_3_3_3_2","doi-asserted-by":"publisher","DOI":"10.1097\/gme.0b013e31815a5168"},{"key":"e_1_3_3_4_2","doi-asserted-by":"publisher","DOI":"10.4065\/mcp.2009.0413"},{"key":"e_1_3_3_5_2","doi-asserted-by":"publisher","DOI":"10.1097\/GME.0000000000000329"},{"key":"e_1_3_3_6_2","doi-asserted-by":"publisher","DOI":"10.1097\/GME.0000000000000464"},{"key":"e_1_3_3_7_2","doi-asserted-by":"publisher","DOI":"10.1097\/GME.0b013e3182a122c2"},{"key":"e_1_3_3_8_2","doi-asserted-by":"publisher","DOI":"10.1097\/GME.0b013e318295236f"},{"key":"e_1_3_3_9_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.maturitas.2013.05.003"},{"key":"e_1_3_3_10_2","doi-asserted-by":"publisher","DOI":"10.3109\/13697137.2011.647840"},{"key":"e_1_3_3_11_2","doi-asserted-by":"publisher","DOI":"10.3109\/13697137.2012.756466"},{"key":"e_1_3_3_12_2","doi-asserted-by":"publisher","DOI":"10.1097\/GME.0b013e318287342d"},{"key":"e_1_3_3_13_2","doi-asserted-by":"publisher","DOI":"10.1097\/GME.0000000000000316"},{"key":"e_1_3_3_14_2","unstructured":"Osphena\u00ae [(ospemifene) tablets for oral use]. Prescribing Information. Florham Park NJ: Shionogi Inc. 2013."},{"key":"e_1_3_3_15_2","unstructured":"Senshio (60\u2009mg film-coated tablets). Ospemifene Summary of Product Characteristics. 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