What side effects are associated with this type of intervention?

Common treatments for uterine fibroids include surgical options like myomectomy, which can lead to complications such as infection, bleeding, and the potential for fibroid recurrence. Medical therapies like GnRH agonists can cause menopausal symptoms, including hot flashes, mood swings, and bone density loss. Alternative treatments, such as green tea extract (EGCG), are generally well-tolerated but may cause mild gastrointestinal issues, liver enzyme alterations, and, in rare cases, hepatotoxicity. Patients should discuss these potential side effects with their healthcare provider to choose the most appropriate treatment.

What prior FDA approvals exist?

The FDA has approved several treatments for uterine fibroids, including medications and surgical options. Among the medications, Gonadotropin-releasing hormone (GnRH) agonists like leuprolide acetate are commonly used for their ability to shrink fibroids by reducing estrogen levels. More recently, the FDA approved elagolix, an oral GnRH antagonist, often combined with estradiol and norethindrone acetate, which also works by lowering hormone levels to reduce fibroid size and symptoms. While these treatments focus on hormonal pathways, there is ongoing research into non-hormonal options like Green Tea Extract (EGCG), known for its anti-inflammatory and anti-proliferative properties, though it has not yet received FDA approval specifically for fibroids.

What other types of research exist?

Promising novel alternatives to Green Tea Extract (EGCG) for uterine fibroids include Dienogest, which has shown efficacy in reducing endometrioma recurrence and preserving ovarian function. Additionally, Levonorgestrel intrauterine devices (LNG IUDs) have been noted for reducing dysmenorrhea, although their impact on fibroid recurrence is less clear. Further research and larger trials are needed to establish their effectiveness definitively.

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Polyphenol

Fibroids & Infertility (FRIEND Trial)

Q: What is the mechanism of action of this treatment?

Common treatments for uterine fibroids often focus on reducing inflammation and inhibiting cell proliferation. Green Tea Extract (EGCG) is being studied for its anti-inflammatory and anti-proliferative properties, which can help reduce the size and symptoms of fibroids. These mechanisms are crucial as they target the underlying processes that contribute to fibroid growth and symptom severity. By reducing inflammation, these treatments can alleviate pain and discomfort, while anti-proliferative effects can limit the growth and recurrence of fibroids, offering a non-surgical option for management.

Phase 3

Recruiting

Research Sponsored by Yale University

Eligibility Criteria Checklist

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

Must have

Intramural fibroids and/or subserosal fibroids that meet the criteria for FIGO types 2-6; at least one fibroid with an average diameter of at least 1 cm in three dimensions. Participants with multiple fibroids including FIGO type 0 and type 1 will be allowed only in combination with additional fibroids type 2-6.

Women ≥18 to ≤40 years of age, with six months or more infertility history, desirous of conceiving, regularly ovulating (defined as 9 or more menses per year), at initiation of participation. Women < 35 years of age must have at least 12 months of infertility history.

Timeline

Screening 0.5 days

Treatment 3 months

Follow Up 3 months

Awards & highlights

Pivotal Trial

Summary

This trial tests if a low caffeine green tea extract with high EGCG can help women aged 18-40 with fibroids get pregnant. The EGCG may shrink fibroids and improve the uterus lining, increasing pregnancy chances. EGCG, a major component of green tea, has been studied for its potential benefits in reducing uterine fibroids and improving reproductive health.

Who is the study for?

This trial is for women aged 18-40 with a desire to conceive, who have been infertile for at least six months and have certain types of uterine fibroids (FIGO types 2-6). They must be regularly ovulating, have at least one open fallopian tube, and their male partner should have a sufficient sperm count. Women can't join if they've had severe endometriosis, unexplained bleeding, alcohol abuse issues or a history of blood clots.

What is being tested?

The study aims to see if taking green tea extract containing epigallocatechin gallate (EGCG) affects the size of fibroids in the uterus and improves chances of pregnancy and live births compared to those taking a placebo. The trial involves 200 women seeking fertility treatment.

What are the potential side effects?

While not explicitly stated here, potential side effects from green tea extract could include stomach upset or constipation. High doses might cause more serious problems like liver damage but are unlikely given careful monitoring in the trial.

Eligibility Criteria

Inclusion Criteria

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

Select...

I have fibroids of specific types and sizes according to FIGO classifications.

Select...

I am a woman aged 18-40, trying to conceive for 6+ months, with regular periods.

Select...

My male partner has a sperm count of at least 5 million motile sperm/ml in the past year.

Select...

I agree not to consume any green tea products during the study.

Timeline

Screening ~ 0.5 days8 visits

Treatment ~ 3 months3 visits

Follow Up ~ 3 months1 visit

Screening ~ 0.5 days

Treatment ~ 3 months

Follow Up ~3 months

This trial's timeline: 0.5 days for screening, 3 months for treatment, and 3 months for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Cumulative live birth rate.

Secondary study objectives

The change of fibroid symptom severity score

The change of fibroid volume

The change of health-related quality-of-life questionnaire score

+3 more

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Green tea extract containing 45% epigallocatechin gallate (EGCG)Experimental Treatment1 Intervention

Low caffeine green tea extract (1650mg in 6 capsules) taken orally on a daily basis (QD) along with Clomiphene citrate-intrauterine insemination (CC_IUI) cycle, up to 4 cycles if no pregnancy is achieved, participant will stop green tea if she becomes pregnant

Group II: PlaceboPlacebo Group1 Intervention

Placebo (1650mg in 6 capsules) matched (smell, taste, color, texture) capsules taken orally on a daily basis (QD) along with Clomiphene citrate-intrauterine insemination (CC_IUI) cycle, up to 4 cycles if no pregnancy is achieved, participant will stop placebo if she becomes pregnant

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Green Tea Extract

2019

N/A

~40

0 / 6Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for uterine fibroids often focus on reducing inflammation and inhibiting cell proliferation. Green Tea Extract (EGCG) is being studied for its anti-inflammatory and anti-proliferative properties, which can help reduce the size and symptoms of fibroids. These mechanisms are crucial as they target the underlying processes that contribute to fibroid growth and symptom severity. By reducing inflammation, these treatments can alleviate pain and discomfort, while anti-proliferative effects can limit the growth and recurrence of fibroids, offering a non-surgical option for management.

Randomized double-blind trial comparing low dose and conventional dose of a modified traditional herbal formula Guizhi Fuling Wan in women with symptomatic uterine fibroids.Adjuvant therapy of Chinese herbal medicine for the treatment of adenomyosis: A protocol for systematic review.Selection and efficacy of self-management strategies for dysmenorrhea in young Taiwanese women.