Uterine FibroidsPhase 1NCT04177693

Pharmacokinetics and Hepatic Safety of EGCG

A Phase 1 study testing Epigallocatechin gallate (EGCG), Clomiphene Citrate and Letrozole in people with Uterine Fibroids, run by Yale University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

A trial to assess the pharmacokinetics and hepatic safety of EGCG in women with and without uterine fibroids. Read more about this study

Who is it for?: Ages 18 to 40 years, women onlyHealthy volunteers can take part
Conditions the study is for: Uterine Fibroids
What is being tested?: Epigallocatechin gallate (EGCG), Clomiphene Citrate and Letrozole
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 39 participants
Where: 1 siteUnited States
Study dates: 24 Nov 2020to 31 Jan 2022
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 40 years
Women only
Healthy volunteers accepted
Adult

Who may be able to join

Healthy women ≥18 to ≤40 years of age with or without uterine fibroids
Must use a double-barrier method for contraception

Who cannot join

Subjects using green tea/EGCG within 2 weeks prior to study enrollment
Known liver disease (defined as AST or ALT>2 times normal, or total bilirubin >2.5 mg/dL).
History of alcohol abuse (defined as >14 drinks/week) or binge drinking of ≥ 6 drinks at one time).
Subject using hormonal contraceptives
Subjects who are pregnant or breastfeeding
Known hypersensitivity to the study drugs
Any chronic disease

Trial locations and contacts

1 site in 1 country.

United States1 site

Johns Hopkins Medicine
Baltimore, Maryland, 21205

Other trials in United States

About this study

A trial to assess the pharmacokinetics and hepatic safety of EGCG in women with and without uterine fibroids.

Read the detailed description

This will be a randomized, multi-center, pharmacokinetics and hepatic safety trial of EGCG with 36 total patients in 3 treatment arms. 36 women will be randomized to one of the following groups: EGCG daily alone, EGCG daily with clomiphene citrate and EGCG daily with letrozole. The randomization scheme will be stratified for age groups 18-29 and 30-40 and presence of uterine fibroids. The pharmacokinetics and hepatic safety of EGCG with clomiphene citrate and letrozole are unknown. The trial conducted in women with and without fibroids will allow comparisons between these groups. The results of this study will be used to confirm hepatic safety for the larger multi-center FRIEND study.

Conditions: Uterine Fibroids
Being tested: Epigallocatechin gallate (EGCG), Clomiphene Citrate, Letrozole
Medical subject headings: Leiomyoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Epigallocatechin gallate (EGCG)Dietary supplement
800 mg (4 capsules) of EGCG (green tea extract), taken orally on a daily basis for up to 2 months
Clomiphene CitrateDrug
Also called Clomid, Serophene
100 mg for 5 days
LetrozoleDrug
Also called Femara
5 mg for 5 days

Study groups in NCT04177693
Study group	Role	What they receive
EGCG daily alone.	Experimental	EGCG daily alone. 800mg Receives: Dietary Supplement: Epigallocatechin gallate (EGCG)
EGCG with clomiphene citrate	Experimental	EGCG 800 mg daily with clomiphene citrate 100mg for 5 days. Receives: Dietary Supplement: Epigallocatechin gallate (EGCG); Drug: Clomiphene Citrate
EGCG with letrozole	Experimental	EGCG 800mg daily with letrozole 5mg for 5 days. Receives: Dietary Supplement: Epigallocatechin gallate (EGCG); Drug: Letrozole

What is being measured

The primary outcome is the main question the study is designed to answer.

Changes in Epigallocatechin Gallate (EGCG)
Changes in epigallocatechin gallate (EGCG) from Visit 1 to Visit 4 (end of study). EGCG levels measured at 1 hour after taking study medication were used for both visits.
Measured: Baseline, and Visit 4 (end of study, up to 40 days)
Changes in Epigallocatechin (EGC)
Changes in epigallocatechin (EGC) from Visit 1 to Visit 4 (end of study). EGC levels measured at 1 hour after taking study medication were used for both visits.
Measured: Baseline, and Visit 4 (end of study, up to 40 days)
Changes in Epicatechin Gallate(ECG)
Changes in epicatechin gallate(ECG) from Visit 1 to Visit 4 (end of study). ECG levels measured at 1 hour after taking study medication were used for both visits.
Measured: Baseline, and Visit 4 (end of study, up to 40 days)

