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NCT07746349Not yet recruiting

Terlipressin vs Placebo to Reduce Bleeding in Fibroid Surgery

Efficacy of Subcapsular Diluted Terlipressin Versus Placebo in Reducing Intraoperative Blood Loss During Myomectomy: A Randomized, Double-Blind, Placebo-Controlled Trial

Source: ClinicalTrials.gov · Last updated 5 Aug 2026

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Study type
Interventional
Enrollment
80 (estimated)
First submitted
24 Jul 2026
Start date
1 Aug 2026
Primary completion date
Dec 2026
Lead sponsor
Sevil Cankaya
NCT number
NCT07746349

What you commit to

  • Study type: Interventional
  • Planned participants: 80
  • From 1 Aug 2026 to the primary completion date, Dec 2026
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Current anticoagulant or antiplatelet therapy
  • Previous myomectomy
  • Concurrent pelvic pathology requiring additional surgical intervention
  • Treatment with a GnRH agonist or ulipristal acetate within the 3 months preceding surgery

Other illness

  • History of bleeding disorders or coagulopathy
  • Known hypersensitivity or contraindication to terlipressin
  • Uncontrolled hypertension
  • Severe cardiac arrhythmia
  • Uncontrolled ischemic heart disease
  • Peripheral vascular disease
  • Suspected uterine malignancy, such as leiomyosarcoma

Other

  • Pregnancy or suspected pregnancy
  • Inability to understand or provide informed consent

Who the study is looking for

  • 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

Sex: Female · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.