The Efficacy of Carbitocin in Reduction of Blood Loss During Myomectomy

What Was Tested

This registered early phase 1 trial tested Carbetocin.

The uterine fibroids are the most common benign tumors found in the female reproductive system.

Uterine fibroids commonly cause heavy menstrual periods.

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

Will receive intravenous placebo (Injection water).

The registry classes the interventions as drug.

More on the Plan

INTRODUCTION The uterine fibroids - heavy bleeding during myomectomy.

Cabetocin is a synthetic analogue of oxytocin, with a longer half-life than oxytocin.

To determine if the FIGO stage (Munro, 2011) of the Myoma affect the cabetocin effect.

To assess any intraoperative side effect.

Who Took Part

Enrollment: 900 planned participants were the target.

It was open to women only.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: All consented women booked for myomectomy. No know allergy to Cabetocin. Billed for open abdominal myomectomy.

The full record lists 3 inclusion and 11 exclusion criteria; among the exclusions: declined consent; allergy to cabetocin; planned for additional uterotonic.

How the Study Was Run

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

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

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

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

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

It started in 2026-08-15 with completion listed for 2028-08-14.

Its stated primary purpose is prevention.

What Was Measured

Primary outcome: Haemoglobin Change (time frame: 24months).

It also tracked 1 secondary outcome, for example Transfusion rates.

What This Means in Plain Language

Put simply, this is a early phase 1, randomized trial of Carbetocin in 900 people.

With 900 participants it is a large trial for this field.

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

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