Secondary outcomes (8)

Changes in Total Bilirubin
Changes in total bilirubin between the 3 groups.
Measured: Baseline, and Visit 4 (end of study, up to 40 days)
Changes in ALT/SGPT
Changes in alanine aminotransferase /SGPT between the 3 groups.
Measured: Baseline, and Visit 4 (end of study, up to 40 days)
Changes in Alkaline Phosphatase
Changes in Alkaline Phosphatase between the 3 groups.
Measured: Baseline, and Visit 4 (end of study, up to 40 days)
Changes in Estrogen (E2)
Changes in Estrogen (E2) between the 3 groups.
Measured: Baseline, and Visit 4 (end of study, up to 40 days)
Changes in Endometrial Thickness
Changes in endometrial thickness between the 3 groups.
Measured: Baseline, and Visit 4 (end of study, up to 40 days)
Change in Serum Folate Level Between MTHFR677-Wild Type (WT) Group and MTHFR677-Hetero Group
Change in serum folate levels between MTHFR677-Wild Type (WT) group and MTHFR677-Hetero group
Measured: Baseline, and Visit 4 (end of study, up to 40 days)
Change in Serum Folate Level Between MTHFR1298-Wild Type (WT) Group and MTHFR1298-Hetero Group
Change in serum folate levels between MTHFR1298-Wild Type (WT) group and MTHFR1298-Hetero group
Measured: Baseline, and Visit 4 (end of study, up to 40 days)
Change in Serum Folate Level Between DHFR-Wild Type (WT) Group and DHFR-Hetero or Homo Group.
Change in serum folate levels between DHFR-Wild Type (WT) group and DHFR-Hetero or homo group.
Measured: Baseline, and Visit 4 (end of study, up to 40 days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

24 Nov 202031 Jan 2022

First posted26 Nov 2019
Study start24 Nov 2020
Primary completion31 Jan 2022
Study completion31 Jan 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Uterine FibroidsStudies of the same condition, open and under way.
More trials run by Yale UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Model description: The 36 women will be randomized to one of the following groups: 1. EGCG daily alone. 2. EGCG daily with clomiphene citrate 100mg for 5 days. 3. EGCG daily with letrozole 5mg for 5 days.
Masking: None (open label)
Enrolment: 39 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04177693
Sponsor's protocol ID: 2000028370
Other IDs: 1R01HD100369-01
Status last verified: May 2023
First submitted: 20 Nov 2019
Last updated: 5 Jun 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

Publications

Johnson JJ, Siblini H, Al-Hendy A, Segars JH, Gonzalez F, Taylor HS, Singh B, Carson SA, Christman GM, Huang H, Dangi B, Zhang H. Evaluating the Effect of Epigallocatechin Gallate (EGCG) in Reducing Folate Levels in Reproductive Aged Women by MTHFR and DHFR Genotype in Combination With Letrozole or Clomiphene. Clin Transl Sci. 2025 Mar;18(3):e70189. doi: 10.1111/cts.70189.
PubMed 40077973

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruiting
Prospective Study of TVRFA Treatment for FIGO Type 3-5 Uterine Fibroids
Leiomyoma (Uterine Fibroids)
RecruitingObservational study
Hereditary Leiomyomatosis Renal Cell Cancer - Study of the Genetic Cause and the Predisposition to Renal Cancer
Renal Tumor Histology, Cutaneous Leiomyoma
Active, not recruiting
Life Study: Lifestyle Intervention in Fibroid Elimination
Uterine Fibroid
Not yet recruiting
Office Hysteroscopy Versus Operating-room Hysteroscopy for Uterine Lesions
Uterine Polyps, Uterine Fibroids
RecruitingObservational study
Predictors of Success and Failure of v-NOTES Hysterectomy for Large and Very Large Uteri
Uterine Fibroids, Hysterectomy

All Uterine Fibroids trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Pharmacokinetics and Hepatic Safety of EGCG
ClinicalTrials.gov ID: NCT04177693
Acronym / sponsor ID: 2000028370
Conditions: Uterine Fibroids
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 39 participants (actual)
Lead sponsor: Yale UniversityUniversity, hospital or other
Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), University of Illinois Chicago, Johns Hopkins University, University of Chicago
Study start: 24 Nov 2020 (actual)
Primary completion: 31 Jan 2022 (actual)
Study completion: 31 Jan 2022 (actual)
First posted: 26 Nov 2019 (actual)
Results: Posted 5 Jun 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

A trial to assess the pharmacokinetics and hepatic safety of EGCG in women with and without uterine fibroids.

