Note: Descriptions are shown in the official language in which they were submitted.
CA 02762355 2011-12-16
2313-26
METHODS AND COMPOSITIONS FOR TREATMENTS
FOR ADMINISTRATION TO THE PENIS
FIELD OF THE INVENTION
The invention relates to methods and compositions for increasing growth of the
penis;
enhancing male erectile function; treatment of Peyronie's disease and other
disorders of the
penis associated with fibrosis and increased collagen comprising an erectile
function-
enhancing amount of a blocker selected from the group consisting of a calcium
channel
blocker, a metabolite thereof, a calmodulin blocker and a metabolite thereof,
and a
pharmaceutically acceptable diluent or carrier.
SUMMARY OF THE INVENTION
The inventor has discovered that males stimulating growth in their penis by
any form
of biomechanical stimulation will also stimulate a build up of collagen in the
penis. The
inventor has discovered that certain doses of Calcium Channel Blockers and
Calmodulin
Blockers and Prostaglandins and IGF1 receptor agonists can increase the rate
of penis
growth and increase the effectiveness of all forms of penis enlargement.
Penis enlargement refers to any method that stimulates cellular and molecular
activities in the penis to cause tissue remodeling that results in changes in
the molecular and
cellular elements of the penis that will effect a true dimensional increase in
the penis, which
will result in a true increase in the size of the penis from maximally
vasoconstricted, to
flaccid, to semi-erect through to a maximally expanded and fully erect size.
Any method of
penis enlargement to cause this true hypertrophy or growth will have to induce
remodeling of
the connective tissues of which the major structural component is collagen.
This means that
penis growth can only occur with remodeling of these structural collagen
fibres.
The inventor has observed by direct manual examination that patients who
develop
thickening of these structural collagen elements in their penis will have a
deceleration of their
growth rate, and if thickening and strengthening of these penile structures
continues it will
result in a permanent arrest of the enlargement process. The inventor has
observed this to
happen in all patients whose growth rate slows and stops. The inventor
hypothesizes that an
important reason why penis growth slows and stops after several months in all
patients he has
observed who have enlarged their penises is because the rate of new collagen
formed is faster
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than the rate that it is being removed and that this hypertrophy of the
structural collagen
fibers which the inventor has observed in all patients whose growth has
slowed, must reduce
the effectiveness of any further biomechanical stimulation.
The inventor found that when he was following the medical literature and
trying many
of the previously described treatments for fibrosis he did not observe any
changes in the
patients receiving these treatments. The inventor treated several patients'
Peyronies's Disease
and penis enlargement patients whose penis growth had arrested with the
recommended
dosing at the recommended frequency for direct Verapamil injections into the
penis and into
plaque with no observable effect. The inventor tried the recommended topical
doses of
Calcium Channel and Calmodulin Blockers on patients with Peyronie's Disease
and arrested
penile growth using the previously described and recommended doses, rates and
methods for
topical method using Calcium Channel Blockers recommended for Peyronie's
Disease and
the inventor could not detect any clinical response. The inventor found they
were ineffective
in increasing penile growth or reducing penile fibrosis, plaque or treating
Peyronie's Disease.
But the inventor has discovered that certain doses of Calcium Channel Blockers
and
Calmodulin Blockers when applied topically or infused continuously or applied
intermittently
at a higher frequency than was recommended in the medical literature improved
their clinical
efficacy. When used in a way to constantly maintain and replenish these agents
within the
penis by either topical or parenteral administration the inventor has
discovered that there was
a significant reduction in fibrosis. That inventor observed that with
increased frequency of
small topical applications of Calcium Channel Blockers and Calmodulin Blockers
the
patients with Peyronie's Disease would within days a experience a noticeable
softening and
shrinkage of the plaques which over the course of weeks and months, in most
cases, resulted
in complete clearance of their plaque and fibrosis, and when incomplete, there
would only be
some small nodules remaining. Additionally, upon careful history taking, the
inventor
observed a clinical improvement in their erectile function.
That is, patients using these Calcium Channel Blockers and Calmodulin Blockers
when applied in this modified way so as to reduce fibrosis, that those
Peyronie's patients who
were experiencing mild erectile dysfunction prior to beginning the treatment
would start
getting functional erections without having to rely on PDE5's or
intracavernosal injections,
and if they had severe erectile dysfunction to begin with, and could not get
or maintain
functional erections with PDE5's or intracavernosal injections that they would
start getting
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better spontaneous erections and that with PDE5's or intracavernosal
injections they could
now successfully maintain a usable erection.
