Vasopressin Versus Epinephrine in Myomectomy

What Was Tested

In this phase 3 trial, researchers set out to test Vasopressin.

Uterine myomas (fibroids or leiomyomas) are the most common benign tumor of the female genital tract and the leading indication for hysterectomy.

Although hysterectomy is the definitive treatment of myomas, myomectomy remains the gold standard treatment for women desiring future fertility and uterine conservation3.

However, bleeding is often a problem in myomectomy and can results in intraoperative hypovolemic shock, postoperative anemia, pelvic infection, and adhesions with infertility.

It had two arms (groups): Epinephrine (experimental) and Vasopressin (active comparator).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 60 actual participants took part.

It was open to women only aged from 18 years up to 75 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Women who had myoma-related symptoms such as menorrhagia, pelvic pressure/pain, or infertility. Women who were not pregnant at the time of presentation (i.e., negative for urine pregnancy test or last menstrual period within the last 4 weeks). Women who were appropriated medical status for laparoscopic surgery (American Society of Anesthesiologists Physical Status classification 1 or 2).

The full record lists 3 inclusion and 6 exclusion criteria; among the exclusions: any pelvic abnormalities requiring concomitant surgery; the presence of pedunculated subserosal or submucosal myoma as a dominant myoma; the presence of myoma of maximum diameter 10 cm based on the preoperative ultrasound.

How the Study Was Run

It was run as a randomized, parallel-group and triple-blind study.

The participants were allocated by chance, so the Vasopressin group and the comparison group should start out alike.

The Vasopressin group and the comparison group ran side by side rather than switching.

Neither the participants nor the staff measuring them knew who was on Vasopressin, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant, investigator and outcomes assessor.

It started in 2013-05 with completion listed for 2014-03.

It ran at 1 site in South Korea.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Operative blood loss (time frame: Surgery date).

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Vasopressin in 60 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Vasopressin compound page, all human trials.