![]() There were no significant adverse events following injection of EN3835 into uterine fibroids. Primary outcome measures were safety and tolerability of the injection and change in collagen content between treated and control tissues. Three subjects received saline and methylene blue, three subjects received a fixed dose of EN3835, and 9 subjects received stepped, increasing dosages of EN3835, all by transvaginal, ultrasound-guided injections. The study participants were fifteen women aged 35–50 years with symptomatic uterine fibroids planning to undergo hysterectomy. This was a prospective, open label, dose escalation study. The objective was to assess the safety and tolerability of collagenase injection directly into uterine fibroids. Previous ex vivo studies showed an FDA-approved collagenase (EN3835)-digested types I and III collagen fibers in fibroid tissues however, collagenase had not been evaluated in vivo for effects on uterine fibroids. Uterine fibroids feature excessive deposition of types I and III collagen. ![]()
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May 2023
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