Terlipressin vs Placebo to Reduce Bleeding in Fibroid Surgery (NCT07746349) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Terlipressin vs Placebo to Reduce Bleeding in Fibroid Surgery
80 participantsStarted 2026-08-01
Plain-language 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.
Who can participate
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is comparing terlipressin to a placebo during fibroid surgery to see if it reduces blood loss — can you explain how terlipressin is supposed to work, and whether there's already evidence suggesting it might help in surgeries like mine?
2Since this trial isn't recruiting yet, how long do you think it might be before I could even have the option to enroll, and is waiting a realistic choice given my current fibroid symptoms?
3The trial is listed as Phase NA, which I understand might mean it's a practical or surgical intervention study rather than an early drug trial — what does that mean for how much is already known about the safety of using terlipressin during this type of surgery?
4If the main thing being measured is how much blood I lose during surgery, what are the potential risks if the terlipressin doesn't work as hoped, and would I have access to standard blood-loss management techniques either way?
5Are there already approved or standard approaches to reducing blood loss during fibroid removal surgery that I should consider first, or would participating in this trial be a reasonable alternative to explore alongside those options?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Intraoperative Blood Loss
Timeframe: Intraoperative period (from skin incision to skin closure)