Detailed description

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3
Model description: The 36 women will be randomized to one of the following groups: 1. EGCG daily alone. 2. EGCG daily with clomiphene citrate 100mg for 5 days. 3. EGCG daily with letrozole 5mg for 5 days.

Arm	Type	Receives
EGCG daily alone.	Experimental	Dietary Supplement: Epigallocatechin gallate (EGCG)EGCG daily alone. 800mg
EGCG with clomiphene citrate	Experimental	Dietary Supplement: Epigallocatechin gallate (EGCG), Drug: Clomiphene CitrateEGCG 800 mg daily with clomiphene citrate 100mg for 5 days.
EGCG with letrozole	Experimental	Dietary Supplement: Epigallocatechin gallate (EGCG), Drug: LetrozoleEGCG 800mg daily with letrozole 5mg for 5 days.

Who may qualify

Ages: 18 to 40 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (2 listed)

Healthy women ≥18 to ≤40 years of age with or without uterine fibroids
Must use a double-barrier method for contraception

Key exclusion criteria (7 listed)

Subjects using green tea/EGCG within 2 weeks prior to study enrollment
Known liver disease (defined as AST or ALT>2 times normal, or total bilirubin >2.5 mg/dL).
History of alcohol abuse (defined as >14 drinks/week) or binge drinking of ≥ 6 drinks at one time).
Subject using hormonal contraceptives
Subjects who are pregnant or breastfeeding

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Epigallocatechin gallate (EGCG)800 mg (4 capsules) of EGCG (green tea extract), taken orally on a daily basis for up to 2 months	Dietary supplement	EGCG daily alone., EGCG with clomiphene citrate, EGCG with letrozole
Clomiphene CitrateAlso: Clomid, Serophene100 mg for 5 days	Drug	EGCG with clomiphene citrate
LetrozoleAlso: Femara5 mg for 5 days	Drug	EGCG with letrozole

Primary outcome

Changes in Epigallocatechin Gallate (EGCG)
Time frame: Baseline, and Visit 4 (end of study, up to 40 days)
Changes in epigallocatechin gallate (EGCG) from Visit 1 to Visit 4 (end of study). EGCG levels measured at 1 hour after taking study medication were used for both visits.
Changes in Epigallocatechin (EGC)
Time frame: Baseline, and Visit 4 (end of study, up to 40 days)
Changes in epigallocatechin (EGC) from Visit 1 to Visit 4 (end of study). EGC levels measured at 1 hour after taking study medication were used for both visits.
Changes in Epicatechin Gallate(ECG)
Time frame: Baseline, and Visit 4 (end of study, up to 40 days)
Changes in epicatechin gallate(ECG) from Visit 1 to Visit 4 (end of study). ECG levels measured at 1 hour after taking study medication were used for both visits.

8 secondary outcomes

Changes in Total Bilirubin
Time frame: Baseline, and Visit 4 (end of study, up to 40 days)
Changes in ALT/SGPT
Time frame: Baseline, and Visit 4 (end of study, up to 40 days)
Changes in Alkaline Phosphatase
Time frame: Baseline, and Visit 4 (end of study, up to 40 days)
Changes in Estrogen (E2)
Time frame: Baseline, and Visit 4 (end of study, up to 40 days)
Changes in Endometrial Thickness
Time frame: Baseline, and Visit 4 (end of study, up to 40 days)
Change in Serum Folate Level Between MTHFR677-Wild Type (WT) Group and MTHFR677-Hetero Group
Time frame: Baseline, and Visit 4 (end of study, up to 40 days)
Change in Serum Folate Level Between MTHFR1298-Wild Type (WT) Group and MTHFR1298-Hetero Group
Time frame: Baseline, and Visit 4 (end of study, up to 40 days)
Change in Serum Folate Level Between DHFR-Wild Type (WT) Group and DHFR-Hetero or Homo Group.
Time frame: Baseline, and Visit 4 (end of study, up to 40 days)

