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A CLINICAL STUDY REPORT VIGRX PLUS In Male Sexual Health
A CLINICAL STUDY REPORT VIGRX PLUS In Male Sexual Health
Part 1
SYNOPSIS
Name of sponsor company : DM Contact Management Ltd.
Name of finished product : VigRX Plus capsules
Name of active ingredients:
Panax ginseng (Korean Red Ginseng)
Serenoa repens (Saw Palmetto)
Crataegus rivularis ( Hawthorne)
Ginkgo biloba
Turnera diffusa (Damiana)
Tribulus terrestris
Erythroxylum catuaba
Ptychopetalum olacoides (Muira Puama)
Cuscuta chinensis
Epimedium sagittatum
Bioperine (extract from Piper nigrum fruit )
Title of the study: A triple blind, placebo controlled, randomized study to evaluate the
safety and efficacy of VigRX Plus capsules as a dietary supplement to improve erectile
function and maintain Male Sexual Health.
Investigators and study centres:
1)Dr. Gaurang Shah
Jivdaya Hospital,Dharmoday bldg, Jivdaya lane, L.B.S. Marg, Ghatkopar (W), Mumbai-
86.INDIA.Mob: 9821019432.
2)Dr. R. K. Shimpi
Dept. of Urology,Noble Hospital, 153,Magarpatta City Road, Hadapsar,Pune-411 013.
INDIA.Mob : 9822059799
3)Dr. Suresh Patankar
Institute of urology,Survey no. 32/2A, Erandwane, Behind Mehendale garage,Gulwani
Maharaj road, Pune-4.INDIA.Mob : 9881256992
4)Dr. Manoj Chaudhari
169, Parvati gaon, Bhaghirathi Medical Foundation, Pune – 400009, Phone. 9225571450
5)Dr. Vilas Sabale
First floor, Vithal Acrade, Near Rupee bank, Pune Nasik Highway,Bhosari, Pune-411039
Mobile: 9822004630
Study period:
Date of first enrollment: 07/05/2009
Date of last completed: 17/12/2009
Phase of study : Therapeutic exploratory
Objectives
Primary objective
To evaluate the efficacy of VigRX Plus capsules as a dietary supplement to improve
erectile function as assessed by Erectile function subscale of IIEF Questionnaire (IIEF-A)
from baseline to end of treatment as compared to placebo.
Secondary objectives
• To evaluate the efficacy of VigRX Plus capsules as a dietary supplement for Male
Sexual Health as assessed by IIEF (Total) (International Index of Erectile Function)
questionnaire from baseline to end of treatment as compared to placebo
• To evaluate the efficacy of VigRX Plus capsules as a dietary supplement for Male
Sexual Health as assessed by IIEF-B questionnaire (sum of all the subscales of IIEF
except erectile function subscale) from baseline to end of treatment as compared to
placebo
• To evaluate the impact of VigRX Plus capsules as a dietary supplement for Male
Sexual Health as assessed by EDITS questionnaire (Patient & Partner version) as
compared to placebo
• To evaluate the safety of VigRX Plus capsules as a dietary supplement for Male
Sexual Health from baseline to end of treatment as compared to placebo
• To assess the effect of VigRX Plus on the sperm count, motility, semen volume from
baseline to end of treatment.
• To assess the effect of VigRX Plus on Serum testosterone from baseline to end of
treatment as compared to placebo
Diagnosis and main criteria for inclusion
1. Male subjects aged between 25-50 years
2. Subject having a monogamous, heterosexual relationship
3. Male subjects with IIEF-A score 11 to 23 & IIEF-B score 21 to 35 at screening visit &
baseline visit
4. Subject provides written informed consent and comes for regular follow up
Methodology
75 males between 25-50 years of age were recruited to get 60 completed cases.
Subjects with an IIEF erectile function domain score of 11-23 and remaining domains
score of 21-35 were eligible for the study. For each subject the study terminated after a
maximal period of 84 days from enrollment and included 5 follow up visits. After
consenting to participate subjects were put on 15 days wash-out period before being
administered the investigational product or placebo. On baseline visit (Day 1), medical
history and physical examination were performed, IIEF Total questionnaire was
assessed and the trial medications were dispensed. At all the follow-up visits (at an
interval of 28 days) each subject was administered a new IIEF (Total) and an EDITS
questionnaire. Each subject received another supply of the trial medications during these
visits. On Day 28 and Day 84 EDITS questionnaire partner version scores were obtained
from partners who consented for the same. Additionally at these visits subjects rated the
tolerability of the treatment they received. At the end of treatment investigator’s global
opinion of therapy and subject’s opinion on continuing with the trial medication was
obtained.