The inventor also observed that if these same protocols for the use of Calcium
Channel Blockers and Calmodulin Blockers were used by men with erectile
dysfunction who
did not have Peyronie's Disease that their erectile function would also
improve. In younger
men, simply adding some Calcium Channel Blockers and Calmodulin Blockers
directly to
their intracavernosal injection medication would immediately result in a
harder and longer
lasting erection indicating direct potentiation of vasodilation of the
erectile tissue with a
single dose. This immediate improvement in erectile function was also observed
even in men
without erectile dysfunction with topical use of Calcium Channel Blockers and
Calmodulin
Blockers. But men with significant fibrotic changes in their penis would also
have continued
improvement in their erectile function as the fibrosis in their penis was
reduced and
eliminated.
As well, it was observed that in men who had been unsafely injecting
intracavernosal
medications and who had induced fibrotic changes within their penis as a
result, that using
Calcium Channel Blockers and Calmodulin Blockers would reduce and eliminate
the fibrosis
from their penis and this usually would be accompanied by an improvement in
erectile
function. As well, two patients who had developed severe erectile dysfunction
from extensive
fibrosis in their penis, one who had injected acetic acid into his penis and
had extensive
destruction and fibrosis of his cavernosal tissue, and a second patient who
had almost
complete obliteration and fibrosis of the carvernosal tissue from recurrent
spontaneous
priapisms; both of these patients had dramatic reduction in the cavernosal
fibrosis and a
restoration of functional spontaneous erections after receiving a course of
Calcium Channel
Blockers treatment by the inventor.
In addition, the inventor has observed that the use of Calcium Channel
Blockers and
Calmodulin Blockers on men enlarging their penises with any form of
biomechanical
stimulation would benefit by a prolongation in the period of active penile
growth and
experience an acceleration of the rate of penile growth; there seems to be an
overall synergist
effect of Calcium Channel Blockers and Calmodulin Blockers on all observable
and
measurable parameters of penile growth and enlargement. And this effect is not
limited to the
connective tissue growth and structural collagen elongation within the penis,
but could
potentiate collagen elongation and remodeling outside of the penis.
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The inventor has observed that Calcium Channel Blockers and Calmodulin
Blockers
will potentate biomechanical growth in other tissues when they are combined
with any of the
multitude of methods that produce biomechanical stimulation.
The inventor has also discovered several other pharmacological agents that can
increase penile and connective tissue growth when combined with any form of
biomechanical
stimulation. For example the inventor has found that the local application of
small doses of
IGF1 receptor agonists, relaxin receptor agonists, and certain prostinoid
receptor agonists
when combined with biomechanical stimulation can also potentiate, accelerate
and generally
increase the rate of penis growth.
When referring or using the term, "biomechanical stimulation' the inventor is
specifically indicating methods of producing mechanical forces that will
increase or
accelerate the natural remodeling that occurs in all biological tissues.
Biomechanical
stimulation for penis enlargement would include the use of intracavemosal
vasodilators and
mechanical traction to the penis. In summary, the inventor has found that all
known methods
of penis elongation and penis enlargement can be accelerated and potentiated
by Calcium
Channel Blockers and Calmodulin Blockers.
The inventor had previously discovered that penis growth with vasodilators
alone was
potentiated by Relaxin receptor agonists.
The inventor has also discovered the Relaxin receptor agonists will accelerate
and
potentiate the penile growth experienced by men using effective traction
devices.
The inventor also discovered that the prostinoid receptor agonists PGF2alpha,
Dinoprost, Bitamoprost, PGE2, and Dinoprostone when applied in very low doses
locally to
the penis would accelerate penis growth rates from biomechanical stimulation,
such as a man
using a traction device. And even men whose growth had stopped in some cases
could be
induced to start growing again with the prostinoid receptor agonists,
PGF2alpha and PGE2,
listed above.
The inventor has also discovered that penis enlargement can be accelerated and
potentiated with IGF1 receptor agonists such as IGF1 and LR3 IGF1.
So, to summarize, the presence of Calcium Channel Blockers, Calmodulin
Blockers,
specific Prostaglandins, and IGF1 receptor agonists at therapeutic levels for
sufficient
duration of time can cause penis growth if combined with penile traction
devices or other
forms of biomechanical stimulation to enlarge the penis. Because of the
penises location and
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CA 02762355 2011-12-16
the large ratio between the size of the body relative to the penis, the
preferred embodiment
for these agents would be topical creams, gels, patches or local injections in
combination with
some form of mechanical mechanism also applied to the penis.
