CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 74 enrolled
Drug / intervention
Standard +1 moredrug
Likely dose
Standard 20 unitsfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03815344
NCT03815344Phase 4Completed
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A Randomized Control Trial of Combined Vaginal Misoprostol and Perivascular Vasopressin During Robotic Myomectomy

Antonios Likourezos·interventional·Posted Jan 24, 2019·Updated Jan 9, 2024

In Brief

A Phase 4 clinical trial evaluating Standard and Standard-vaginal misoprostol for Leiomyoma and 2 related conditions. Completed, enrolled 74 participants across 1 site.

Detailed Summary

Injection of Vasopressin into the uterine tissue surrounding fibroids constricts blood vessels, and has been found to be beneficial by decreasing blood flow to fibroids, and thereby resulting in less bleeding with removal. Additionally, Misoprostol has been looked at as an additional method to decrease operative blood loss given its ability to increase uterine muscle tone, which therefore constricts the amount of blood flow to the uterus.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLeiomyoma, Laparoscopy, Uterine Myomectomy
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
201820192020202120222023202420252026
First PostedJan 24, 2019
Enrollment StartApr 26, 2017
Primary CompletionJun 30, 2019
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 7.4 years ago

Interventions

Standarddrug

20 units diluted in 100mL of Normal Saline injected laparoscopic needle

Standard-vaginal misoprostoldrug

20 units diluted in 100mL of Normal Saline injected laparoscopic needle and misoprostol 400 mcg