Number of patients planned: 60 completed cases
Number of patients analysed :75
Test product, dose and mode of administration, batch number
VigRx Plus -2 capsules twice a day with meals for 12 weeks, Batch No:VP01.
Reference therapy: Placebo 2 capsules twice a day with meals for 12 weeks
Batch No: VX01,
Criteria for evaluation:
Primary efficacy evaluation
Improvement in IIEF-A (Erectile function domain of the International Index of Erectile
Function) score for erectile function domain as compared to placebo
Secondary efficacy evaluation:
• Increase in total score of quality of sexual life questionnaire-IIEF (Total) as
compared to placebo
Secondary efficacy evaluation (continued)
• Improvement in IIEF-B (other than the erectile function domain) score as
compared to placebo
• Satisfaction with treatment (EDITS Patient & partner version) as compared to
placebo
• Improvement in Semen Analysis Parameters as compared to placebo
• Improvement in Serum Testosterone (Total) levels , as compared to placebo
Safety
Monitoring of adverse events. Clinical examination, Assessment of vitals and laboratory
parameters.
Statistical methods
Analysis for safety was done on an intention-to treat population. This included subjects
who received at least one dose of treatment post randomization and for whom at least
one post baseline measurement was available. Missing data were imputed using last
observation carried forward (LOCF) method.
Analysis of efficacy was primarily done on a per protocol data set constituting of subjects
completing all the protocol required visits. Changes from baseline in IIEF scores were
asessed using analysis of covariance (ANCOVA). Data on EDITS (patient and partner
versions) were analysed by independent sample t test. Chi-square test was used to
analyse investigators’ assessment and subjects, opinion across the two groups. All
statistical tests were applied at 5% level of significance.
Results
Efficacy
Treatment with VigRx Plus resulted in a statistically significant increase (p<0.0001) of
IIEF-A, IIEF-B and IIEF-Total scores as compared to placebo, on Day 84 (end of
treatment).In subjects treated with VigRx Plus, mean increases from baseline to end of
treatment for IIEF-A, IIEF-B and IIEF-Total were 9, 20.1 and 11.56 respectively. The
corresponding increases in the placebo group were 0.62, 1 and 0.68.Treatment
satisfaction as assessed by EDITS (patient version) was statistically significantly higher
in the VigRx Plus group as compared to placebo on Day 28, Day 56 and Day 84. At the
end of treatment, mean EDITS score was 82.31 in the VigRx Plus group and 36.78 in
the placebo group.
Results (continued)
Female partners reciprocated the satisfaction levels experienced by their male
counterparts treated with VigRx Plus, with the mean EDITS (partner version) score of
69.58 in the VigRx Plus group being statistically greater than that of 25.5 in the placebo
group.
There was no statistically significant difference in the sperm count, semen volume and
sperm motility between the two treatment groups. Serum Testosterone levels did not
change significantly in any of the study groups.
At the end of study, global assessment of therapy by investigator clearly saw a
superiority of outcomes in subjects receiving VigRx Plus as compared to those receiving
placebo, with statistical significance. Subjects’ opinion was also statistically significant in
favor of VigRx Plus.
Safety
VigRx Plus and placebo both were safe and well tolerated in the study. Changes in
laboratory and vital signs were clinically insignificant. The only serious adverse event
reported in this study was when one subject from the VigRx Plus group suffered from
infection due to malarial parasite and was subsequently withdrawn from the study.
Conclusion
In conclusion, use of VigRx Plus for twelve weeks was significantly better than placebo
in improving erectile function in subjects with sexual dysfunction. It was also significantly
superior to placebo in improving the other aspects of sexual health such as libido,
intercourse satisfaction, orgasmic function and overall satisfaction. The enhancement of
sexual function was endorsed by female partners of subjects receiving VigRx Plus.
VigRx Plus was safe and well tolerated in subjects with male sexual dysfunction.
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Part 1
SYNOPSIS
Name of sponsor company : DM Contact Management Ltd.
Name of finished product : VigRX Plus capsules
Name of active ingredients:
Panax ginseng (Korean Red Ginseng)
Serenoa repens (Saw Palmetto)
Crataegus rivularis ( Hawthorne)
Ginkgo biloba
Turnera diffusa (Damiana)
Tribulus terrestris
Erythroxylum catuaba
Ptychopetalum olacoides (Muira Puama)
Cuscuta chinensis
Epimedium sagittatum
Bioperine (extract from Piper nigrum fruit )
Title of the study: A triple blind, placebo controlled, randomized study to evaluate the
safety and efficacy of VigRX Plus capsules as a dietary supplement to improve erectile
function and maintain Male Sexual Health.
