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Terlipressin vs Placebo to Reduce Bleeding in Fibroid Surgery

NCT07746349 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2026-08-05

No results posted yet for this study

Summary

A myomectomy is a surgery to remove noncancerous growths (fibroids) from the uterus while keeping the uterus in place. This surgery can cause significant blood loss. Terlipressin is a medicine that narrows blood vessels and may help reduce bleeding.

This study will test whether injecting a diluted terlipressin solution under the outer covering of the fibroid, before it is removed, reduces the amount of blood lost during surgery, compared to an inactive solution (placebo). Women scheduled for myomectomy will be randomly assigned to receive either terlipressin or placebo. Neither the patients nor the surgical team will know which one was given until the study is finished. The main question this study will answer is how much blood is lost during surgery in each group.

Conditions

  • Uterine Fibroids (Leiomyoma)
  • Uterine Myoma
  • Leiomyoma

Interventions

DRUG

terlipressin (vasoconstrictor)

Terlipressin 1 mg diluted in 40 mL normal saline, administered as a single subcapsular injection prior to fibroid enucleation

DRUG

Placebo

40 mL normal saline, administered as a single subcapsular injection prior to fibroid enucleation

Sponsors & Collaborators

  • Sevil Cankaya

    lead OTHER

Principal Investigators

  • Sevil Çankaya, MD · Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-01
Primary Completion
2026-12-31
Completion
2027-01-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07746349 on ClinicalTrials.gov