Tranexamic Acid for Uterine Fibroids

Overseen By Traci Ito, MD

Age: 18 - 65

Sex: Female

Trial Phase: Phase 3

Sponsor: Eastern Virginia Medical School

Must not be taking: Estrogen, Oral contraceptives

Disqualifiers: Heart, Liver, Kidney, Pregnancy, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 5 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

Duration: 1 day

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This is a Double-blinded randomized placebo-controlled trial based at Eastern Virginia Medical School. Subjects who are identified in clinic having menorrhagia or abnormal Uterine bleeding (AUB) due to uterine fibroids and meet inclusion criteria based on the ultrasound (US) or Magnetic Resonance Imaging (MRI), aged 18-45 undergoing laparoscopic or Robotic assisted myomectomies. A total of 50 women in each arm of the study with symptomatic fibroids. Patients will be randomized to receive a single IV bolus injection of TXA 30mg/kg in 50ml of normal saline (intervention group) versus an IV bolus injection of normal saline of equivalent volume (placebo group) 15 minutes prior to initial surgical incision.

Who Is on the Research Team?

Seifeldin Sadek, MD

Principal Investigator

Eastern Virginia Medical School

Are You a Good Fit for This Trial?

This trial is for women aged 18-45 with abnormal uterine bleeding due to fibroids, who are undergoing laparoscopic myomectomy. They must have at least one large fibroid or multiple smaller ones and no history of blood clots, stroke, severe organ issues, or certain medication use that could interfere with the study.

Inclusion Criteria

I have a fibroid that is 4 cm or larger.

At least 3 total fibroids based on preoperative imaging

I am scheduled for a laparoscopic surgery to remove fibroids.

Exclusion Criteria

I have had a blood clot in my lung, arm, or leg before.

Pregnancy

I am currently using oral contraceptives.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person)

Treatment

Participants undergo laparoscopic or robotic-assisted myomectomies with either TXA or placebo administered 15 minutes prior to surgery

1 day

1 visit (in-person)

Postoperative Monitoring

Participants are monitored for immediate postoperative complications and assessed for side effects of the medication

2 days

In-hospital stay

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments at 2-week and 6-week postoperative visits

6 weeks

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Placebos
• Tranexamic Acid

Trial Overview The study tests if Tranexamic Acid (TXA) can reduce bleeding during minimally invasive surgery for uterine fibroids. Participants will either receive TXA or a placebo before surgery in this double-blinded trial where neither they nor the doctors know who gets which treatment.

How Is the Trial Designed?

Group I: Tranexamic Acid Experimental Treatment 1 Intervention

Patients will receive a single IV bolus injection of TXA 30mg/kg in 50ml of normal saline 15 minutes prior to initial surgical incision time

Group II: Placebo Placebo Group 1 Intervention

Patients will receive an IV bolus injection of normal saline of equivalent volume (placebo group) 15 minutes prior to initial surgical incision

Tranexamic Acid is already approved in United States, European Union, Canada, Japan for the following indications:

Approved in United States as Tranexamic Acid for:

• Heavy menstrual bleeding
• Prevention of excessive bleeding during surgeries

Approved in European Union as Tranexamic Acid for:

• Heavy menstrual bleeding
• Prevention of excessive bleeding during surgeries
• Hereditary angioedema

Approved in Canada as Tranexamic Acid for:

• Heavy menstrual bleeding
• Prevention of excessive bleeding during surgeries

Approved in Japan as Tranexamic Acid for:

• Heavy menstrual bleeding
• Prevention of excessive bleeding during surgeries

Who Is Running the Clinical Trial?

Eastern Virginia Medical School

Lead Sponsor

Trials

77

Recruited

16,500+