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Carboprost for Fibroid Resection

Phase < 1

Waitlist Available

Led By Magdy p Milad, MD, MS

Research Sponsored by Northwestern University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients scheduled to undergo myomectomy with a surgeon in the division of Minimally Invasive Gynecologic Surgery

Be older than 18 years old

Must not have

Anemia (Hgb < 7g/dL), diabetes mellitus, jaundice, or epilepsy

Active cardiac disease, pulmonary disease, or pelvic inflammatory disease (PID)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, up to 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial will test if a low dose of carboprost helps remove fibroids during surgery.

Who is the study for?

This trial is for patients planning to have fibroid removal surgery with a specific team of surgeons and who can understand and sign consent. It's not for those who've taken certain labor-inducing drugs, have active heart or lung disease, PID, severe anemia, diabetes, jaundice, epilepsy, or kidney/liver problems.

What is being tested?

The study is testing whether a low dose of Carboprost (Hemabate) makes it easier to remove uterine fibroids during surgery. The focus is on using less than the usual amount of this medication to see if it still helps in the surgical process.

What are the potential side effects?

Carboprost may cause side effects like nausea and vomiting, diarrhea, fever or chills; it might also induce strong contractions of the uterus which could be uncomfortable.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am scheduled for a myomectomy with a minimally invasive gynecologic surgeon.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have anemia, diabetes, jaundice, or epilepsy.

Select...

I do not have active heart, lung, or pelvic inflammatory disease.

Select...

I have had kidney or liver problems in the past.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, up to 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Carboprost

Secondary study objectives

To quantitatively assess the efficiency of fibroid resection after carboprost administration by analyzing the video recording from surgery

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: HemabateExperimental Treatment1 Intervention

Dilute the 250mcg/mL vial with 25mL saline to create a solution of 10mcg/mL, and inject no more than 10mL of diluted solution at the base of the fibroid. The route of administration depends on the location of the fibroid.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Carboprost Tromethamine

2022

Completed Early Phase 1

~20

0 / 4Eligibility criteria met