Trial Outcomes & Findings for Pharmacokinetics and Hepatic Safety of EGCG (NCT NCT04177693)
NCT ID: NCT04177693
Last Updated: 2023-06-05
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
39 participants
Primary outcome timeframe
Baseline, and Visit 4 (end of study, up to 40 days)
Results posted on
2023-06-05
Participant Flow
Participant milestones
| Measure |
EGCG Daily Alone.
EGCG daily alone. 800mg
Epigallocatechin gallate (EGCG): 800 mg (4 capsules) of EGCG (green tea extract), taken orally on a daily basis for up to 2 months
|
EGCG With Clomiphene Citrate
EGCG 800 mg daily with clomiphene citrate 100mg for 5 days.
Epigallocatechin gallate (EGCG): 800 mg (4 capsules) of EGCG (green tea extract), taken orally on a daily basis for up to 2 months
Clomiphene Citrate: 100 mg for 5 days
|
EGCG With Letrozole
EGCG 800mg daily with letrozole 5mg for 5 days.
Epigallocatechin gallate (EGCG): 800 mg (4 capsules) of EGCG (green tea extract), taken orally on a daily basis for up to 2 months
Letrozole: 5 mg for 5 days
|
|---|---|---|---|
|
Overall Study
STARTED
|
16
|
11
|
12
|
|
Overall Study
COMPLETED
|
14
|
11
|
11
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pharmacokinetics and Hepatic Safety of EGCG
Baseline characteristics by cohort
| Measure |
EGCG Daily Alone.
n=16 Participants
EGCG daily alone. 800mg
Epigallocatechin gallate (EGCG): 800 mg (4 capsules) of EGCG (green tea extract), taken orally on a daily basis for up to 2 months
|
EGCG With Clomiphene Citrate
n=11 Participants
EGCG 800 mg daily with clomiphene citrate 100mg for 5 days.
Epigallocatechin gallate (EGCG): 800 mg (4 capsules) of EGCG (green tea extract), taken orally on a daily basis for up to 2 months
Clomiphene Citrate: 100 mg for 5 days
|
EGCG With Letrozole
n=12 Participants
EGCG 800mg daily with letrozole 5mg for 5 days.
Epigallocatechin gallate (EGCG): 800 mg (4 capsules) of EGCG (green tea extract), taken orally on a daily basis for up to 2 months
Letrozole: 5 mg for 5 days
|
Total
n=39 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
29.6 years
STANDARD_DEVIATION 6.3 • n=5 Participants
|
27.2 years
STANDARD_DEVIATION 6.6 • n=7 Participants
|
29.3 years
STANDARD_DEVIATION 6.3 • n=5 Participants
|
28.8 years
STANDARD_DEVIATION 6.3 • n=4 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
39 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
14 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
33 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
EGCG Daily Alone.
n=12 Participants
EGCG daily alone. 800mg
Epigallocatechin gallate (EGCG): 800 mg (4 capsules) of EGCG (green tea extract), taken orally on a daily basis for up to 2 months
|
EGCG With Clomiphene Citrate
n=10 Participants
EGCG 800 mg daily with clomiphene citrate 100mg for 5 days.
Epigallocatechin gallate (EGCG): 800 mg (4 capsules) of EGCG (green tea extract), taken orally on a daily basis for up to 2 months
Clomiphene Citrate: 100 mg for 5 days
|
EGCG With Letrozole
n=8 Participants
EGCG 800mg daily with letrozole 5mg for 5 days.
Epigallocatechin gallate (EGCG): 800 mg (4 capsules) of EGCG (green tea extract), taken orally on a daily basis for up to 2 months
Letrozole: 5 mg for 5 days
|
|---|---|---|---|
|
Changes in Epigallocatechin Gallate (EGCG)
|
5.8 nM
Interval -418.2 to 263.1
|
256.3 nM
Interval 37.9 to 770.1
|
86.4 nM
Interval -130.6 to 788.1
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
EGCG Daily Alone.
n=5 Participants
EGCG daily alone. 800mg
Epigallocatechin gallate (EGCG): 800 mg (4 capsules) of EGCG (green tea extract), taken orally on a daily basis for up to 2 months
|
EGCG With Clomiphene Citrate
n=5 Participants
EGCG 800 mg daily with clomiphene citrate 100mg for 5 days.
