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Can a single injection curb blood loss in fibroid surgery?

NCT ID NCT07746349

Disease control Sponsor: Sevil Cankaya Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 05, 2026 · Last updated Aug 06, 2026 · Updated 1 time

Summary

This trial tests whether injecting a diluted solution of terlipressin, a drug that narrows blood vessels, under the outer layer of a uterine fibroid before removal can reduce blood loss during myomectomy surgery. Women scheduled for myomectomy will be randomly assigned to receive either the terlipressin injection or a placebo (salt water), and neither they nor the surgical team will know which they received. The main goal is to measure the amount of blood lost during surgery in each group, with additional checks on hemoglobin changes, transfusion needs, and surgery duration.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
terlipressin (a vasoconstrictor drug) injected under the fibroid capsule before removal
What this could lead to
If effective, this approach could reduce bleeding during fibroid surgery, lowering the need for transfusions and improving surgical safety.
What could go wrong
This is a small, early-stage trial, and the benefit may be modest or not confirmed. Terlipressin can cause side effects like high blood pressure or reduced blood flow to organs.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 80 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Jan 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Symptomatic uterine fibroid(s) with an indication for myomectomy, including menorrhagia, pelvic pain/pressure, or infertility * Largest myoma diameter between 4 and 10 cm * Baseline hemoglobin ≥ 9 g/dL * 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 Exclusion Criteria: * History of bleeding disorders or coagulopathy * Current anticoagulant or antiplatelet therapy * Known hypersensitivity or contraindication to terlipressin * Uncontrolled hypertension * Severe cardiac arrhythmia * Uncontrolled ischemic heart disease * Peripheral vascular disease * Pregnancy or suspected pregnancy * Previous myomectomy * Concurrent pelvic pathology requiring additional surgical intervention * Treatment with a GnRH agonist or ulipristal acetate within the 3 months preceding surgery * Suspected uterine malignancy, such as leiomyosarcoma * Inability to understand or provide informed consent

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Conditions

The condition(s) this trial relates to.

leiomyoma myofibroma uterine corpus leiomyoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Leiomyoma Uterine fibroids (leiomyoma) Uterine myoma

How to take part

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  1. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  2. A doctor treating you

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