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Safety and Tolerability of Collagenase Clostridium Histolyticum (EN3835) to Treat Uterine Leiomyoma (Fibroids)

Leiomyoma Clinical Trial

Official title:
An Open Label, Dose Escalation Study to Assess Safety and Tolerability of Collagenase Clostridium Histolyticum (EN3835) in Subjects With Uterine Leiomyoma (Fibroids)

Clinical Trial 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.

Clinical Trial Description

Collagenase enzyme breaks down collagen and has shown efficacy in clinical trials for a number of diseases for which there is an accumulation of collagen.

It is possible that lysis of collagen may reduce the collagen content of fibroids thus decreasing the size of fibroids, and possibly reducing the stiffness of fibroids. This may result in reducing the symptoms of pain and bleeding associated with fibroids.

In this study three subjects will be injected with saline only followed immediately by hysterectomy in order to evaluate the safety and effectiveness of the injection method.

Twelve subjects will receive a single injection of study drug as follows: three subjects will receive a set dose of collagenase enzyme followed by hysterectomy or myomectomy 24-96 hours later (Group 1) to evaluate safety of the injection of study drug. Nine subjects will then receive increasing doses of collagenase enzyme followed by hysterectomy or myomectomy 60-90 days later (Group 2). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02889848
Study type Interventional
Source Advance Biofactures Corporation
Contact
Status Completed
Phase Phase 1
Start date October 27, 2016
Completion date November 15, 2018
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