Epigallocatechin gallate (EGCG): 800 mg (4 capsules) of EGCG (green tea extract), taken orally on a daily basis for up to 2 months
Clomiphene Citrate: 100 mg for 5 days
|
EGCG With Letrozole
n=5 Participants
EGCG 800mg daily with letrozole 5mg for 5 days.
Epigallocatechin gallate (EGCG): 800 mg (4 capsules) of EGCG (green tea extract), taken orally on a daily basis for up to 2 months
Letrozole: 5 mg for 5 days
|
|---|---|---|---|
|
Changes in Epigallocatechin (EGC)
|
-58.9 nM
Interval -66.2 to 62.2
|
8.9 nM
Interval -0.3 to 17.3
|
35.4 nM
Interval -19.7 to 193.6
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
EGCG Daily Alone.
n=10 Participants
EGCG daily alone. 800mg
Epigallocatechin gallate (EGCG): 800 mg (4 capsules) of EGCG (green tea extract), taken orally on a daily basis for up to 2 months
|
EGCG With Clomiphene Citrate
n=5 Participants
EGCG 800 mg daily with clomiphene citrate 100mg for 5 days.
Epigallocatechin gallate (EGCG): 800 mg (4 capsules) of EGCG (green tea extract), taken orally on a daily basis for up to 2 months
Clomiphene Citrate: 100 mg for 5 days
|
EGCG With Letrozole
n=9 Participants
EGCG 800mg daily with letrozole 5mg for 5 days.
Epigallocatechin gallate (EGCG): 800 mg (4 capsules) of EGCG (green tea extract), taken orally on a daily basis for up to 2 months
Letrozole: 5 mg for 5 days
|
|---|---|---|---|
|
Changes in Epicatechin Gallate(ECG)
|
7.6 nM
Interval -121.7 to 63.0
|
64.1 nM
Interval 1.0 to 248.0
|
60.3 nM
Interval -20.2 to 127.7
|
SECONDARY outcome
Timeframe: Baseline, and Visit 4 (end of study, up to 40 days)Changes in total bilirubin between the 3 groups.
Outcome measures
| Measure |
EGCG Daily Alone.
n=15 Participants
EGCG daily alone. 800mg
Epigallocatechin gallate (EGCG): 800 mg (4 capsules) of EGCG (green tea extract), taken orally on a daily basis for up to 2 months
|
EGCG With Clomiphene Citrate
n=11 Participants
EGCG 800 mg daily with clomiphene citrate 100mg for 5 days.
Epigallocatechin gallate (EGCG): 800 mg (4 capsules) of EGCG (green tea extract), taken orally on a daily basis for up to 2 months
Clomiphene Citrate: 100 mg for 5 days
|
EGCG With Letrozole
n=12 Participants
EGCG 800mg daily with letrozole 5mg for 5 days.
Epigallocatechin gallate (EGCG): 800 mg (4 capsules) of EGCG (green tea extract), taken orally on a daily basis for up to 2 months
Letrozole: 5 mg for 5 days
|
|---|---|---|---|
|
Changes in Total Bilirubin
|
0.1 mg/dL
Standard Deviation 0.2
|
0 mg/dL
Standard Deviation 0
|
0 mg/dL
Standard Deviation 0.1
|
SECONDARY outcome
Timeframe: Baseline, and Visit 4 (end of study, up to 40 days)Changes in alanine aminotransferase /SGPT between the 3 groups.
Outcome measures
| Measure |
EGCG Daily Alone.
n=15 Participants
EGCG daily alone. 800mg
Epigallocatechin gallate (EGCG): 800 mg (4 capsules) of EGCG (green tea extract), taken orally on a daily basis for up to 2 months
|
EGCG With Clomiphene Citrate
n=11 Participants
EGCG 800 mg daily with clomiphene citrate 100mg for 5 days.
Epigallocatechin gallate (EGCG): 800 mg (4 capsules) of EGCG (green tea extract), taken orally on a daily basis for up to 2 months
Clomiphene Citrate: 100 mg for 5 days
|
EGCG With Letrozole
n=12 Participants
EGCG 800mg daily with letrozole 5mg for 5 days.