Investigators and study centres:
1)Dr. Gaurang Shah
Jivdaya Hospital,Dharmoday bldg, Jivdaya lane, L.B.S. Marg, Ghatkopar (W), Mumbai-
86.INDIA.Mob: 9821019432.
2)Dr. R. K. Shimpi
Dept. of Urology,Noble Hospital, 153,Magarpatta City Road, Hadapsar,Pune-411 013.
INDIA.Mob : 9822059799
3)Dr. Suresh Patankar
Institute of urology,Survey no. 32/2A, Erandwane, Behind Mehendale garage,Gulwani
Maharaj road, Pune-4.INDIA.Mob : 9881256992
4)Dr. Manoj Chaudhari
169, Parvati gaon, Bhaghirathi Medical Foundation, Pune – 400009, Phone. 9225571450
5)Dr. Vilas Sabale
First floor, Vithal Acrade, Near Rupee bank, Pune Nasik Highway,Bhosari, Pune-411039
Mobile: 9822004630
Study period:
Date of first enrollment: 07/05/2009
Date of last completed: 17/12/2009
Phase of study : Therapeutic exploratory
Objectives
Primary objective
To evaluate the efficacy of VigRX Plus capsules as a dietary supplement to improve
erectile function as assessed by Erectile function subscale of IIEF Questionnaire (IIEF-A)
from baseline to end of treatment as compared to placebo.
Secondary objectives
• To evaluate the efficacy of VigRX Plus capsules as a dietary supplement for Male
Sexual Health as assessed by IIEF (Total) (International Index of Erectile Function)
questionnaire from baseline to end of treatment as compared to placebo
• To evaluate the efficacy of VigRX Plus capsules as a dietary supplement for Male
Sexual Health as assessed by IIEF-B questionnaire (sum of all the subscales of IIEF
except erectile function subscale) from baseline to end of treatment as compared to
placebo
• To evaluate the impact of VigRX Plus capsules as a dietary supplement for Male
Sexual Health as assessed by EDITS questionnaire (Patient & Partner version) as
compared to placebo
• To evaluate the safety of VigRX Plus capsules as a dietary supplement for Male
Sexual Health from baseline to end of treatment as compared to placebo
• To assess the effect of VigRX Plus on the sperm count, motility, semen volume from
baseline to end of treatment.
• To assess the effect of VigRX Plus on Serum testosterone from baseline to end of
treatment as compared to placebo
Diagnosis and main criteria for inclusion
1. Male subjects aged between 25-50 years
2. Subject having a monogamous, heterosexual relationship
3. Male subjects with IIEF-A score 11 to 23 & IIEF-B score 21 to 35 at screening visit &
baseline visit
4. Subject provides written informed consent and comes for regular follow up
Methodology
75 males between 25-50 years of age were recruited to get 60 completed cases.
Subjects with an IIEF erectile function domain score of 11-23 and remaining domains
score of 21-35 were eligible for the study. For each subject the study terminated after a
maximal period of 84 days from enrollment and included 5 follow up visits. After
consenting to participate subjects were put on 15 days wash-out period before being
administered the investigational product or placebo. On baseline visit (Day 1), medical
history and physical examination were performed, IIEF Total questionnaire was
assessed and the trial medications were dispensed. At all the follow-up visits (at an
interval of 28 days) each subject was administered a new IIEF (Total) and an EDITS
questionnaire. Each subject received another supply of the trial medications during these
visits. On Day 28 and Day 84 EDITS questionnaire partner version scores were obtained
from partners who consented for the same. Additionally at these visits subjects rated the
tolerability of the treatment they received. At the end of treatment investigator’s global
opinion of therapy and subject’s opinion on continuing with the trial medication was
obtained.
Number of patients planned: 60 completed cases
Number of patients analysed :75
Test product, dose and mode of administration, batch number
VigRx Plus -2 capsules twice a day with meals for 12 weeks, Batch No:VP01.
Reference therapy: Placebo 2 capsules twice a day with meals for 12 weeks
Batch No: VX01,
Criteria for evaluation:
Primary efficacy evaluation
Improvement in IIEF-A (Erectile function domain of the International Index of Erectile
Function) score for erectile function domain as compared to placebo
Secondary efficacy evaluation:
• Increase in total score of quality of sexual life questionnaire-IIEF (Total) as
compared to placebo
Secondary efficacy evaluation (continued)
• Improvement in IIEF-B (other than the erectile function domain) score as
compared to placebo
• Satisfaction with treatment (EDITS Patient & partner version) as compared to
placebo
• Improvement in Semen Analysis Parameters as compared to placebo
• Improvement in Serum Testosterone (Total) levels , as compared to placebo
Safety
Monitoring of adverse events. Clinical examination, Assessment of vitals and laboratory
parameters.