Results and safety

Results posted to the registry on 5 Jun 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
EGCG Daily Alone.	16	14
EGCG With Clomiphene Citrate	11	11
EGCG With Letrozole	12	11

Primary outcome: Changes in Epigallocatechin Gallate (EGCG)

Time frame: Baseline, and Visit 4 (end of study, up to 40 days). Median (Inter-Quartile Range). Unit: nM

Measure	EGCG Daily Alone. n = 12	EGCG With Clomiphene Citrate n = 10	EGCG With Letrozole n = 8
Value	5.8 (-418.2 to 263.1)	256.3 (37.9 to 770.1)	86.4 (-130.6 to 788.1)

EGCG Daily Alone. vs EGCG With Clomiphene Citrate vs EGCG With Letrozole: p = 0.112, Kruskal-Wallis

Primary outcome: Changes in Epigallocatechin (EGC)

Time frame: Baseline, and Visit 4 (end of study, up to 40 days). Median (Full Range). Unit: nM

Measure	EGCG Daily Alone. n = 5	EGCG With Clomiphene Citrate n = 5	EGCG With Letrozole n = 5
Value	-58.9 (-66.2 to 62.2)	8.9 (-0.3 to 17.3)	35.4 (-19.7 to 193.6)

EGCG Daily Alone. vs EGCG With Clomiphene Citrate vs EGCG With Letrozole: p = 0.613, Kruskal-Wallis

Primary outcome: Changes in Epicatechin Gallate(ECG)

Time frame: Baseline, and Visit 4 (end of study, up to 40 days). Median (Inter-Quartile Range). Unit: nM

Measure	EGCG Daily Alone. n = 10	EGCG With Clomiphene Citrate n = 5	EGCG With Letrozole n = 9
Value	7.6 (-121.7 to 63.0)	64.1 (1.0 to 248.0)	60.3 (-20.2 to 127.7)

EGCG Daily Alone. vs EGCG With Clomiphene Citrate vs EGCG With Letrozole: p = 0.202, Kruskal-Wallis

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 60 days. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
EGCG Daily Alone.	0 of 16 (0%)	2 of 16 (12.5%)	0 of 16
EGCG With Clomiphene Citrate	0 of 11 (0%)	4 of 11 (36.4%)	0 of 11
EGCG With Letrozole	0 of 12 (0%)	6 of 12 (50%)	0 of 12

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 40077973Johnson JJ, Siblini H, Al-Hendy A, Segars JH, Gonzalez F, Taylor HS, Singh B, Carson SA, Christman GM, Huang H, Dangi B, Zhang H. Evaluating the Effect of Epigallocatechin Gallate (EGCG) in Reducing Folate Levels in Reproductive Aged Women by MTHFR and DHFR Genotype in Combination With Letrozole or Clomiphene. Clin Transl Sci. 2025 Mar;18(3):e70189. doi: 10.1111/cts.70189.

Related trials for Uterine Fibroids

Active, not recruiting
Prospective Study of TVRFA Treatment for FIGO Type 3-5 Uterine Fibroids
Leiomyoma (Uterine Fibroids)
RecruitingObservational study
Hereditary Leiomyomatosis Renal Cell Cancer - Study of the Genetic Cause and the Predisposition to Renal Cancer
Renal Tumor Histology, Cutaneous Leiomyoma
Active, not recruiting
Life Study: Lifestyle Intervention in Fibroid Elimination
Uterine Fibroid
Not yet recruiting
Office Hysteroscopy Versus Operating-room Hysteroscopy for Uterine Lesions
Uterine Polyps, Uterine Fibroids
RecruitingObservational study
Predictors of Success and Failure of v-NOTES Hysterectomy for Large and Very Large Uteri
Uterine Fibroids, Hysterectomy

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Esther Eisenberg, MD study director

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Ayman Al-Hendy, MD,PhD principal investigator

University of Chicago

Heping Zhang, PhD study director

Yale University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Epigallocatechin gallate (EGCG), Clomiphene Citrate and Letrozole in people with Uterine Fibroids, run by Yale University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Jun 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in Epigallocatechin Gallate (EGCG) (time frame: Baseline, and Visit 4 (end of study, up to 40 days)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04177693, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2023.