Clinical Trials

Carbetocin Acetate has been evaluated across numerous clinical trials focusing primarily on the prevention and management of postpartum hemorrhage, uterine atony, and surgical blood loss during cesarean sections and myomectomy procedures. These investigations encompass early phase 1 through phase 4 clinical trials, examining parameters such as optimal dosing, comparative efficacy against standard uterotonics, and cardiac safety profiles like QTc interval evaluations in studies such as NCT05924321. Sponsored by academic medical centers, university hospitals, and pharmaceutical organizations including Ferring Pharmaceuticals and Cairo University, the clinical portfolio features varied recruitment statuses ranging from completed and active recruiting to terminated studies. Trials such as NCT02277067 and NCT02303418 specifically assess its therapeutic utility in high-risk obstetric cohorts undergoing surgical deliveries.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07721623 NOT_YET_RECRUITING
Blood Loss, Surgical
Alex Ekwueme Federal University Teaching Hospital
 2026-08-15 EARLY_PHASE1
NCT07636421 NOT_YET_RECRUITING
Postpartum Hemorrhage; Uterine Atony; Cesarean Section; Blood Loss, Surgical
Mansoura University
 2026-08 PHASE4
NCT07401524 RECRUITING
Postpartum Hemorrhage; Twin Pregnancy
Sheba Medical Center
 2026-05-05 PHASE4
NCT07353281 NOT_YET_RECRUITING
Postpartum Complication; Postpartum Hemorrhage
Western Galilee Hospital-Nahariya
 2026-01-31
NCT06285409 RECRUITING
Postpartum Hemorrhage
Samuel Lunenfeld Research Institute, Mount Sinai Hospital
 2024-04-04
NCT07187544 RECRUITING
Postpartum Hemorrhage (Primary)
Samuel Lunenfeld Research Institute, Mount Sinai Hospital
 2025-12-01
NCT06333340 RECRUITING
Post Partum Hemorrhage
Samuel Lunenfeld Research Institute, Mount Sinai Hospital
 2025-01-14
NCT06946589 NOT_YET_RECRUITING
Cardiac Ischemia; Cesarian Section
Jordan Leitch
 2025-08-01 PHASE4
NCT07390864 RECRUITING
Myoma;Uterus
Cairo University
 2026-01-18
NCT07318467 NOT_YET_RECRUITING
Post Partum Hemorrhage
Cairo University
 2026-01-01
NCT06930391 RECRUITING
Postpartum Hemorrhage (Primary)
Samuel Lunenfeld Research Institute, Mount Sinai Hospital
 2025-09-15
NCT06420297 TERMINATED
Hyperphagia in Prader-Willi Syndrome
ACADIA Pharmaceuticals Inc.
 2024-03-11 PHASE3
NCT06173531 ACTIVE_NOT_RECRUITING
Hyperphagia in Prader-Willi Syndrome
ACADIA Pharmaceuticals Inc.
 2023-11-27 PHASE3
NCT07380529 COMPLETED
Postpartum Hemorrhage \(PPH\)
Ankara Etlik City Hospital
 2024-10-01
NCT06776926 COMPLETED
Postpartum Hemorrhage; Carbetocin
Mehmet Mete Kırlangıç
 2025-01-10
NCT05266534 RECRUITING
Myoma
Wael Elbanna Clinic
 2021-12-30
NCT05806307 UNKNOWN
Misoprostol Allergy; Oxytocin Allergy; Tranexamic Acid Allergy; Ethamsylate Allergy; Myoma; Blood Loss, Surgical
Cairo University
 2023-03-15 PHASE4
NCT06217354 COMPLETED
Obesity, Maternal; Post Partum Hemorrhage
Cairo University
 2023-07-06 PHASE1; PHASE2
NCT05924321 COMPLETED
Postpartum Hemorrhage
Ferring Pharmaceuticals
 2023-05-25 PHASE1
NCT05986266 COMPLETED
Uterine Fibroid
Egymedicalpedia
 2023-02-01 PHASE1
NCT05110482 UNKNOWN
Adverse Effect of Oxytocic Drugs
Cairo University
 2021-11-30 PHASE4
NCT05742854 UNKNOWN
Carbetocin; Oxytocic Drugs Causing Adverse Effects in Therapeutic Use
Ege University
 2023-03-09 PHASE4
NCT05664659 COMPLETED
Blood Loss, Surgical; Intrapartum Hemorrhage
Ain Shams Maternity Hospital
 2022-12-20 PHASE4