Statistical methods
Analysis for safety was done on an intention-to treat population. This included subjects
who received at least one dose of treatment post randomization and for whom at least
one post baseline measurement was available. Missing data were imputed using last
observation carried forward (LOCF) method.
Analysis of efficacy was primarily done on a per protocol data set constituting of subjects
completing all the protocol required visits. Changes from baseline in IIEF scores were
asessed using analysis of covariance (ANCOVA). Data on EDITS (patient and partner
versions) were analysed by independent sample t test. Chi-square test was used to
analyse investigators’ assessment and subjects, opinion across the two groups. All
statistical tests were applied at 5% level of significance.
Results
Efficacy
Treatment with VigRx Plus resulted in a statistically significant increase (p<0.0001) of
IIEF-A, IIEF-B and IIEF-Total scores as compared to placebo, on Day 84 (end of
treatment).In subjects treated with VigRx Plus, mean increases from baseline to end of
treatment for IIEF-A, IIEF-B and IIEF-Total were 9, 20.1 and 11.56 respectively. The
corresponding increases in the placebo group were 0.62, 1 and 0.68.Treatment
satisfaction as assessed by EDITS (patient version) was statistically significantly higher
in the VigRx Plus group as compared to placebo on Day 28, Day 56 and Day 84. At the
end of treatment, mean EDITS score was 82.31 in the VigRx Plus group and 36.78 in
the placebo group.
Results (continued)
Female partners reciprocated the satisfaction levels experienced by their male
counterparts treated with VigRx Plus, with the mean EDITS (partner version) score of
69.58 in the VigRx Plus group being statistically greater than that of 25.5 in the placebo
group.
There was no statistically significant difference in the sperm count, semen volume and
sperm motility between the two treatment groups. Serum Testosterone levels did not
change significantly in any of the study groups.
At the end of study, global assessment of therapy by investigator clearly saw a
superiority of outcomes in subjects receiving VigRx Plus as compared to those receiving
placebo, with statistical significance. Subjects’ opinion was also statistically significant in
favor of VigRx Plus.
Safety
VigRx Plus and placebo both were safe and well tolerated in the study. Changes in
laboratory and vital signs were clinically insignificant. The only serious adverse event
reported in this study was when one subject from the VigRx Plus group suffered from
infection due to malarial parasite and was subsequently withdrawn from the study.
Conclusion
In conclusion, use of VigRx Plus for twelve weeks was significantly better than placebo
in improving erectile function in subjects with sexual dysfunction. It was also significantly
superior to placebo in improving the other aspects of sexual health such as libido,
intercourse satisfaction, orgasmic function and overall satisfaction. The enhancement of
sexual function was endorsed by female partners of subjects receiving VigRx Plus.
VigRx Plus was safe and well tolerated in subjects with male sexual dysfunction.
Popular tags: vigrx, vigrx plus, does vigrx really work, vigrx oil, vigrx plus reviews, vigrx store, vigrx forum, vigrx reviews, canada vigrx, vigrx before after, vigrx plus testimonials, vigrx oil review, vigrx pillole, does vigrx work, study vigrx, vigrx review, reviews of vigrx cream,vigrx information, vigrx plus forum, vigrx plus review, vigrx recensione, vigrx side effects, cheapest to order vigrx oil, real vigrx, vigrx ingredients, vigrx plus comments, vigrx recensioni, buying vigrx plus, does vigrx work? is vigrx plus permanent,review vigrx, vigrx canada, vigrx consumer reviews, vigrx does not work, vigrx ds, vigrx olio, vigrx plus in stores, vigrx plus pictures, how long for vigrx to work? improve male labido vigrx, medical evaluation of vigrx, vigrx +penis, vigrx australia, vigrx capsules, vigrx or pro+plus, vigrx plus before and after photos, vigrx plus pill reveiw, vigrx plus results, vigrx scam, will vigrx oil give me an erection, buy vigrx, comments on vigrx, disadvantage when you stop using vigrx plus, does vigrx damage liver, how big does the pines get with vigrx, is prosolution better than vigrx plus, male enhancement vigrx, orexis and vigrx plus comparison, vigrx customer reviews, vigrx from uk, vigrx mechanism of action, vigrx oil canada, vigrx oil free sample, vigrx oil not working? vigrx plus free samples, vigrx plus increase size, vigrx plus ingredients, vigrx plus pills, vigrx plus success stories, vigrx sold in stores,vigrx take how long, whats the diffrence between vigrx and vigrx plus, where is vigrx plus available, where to buy vigrx
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