{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,13]],"date-time":"2026-10-13T07:06:27Z","timestamp":1791875187509,"version":"4.3.4"},"reference-count":22,"publisher":"Wiley","issue":"4","license":[{"start":{"date-parts":[[2022,1,18]],"date-time":"2022-01-18T00:00:00Z","timestamp":1642464000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Andrology"],"published-print":{"date-parts":[[2022,5]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Background<\/jats:title><jats:p>Male hypogonadism (testosterone level\u00a0&lt;\u00a0300\u00a0ng\/dl) is a clinical syndrome that results from failure of the testis to produce physiological levels of testosterone. Most marketed testosterone replacement therapy products often require multiple dose adjustment clinic visits to achieve the desired, eugonadal testosterone levels.<\/jats:p><\/jats:sec><jats:sec><jats:title>Objective<\/jats:title><jats:p>To evaluate the efficacy and safety of a novel oral testosterone undecanoate therapy for the treatment of hypogonadism.<\/jats:p><\/jats:sec><jats:sec><jats:title>Material and methods<\/jats:title><jats:p>Ninety\u2010five (<jats:italic>N<\/jats:italic>\u00a0=\u00a095) hypogonadal men were enrolled in this open\u2010label, single\u2010arm, multicenter study in the United States (NCT03242590). Subjects received 225\u00a0mg of oral testosterone undecanoate (TLANDO) twice a day for 24 days without dose adjustment. Primary efficacy was percentages of subjects who achieved mean 24\u2010h testosterone levels within the eugonadal range and secondary efficacies were evaluated based on the upper limit of lab normal range of testosterone concentration.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Subjects enrolled were on average age of 56 years, with about 17% of subjects older than 65 years. The mean body mass index was 32.8\u00a0kg\/m<jats:sup>2<\/jats:sup>. The baseline mean total testosterone values were below the normal range (202 \u00b1 74\u00a0ng\/dl). Post\u2010treatment with 450\u00a0mg testosterone undecanoate daily dose without dose adjustment, 80% of subjects (95% confidence interval of 72%\u201388%) achieved a testosterone Cavg in the normal range and restored testosterone levels to mean testosterone Cavg of 476 \u00b1 184\u00a0ng\/dl at steady state. Testosterone restoration was comparable to other approved testosterone replacement therapy products. TLANDO was well tolerated with no deaths, no drug\u2010related serious adverse events, and no hepatic adverse events.<\/jats:p><\/jats:sec><jats:sec><jats:title>Discussion and conclusions<\/jats:title><jats:p>TLANDO restored testosterone levels to the normal range in the majority of hypogonadal males. This new oral testosterone replacement therapy can provide an option for no\u2010titration oral testosterone replacement therapy. This therapy has the potential to improve patient compliance in testosterone replacement therapy.<\/jats:p><\/jats:sec>","DOI":"10.1111\/andr.13153","type":"journal-article","created":{"date-parts":[[2022,1,7]],"date-time":"2022-01-07T08:09:32Z","timestamp":1641542972000},"page":"669-676","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":16,"title":["A new oral testosterone (TLANDO) treatment regimen without dose titration requirement for male hypogonadism"],"prefix":"10.1111","volume":"10","author":[{"given":"Anthony","family":"DelConte","sequence":"first","affiliation":[{"name":"Lipocine Inc.  Salt Lake City Utah USA"},{"name":"Pharmaceutical and Healthcare Marketing Saint Joseph's University  Philadelphia Pennsylvania USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kongnara","family":"Papangkorn","sequence":"additional","affiliation":[{"name":"Lipocine Inc.  Salt Lake City Utah USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kilyoung","family":"Kim","sequence":"additional","affiliation":[{"name":"Lipocine Inc.  Salt Lake City Utah USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Benjamin J.","family":"Bruno","sequence":"additional","affiliation":[{"name":"Lipocine Inc.  Salt Lake City Utah USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nachiappan","family":"Chidambaram","sequence":"additional","affiliation":[{"name":"Lipocine Inc.  