Erectile dysfunction (ED) is defined as the inability to achieve and maintain
a penile
erection adequate for sexual intercourse. This may be a relative term wherein
the frequency
of occurrences in which a patient is able to achieve and maintain a penile
erection adequate
for sexual intercourse has decreased over time as a part of natural aging
which is
superimposed with other internal and external factors that impact negatively
upon the natural
sexual responses of males. It is a male health problem which in its most
severe form has
been estimated to affect about 150 million men worldwide. But in North America
it is
estimated that by the age of 40 years, approximately 25% of men are having
problems with
achieving and sustaining an erection, and this probably increases to over 50%
for men over
60 years of age.
Impotence generally refers to a severe form of male erectile dysfunction and
is
defined as the general inability to achieve and sustain an erection sufficient
for intercourse.
Erectile function naturally declines with age and like the aging process, the
decline in erectile
function experienced by men as they age is a complex biological phenomenon
that results
from complicated interactions between psychological, emotional, spiritual and
physical
factors. Some of the physical factors include genetics, diet, nutrition,
environmental
exposures to toxins, radiation, hormonal factors such as thyroid, adrenal,
gonadal, and growth
hormones among others; as well as effects from medications and other
iatrogenic effects of
medical treatments. These are only some of the various factors that may
contribute to natural
diseases that combine with aging to cause declining sexual function in men and
women.
The complexity of the body makes the diagnosis and treatment of ED imprecise.
The
hormonal issues are rarely considered in diagnostic workups. For example, the
assessment of
thyroid, adrenal and growth hormones are not part of the usual diagnostic
workup. Even
though physicians and the medical literature are now starting to acknowledge
testosterone in
practical terms, it is rarely considered when a man is being treated for
erectile dysfunction.
Even though disturbances in these hormonal systems will significantly impact
erectile
function, they are generally ignored when erectile dysfunction is assessed and
treated. In
summary, the understanding of erectile dysfunction is very imprecise in modern
medical
practice.
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There is currently no standardized method of diagnosis or treatment that
begins to
address the many normal causes of ED. The diagnosis of erectile dysfunction
generally relies
on self-reporting by patients. Since the majority of men experiencing
significant erectile
dysfunction will not be aware that they are having erectile dysfunction they
will not report
any concerns to their physician. Even when they are given medical therapies
that worsen
their erectile function, for example, many common prescription medications,
such as anti-
hypertensives will worsen erectile function while other medications may
improve their
erectile function, they will be unaware of these changes. It is the experience
of the inventor
that patients and physicians tend to recognize only more profound levels of
erectile
dysfunction and most cases of declining or improving erectile function go
unrecognized.
Histologically there are specific changes that have been well documented in
the penis
of men with erectile dysfunction that tend to increase with age. Men who
experience
declining erectile function have actual physical changes within their penis.
Some of these
changes include reduced smooth muscle, reduced diameter and size of the
cavernosal nerves,
reduced levels of elastin and increased levels of collagen all of which result
in impaired
vascular response, reduced relaxation of the cavernosal sinuses and impairment
of the veno-
occlusive mechanism to properly pressurize the cavernosal system. None of the
current
therapies for erectile function address or are known to treat or improve these
physical
changes.
All of the current medications being used to treat erectile dysfunction work
by
directly or indirectly causing smooth muscle relaxation in the erectile
tissue. This results in
dilation of the arteries bringing blood into the erectile tissue and dilation
of the cavernosal
sinuses. These effects are transient, from minutes to several hours and they
can only be
effective while they are present in the penis at therapeutic levels, and this
would include oral
agents (phosphodiesterase-5 inhibitors, such as LevitraTM, ViagraTM, and
CialisTM,
dopamine agonists, such as UprimaTM, and alpha-receptor blocking drugs),
intracavernosally
injected vasodilators (papaverine, phentolamine, prostaglandin El, vasoactive
intestinal
peptide), transurethral vasoactive agents (prostaglandin El, sometimes
marketed as
MUSETM), vacuum erection devices, and vascular surgery. Rings work by reducing
venous
out flow relative to inflow. Penile prostheses simply replace the erectile
tissue with a rigid or
semi-rigid structure. Each of these options has its own disadvantages.
