Trials / Active Not Recruiting
Active Not RecruitingNCT04300855
Clinical Trial of Green Tea Catechins in Men on Active Surveillance
Phase II Clinical Trial of Green Tea Catechins in Men on Active Surveillance (AS)
- Status
- Active Not Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 115 (actual)
- Sponsor
- H. Lee Moffitt Cancer Center and Research Institute · Academic / Other
- Sex
- Male
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This randomized double-blinded Phase II clinical trial will evaluate the bioavailability, safety, effectiveness and validate the mechanism by which a standardized formulation of whole Green Tea Catechin, (Sunphenon® 90D) containing 405 mgs vs. Placebo, administered for 24 months in a cohort of men with low to intermediate grade prostate managed on active surveillance
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Sunphenon | The study agent will be administered in divided doses with food, three capsules twice a day (405 mg) for 24 months |
| DRUG | Placebo | Matching placebo |
Timeline
- Start date
- 2020-08-21
- Primary completion
- 2027-02-27
- Completion
- 2027-02-27
- First posted
- 2020-03-09
- Last updated
- 2026-04-01
Locations
2 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04300855. Inclusion in this directory is not an endorsement.