Table 1

Trial nameInterventionOutcomeProject finish date

Effects of plant extracts on semen quality (NCT01357044)Pomegranate versus placeboPrimary outcome measures:   
(i) count of motile sperm per ejaculate (time frame: up to two years)   
designated as safety issue: no)   
Secondary outcome measures:   
(i) morphology: percentage of morphologically abnormal sperm in the ejaculate (time frame: up to two years) (designated as safety issue: no)   
If we find an increase in the primary outcome measure in data from participants receiving plant extracts and not in those receiving placebo tablets, we wish to further investigate whether sperm morphology also improves when consuming the plant extracts, for example, whether the percentage of abnormal sperm in an ejaculate decreases in the group of participants receiving the active plant extracts
October 2012

Study of POMELLA extract to treat prostate cancer (NCT01100866)Pomegranate versus placeboPrimary outcome measures:   
(i) tissue collection and bioanalysis of the specimens collected (time frame: tissue collected on day 31 (after 30 days of study treatment)) (designated as safety issue: no)   
Prostate tissue are collected at radical prostatectomy. These specimens are used to explore the effects of treatment on the expression of the proliferation markers, enzymes, hormones, receptors, and cell signaling proteins known to influence prostate cancer progression
December 2013

Pomegranate Juice in treating patients with recurrent prostate cancer (NCT00060086)Pomegranate juice versus placeboPrimary outcome measures:   
(i) clinical efficacy, in terms of overall response rate, measured by serum prostate-specific antigen (PSA) levels every 3 months (time frame: evaluated every 3 months for 18 months) (designated as safety issue: no)
December 2012

Extension to study of effects of pomegranate extract on rising PSA levels after primary therapy for prostate cancer (NCT00732043)Pomegranate extract versus placeboPrimary outcome measures:   
(i) the primary outcome variable will be the mean PSA doubling time at the end of 12, 24, 36, and 48 months (time frame: 48 months) (designated as safety issue: no)   
Secondary outcome measures:   
(i) the mean change in PSA doubling time from baseline to end of treatment (time frame: 48 months) (designated as safety issue: no)   
(ii) response rates in positive and negative PSA doubling times with a clinically significant positive doubling time is defined as >150% of baseline (time frame: 48 months) (designated as safety issue: no)   
(iii) overall efficacy responses categorized as objective response, progressive disease, and stable disease (time frame: 48 months) (designated as safety issue: no)   
(iv) measures of tolerability (adverse events) and toxicity (clinical chemistries, etc.) (time frame: 48 months) (designated as safety issue: yes)
January 2015

A pilot study to evaluate the effect of pomegranate juice on semen parameters in healthy male volunteers (NCT01595308)PomegranatePrimary outcome measures:   
(i) change in sperm counts (time frame: baseline and 6 months) (designated as safety issue: no)   
The primary outcome will be change in sperm counts relative to baseline with and without POM   
Secondary outcome measures:   
(i) change in sperm count (time frame: 6 months) (designated as safety issue: no)   
The secondary outcome will be change in sperm counts relative to baseline with and without POM
May 2012

Open-label extension study of the effects of pomegranate extract on rising PSA after primary therapy for prostate cancer (NCT00731848)Pomegranate liquid extractPrimary outcome measures:   
(i) the within-subject difference between the PSA doubling time from the end of double-blind placebo treatment to the end of open-label pomegranate extract treatment (time frame: 12 months) (designated as safety issue: no)   
Secondary outcome measures:   
(i) the effect of treatments on response rates for positive PSA doubling times (greater than 150% baseline), for negative posttreatment PSA doubling time (i.e., declining PSA), and for changes in absolute PSA values (time frame: 12 months) (designated as safety issue: no)
January 2015

For more information go to: http://clinicaltrials.gov/.