Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
39 participants
INTERVENTIONAL
2020-11-24
2022-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
1. EGCG daily alone.
2. EGCG daily with clomiphene citrate 100mg for 5 days.
3. EGCG daily with letrozole 5mg for 5 days.
OTHER
NONE
Study Groups
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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
Interventions
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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
Letrozole
5 mg for 5 days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Must use a double-barrier method for contraception
Exclusion Criteria
2. Known liver disease (defined as AST or ALT\>2 times normal, or total bilirubin \>2.5 mg/dL).
3. History of alcohol abuse (defined as \>14 drinks/week) or binge drinking of ≥ 6 drinks at one time).
4. Subject using hormonal contraceptives
5. Subjects who are pregnant or breastfeeding
6. Known hypersensitivity to the study drugs
7. Any chronic disease
18 Years
40 Years
FEMALE
Yes
Sponsors
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Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
University of Illinois at Chicago
OTHER
Johns Hopkins University
OTHER
University of Chicago
OTHER
Yale University
OTHER
Responsible Party
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Hugh Taylor
Chair of Obstetrics, Gynecology and Reproductive Sciences
Principal Investigators
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Esther Eisenberg, MD
Role: STUDY_DIRECTOR
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Ayman Al-Hendy, MD,PhD
Role: PRINCIPAL_INVESTIGATOR
University of Chicago
Heping Zhang, PhD
Role: STUDY_DIRECTOR
Yale University
James Segars, MD
Role: STUDY_DIRECTOR
Johns Hopkins University
Hugh Taylor, MD
Role: STUDY_DIRECTOR
Yale University
Frank Gonzales, MD
Role: STUDY_DIRECTOR
University of Illinois Chicago
Locations
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Johns Hopkins Medicine
Baltimore, Maryland, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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2000028370
Identifier Type: -
Identifier Source: org_study_id
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