AxcilTM Proven by Clinical Trial to be Highly Effective and Safe for Improving Erectile Function and Sexual Desire
Vitogen, Inc. announced successful completion of a randomized, double-blind, placebo-controlled clinical trial that showed AxcilTM (GL49) is effective and safe in men with mild and moderate erectile dysfunction (ED).
(PRWEB) January 26, 2005 -- Vitogen, Inc. ("Vitogen" or the "Company")
announced the clinical study results of its randomized, double-blind,
placebo-controlled clinical trial of AxcilTM (GL49) for the treatment of mild
and moderate erectile dysfunction (ED). The paper describing this study has been
submitted for publication in European Urology, a peer-reviewed, prominent
international journal.
About Erectile Dysfunction (ED)
ED is defined
as the consistent inability to obtain and maintain an erection sufficient for
completing sexual intercourse. The condition may be correlated with aging,
cardiovascular conditions, hypertension, diabetes, hyperlipidemia, drinking and
smoking. In addition, some prescription drugs and psychogenic issues may
contribute to ED. ED is a widespread problem affecting estimated half of all men
over age 40. About 150 million men worldwide and 30 million American men suffer
from ED.
Current Erectile Dysfunction Treatments
Currently several
PDE-5 inhibitors are used as effective first-line treatment for ED. They
primarily target Nitric Oxide (NO) synthesis pathway in the vascular system.
PDE-5 inhibitors contraindicated with nitrates and medications containing
alpha-blockers. PDE-5 inhibitors have not been shown by any clinical study to
have effect on sexual desire. Current literature indicates that about half of
all patients who receive an initial prescription for a PDE-5 inhibitor do not
renew the prescription due to adverse side effects, drug interaction issues,
and/or lack of efficacy.
About AxcilTM (GL49)
AxcilTM (GL49) is a
dietary supplement that contains a proprietary standardized botanical extract
acting synergistically to promote erectile function and sexual desire in men.
AxcilTM (GL49) is a combination of many ingredients and compounds, all of which
are generally considered safe by United States Food and Drug Administration
(FDA) and are on the list of FDA approved Old Dietary Ingredient List. Multiple
pathways and mechanisms of action might be involved. Although the mechanisms are
not completely understood, individual ingredients in AxcilTM (GL49) have been
studied and reported by various laboratories. Several ingredients were shown to
increase L-Arginine-NO pathway activity (important for penile smooth muscle
relaxation and erectile function), some were found to increase testosterone
production (one of the important mechanisms to increase sexual desire). Other
potentially relevant mechanisms include increasing angiogenetic, cardiovascular
protection and anti-oxidative activities. The ingredients in AxcilTM (GL49) may
act synergistically in multiple pathways critical for sexual function and
desire.
Clinical Study Design
The purpose of this study was to
evaluate the efficacy and safety of AxcilTM (GL49) for the treatment of men with
mild to moderate ED. 47 men with mild to moderate ED were randomized to received
placebo or AxcilTM (GL49) for one month in a double-blind, placebo-controlled
manner. Efficacy was assessed by International Index of Erectile Function
(IIEF), Sexual Encounter Profile (SEP) questionnaires, global assessment
questionnaires and diary after each sexual activity. Safety was assessed by
subject report on adverse events and blood tests.
Clinical Study
Results
After 4 weeks, subjects taking AxcilTM (GL49) continuously every 48
hours showed a significant improvement on erectile function, as measured by IIEF
EF domain score (7.65 increase from baseline, P less then 0.0001), IIEF Question
3 and 4 (P less than 0.0001), IIEF overall satisfaction domain score (2.00
increase from baseline, P less than 0.003), rates of penetration success (91.60%
from 55.80% at baseline, p less than 0.0001), intercourse completion (85.70%
from 45.00% at baseline, P less than 0.0001) and rate of subjects retaining
normal sexual function (62.5%, P less than 0.0001). In addition, AxcilTM (GL49)
significantly increased IIEF sexual desire domain score (1.46 increase from
baseline, P less than 0.01). Furthermore, GL49 significantly improved erection,
sexual relationship and quality of life as measured by global assessment
questionnaires. No significant improvement was noted in subjects taking placebo.
GL49 was safe with no serious adverse events. The results suggest that AxcilTM
(GL49) continuous therapy may significantly improve erectile function and sexual
desire in men with mild to moderate erectile dysfunction.
Steven
Wunschel, MD, a board-certified urologist and assistant clinical professor at UC
Davis served as lead investigator in the study. Dr. Wunschel stated, “The
clinical study results are very encouraging. They suggest that AxcilTM (GL49)
may be a safe, fast-acting, clinically proven natural product. It may not only
improve sexual function, but also increases sexual desire.”
Dr. Heather
Liao, Chief Executive Officer of Vitogen stated, "This new clinical study data,
and collectively all the pilot clinical study data before it, are very exciting
and clearly demonstrate to me the potential of AxcilTM (GL49) as an effective
and safe product for treating mild to moderate ED. In particular, we are very
pleased to find that AxcilTM (GL49) can increase sexual desire in men with
normal or low sex drive. And more importantly, AxcilTM (GL49) is safe with no
serious side effects, only very low incidence of temporary and mild side
effects. In addition, unlike current ED drugs, AxcilTM (GL49) appeared not to
contraindicate with nitrate or alpha-blockers and is safe for men with
cardiovascular conditions. Most importantly, the study subjects reported ability
to perform at any time if taking AxcilTM (GL49) continuously every 48 hours. We
are currently planning to conduct a bigger clinical trial at Stanford University
VA Hospital to further test the efficacy and safety of AxcilTM (GL49) in mild to
severe ED and as an on-demand treatment. We hope AxcilTM (GL49) will help many
men suffering the problems and improve their erectile function and sexual
desire."
About Vitogen
Vitogen is a bio-pharmaceutical company
founded by a biomedical PhD scientist. Vitogen is committed to improving
people’s health and wellness by developing science-based, clinically-proven,
efficacious and safe phyto-pharmaceutical treatments for unmet medical needs.
Through continuous innovations and rigorous clinical and scientific studies,
Vitogen is developing next generation treatments for arthritis, hair loss,
osteoporosis, sexual dysfunction, cancers, cardiovascular diseases, skin
rejuvenation, Alzheimer’s Disease, etc.
This press release contains
forward-looking statements within the meaning of the "Safe Harbor" provisions of
The Private Securities Litigation Reform Act of 1995, including statements
regarding the interpretation of clinical results. Forward-looking statements
provide Vitogen's current expectations or forecasts of future events. Vitogen's
performance and financial results could differ materially from those reflected
in these forward-looking statements due to general financial, economic,
regulatory and political conditions affecting the supplement and pharmaceutical
industries. Given these risks and uncertainties, any or all of these forward-
looking statements may prove to be incorrect. You should not rely on any such
factors or forward-looking statements. Vitogen undertakes no obligation to
update publicly any forward-looking statement.
-Vitogen,
Inc.
Contact: Dr. Heather Liao
Vitogen, Inc. 1-650-776-8378
e-mail
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Web site: http://www.axcil.com
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Source : http://www.prweb.com/releases/2005/1/prweb201209.htm