Epigallocatechin gallate (EGCG): 800 mg (4 capsules) of EGCG (green tea extract), taken orally on a daily basis for up to 2 months
Letrozole: 5 mg for 5 days
|
|---|---|---|---|
|
Changes in ALT/SGPT
|
1.1 U/L
Standard Deviation 5.1
|
4.4 U/L
Standard Deviation 11.7
|
-1.0 U/L
Standard Deviation 7.6
|
SECONDARY outcome
Timeframe: Baseline, and Visit 4 (end of study, up to 40 days)Changes in Alkaline Phosphatase between the 3 groups.
Outcome measures
| Measure |
EGCG Daily Alone.
n=15 Participants
EGCG daily alone. 800mg
Epigallocatechin gallate (EGCG): 800 mg (4 capsules) of EGCG (green tea extract), taken orally on a daily basis for up to 2 months
|
EGCG With Clomiphene Citrate
n=11 Participants
EGCG 800 mg daily with clomiphene citrate 100mg for 5 days.
Epigallocatechin gallate (EGCG): 800 mg (4 capsules) of EGCG (green tea extract), taken orally on a daily basis for up to 2 months
Clomiphene Citrate: 100 mg for 5 days
|
EGCG With Letrozole
n=12 Participants
EGCG 800mg daily with letrozole 5mg for 5 days.
Epigallocatechin gallate (EGCG): 800 mg (4 capsules) of EGCG (green tea extract), taken orally on a daily basis for up to 2 months
Letrozole: 5 mg for 5 days
|
|---|---|---|---|
|
Changes in Alkaline Phosphatase
|
-1.5 U/L
Standard Deviation 5.4
|
-5.6 U/L
Standard Deviation 10.2
|
-6.0 U/L
Standard Deviation 9.1
|
SECONDARY outcome
Timeframe: Baseline, and Visit 4 (end of study, up to 40 days)Changes in Estrogen (E2) between the 3 groups.
Outcome measures
| Measure |
EGCG Daily Alone.
n=15 Participants
EGCG daily alone. 800mg
Epigallocatechin gallate (EGCG): 800 mg (4 capsules) of EGCG (green tea extract), taken orally on a daily basis for up to 2 months
|
EGCG With Clomiphene Citrate
n=11 Participants
EGCG 800 mg daily with clomiphene citrate 100mg for 5 days.
Epigallocatechin gallate (EGCG): 800 mg (4 capsules) of EGCG (green tea extract), taken orally on a daily basis for up to 2 months
Clomiphene Citrate: 100 mg for 5 days
|
EGCG With Letrozole
n=12 Participants
EGCG 800mg daily with letrozole 5mg for 5 days.
Epigallocatechin gallate (EGCG): 800 mg (4 capsules) of EGCG (green tea extract), taken orally on a daily basis for up to 2 months
Letrozole: 5 mg for 5 days
|
|---|---|---|---|
|
Changes in Estrogen (E2)
|
-50.9 pg/mL
Standard Deviation 122.4
|
-49.4 pg/mL
Standard Deviation 76.6
|
-50.2 pg/mL
Standard Deviation 127.9
|
SECONDARY outcome
Timeframe: Baseline, and Visit 4 (end of study, up to 40 days)Changes in endometrial thickness between the 3 groups.
Outcome measures
| Measure |
EGCG Daily Alone.
n=13 Participants
EGCG daily alone. 800mg
Epigallocatechin gallate (EGCG): 800 mg (4 capsules) of EGCG (green tea extract), taken orally on a daily basis for up to 2 months
|
EGCG With Clomiphene Citrate
n=11 Participants
EGCG 800 mg daily with clomiphene citrate 100mg for 5 days.
Epigallocatechin gallate (EGCG): 800 mg (4 capsules) of EGCG (green tea extract), taken orally on a daily basis for up to 2 months
Clomiphene Citrate: 100 mg for 5 days
|
EGCG With Letrozole
n=11 Participants
EGCG 800mg daily with letrozole 5mg for 5 days.
