Effect of Maxoderm on Sexual Enhancement in
Healthy Men: A Pilot Study
Confidentially Prepared For:
Barmensen Labs, LLC
Date: March 2, 2006
By:
KGK SYNERGIZE INC.
255 Queens Ave., Suite 1030
London, Ontario
CANADA N6A 5R8
Telephone 519-438-9374
Facsimile 519-438-8314
Principal Investigator
David Crowley, MD
Co-Investigators
Jay Udani, MD & Pratibha Chaturvedi, PhD
Effect of Maxoderm on Sexual Enhancement
in Healthy Men: A Pilot Study
STUDY TITLE:
Effect of Maxoderm on Sexual Enhancement in Healthy
Men: A Pilot Study
STUDY REPORT NO:
05-MSHB
STUDY INITIATION DATE:
2005
DATE OF EARLY STUDY
TERMINATION:
N/A
STUDY COMPLETION DATE:
February, 2006
TESTED PRODUCT:
Maxoderm
INDICATION STUDIED:
Markers of quality of sexual life
KEYWORDS:
Maxoderm, erectile function, quality of sexual life
KGK SYNERGIZE
INVESTIGATORS:
Pratibha Chaturvedi, Ph.D.,
D.C. Crowley, M.D.
EXTERNAL INVESTIGATORS:
Jay Udani, MD
SPONSOR:
Barmensen Labs., LLC
STUDY LOCATION:
KGK Synergize Inc.
TOTAL PAGES: 61
KGK SYNERGIZE INC.
CONFIDENTIAL
2
Effect of Maxoderm on Sexual Enhancement
in Healthy Men: A Pilot Study
ABSTRACT
The objective of the study was to determine the efficacy and safety of 4 weeks
use of
Maxoderm in healthy men. The endpoints to be determined were
weekly adverse effects,
IIEF questionnaire scores and partial QVS scores.
Maxoderm had no negative effect on anthropometric measurements, blood chemistry, or
observed side effects for healthy men.
These specific
results support the safe use of
Maxoderm by healthy men.
There was no effect of Maxoderm on IIEF scores as compared with placebo
(P>0.05). IIEF
scores increased non-significantly in both groups versus baseline.
An improvement in the intensity of orgasms was noted after use of Maxoderm
cream, as
compared with baseline, but not
compared to the placebo group. Although there were
other
non-significant improvements in IIEF and QVS scores
versus
baseline with Maxoderm, the
placebo cream had a similar effect. Benefit to
healthy men that may be due to specific
ingredients of Maxoderm may require increased dosage levels to be significant.
The results of this study suggest that use of
Maxoderm by healthy men is safe. However, no
significant benefit of Maxoderm could be demonstrated against placebo with
respect to IIEF
or QVS score improvements after 4 weeks of use by healthy men. Future work
may focus
on a different target group and/or product reformulation to
demonstrate significant benefits of
Maxoderm cream use.
KGK SYNERGIZE INC.
CONFIDENTIAL
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Effect of Maxoderm on Sexual Enhancement
in Healthy Men: A Pilot Study
Effect of Maxoderm on Anthropometric Measurements:
Analysis of anthropometric
measurements at baseline and at
the end of the study showed few significant changes.
Pulse and respiratory rate were higher after use of placebo cream, as compared with
baseline. Pulse changes differed between the two groups,
post-treatment (p<0.05).
Anthropometric measurements are summarized in
Table 4. These results demonstrate the
lack of effect of Maxoderm cream on anthropomorphic measurements, and further support its
safe use.
Effect of Maxoderm on IIEF Scores: The data presented in Table 5 show the IIEF scores
at baseline and at the end of the study in both the treatment and placebo
groups. With use
of placebo cream, there was a significant increase in the score for question
5, suggesting a
greater ease of erection maintenance. There
was a significant increase in the IIEF scores
for questions 6 and 7 with Maxoderm treatment as compared with placebo
(P>0.05),
suggesting an increased libido effected by the Maxoderm cream.
Effect of Maxoderm on Partial QVS Scores:
The data presented in Table 6 show the partial
QVS scores at baseline and at the end of the
study. With use of Maxoderm, there was a significant increase
in the score for question 7A,
suggesting an improvement in the intensity of orgasms. There
was no effect of Maxoderm
on other partial QVS scores as compared with placebo (P>0.05).
KGK SYNERGIZE INC.
CONFIDENTIAL
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Effect of Maxoderm on Sexual Enhancement
in Healthy Men: A Pilot Study
DISCUSSION
Overall, based on blood chemistry and side effect data,
Maxoderm had no negative side
effects in participants. No changes in blood chemistry occurred in either treatment group.
And only one adverse reaction was reported, which was not related to treatment with the
Maxoderm cream. This data supports the safe use of Maxoderm cream.
An improvement in the intensity of orgasms was noted after use of Maxoderm
cream, as
compared with baseline, but not the placebo group.
Although there
were other non-
significant improvements in IIEF and QVS scores versus baseline with
Maxoderm, the
placebo cream had a similar effect, suggesting
that there was no benefit attributable to
specific ingredients of Maxoderm
or the combination product itself. Higher addition levels of
one or more of the active herbal ingredients in the Maxoderm
formulation may be required to
effect a statistically significant
beneficial effect. The target
group in this study was healthy
men: the effects of the Maxoderm cream
on men with sexual dysfunction were not
determined here, but may have resulted in a significant beneficial effect. The results of this
study showed that there was
no benefit of Maxoderm for healthy men, compared with
placebo, for any IIEF or QVS scores.
KGK SYNERGIZE INC.
CONFIDENTIAL
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Effect of Maxoderm on Sexual Enhancement
in Healthy Men: A Pilot Study
ADVERSE EVENTS
There was one reported adverse event, cellulites in the right foot, which was not thought to
be due to study treatment. The subject was in the group using placebo cream.
KGK SYNERGIZE INC.
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