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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01HD100369-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
| University of Illinois at Chicago | OTHER |
| Johns Hopkins University | OTHER |
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A trial to assess the pharmacokinetics and hepatic safety of EGCG in women with and without uterine fibroids.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EGCG daily alone. | Experimental | EGCG daily alone. 800mg |
|
| EGCG with clomiphene citrate | Experimental | EGCG 800 mg daily with clomiphene citrate 100mg for 5 days. |
|
| EGCG with letrozole | Experimental | EGCG 800mg daily with letrozole 5mg for 5 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | Baseline, and Visit 4 (end of study, up to 40 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Total Bilirubin | Changes in total bilirubin between the 3 groups. | Baseline, and Visit 4 (end of study, up to 40 days) |
| Changes in ALT/SGPT | Changes in alanine aminotransferase /SGPT between the 3 groups. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Esther Eisenberg, MD | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | Study Director |
| Ayman Al-Hendy, MD,PhD | University of Chicago | Principal Investigator |
| Heping Zhang, PhD | Yale University | Study Director |
| James Segars, MD | Johns Hopkins University | Study Director |
| Hugh Taylor, MD | Yale University | Study Director |
| Frank Gonzales, MD | University of Illinois at Chicago | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins Medicine | Baltimore | Maryland | 21205 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| FG002 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | EGCG With Clomiphene Citrate |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Median | Inter-Quartile Range | nM | Baseline, and Visit 4 (end of study, up to 40 days) |
|
Up to 60 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal discomfort and loose stool | Gastrointestinal disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Heping Zhang | Yale University | 2037855185 | heping.zhang@yale.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 29, 2021 | Feb 27, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D007889 | Leiomyoma |
| ID | Term |
|---|---|
| D009379 | Neoplasms, Muscle Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C045651 | epigallocatechin gallate |
| D002996 | Clomiphene |
| D000077289 | Letrozole |
| ID | Term |
|---|---|
| D013267 | Stilbenes |
| D001597 | Benzylidene Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
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| University of Chicago |
| OTHER |
The 36 women will be randomized to one of the following groups:
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| Clomiphene Citrate | Drug | 100 mg for 5 days |
|
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| Letrozole | Drug | 5 mg for 5 days |
|
|
| Baseline, and Visit 4 (end of study, up to 40 days) |
| Changes in Alkaline Phosphatase | Changes in Alkaline Phosphatase between the 3 groups. | Baseline, and Visit 4 (end of study, up to 40 days) |
| Changes in Estrogen (E2) | Changes in Estrogen (E2) between the 3 groups. | Baseline, and Visit 4 (end of study, up to 40 days) |
| Changes in Endometrial Thickness | Changes in endometrial thickness between the 3 groups. | 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 | 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 | 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. | Baseline, and Visit 4 (end of study, up to 40 days) |
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
| BG002 | 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 |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| OG002 | 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 |
|
|
|
| Primary | 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. | Posted | Median | Full Range | nM | Baseline, and Visit 4 (end of study, up to 40 days) |
|
|
|
|
| Primary | 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. | Posted | Median | Inter-Quartile Range | nM | Baseline, and Visit 4 (end of study, up to 40 days) |
|
|
|
|
| Secondary | Changes in Total Bilirubin | Changes in total bilirubin between the 3 groups. | Posted | Mean | Standard Deviation | mg/dL | Baseline, and Visit 4 (end of study, up to 40 days) |
|
|
|
|
| Secondary | Changes in ALT/SGPT | Changes in alanine aminotransferase /SGPT between the 3 groups. | Posted | Mean | Standard Deviation | U/L | Baseline, and Visit 4 (end of study, up to 40 days) |
|
|
|
|
| Secondary | Changes in Alkaline Phosphatase | Changes in Alkaline Phosphatase between the 3 groups. | Posted | Mean | Standard Deviation | U/L | Baseline, and Visit 4 (end of study, up to 40 days) |
|
|
|
|
| Secondary | Changes in Estrogen (E2) | Changes in Estrogen (E2) between the 3 groups. | Posted | Mean | Standard Deviation | pg/mL | Baseline, and Visit 4 (end of study, up to 40 days) |
|
|
|
|
| Secondary | Changes in Endometrial Thickness | Changes in endometrial thickness between the 3 groups. | Posted | Mean | Standard Deviation | mm | Baseline, and Visit 4 (end of study, up to 40 days) |
|
|
|
|
| Secondary | 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 | Posted | Mean | Standard Deviation | ng/mL | Baseline, and Visit 4 (end of study, up to 40 days) |
|
|
|
|
| Secondary | 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 | Posted | Mean | Standard Deviation | ng/mL | Baseline, and Visit 4 (end of study, up to 40 days) |
|
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | ng/mL | Baseline, and Visit 4 (end of study, up to 40 days) |
|
|
|
|
| 0 |
| 16 |
| 0 |
| 16 |
| 2 |
| 16 |
| EG001 | 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 | 0 | 11 | 0 | 11 | 4 | 11 |
| EG002 | 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 | 0 | 12 | 0 | 12 | 6 | 12 |
| Diarrhea | Gastrointestinal disorders | Non-systematic Assessment |
|
| Dizziness | General disorders | Non-systematic Assessment |
|
| Facial flushing, muscle ache, and diarrhea after letrozole | General disorders | Non-systematic Assessment |
|
| Greenish discharge | Gastrointestinal disorders | Non-systematic Assessment |
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| Headaches | General disorders | Non-systematic Assessment |
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| Insomnia | General disorders | Non-systematic Assessment |
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| Kidney pain | Renal and urinary disorders | Non-systematic Assessment |
|
| Loose stool | Gastrointestinal disorders | Non-systematic Assessment |
|
| Low mood | General disorders | Non-systematic Assessment |
|
| Migraine after vaccine | Immune system disorders | Non-systematic Assessment |
|
| Nausea with EGCG | Gastrointestinal disorders | Non-systematic Assessment |
|
| Pelvic cramps, dull and intermittent aching after letrozole | General disorders | Non-systematic Assessment |
|
| Vomiting and diarrhea after clomid | Gastrointestinal disorders | Non-systematic Assessment |
|
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| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D009570 | Nitriles |
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |