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Fibroids, Uterine clinical trials

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NCT ID: NCT02889848 Completed - Leiomyoma Clinical Trials

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

Start date: October 27, 2016
Phase: Phase 1
Study type: Interventional

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.

NCT ID: NCT02260752 Completed - Fibroids, Uterine Clinical Trials

Patient Centered Results for Uterine Fibroids

COMPARE-UF
Start date: November 2015
Phase:
Study type: Observational [Patient Registry]

The overall goal of this project is to better enable patients with uterine fibroids (UF) to make informed decisions about treatment options by leveraging the highest possible evidence of healthcare quality. The foundation of this project will be a multi-site, prospective registry of a diverse group of women who have undergone either medical or surgical treatment for UF. Specifically, the investigators are interested in: comparing management options for symptom relief; comparing management options for preserving reproductive function; and comparing effectiveness among different subpopulations, including consideration of patient needs and preferences of treatment options.