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Hormone Therapy

Carbetocin for Postpartum Hemorrhage

Phase 1
Waitlist Available
Research Sponsored by Ferring Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 240 minutes after start of infusion
Awards & highlights

Study Summary

This trial will look at the effects of carbetocin, a drug used to prevent bleeding after birth, on the electrical signals in the heart of healthy people.

Eligible Conditions
  • Postpartum Hemorrhage

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 240 minutes after start of infusion
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 240 minutes after start of infusion for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change from baseline of HR (∆HR).
Observed Heart rate(HR) values
Placebo-corrected change from baseline in QT interval (∆∆QTc) using the most appropriate HR correction method (i.e., ∆∆QTcF if Fridericia's method is used).
Secondary outcome measures
12-lead safety ECGs
Abnormalities in T wave morphology and pathologic U waves, as appropriate.
Carbetocin PK parameters: AUC%extrap
+52 more

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: CarbetocinExperimental Treatment1 Intervention
Single IV infusion of carbetocin
Group II: Placebo and MoxifloxacinActive Control1 Intervention
Single IV infusion of matching placebo with a single oral dose of moxifloxacin
Group III: PlaceboPlacebo Group1 Intervention
Single IV Infusion of matching placebo
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Carbetocin
2019
Completed Phase 4
~8290

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Ferring PharmaceuticalsLead Sponsor
313 Previous Clinical Trials
440,818 Total Patients Enrolled
1 Trials studying Postpartum Hemorrhage
5,798 Patients Enrolled for Postpartum Hemorrhage
Global Clinical ComplianceStudy DirectorFerring Pharmaceuticals
62 Previous Clinical Trials
357,355 Total Patients Enrolled

Media Library

Carbetocin (Hormone Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05924321 — Phase 1
Postpartum Hemorrhage Research Study Groups: Placebo and Moxifloxacin, Carbetocin, Placebo
Postpartum Hemorrhage Clinical Trial 2023: Carbetocin Highlights & Side Effects. Trial Name: NCT05924321 — Phase 1
Carbetocin (Hormone Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05924321 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are actively engaging in this trial?

"Affirmative. Per the information hosted on clinicaltrials.gov, this medical study is still actively recruiting participants since it was first posted on May 25th 2023 and last updated June 20th of the same year. The trial seeks 48 individuals from a single site."

Answered by AI

Am I eligible to partake in this medical study?

"In order to be admitted into this clinical trial, the patient must have experienced postpartum hemorrhaging and fall within the age range of 18-45. A total of 48 individuals are needed for enrollment."

Answered by AI

Has Carbetocin been given regulatory clearance by the Food and Drug Administration?

"Due to the limited clinical data available, Carbetocin's safety score was assigned a value of 1. This is because it is currently in Phase 1 trials and its efficacy remains largely untested."

Answered by AI

What beneficial results are researchers expecting from this clinical trial?

"The primary purpose of this 240 minute trial is to measure the variation in heart rate (∆HR) from baseline. Secondary objectives include analysing changes in bilirubin concentration, leukocyte count and specific gravity via blood sample collection and urine sample collection respectively."

Answered by AI

Does this clinical exploration accept participants of legal age?

"The age range for participants in this trial starts at 18 years and concludes before the patient is 45."

Answered by AI

Are there any unfilled slots for participants in this experiment?

"Affirmative. The clinicaltrials.gov entry for this trial has been updated on June 20th, evidencing that it is actively recruiting participants. It was first listed on May 25th and the investigators are searching to enrol 48 patients from a single site."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Study to Evaluate the Effect of Carbetocin on the QT/QTc Interval in Healthy Subjects
2023. "A Study to Evaluate the Effect of Carbetocin on the QT/QTc Interval in Healthy Subjects". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05924321.
~21 spots leftby Apr 2025
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