Uterine Fibroids (Leiomyoma)NCT07746349
Terlipressin vs Placebo to Reduce Bleeding in Fibroid Surgery
A study testing terlipressin (vasoconstrictor) in people with Uterine Fibroids (Leiomyoma) and Uterine Myoma, run by Sevil Cankaya.
Trial 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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Uterine Fibroids (Leiomyoma), Uterine Myoma, Leiomyoma
- What is being tested?
- terlipressin (vasoconstrictor)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2026to Jan 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Ahmet Kale, MD contact
About this study
Official title: Efficacy of Subcapsular Diluted Terlipressin Versus Placebo in Reducing Intraoperative Blood Loss During Myomectomy: A Randomized, Double-Blind, Placebo-Controlled Trial
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.
Read the detailed description
Myomectomy is frequently complicated by significant intraoperative bleeding. While vasoconstrictive and uterotonic agents such as vasopressin, carbetocin, and undiluted terlipressin have been studied for hemostasis, no prior trial has evaluated a diluted terlipressin solution administered via the subcapsular route. This study aims to address this gap by comparing 1 mg terlipressin diluted in 40 mL normal saline, injected subcapsularly, versus placebo, with intraoperative blood loss as the primary outcome
- Conditions
- Uterine Fibroids (Leiomyoma), Uterine Myoma, Leiomyoma
- Being tested
- terlipressin (vasoconstrictor), Placebo
- Keywords
- Terlipressin, Myomectomy, Uterine Fibroids, Subcapsular Injection, Intraoperative Blood Loss, Vasopressin Analog, Placebo-Controlled Trial
- Medical subject headings
- Leiomyoma, Myofibroma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
terlipressin (vasoconstrictor)Drug
Terlipressin 1 mg diluted in 40 mL normal saline, administered as a single subcapsular injection prior to fibroid enucleation
PlaceboDrug
40 mL normal saline, administered as a single subcapsular injection prior to fibroid enucleation
| Study group | Role | What they receive |
|---|---|---|
| Terlipressin Group | Experimental | Subcapsular injection of 1 mg terlipressin diluted in 40 mL normal saline, administered prior to fibroid enucleation during myomectomy Receives: Drug: terlipressin (vasoconstrictor) |
| Placebo Group | Placebo comparator | Subcapsular injection of 40 mL normal saline (no active drug), administered prior to fibroid enucleation during myomectomy Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraoperative Blood Loss
Blood loss will be measured gravimetrically as the difference in weight of surgical sponges and drapes before and after use, plus the volume collected in the suction canister, minus the volume of irrigation fluid used. The result will be expressed in milliliters (mL).
Measured: Intraoperative period (from skin incision to skin closure)
Secondary outcomes (8)
Change in Hemoglobin and Hematocrit Levels
Difference between preoperative and 24-hour postoperative hemoglobin (g/dL) and hematocrit (%) levels
Measured: Baseline (preoperative) to 24 hours postoperative
Rate of Blood Transfusion
Proportion of participants requiring intraoperative or postoperative blood transfusion
Measured: From surgery through hospital discharge
Duration of Surgery
Time from skin incision to skin closure, recorded in minutes
Measured: Intraoperative period
Requirement for Supplementary Hemostatic Intervention
Proportion of participants requiring additional hemostatic measures (e.g., additional sutures, electrocautery) beyond the study intervention
Measured: Intraoperative period
Change in Blood Pressure
Systolic and diastolic blood pressure measured at predefined time points.
Measured: Pre-injection through 30 minutes post-injection
Rate of Postoperative Complications
Incidence of complications including wound infection, hematoma, and other surgery-related adverse events
Measured: Through hospital discharge (and 30-day follow-up, if planned)
Duration of Hospitalization
Number of days from surgery to discharge
Measured: From the day of surgery until hospital discharge
Change in Heart Rate
Heart rate measured at predefined time points.
Measured: Pre-injection through 30 minutes post-injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2026
- Study start1 Aug 2026 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Uterine Fibroids (Leiomyoma)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly allocated in a 1:1 ratio to receive either subcapsular diluted terlipressin or placebo (saline) injection prior to fibroid enucleation during myomectomy. Both groups will be followed using identical perioperative and postoperative assessment protocols.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sevil Cankaya
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sevil Cankaya, Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital
- Investigators
- Sevil Çankaya, MD, Principal investigator, Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07746349
- Sponsor's protocol ID
- 2025/490
- Status last verified
- Jul 2026
- First submitted
- 24 Jul 2026
- Last updated
- 5 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan currently exists for IPD sharing beyond what is reported in the results of this study. Data will be made available from the corresponding author upon reasonable request, subject to institutional and ethics committee approval
Publications
Taher A, Farouk D, Mohamed Kotb MM, Ghamry NK, Kholaif K, A Mageed A Allah A, Ali AS, Osman OM, Nabil H, Islam Y, Bakry MS, Islam BA, Alalfy M, Nassar SA, Bosilah AH, Ghanem AA, Ali Rund NM, Refaat R, Abdel Wahed Ali HA, Bakry A, Ashour ASA, Nabil M, Zaki SS. Evaluating efficacy of intravenous carbetocin in reducing blood loss during abdominal myomectomy: a randomized controlled trial. Fertil Steril. 2021 Mar;115(3):793-801. doi: 10.1016/j.fertnstert.2020.09.132. Epub 2021 Jan 16.
PubMed 33461754Elbanna W, Al Sheikh MM, Azmy OM. The effect of intramyometrial injection of terlipressin versus carbetocin on hemoglobin and blood loss during open myomectomy operations without using haemostatic tourniquets: Double blinded randomized placebo-controlled trial. Eur J Obstet Gynecol Reprod Biol. 2025 May;309:186-191. doi: 10.1016/j.ejogrb.2025.03.041. Epub 2025 Mar 22.
PubMed 40164039Matasariu DR, Ursache A, Himiniuc L, Toma B, Boiculese VL, Rudisteanu D, Dumitrascu I. A Romanian study on the impact of glypressin in laparoscopic myomectomy. Exp Ther Med. 2021 Sep;22(3):955. doi: 10.3892/etm.2021.10387. Epub 2021 Jul 6.
PubMed 34335897