Status:
COMPLETED
A Clinical Study to Determine Factors Affecting Absorption and Serum Levels of Lycopene After Supplementation
Lead Sponsor:
National Taiwan University Hospital
Conditions:
BPH
Eligibility:
MALE
40+ years
Phase:
PHASE2
Brief Summary
Primary: To determine factors that affect absorption and serum levels of lycopene after supplementation. Secondary: 1. To evaluate general safety and tolerability of oral lycopene 15 or 30 mg per da...
Detailed Description
This is an uncontrolled intervention study in which eligible male subjects (N=60), after a two-week washout, will be randomized to receive lycopene either 15 or 30 mg per day for 12 weeks. About equal...
Eligibility Criteria
Inclusion
- Male subjects aged 40 or older with no pathologically-proven prostate cancer or other cancers. Patients who have had a negative prostate biopsy are still acceptable.
- Subjects with a PSA between 2.5 and 20.0 ng/ml.
- Subjects understand the study procedures and agree to participate in the study by providing a written informed consent and scheduled blood or urine samples.
- Subjects whose liver function and renal function tests are within normal range.
Exclusion
- Subjects who may have fluctuated serum PSAs, such as urinary tract infection, prostatitis, acute urinary retention, receiving radiotherapy to the pelvis, etc.
- Subjects who have received a prostate surgery or biopsy within 6 weeks before the initiation of lycopene supplementation.
- Subjects who may or will receive a prostate surgery or biopsy within 12 weeks of the initiation of lycopene supplementation.
- Subjects who have known allergic reaction to carotenoids including lycopene.
- Subjects who are participating or will participate in other clinical trials.
- Subjects who are taking medications that may alter serum PSA levels, such as 5-alpha reductase inhibitor (eg. finasteride), sex steroids or hormonal agents (eg. luteinizing hormone releasing hormone agonists, cyproterone acetate, flutamide, bicalutamide, megesterol acetate, etc.).
- Subjects who may require increased dosage of medications for lower urinary tract symptoms (LUTS) during the 12 weeks of protocol treatment. Subjects who have been put on medications for LUTS before entry and have a stabilized disease are still acceptable. These medications include, but note limited to, selective or non-selective alpha-blockers and anti-cholinergics.
- Subjects who have or have had clinical gastrointestinal malabsorption regardless of the etiology.
Key Trial Info
Start Date :
March 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2005
Estimated Enrollment :
74 Patients enrolled
Trial Details
Trial ID
NCT00154843
Start Date
March 1 2004
End Date
June 1 2005
Last Update
January 14 2008
Active Locations (1)
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1
National Taiwan University Hospital
Taipei, Taiwan, 100