Salt Lake City Utah USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mohit","family":"Khera","sequence":"additional","affiliation":[{"name":"Department of Urology Baylor College of Medicine  Houston Texas USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Irwin","family":"Goldstein","sequence":"additional","affiliation":[{"name":"San Diego Sexual Medicine Alvarado Hospital Medical Center  San Diego California USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tobias S.","family":"Kohler","sequence":"additional","affiliation":[{"name":"Department of Urology Mayo Clinic  Rochester Minnesota USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Martin","family":"Miner","sequence":"additional","affiliation":[{"name":"Family Medicine and Urology Warran Alpert Medical School Brown University  Providence Rhode Island USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Adrian S.","family":"Dobs","sequence":"additional","affiliation":[{"name":"Division of Endocrinology Johns Hopkins University  Baltimore Maryland USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mahesh V.","family":"Patel","sequence":"additional","affiliation":[{"name":"Lipocine Inc.  Salt Lake City Utah USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2022,1,18]]},"reference":[{"key":"e_1_2_9_2_1","doi-asserted-by":"publisher","DOI":"10.1210\/jc.2018-00229"},{"key":"e_1_2_9_3_1","doi-asserted-by":"publisher","DOI":"10.1038\/s41572-019-0087-y"},{"key":"e_1_2_9_4_1","doi-asserted-by":"publisher","DOI":"10.1210\/jc.2003-031719"},{"key":"e_1_2_9_5_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.sxmr.2017.10.001"},{"key":"e_1_2_9_6_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.sxmr.2018.11.005"},{"key":"e_1_2_9_7_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.sxmr.2018.03.002"},{"key":"e_1_2_9_8_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.sxmr.2019.06.003"},{"key":"e_1_2_9_9_1","doi-asserted-by":"publisher","DOI":"10.1159\/000178904"},{"key":"e_1_2_9_10_1","doi-asserted-by":"publisher","DOI":"10.1124\/jpet.103.052522"},{"key":"e_1_2_9_11_1","doi-asserted-by":"publisher","DOI":"10.1002\/j.1939-4640.1994.tb00433.x"},{"key":"e_1_2_9_12_1","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.291.6496.637"},{"key":"e_1_2_9_13_1","unstructured":"Lipocine.Lipocine physician quantitive survey. In: Quintiles IMS;2017.Unpublished."},{"issue":"4","key":"e_1_2_9_14_1","first-page":"e670","article-title":"A novel oral testosterone therapy restores testosterone to eugonadal levels without dose titration","volume":"203","author":"DelConte A","year":"2020","journal-title":"J Urol"},{"key":"e_1_2_9_15_1","unstructured":"U.S. Food and Drug AdministrationTLANDO^TM \u2013 (Oral testosterone undecanoate capsules) for testosterone replacement therapy in hypogonadal men. NDA 208088. Briefing Document For Bone Reproductive and Urologic Advisory Committee Meeting.https:\/\/www.fda.gov\/media\/110373\/download. Accessed September 2018."},{"issue":"3","key":"e_1_2_9_16_1","first-page":"e637","article-title":"Clinical Experience with TLANDO in Hypogonadal Men","volume":"206","author":"Papangkorn K","year":"2021","journal-title":"J Urol"},{"key":"e_1_2_9_17_1","unstructured":"Lipocine Inc.Study of blood collection tubes following single dose administration of oral testosterone undecanoate (TU LPCN 1021). In: Lipocine Inc; 2018. Unpublished."},{"key":"e_1_2_9_18_1","doi-asserted-by":"publisher","DOI":"10.1210\/clinem\/dgaa238"},{"key":"e_1_2_9_19_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jsxm.2019.11.128"},{"key":"e_1_2_9_20_1","doi-asserted-by":"publisher","DOI":"10.1002\/hep4.1571"},{"key":"e_1_2_9_21_1","doi-asserted-by":"publisher","DOI":"10.1111\/jch.14297"},{"key":"e_1_2_9_22_1","doi-asserted-by":"publisher","DOI":"10.1177\/10742484211027394"},{"key":"e_1_2_9_23_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.ahj.2020.03.016"}],"container-title":["Andrology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/andr.13153","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/full-xml\/10.1111\/andr.13153","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/andr.13153","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,8,20]],"date-time":"2023-08-20T12:54:12Z","timestamp":1692536052000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1111\/andr.13153"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2022,1,18]]},"references-count":22,"journal-issue":{"issue":"4","published-print":{"date-parts":[[2022,5]]}},"alternative-id":["10.1111\/andr.13153"],"URL":"https:\/\/doi.org\/10.1111\/andr.13153","archive":["Portico"],"relation":{},"ISSN":["2047-2919","2047-2927"],"issn-type":[{"value":"2047-2919","type":"print"},{"value":"2047-2927","type":"electronic"}],"subject":[],"published":{"date-parts":[[2022,1,18]]},"assertion":[{"value":"2021-09-15","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2021-12-17","order":1,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2022-01-18","order":2,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}