TriNaV for Uterine Fibroids

(PEDD-UFE Trial)

Recruiting at 1 trial location

Overseen by Dania Daye, MD

Age: 18 - 65

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Massachusetts General Hospital

Must not be taking: GnRH agonists, GnRH antagonists

Disqualifiers: Pregnancy, Adenomyosis, Endometriosis, Gynecologic malignancy, others

No Placebo Group

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?

The goal of this study is to assess of Pressure-Enabled Drug Delivery on fibroid treatment in patients undergoing UFE.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, if you are on GnRH agonist or antagonist therapy, you must stop it at least 6 months or 1 month before the study, respectively.

What data supports the effectiveness of the treatment TriNaV for uterine fibroids?

Research on similar treatments, like transcervical fibroid ablation (TFA) and radiofrequency ablation (RFA), shows they significantly reduce fibroid symptoms and improve quality of life with low rates of needing further surgery. These treatments have been effective in reducing fibroid size and improving life quality over several years. ^{1 2 3 4 5}

How does the drug TriNaV differ from other treatments for uterine fibroids?

TriNaV, also known as relugolix/estradiol/norethisterone acetate, is unique because it combines a GnRH receptor antagonist with hormone therapy to manage uterine fibroid symptoms while minimizing bone loss and hot flashes. This oral, once-daily combination is a convenient option compared to other treatments that may require more frequent dosing or surgical intervention. ^{6 7 8 9 10}

Research Team

Dania Daye, MD

Principal Investigator

Massachusetts General Hospital

Eligibility Criteria

This trial is for women over 18 with uterine fibroids who have decided to undergo Uterine Fibroid Embolization (UFE). They should have symptoms like heavy bleeding or a feeling of fullness and must not be pregnant, post-menopausal, or have had certain hormone treatments recently. Women with gynecologic cancer, pelvic inflammatory disease, or allergies to specific pain medications cannot participate.

Inclusion Criteria

I have been recommended for uterine fibroid embolization.

I am a woman over 18 years old.

I experience heavy menstrual bleeding or symptoms due to large growths.

Exclusion Criteria

Lack of ovarian perfusion on baseline MRI

I have received hormone therapy for cancer within the last 6 months.

I have been diagnosed with endometriosis.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo Uterine Fibroid Embolization (UFE) using Pressure-Enabled Drug Delivery (PEDD)

1 day

1 visit (in-person)

Follow-up

Participants are monitored for changes in ovarian perfusion and pain reduction post-intervention

6 months

Regular visits for ultrasound doppler imaging and pain assessment

Treatment Details

Interventions

• TriNaV (Procedure)

Trial Overview The study tests the effectiveness of TriNaV in improving drug delivery during UFE procedures aimed at treating fibroids. It evaluates if this method can better reduce pain and enhance blood flow to the ovaries after treatment compared to standard approaches.

Participant Groups

Group I: Intervention Arm Experimental Treatment 1 Intervention

Patient will undergo UFE using PEDD

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

TriSalus Life Sciences, Inc.

Industry Sponsor

Trials

10

Recruited

420+

Findings from Research

In the SONATA trial involving 147 premenopausal women, sonography-guided transcervical ablation of uterine fibroids led to a significant and lasting reduction in fibroid-related symptoms over 3 years, with a mean Symptom Severity Score dropping from 55 to 22.

The treatment demonstrated a low surgical reintervention rate of 9.2% and high patient satisfaction, with 94% of participants reporting satisfaction and significant improvements in quality of life and work productivity, indicating its efficacy and safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Three-Year Results of the SONATA Pivotal Trial of Transcervical Fibroid Ablation for Symptomatic Uterine Myomata. Lukes, A., Green, MA.[2020]

Radiofrequency ablation (RFA) is a safe and effective treatment for symptomatic uterine fibroids, with a mean procedure time of 49 minutes and a quick recovery, allowing patients to return to normal activities in about 5 days.

At 12 months post-treatment, RFA led to a 66% reduction in fibroid volume and significant improvements in health-related quality of life and symptom severity, with low reintervention rates of 4.2% to 11.5% over three years.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical Performance of Radiofrequency Ablation for Treatment of Uterine Fibroids: Systematic Review and Meta-Analysis of Prospective Studies. Bradley, LD., Pasic, RP., Miller, LE.[2020]

The SAGE registry, involving up to 500 women over 5 years, shows that transcervical fibroid ablation (TFA) is a safe and effective treatment for symptomatic uterine fibroids, with a low device-related adverse event rate of 0.6%.

Preliminary results from 160 women indicate that TFA significantly reduces fibroid volume and improves quality of life, demonstrating its broad applicability across various fibroid types and sizes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcervical Radiofrequency Ablation of Uterine Fibroids Global Registry (SAGE): Study Protocol and Preliminary Results. Christoffel, L., Römer, T., Schiermeier, S.[2022]

In a study of 1384 women aged 31 to 45, all surgical treatments for uterine fibroids led to significant improvements in health-related quality of life and symptom severity one year after treatment, with laparoscopic hysterectomy showing the largest improvement.

