Terlipressin vs Placebo to Reduce Bleeding in Fibroid Surgery

What Was Tested

In this not phased trial, researchers set out to test Terlipressin.

A myomectomy is a surgery to remove noncancerous growths (fibroids) from the uterus while keeping the uterus in place.

It had two arms (groups): Terlipressin Group (experimental) and Placebo Group (placebo comparator).

The registry classes the interventions as drug.

Who Took Part

80 planned participants were the target.

It was open to women only.

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

Examples of who could join: Symptomatic uterine fibroid(s) with an indication for myomectomy, including menorrhagia, pelvic pain/pressure, or infertility. Largest myoma diameter between 4 and 10 cm. Not pregnant at the time of enrollment. Negative urine pregnancy test or last menstrual period within 4 weeks. Willing and able to provide written informed consent.

The full record lists 6 inclusion and 13 exclusion criteria; among the exclusions: history of bleeding disorders or coagulopathy; current anticoagulant or antiplatelet therapy; known hypersensitivity or contraindication to terlipressin.

How the Study Was Run

The set-up was randomized, parallel-group and double-blind.

Random assignment meant chance, not the researchers, decided who got Terlipressin and who got the comparison, which limits bias.

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

As a double-blind Terlipressin study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant and outcomes assessor.

It started in 2026-08-01 with completion listed for 2026-12.

Its stated primary purpose is prevention.

What Was Measured

Primary outcome: Intraoperative Blood Loss (time frame: Intraoperative period (from skin incision to skin closure)).

It also tracked 8 secondary outcomes, for example Change in Hemoglobin and Hematocrit Levels, Rate of Blood Transfusion, Duration of Surgery, Requirement for Supplementary Hemostatic Intervention, Change in Blood Pressure and Rate of Postoperative Complications.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Terlipressin in 80 people.

Its status is not yet recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

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