Status:
COMPLETED
Combined Vaginal Misoprostol and Perivascular Vasopressin
Lead Sponsor:
Antonios Likourezos
Conditions:
Leiomyoma
Laparoscopy
Eligibility:
FEMALE
18-55 years
Phase:
PHASE4
Brief 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 ...
Detailed Description
Uterine fibroids are common benign tumors affecting women, and produce symptoms severe enough to warrant treatment in 20-50% of reproductive age women, including abnormal uterine bleeding, pelvic pain...
Eligibility Criteria
Inclusion
- Reproductive aged women between in ages of 18 to 55 undergoing robotic assisted laparoscopic myomectomy.
Exclusion
- History of adverse reaction or allergy to Vasopressin.
- History of adverse reaction or allergy to Misoprostol.
- Medical contraindication to use of Vasopressin or Misoprostol
- Suspicion of possible reproductive cancer with contraindication of morcellation of uterine tissue.
- Significant medical condition or laboratory result that in the opinion of the Investigator indicate an increased vulnerability to study subject which exposes the subject to an unreasonable risk as a result of participating.
- Any clinically significant even or condition uncovered during the surgery, such as excessive bleeding or decompensation, that might render the subject medically unstable to continue the study or complicate the subject's intraoperative or postoperative course.
- Pregnant women
Key Trial Info
Start Date :
April 26 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2019
Estimated Enrollment :
74 Patients enrolled
Trial Details
Trial ID
NCT03815344
Start Date
April 26 2017
End Date
June 30 2019
Last Update
January 9 2024
Active Locations (1)
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1
Maimonides Medical Center
Brooklyn, New York, United States, 11219