While improvements were noted across all treatment types, those undergoing abdominal myomectomy, laparoscopic myomectomy, and uterine artery embolization experienced a gradual decline in symptom relief and quality of life by the third year post-treatment, indicating the need for ongoing management of symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term health-related quality of life and symptom severity following hysterectomy, myomectomy, or uterine artery embolization for the treatment of symptomatic uterine fibroids. Anchan, RM., Spies, JB., Zhang, S., et al.[2023]

In a study involving 197 women with submucous and large uterine fibroids, 86% of those with submucous fibroids and 81% with large fibroids experienced a reduction in bleeding within 3 months after transcervical fibroid ablation (TFA) using the Sonata system.

TFA led to significant and sustained improvements in symptom severity and health-related quality of life over 12 months, with a low rate of surgical reintervention (3.7% for submucous fibroids) indicating its effectiveness as a treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcervical fibroid ablation with the Sonata™ system for treatment of submucous and large uterine fibroids. Shifrin, G., Engelhardt, M., Gee, P., et al.[2021]

Both the levonorgestrel intrauterine system (LNG-IUS) and transcervical resection of the endometrium (TCRE) significantly reduced menstrual blood loss by 97% and 94%, respectively, over a 12-month period in a study of 50 women.

While both treatments were equally effective, the LNG-IUS is easier to administer, has no operative hazards, and also provides effective contraception, making it a more convenient option for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Levonorgestrel-releasing intrauterine system vs. transcervical endometrial resection for dysfunctional uterine bleeding. Gupta, B., Mittal, S., Misra, R., et al.[2016]

The combination of relugolix, estradiol, and norethisterone acetate (Ryeqo®; Myfembree®) effectively reduces heavy menstrual bleeding and improves other symptoms associated with uterine fibroids, as demonstrated in two phase 3 LIBERTY trials.

This treatment is generally well tolerated, with minimal risk of clinically significant bone loss over up to 2 years, making it a safe and convenient once-daily option for premenopausal women suffering from symptomatic uterine fibroids.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Relugolix/Estradiol/Norethisterone (Norethindrone) Acetate: A Review in Symptomatic Uterine Fibroids. Syed, YY.[2022]

Gonadotrophin-releasing hormone analogues (GnRHa) effectively reduce fibroid and uterine volume and alleviate heavy bleeding in pre-menopausal women, but their long-term use is limited due to menopausal symptoms and bone loss.

Add-back therapies, such as progestagen or raloxifene, may help mitigate the side effects of GnRHa, but more high-quality research is needed to confirm their efficacy and safety in managing fibroids.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An evidence-based approach to hormonal therapies for premenopausal women with fibroids. Lethaby, AE., Vollenhoven, BJ.[2015]

In a study of 51 patients undergoing transcervical resection of submucous fibroids, 94.1% achieved control of abnormal uterine bleeding after treatment, highlighting the efficacy of this procedure.

The study found that complete resection of fibroids significantly improves long-term outcomes, but cases with more than 50% intramural extension may require multiple procedures for successful treatment, suggesting a need for careful patient selection.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcervical hysteroscopic resection of submucous fibroids for abnormal uterine bleeding: results regarding the degree of intramural extension. Wamsteker, K., Emanuel, MH., de Kruif, JH.[2022]

In a study of 126 patients undergoing transcervical resection of myoma (TCRM) for submucous fibroids, 56.6% experienced a reduction in heavy menstrual bleeding, with an 86% improvement in PBAC scores six months post-surgery.

Patients reported significant improvements in symptom severity and health-related quality of life, with UFS-QOL scores improving by 59% and HRQOL scores by 102% after six months, indicating TCRM is effective in enhancing overall well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of transcervical resection of submucous fibroids on menstrual blood loss: A prospective cohort study. Keizer, AL., Jacobs, BL., Thurkow, AL., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Three-Year Results of the SONATA Pivotal Trial of Transcervical Fibroid Ablation for Symptomatic Uterine Myomata. [2020]

2. United States pubmed.ncbi.nlm.nih.gov

Clinical Performance of Radiofrequency Ablation for Treatment of Uterine Fibroids: Systematic Review and Meta-Analysis of Prospective Studies. [2020]

3. New Zealand pubmed.ncbi.nlm.nih.gov

Transcervical Radiofrequency Ablation of Uterine Fibroids Global Registry (SAGE): Study Protocol and Preliminary Results. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Long-term health-related quality of life and symptom severity following hysterectomy, myomectomy, or uterine artery embolization for the treatment of symptomatic uterine fibroids. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Transcervical fibroid ablation with the Sonata™ system for treatment of submucous and large uterine fibroids. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Levonorgestrel-releasing intrauterine system vs. transcervical endometrial resection for dysfunctional uterine bleeding. [2016]

7. New Zealand pubmed.ncbi.nlm.nih.gov

Relugolix/Estradiol/Norethisterone (Norethindrone) Acetate: A Review in Symptomatic Uterine Fibroids. [2022]

8. Netherlands pubmed.ncbi.nlm.nih.gov

An evidence-based approach to hormonal therapies for premenopausal women with fibroids. [2015]

9. United States pubmed.ncbi.nlm.nih.gov

Transcervical hysteroscopic resection of submucous fibroids for abnormal uterine bleeding: results regarding the degree of intramural extension. [2022]

10. Ireland pubmed.ncbi.nlm.nih.gov

The effect of transcervical resection of submucous fibroids on menstrual blood loss: A prospective cohort study. [2022]