NCT04182360 COMPLETED
Postpartum Hemorrhage; Twin
Samuel Lunenfeld Research Institute, Mount Sinai Hospital
 2021-10-14
NCT05467462 COMPLETED
Postpartum Hemorrhage
Bezmialem Vakif University
 2022-08-01
NCT05479357 UNKNOWN
Atonic Postpartum Hemorrhage; High Risk Pregnancy
Sohag University
 2022-07-28
NCT04902729 COMPLETED
Post Partum Hemorrhage
Samuel Lunenfeld Research Institute, Mount Sinai Hospital
 2021-07-20
NCT04595812 UNKNOWN
Abdominal Myomectomy; Blood Loss
Cairo University
 2020-11-01 PHASE4
NCT03899961 COMPLETED
Pregnancy Complications
Oslo University Hospital
 2019-04-02 PHASE4
NCT04201665 COMPLETED
Postpartum Hemorrhage
University Medical Centre Ljubljana
 2020-09-13
NCT05083910 COMPLETED
Postpartum Hemorrhage
Bezmialem Vakif University
 2021-07-01
NCT03651882 COMPLETED
Postpartum Hemorrhage
University of Zurich
 2018-08-07 PHASE4
NCT04482959 COMPLETED
Myoma;Uterus
Mansoura University Hospital
 2020-07-15 PHASE4
NCT03870256 COMPLETED
Post Partum Hemorrhage
Aswan University Hospital
 2019-04-01
NCT02277067 UNKNOWN
Postpartum Hemorrhage
Beni-Suef University
 2014-10 PHASE4
NCT03870503 COMPLETED
Postpartum Hemorrhage
Aswan University Hospital
 2019-04-01
NCT02277041 UNKNOWN
Postpartum Hemorrhage
Beni-Suef University
 2014-10 PHASE4
NCT03777878 UNKNOWN
Cesarean Section Complications
Aswan University Hospital
 2019-01-01
NCT04756661 COMPLETED
Preeclampsia Severe
Assiut University
 2020-01-01
NCT03168698 COMPLETED
Postpartum Hemorrhage
Samuel Lunenfeld Research Institute, Mount Sinai Hospital
 2017-05-25
NCT02642263 UNKNOWN
Cesarean Delivery
Insel Gruppe AG, University Hospital Bern
 2019-02-01 PHASE4
NCT04357015 UNKNOWN
Myomectomy
Cairo University
 2020-05-01 PHASE4
NCT04300452 UNKNOWN
Postpartum Hemorrhage
National and Kapodistrian University of Athens
 2018-04-05 PHASE4
NCT03708497 COMPLETED
Postpartum Hemorrhage
Aswan University Hospital
 2018-12-01
NCT03710317 COMPLETED
Cesarean Section Complications
Aswan University Hospital
 2018-12-01
NCT03649477 COMPLETED
Prader-Willi Syndrome
Levo Therapeutics, Inc.
 2018-11-20 PHASE3
NCT03578263 COMPLETED
Cesarean Section Complications
Aswan University Hospital
 2018-04-01
NCT04083625 COMPLETED
Abdominal Myomectomy
Cairo University
 2019-09-10 PHASE4
NCT03404544 COMPLETED
Cesarean Section Complications; Hemodynamic Instability
Ciusss de L'Est de l'Île de Montréal
 2018-06-11 PHASE4
NCT02786992 COMPLETED
Cesarean Section
Ain Shams University
 2016-05 PHASE2; PHASE3
NCT03693599 COMPLETED
Post Partum Hemorrhage
Cairo University
 2018-10-01 PHASE4
NCT03716076 COMPLETED
Cardiac Arrythmias
University of British Columbia
 2018-11-01 PHASE4
NCT03556852 COMPLETED
Postpartum Hemorrhage
Cairo University
 2018-07-02 PHASE4
NCT03672045 COMPLETED
Postpartum Hemorrhage
Samuel Lunenfeld Research Institute, Mount Sinai Hospital
 2018-11-19
NCT04089176 COMPLETED
Postpartum Hemorrhage; Cesarean Section; High Risk Pregnancy
Department of Medical Services Ministry of Public Health of Thailand
 2019-02-01 EARLY_PHASE1
NCT02528136 COMPLETED
Pregnancy
Oslo University Hospital
 2015-09 PHASE4
NCT02216383 COMPLETED
Post Partum Haemorrhage
North Bristol NHS Trust
 2015-02 PHASE3
NCT03755531 COMPLETED
Postpartum Hemorrhage (Primary)
Al-Kindy College of Medicine
 2018-01-04 PHASE4
NCT02303418 UNKNOWN
Post Partum Haemorrhage
Cairo University
 2014-11 PHASE3
NCT02410759 UNKNOWN
Post Partum Hemorrhage
Cairo University
 2015-04 PHASE3
NCT02391636 COMPLETED
Postpartum Hemorrhage
