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| XIAFLEX About Time or Waste of Time? |
Based on the feedback I receive at this site, there is
considerable interest in Xiaflex as a non-surgical
treatment for Peyronies Disease (PD).
The Xiaflex clinical trials are completed and Auxilium
Pharmaceuticals, Inc. has submitted their findings to the
Federal Drug Administration (FDA) for review and on
various website and forums have often been misleading
and at most, only provide a minimal amount of useful
information. The reason is that this more recent material
relates to phase III/open source studies of Xiaflex and
they are press releases. The material in these press
releases are summarized and repeated, mostly on
financial websites concerning whether or not Auxilium
stock is a good buy. Only Auxilium and the FDA have the
data necessary to properly evaluate the findings of the
phase III and open source Xiaflex trials.
The latest Xiaflex Peyronies Disease study with reliable
and detailed information available to the public is from an
earlier phase IIb clinical trial. In the Summer 2010 edition
of this website, I wrote about these study results based
on press releases from Auxilium. If you are considering,
taking Xiaflex for your Peyronies, I urge you to start by
reading that article. Click Here . You can also obtain
additional information on Xiaflex by typing it in the search
box of this site.
More detailed findings from the phase IIb trial have been
published in the June 2012, Journal of Urology article and
findings and protocol information have been posted on
the U.S. Government's clinical trials website. Some of
this information will be repetitive when compared with
the Summer 2010 article, but there is additional, valuable
information to be found.
I was in this phase IIb study where I received a placebo
and also participated in the open source clinical trial
where I did receive the Xiaflex treatment. This open
source trial ran essentially concurrently with the last
phase III Xiaflex trial.
In order to decrease the level of anxiety we all feel when
undergoing medical testing and particularly, penile
injections, I will inform my readers what to expect during
their screening and Xiaflex treatment based on the
current protocol. Unfortunately, I will also discuss what
can go very wrong and how to decrease the odds of
experiencing a serious adverse event or events.
Summary of Phase IIb of the Xiaflex study
considerable interest in Xiaflex as a non-surgical
treatment for Peyronies Disease (PD).
The Xiaflex clinical trials are completed and Auxilium
Pharmaceuticals, Inc. has submitted their findings to the
Federal Drug Administration (FDA) for review and on
various website and forums have often been misleading
and at most, only provide a minimal amount of useful
information. The reason is that this more recent material
relates to phase III/open source studies of Xiaflex and
they are press releases. The material in these press
releases are summarized and repeated, mostly on
financial websites concerning whether or not Auxilium
stock is a good buy. Only Auxilium and the FDA have the
data necessary to properly evaluate the findings of the
phase III and open source Xiaflex trials.
The latest Xiaflex Peyronies Disease study with reliable
and detailed information available to the public is from an
earlier phase IIb clinical trial. In the Summer 2010 edition
of this website, I wrote about these study results based
on press releases from Auxilium. If you are considering,
taking Xiaflex for your Peyronies, I urge you to start by
reading that article. Click Here . You can also obtain
additional information on Xiaflex by typing it in the search
box of this site.
More detailed findings from the phase IIb trial have been
published in the June 2012, Journal of Urology article and
findings and protocol information have been posted on
the U.S. Government's clinical trials website. Some of
this information will be repetitive when compared with
the Summer 2010 article, but there is additional, valuable
information to be found.
I was in this phase IIb study where I received a placebo
and also participated in the open source clinical trial
where I did receive the Xiaflex treatment. This open
source trial ran essentially concurrently with the last
phase III Xiaflex trial.
In order to decrease the level of anxiety we all feel when
undergoing medical testing and particularly, penile
injections, I will inform my readers what to expect during
their screening and Xiaflex treatment based on the
current protocol. Unfortunately, I will also discuss what
can go very wrong and how to decrease the odds of
experiencing a serious adverse event or events.
Summary of Phase IIb of the Xiaflex study
- total of 147 participants
- mean age was 57 years
- mean curvature was 54 degrees (range 33-89)
- majority of men reported some degree of erectile
dysfunction
- modeling is defined as gently stretching the
placid penis in the opposite direction of the
curvature and holding it in that position for 30
seconds before allowing the penis to return to
the non-modeled state for 39 seconds. This
procedure was repeated 3 times 24 to 72 hours
after the 2nd injection at each treatment cycle in
the phase IIb Xiaflex clinical trial. Men in the
modeling group were also instructed to perform
this procedure at home.
- 74 men were in the modeling group - 54 received
Xiaflex and 20 received a placebo
- 73 men were in the non-modeling group - 57
received Xiaflex and 16 received a placebo
- each cycle of injections consisted of 2 injections
with an interval of 24 to 72 hours
- this regimen was repeated after 6 weeks for a
period of up to 3 treatment cycles
In the last edition of
this site, I reviewed
the use of
coenzyme Q10 for
the treatment of
Peyronies. If you
want to read the
entire article on this
topic Click
this site, I reviewed
the use of
coenzyme Q10 for
the treatment of
Peyronies. If you
want to read the
entire article on this
topic Click
There is a man who
had Peyronies and
through treatment
was able to become
sexually functional
again. He has
started a website
and I recommend
you also visit his
site. Click
Here is another
informational
Peyronies site that I
would recommend
Click
had Peyronies and
through treatment
was able to become
sexually functional
again. He has
started a website
and I recommend
you also visit his
site. Click
Here is another
informational
Peyronies site that I
would recommend
Click
| If you have any comments, suggestions click the above feedback icon |
In our culture we
are bombarded with
news about health,
diet & fitness. Often
these stories are
not very well
developed and are
more misleading
than enlightening.
Here is a website
that is excellent and
highly
recommended. It is
written by medical
professionals and
reviews articles on
health for accuracy
and usefulness.
Again, highly
recommended.
Check out their
search box for their
review of articles
on Xiaflex and
prostate issues.
Click
are bombarded with
news about health,
diet & fitness. Often
these stories are
not very well
developed and are
more misleading
than enlightening.
Here is a website
that is excellent and
highly
recommended. It is
written by medical
professionals and
reviews articles on
health for accuracy
and usefulness.
Again, highly
recommended.
Check out their
search box for their
review of articles
on Xiaflex and
prostate issues.
Click
2 Recent
Prostate
Cancer-
Penis
Shrinkage
Studies
Contradict
Previous
Findings
And Each
Other! All
Studies
Agree On
Only One
Fact.
What Does
It All
Mean?
Prostate
Cancer-
Penis
Shrinkage
Studies
Contradict
Previous
Findings
And Each
Other! All
Studies
Agree On
Only One
Fact.
What Does
It All
Mean?
Old Men & Sex