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
- Are there results?
- Not yet: the study is under way
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
Show all 13Show fewer
- 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
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Subcapsular Diluted Terlipressin Versus Placebo in Reducing Intraoperative Blood Loss During Myomectomy: A Randomized, Double-Blind, Placebo-Controlled Trial
- ClinicalTrials.gov ID
- NCT07746349
- Acronym / sponsor ID
- 2025/490
- Conditions
- Uterine Fibroids (Leiomyoma), Uterine Myoma, Leiomyoma
- Keywords
- Terlipressin, Myomectomy, Uterine Fibroids, Subcapsular Injection, Intraoperative Blood Loss, Vasopressin Analog, Placebo-Controlled Trial
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Sevil CankayaUniversity, hospital or other
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 5 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Terlipressin Group | Experimental | Drug: terlipressin (vasoconstrictor)Subcapsular injection of 1 mg terlipressin diluted in 40 mL normal saline, administered prior to fibroid enucleation during myomectomy |
| Placebo Group | Placebo comparator | Drug: PlaceboSubcapsular injection of 40 mL normal saline (no active drug), administered prior to fibroid enucleation during myomectomy |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (13 listed)
- History of bleeding disorders or coagulopathy
- Current anticoagulant or antiplatelet therapy
- Known hypersensitivity or contraindication to terlipressin
- Uncontrolled hypertension
- Severe cardiac arrhythmia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| terlipressin (vasoconstrictor)Terlipressin 1 mg diluted in 40 mL normal saline, administered as a single subcapsular injection prior to fibroid enucleation | Drug | Terlipressin Group |
| Placebo40 mL normal saline, administered as a single subcapsular injection prior to fibroid enucleation | Drug | Placebo Group |
Primary outcome
Intraoperative Blood Loss
Time frame: Intraoperative period (from skin incision to skin closure)
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).
8 secondary outcomes
Change in Hemoglobin and Hematocrit Levels
Time frame: Baseline (preoperative) to 24 hours postoperative
Rate of Blood Transfusion
Time frame: From surgery through hospital discharge
Duration of Surgery
Time frame: Intraoperative period
Requirement for Supplementary Hemostatic Intervention
Time frame: Intraoperative period
Change in Blood Pressure
Time frame: Pre-injection through 30 minutes post-injection
Rate of Postoperative Complications
Time frame: Through hospital discharge (and 30-day follow-up, if planned)
Duration of Hospitalization
Time frame: From the day of surgery until hospital discharge
Change in Heart Rate
Time frame: Pre-injection through 30 minutes post-injection
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2026.
- Results publication: PubMed 33461754Taher 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.
- Results publication: PubMed 40164039Elbanna 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.
- Results publication: PubMed 34335897Matasariu 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.
- A Romanian study on the impact of glypressin in laparoscopic myomectomyLink provided by the sponsor.
- 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 trialLink provided by the sponsor.
- Evaluating efficacy of intravenous carbetocin in reducing blood loss during abdominal myomectomy: a randomized controlled trialLink provided by the sponsor.
- Individual participant dataSharing planned: 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ahmet Kale, MD contact
Sevil Çankaya, MD principal investigator
Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital
Questions about this trial
What is this clinical trial studying?
A study testing terlipressin (vasoconstrictor) in people with Uterine Fibroids (Leiomyoma) and Uterine Myoma, run by Sevil Cankaya.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sevil Çankaya, MD (+90 505 866 34 09, sevilsaltek82@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intraoperative Blood Loss (time frame: Intraoperative period (from skin incision to skin closure)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07746349, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2026; AzTrials last refreshed its copy on 8 Nov 2026.