Safety and Tolerability of Collagenase Clostridium Histolyticum (EN3835) to Treat Uterine Leiomyoma (Fibroids)
Status:
Completed
Trial end date:
2018-11-15
Target enrollment:
Participant gender:
Summary
This pilot study evaluates the safety and tolerability of a single injection of collagenase
enzyme directly into a uterine fibroid in subjects already selected for hysterectomy or
myomectomy.
Fibroids contain excessive amounts of collagen and it is possible that digestion of collagen
may be beneficial in reducing pain and bleeding associated with fibroids.
Three subjects will be injected with saline only to evaluate the safety and effectiveness of
the injection method. Additional subjects will then be injected with increasing doses of
study drug.