Ghamra Military Hospital
 2015-02 PHASE4
NCT02636816 COMPLETED
Effect of Carbetocin on Cardiovascular System; Pregnancy
University of British Columbia
 2016-03 PHASE4
NCT02044549 COMPLETED
Postpartum Hemorrhage; Blood Loss
Cairo University
 2014-06 PHASE4
NCT01382732 UNKNOWN
Severe Preeclampsia; Postpartum Hemorrhage
Saint Thomas Hospital, Panama
 2012-01 PHASE3
NCT02221531 COMPLETED
Complications; Cesarean Section; Anesthesia; Reaction
University Hospital, Basel, Switzerland
 2014-08 PHASE4
NCT02396303 UNKNOWN
Postpartum Haemorrhage
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
 2015-06 EARLY_PHASE1
NCT02086994 COMPLETED
Severe Pre-eclampsia, Postpartum Condition or Complication
khalid abd aziz mohamed
 2013-03 PHASE3
NCT02304042 COMPLETED
Delivery
Cairo University
 2014-11 PHASE3
NCT02101567 COMPLETED
Bleeding; Anemia
Beni-Suef University
 2014-05 PHASE4
NCT02264769 COMPLETED
Postpartum Hemorrhage
Samuel Lunenfeld Research Institute, Mount Sinai Hospital
 2014-10
NCT01918475 COMPLETED
Pain; Hyperalgesia; Central Sensitization
Insel Gruppe AG, University Hospital Bern
 2013-07
NCT02304055 COMPLETED
Obstetrics
Cairo University
 2013-05 PHASE3
NCT01968187 COMPLETED
Hyperphagia in Prader-Willi Syndrome
Ferring Pharmaceuticals
 2014-01-20 PHASE2
NCT01719952 COMPLETED
Pregnancy Related; Anaesthesia
Universiti Kebangsaan Malaysia Medical Centre
 2012-01
NCT01827124 UNKNOWN
CARBETOCIN FOR PREVENTION OF PLACENTAL RETAINED
Wafaa Uthman Ahmed
 2013-04 PHASE4
NCT02079558 COMPLETED
Postpartum Hemorrhage
Shahid Beheshti University of Medical Sciences
 2012-09 PHASE2
NCT02053922 COMPLETED
Postpartum Hemorrhage
Ain Shams University
 2012-12 PHASE3
NCT01600612 UNKNOWN
Postpartum Hemorrhage
Sohag University
 2012-09
NCT01579201 UNKNOWN
Postpartum Hemorrhage; Uterine Atony
Maisonneuve-Rosemont Hospital
 2012-03 PHASE4
NCT01725243 COMPLETED
Postpartum Hemorrhage
Samuel Lunenfeld Research Institute, Mount Sinai Hospital
 2012-11
NCT01651130 COMPLETED
Postpartum Hemorrhage
Samuel Lunenfeld Research Institute, Mount Sinai Hospital
 2012-06
NCT01630187 COMPLETED
Uterine Atony; Post-partum Hemorrhage
Laval University
 2012-04 PHASE4
NCT01689298 COMPLETED
Postpartum Hemorrhage
Samuel Lunenfeld Research Institute, Mount Sinai Hospital
 2010-01
NCT01428817 COMPLETED
Postpartum Hemorrhage
Samuel Lunenfeld Research Institute, Mount Sinai Hospital
 2011-06
NCT00977769 COMPLETED
Effects of; Anesthesia, in Pregnancy
Oslo University Hospital
 2009-11 PHASE4
NCT01262742 COMPLETED
Postpartum Hemorrhage
Samuel Lunenfeld Research Institute, Mount Sinai Hospital
 2010-11
NCT00499005 COMPLETED
Postpartum Haemorrhage
National University Hospital, Singapore
 2006-11 PHASE4

(data from https://clinicaltrials.gov, updated on 2026-07-23)

Check the Carbetocin Acetate product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Carbetocin Acetate acts as a potent agonist of the oxytocin receptor (OXTR), selectively binding to transmembrane receptors on myometrial cells to trigger phospholipase C activation and intracellular calcium mobilization. This signaling cascade promotes sustained rhythmic uterine contractions and increased muscular tone, thereby counteracting uterine atony and reducing excessive blood loss in patients undergoing cesarean delivery or myomectomy procedures.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

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Note: Technical data last updated: Sep 1, 2026.