Completed PHASE1 INTERVENTIONAL 5-arm NCT02889848

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

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

Sponsor: Advance Biofactures Corporation

Conditions Fibroids, Uterine Leiomyoma

Interventions EN3835 Saline

Updated 8 times since 2017 Last updated: Jul 9, 2019 Started: Oct 27, 2016 Primary completion: Oct 5, 2018 Completion: Nov 15, 2018

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT02889848, this PHASE1 trial focuses on Fibroids, Uterine and Leiomyoma and remains completed. Sponsored by Advance Biofactures Corporation, it has been updated 8 times since 2016, reflecting limited change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.

Status Flow

Change History

8 versions recorded

Sep 2024 — Present [monthly]

Completed PHASE1
Jul 2024 — Sep 2024 [monthly]

Completed PHASE1
Jan 2021 — Jul 2024 [monthly]

Completed PHASE1
Aug 2019 — Jan 2021 [monthly]

Completed PHASE1

Status: Active Not Recruiting → Completed
Jul 2018 — Aug 2019 [monthly]

Active Not Recruiting PHASE1

Status: Recruiting → Active Not Recruiting

▶ Show 3 earlier versions

Jun 2018 — Jul 2018 [monthly]

Recruiting PHASE1
Feb 2017 — Jun 2018 [monthly]

Recruiting PHASE1
Jan 2017 — Feb 2017 [monthly]

Recruiting PHASE1

First recorded

Oct 2016

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

Advance Biofactures Corporation

Data source: Advance Biofactures Corporation

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

• Baltimore, United States