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Primary outcome measures were safety and tolerability of the injection and change in collagen content between treated and control tissues. There were no significant adverse events following injection of EN3835 into uterine fibroids. Masson\u2019s trichrome stains revealed a 39% reduction in collagen content in treated samples compared to controls (\n                    <jats:italic>p<\/jats:italic>\n                    &lt;0.05). Second harmonic generation (SHG) analysis showed treated samples to have a 21% reduction in density of collagen compared to controls. Picrosirius-stained collagenase-treated fibroids showed collagen fibers to be shorter and less dense compared to controls. Subjects reported a decrease in fibroid-related pain on the McGill Pain Questionnaire after study drug injection in Group 2 at both 4\u20138 days and 60\u201390 days post-injection. The findings indicated that injection of collagenase was safe and well tolerated. These results support further clinical investigation of collagenase as a minimally invasive treatment of uterine fibroids. NCT0289848.\n                  <\/jats:p>","DOI":"10.1007\/s43032-021-00573-8","type":"journal-article","created":{"date-parts":[[2021,4,29]],"date-time":"2021-04-29T10:03:26Z","timestamp":1619690606000},"page":"2699-2709","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":19,"title":["A Phase I Clinical Trial to Assess Safety and Tolerability of Injectable Collagenase in Women with Symptomatic Uterine Fibroids"],"prefix":"10.1007","volume":"28","author":[{"given":"Bhuchitra","family":"Singh","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Holly","family":"Sims","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Irene","family":"Trueheart","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Khara","family":"Simpson","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Karen C.","family":"Wang","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kristin","family":"Patzkowsky","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Thomas","family":"Wegman","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jean-Marie","family":"Soma","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rosina","family":"Dixon","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Friederike","family":"Jayes","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kristin","family":"Voegltine","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gayane","family":"Yenokyan","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Szu-Chi","family":"Su","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Phyllis","family":"Leppert","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5969-376X","authenticated-orcid":false,"given":"James H.","family":"Segars","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2021,4,29]]},"reference":[{"issue":"1","key":"573_CR1","first-page":"100e7","volume":"188","author":"DD Baird","year":"2003","unstructured":"Baird DD, Dunson DB, Hill MC, Cousins D, Schectman JM. 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The late Dr. Thomas Wegman was President of BioSpecifics Technologies Corporation. The study was funded by Advance Biofactures Corporation, Lynbrook, NY, a subsidiary of Biospecifics Technologies Corporation. Biospecifics staff participated in study design, secured the IND, and monitored study progress in keeping with industry standards, and manuscript preparation, but did not participate in subject recruitment, data collection, data analysis, and preparation of figures and tables or influence the presentation or interpretation of results, in keeping with the principles of the Messenden Code of Ethics and Accountability. J.H.S. is active on the following boards: The American Board of Obstetrics and Gynecology, the Society for Reproductive Investigation and the American Gynecological and Obstetrical Society. Dr. Segars has received sponsored research funding for clinical trials involving from Biospecifics, Bayer, and Abbvie and served as a consultant for Myovant. The other author(s) report(s) no conflicts of interest.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing Interests"}}]}}