Trial · NCT02889848
Safety and Tolerability of Collagenase Clostridium Histolyticum (EN3835) to Treat Uterine Leiomyoma (Fibroids)
NCT02889848, Phase 1, Completed, Advance Biofactures Corporation
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Safety and Tolerability of Collagenase Clostridium Histolyticum (EN3835) to Treat Uterine Leiomyoma (Fibroids). Trials, record NCT02889848. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02889848
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Tolerability of Collagenase Clostridium Histolyticum (EN3835) to Treat Uterine Leiomyoma (Fibroids)
- NCT number
- NCT02889848
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 15 participants, actual
- Lead sponsor
- Advance Biofactures Corporation
- Conditions
- Fibroids, Uterine, Leiomyoma
- Interventions
- Saline, EN3835
- First posted
- 2016-09-07
- Last updated
- 2019-07-10
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of participants with treatment-related adverse events following a single injection of EN3835 into a fibroid | Through hysterectomy or myomectomy (average = 60-90 days post injection) | Assessed by number of subjects with uterine injury or peritoneal irritation determined post hysterectomy |
| Secondary | Change in symptoms of pain and bleeding and quality of life | Throughout the study prior to hysterectomy or myomectomy(avg 60-90 days post injection study drug) | Determined by standardized questionnaires for menstrual distress, quality of life and sexual activity; McGill Pain Questionnaire |
| Secondary | Reduction in size of treated fibroids- Group 2 | 60-90 days post injection study drug | Size of fibroid to be determined post hysterectomy or myomectomy |
| Secondary | Increased rate of apoptosis of treated fibroids -Group 2 | 60-90 days post injection study drug | Specimens to be taken post hysterectomy or myomectomy and evaluated by TUNEL staining |
| Secondary | Reduction in collagen content of treated fibroids-Group 2 | 60-90 days post injection study drug | Specimens to be taken post hysterectomy or myomectomy and by tested histology stains |
| Secondary | Reduction in stiffness of treated fibroid-Group 2 | 60-90 days post injection study drug | Specimens to be taken post hysterectomy or myomectomy and tested via rheometry |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 34323413 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02889848
GET https://conductscience.org/api/trials/v1/NCT02889848/registered