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 trial tests the effectiveness of tranexamic acid, a medication, for women with heavy menstrual bleeding due to uterine fibroids. Researchers aim to determine if it can reduce blood loss during fibroid removal surgery. Women with at least three fibroids, including one that is 6 cm or larger, who plan to undergo surgery may qualify. Participants will receive either tranexamic acid or a placebo (a harmless substance) before their surgery. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the opportunity to contribute to a potentially groundbreaking treatment.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that tranexamic acid is generally safe for treating uterine fibroids. Studies have found that it can help reduce the heavy menstrual bleeding often associated with fibroids. Most side effects are mild, though they can occur. The FDA has already approved tranexamic acid for other uses, indicating it is well-tolerated. This approval offers reassurance about its safety for new uses, such as in this trial for uterine fibroids. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for uterine fibroids, which often include hormonal therapies or surgical options, Tranexamic Acid works by stabilizing blood clots to reduce excessive bleeding. Researchers are excited about this treatment because it offers a potentially less invasive option with a unique mechanism of action compared to existing therapies. It is administered as a single intravenous injection, which may provide rapid relief from symptoms, potentially improving quality of life without the need for ongoing medication or surgery.

What evidence suggests that Tranexamic Acid might be an effective treatment for uterine fibroids?

Research has shown that tranexamic acid, which participants in this trial may receive, helps reduce menstrual bleeding in women with uterine fibroids. Studies have found it can decrease bleeding by 26% to 50%, proving more effective than some common pain relievers. For women with heavy periods, tranexamic acid reduced blood loss by an average of 89 mL. It also improved the quality of life for about 40% of women with heavy periods. While it doesn't address the underlying cause of the bleeding, it makes symptom management much easier. ^{1 2 5 6 7}

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4266839/

Tranexamic acid for the management of uterine fibroid tumors CONCLUSION: Tranexamic acid may reduce blood loss perioperatively in myomectomies. It may reduce the menorrhagia in patients with fibroids, however a ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S0015028224002759

The modern management of uterine fibroids-related ... It is effective in reducing menstrual blood loss by 26%–50%, surpassing the efficacy of NSAIDs alone (35). It can be used independently or in conjunction with ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT03317795

Treatment of Heavy Menstrual Bleeding in Women With ... Tranexamic Acid reduces menstrual blood loss in 40% of women and improves quality of life. In women with fibroids, Tranexamic Acid has been shown to decrease ...

4. aafp.org aafp.org/pubs/afp/issues/2011/1015/p883.html

Tranexamic Acid (Lysteda) for Cyclic Heavy Menstrual ... EFFECTIVENESS. Tranexamic acid reduces menstrual blood loss, but it does not affect the underlying cause of the dysfunctional uterine bleeding.

5. obgyn.onlinelibrary.wiley.com obgyn.onlinelibrary.wiley.com/doi/10.1002/ijgo.70497

Medical treatment of fibroids: FIGO best practice guidance - Diaz TXA has shown an average reduction of 89 mL in menstrual bleeding in patients with uterine fibroids. In patients with heavy menstrual bleeding, ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT04694677

Safety of Tranexamic Acid in Reducing Blood Loss ... Study Overview. Brief Summary. Uterine leiomyomas (fibroids) are the most common benign tumors among women . Fibroids are found in approximately 15% to 30% of ...

7. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2020/022430s009lbl.pdf

LYSTEDA® (tranexamic acid) tablets, for oral use Of the 294 evaluable subjects, 115 subjects received LYSTEDA 1950 mg/day, 112 subjects received LYSTEDA. 3900 mg/day and 67 subjects received placebo (subjects ...