Epigallocatechin gallate (EGCG): 800 mg (4 capsules) of EGCG (green tea extract), taken orally on a daily basis for up to 2 months
Letrozole: 5 mg for 5 days
|
|---|---|---|---|
|
Changes in Endometrial Thickness
|
-1.9 mm
Standard Deviation 4.3
|
1.4 mm
Standard Deviation 2.0
|
0.6 mm
Standard Deviation 2.7
|
SECONDARY outcome
Timeframe: Baseline, and Visit 4 (end of study, up to 40 days)Change in serum folate levels between MTHFR677-Wild Type (WT) group and MTHFR677-Hetero group
Outcome measures
| Measure |
EGCG Daily Alone.
n=13 Participants
EGCG daily alone. 800mg
Epigallocatechin gallate (EGCG): 800 mg (4 capsules) of EGCG (green tea extract), taken orally on a daily basis for up to 2 months
|
EGCG With Clomiphene Citrate
n=17 Participants
EGCG 800 mg daily with clomiphene citrate 100mg for 5 days.
Epigallocatechin gallate (EGCG): 800 mg (4 capsules) of EGCG (green tea extract), taken orally on a daily basis for up to 2 months
Clomiphene Citrate: 100 mg for 5 days
|
EGCG With Letrozole
EGCG 800mg daily with letrozole 5mg for 5 days.
Epigallocatechin gallate (EGCG): 800 mg (4 capsules) of EGCG (green tea extract), taken orally on a daily basis for up to 2 months
Letrozole: 5 mg for 5 days
|
|---|---|---|---|
|
Change in Serum Folate Level Between MTHFR677-Wild Type (WT) Group and MTHFR677-Hetero Group
|
-3.2 ng/mL
Standard Deviation 4.1
|
-2.0 ng/mL
Standard Deviation 3.0
|
—
|
SECONDARY outcome
Timeframe: Baseline, and Visit 4 (end of study, up to 40 days)Change in serum folate levels between MTHFR1298-Wild Type (WT) group and MTHFR1298-Hetero group
Outcome measures
| Measure |
EGCG Daily Alone.
n=16 Participants
EGCG daily alone. 800mg
Epigallocatechin gallate (EGCG): 800 mg (4 capsules) of EGCG (green tea extract), taken orally on a daily basis for up to 2 months
|
EGCG With Clomiphene Citrate
n=14 Participants
EGCG 800 mg daily with clomiphene citrate 100mg for 5 days.
Epigallocatechin gallate (EGCG): 800 mg (4 capsules) of EGCG (green tea extract), taken orally on a daily basis for up to 2 months
Clomiphene Citrate: 100 mg for 5 days
|
EGCG With Letrozole
EGCG 800mg daily with letrozole 5mg for 5 days.
Epigallocatechin gallate (EGCG): 800 mg (4 capsules) of EGCG (green tea extract), taken orally on a daily basis for up to 2 months
Letrozole: 5 mg for 5 days
|
|---|---|---|---|
|
Change in Serum Folate Level Between MTHFR1298-Wild Type (WT) Group and MTHFR1298-Hetero Group
|
-1.5 ng/mL
Standard Deviation 3.0
|
-3.8 ng/mL
Standard Deviation 3.7
|
—
|
SECONDARY outcome
Timeframe: Baseline, and Visit 4 (end of study, up to 40 days)Change in serum folate levels between DHFR-Wild Type (WT) group and DHFR-Hetero or homo group.
Outcome measures
| Measure |
EGCG Daily Alone.
n=7 Participants
EGCG daily alone. 800mg
Epigallocatechin gallate (EGCG): 800 mg (4 capsules) of EGCG (green tea extract), taken orally on a daily basis for up to 2 months
|
EGCG With Clomiphene Citrate
n=23 Participants
EGCG 800 mg daily with clomiphene citrate 100mg for 5 days.
Epigallocatechin gallate (EGCG): 800 mg (4 capsules) of EGCG (green tea extract), taken orally on a daily basis for up to 2 months
Clomiphene Citrate: 100 mg for 5 days
|
EGCG With Letrozole
EGCG 800mg daily with letrozole 5mg for 5 days.
Epigallocatechin gallate (EGCG): 800 mg (4 capsules) of EGCG (green tea extract), taken orally on a daily basis for up to 2 months
Letrozole: 5 mg for 5 days
|
|---|---|---|---|
|
Change in Serum Folate Level Between DHFR-Wild Type (WT) Group and DHFR-Hetero or Homo Group.
|
-3.9 ng/mL
Standard Deviation 4.3
|
-2.1 ng/mL
Standard Deviation 3.2
|
—
|
Adverse Events
EGCG Daily Alone.
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
EGCG With Clomiphene Citrate
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
EGCG With Letrozole
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
EGCG Daily Alone.
n=16 participants at risk
EGCG daily alone. 800mg
Epigallocatechin gallate (EGCG): 800 mg (4 capsules) of EGCG (green tea extract), taken orally on a daily basis for up to 2 months
|
EGCG With Clomiphene Citrate
n=11 participants at risk
EGCG 800 mg daily with clomiphene citrate 100mg for 5 days.
Epigallocatechin gallate (EGCG): 800 mg (4 capsules) of EGCG (green tea extract), taken orally on a daily basis for up to 2 months
Clomiphene Citrate: 100 mg for 5 days
|
EGCG With Letrozole
n=12 participants at risk
EGCG 800mg daily with letrozole 5mg for 5 days.
Epigallocatechin gallate (EGCG): 800 mg (4 capsules) of EGCG (green tea extract), taken orally on a daily basis for up to 2 months
Letrozole: 5 mg for 5 days
|
|---|---|---|---|
|
Gastrointestinal disorders
Abdominal discomfort and loose stool
|
0.00%
0/16 • Up to 60 days
|
0.00%
0/11 • Up to 60 days
|
8.3%
1/12 • Up to 60 days
|
|
Gastrointestinal disorders
Diarrhea
|
6.2%
1/16 • Up to 60 days
|
0.00%
0/11 • Up to 60 days
|
0.00%
0/12 • Up to 60 days
|
|
General disorders
Dizziness
|
0.00%
0/16 • Up to 60 days
|
9.1%
1/11 • Up to 60 days
|
0.00%
0/12 • Up to 60 days
|
|
General disorders
Facial flushing, muscle ache, and diarrhea after letrozole
|
0.00%
0/16 • Up to 60 days
|
0.00%
0/11 • Up to 60 days
|
8.3%
1/12 • Up to 60 days
|
|
Gastrointestinal disorders
Greenish discharge
|
0.00%
0/16 • Up to 60 days
|
9.1%
1/11 • Up to 60 days
|
0.00%
0/12 • Up to 60 days
|
|
General disorders
Headaches
|
6.2%
1/16 • Up to 60 days
|
0.00%
0/11 • Up to 60 days
|
0.00%
0/12 • Up to 60 days
|
|
General disorders
Insomnia
|
0.00%
0/16 • Up to 60 days
|
9.1%
1/11 • Up to 60 days
|
8.3%
1/12 • Up to 60 days
|
|
Renal and urinary disorders
Kidney pain
|
0.00%
0/16 • Up to 60 days
|
0.00%
0/11 • Up to 60 days
|
8.3%
1/12 • Up to 60 days
|
|
Gastrointestinal disorders
Loose stool
|
0.00%
0/16 • Up to 60 days
|
0.00%
0/11 • Up to 60 days
|
8.3%
1/12 • Up to 60 days
|
|
General disorders
Low mood
|
0.00%
0/16 • Up to 60 days
|
9.1%
1/11 • Up to 60 days
|
0.00%
0/12 • Up to 60 days
|
|
Immune system disorders
Migraine after vaccine
|
6.2%
1/16 • Up to 60 days
|
0.00%
0/11 • Up to 60 days
|
0.00%
0/12 • Up to 60 days
|
|
Gastrointestinal disorders
Nausea with EGCG
|
0.00%
0/16 • Up to 60 days
|
9.1%
1/11 • Up to 60 days
|
8.3%
1/12 • Up to 60 days
|
|
General disorders
Pelvic cramps, dull and intermittent aching after letrozole
|
0.00%
0/16 • Up to 60 days
|
0.00%
0/11 • Up to 60 days
|
8.3%
1/12 • Up to 60 days
|
|
Gastrointestinal disorders
Vomiting and diarrhea after clomid
|
0.00%
0/16 • Up to 60 days
|
9.1%
1/11 • Up to 60 days
|
0.00%
0/12 • Up to 60 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place