However, all of the
current medications do not reverse or improve the physical changes causing
erectile
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dysfunction, hence, they have no ability to cure erectile dysfunction. They
can be effective
while these medications are present at therapeutic levels in the tissues where
they directly
exert their effects.
Current pharmacological treatments for erectile function such as
phosphodiesterase 5-
blockers and intracavernosally administered medications, such as the
vasodilator PGElalpha
improve erectile responses by transiently producing elevated levels of blood
flow and
increased dilation of the cavernosal tissue to allow the arterial inflow to
sufficiently
pressurize the erectile tissue and activate the veno-occlusive system tissue
to produce a
usable erection.
It is known that men who consistently under all circumstances fail to respond
with
functional erections to maximal pharmacotherapy with oral or intracavernosal
medications
have to resort to using a pump and a very tight penile ring or undergo the
surgical insertion of
an implant. Frequent prolonged use of pumps and rings will damage the penis,
and surgery
results in an immediate irreversible destruction of the erectile tissues.
Histologically, there are specific changes that are associated with erectile
dysfunction.
These histological changes are:
I. increase in the percentage of collagen relative to smooth
muscle in the
cavernosal tissues;
2. decrease in the percentage of smooth muscle relative to collagen in the
cavernosal tissues;
3. reduced elastin; =
4. decreased cavernosal arterial inflow;
5. decreased cavernosal expansion during sexual stimulation; and
6. increased level of sexual stimulation needed to achieve and maintain a
functional erection.
There is, therefore, a need for a safe, effective treatment that would induce
long
lasting physical changes in the penis that would allow a man's penis to be
functional without
the need to take a pill or inject medication into the penis every time he
wants to be sexually
active, and that could actually induce long lasting physical changes in the
penis that would
improve erectile function after medication had been discontinued.
The inventor has discovered that pharmaceutical compositions comprising a
blocker
selected from the group consisting of calcium channel blockers, metabolites
thereof,
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calmodulin blockers and metabolites thereof that have been used to treat
medical conditions
unrelated to erectile dysfunction can effectively treat male erectile
dysfunction and induce
physical changes to improve erectile function.
The invention is of particular value in the treatment of Peyronie's disease.
Accordingly, in one aspect, the invention provides a pharmaceutical
composition for
enhancing male erectile function comprising an erectile function-enhancing
amount of a
blocker selected from the group consisting of a calcium channel blocker, a
metabolite thereof,
a calmodulin blocker and a metabolite thereof, and a pharmaceutical acceptable
diluent or
carrier.
Preferably, the calcium channel blocker is verapamil, diltiazem or felodipine;
and the
calmodulin blocker is trifluoperazine.
Preferably, the composition is in the form of a cream, spray, gel, ointment or
patch.
In a further aspect, the invention provides a use of a male erectile function-
enhancing
amount of a pharmaceutical composition of a blocker selected from the group
consisting of a
calcium channel blocker, a metabolite thereof, a calmodulin blocker and a
metabolite thereof,
and a pharmaceutical acceptable diluent or carrier.
In a yet further aspect, the invention provides a method of enhancing male
erectile
function comprising administering to a male an erectile function-enhancing
amount of a
composition comprising a blocker selected from the group consisting of a
calcium channel
blocker, a metabolite thereof, a calmodulin blocker and a metabolite thereof,
and a
pharmaceutical acceptable diluent or carrier, as hereinabove defined.
Preferably, the administration comprises subcutaneous injection, high pressure
jet
device, intracavernous injection, intravenous injection, intramuscular
injection, intradermal
injection, intra-nasal or, preferably, topical administration.
In a still yet further aspect, the invention provides a method of
manufacturing a
medicament intended for the application of enhancing male erectile function
characterized in
that the medicament is a blocker selected from the group consisting of a
calcium channel
blocker, a metabolite thereof, a calmodulin blocker and a metabolite thereof;
and admixed
with a pharmaceutical acceptable diluent or carrier.
Preferably, the blocker is selected from verapamil, diltiazem, felodipine and
trifluoperazine.
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=
As used herein, "enhanced erectile function" refers to the ability to achieve
and
maintain a penile erection adequate for sexual intercourse more often than the
man was able
to before the treatment presented in the instant application. Indications that
this treatment is
effective include the decreased or eliminated reliance on medications and/or
improved
response to the medications currently used to treat erectile dysfunction or
aid in achieving an
adequate erection, more frequent spontaneous erections, an improved ability to
sustain an
erection before and after ejaculation, a reduction in the absolute and
relative refractory period
after ejaculation before another erection can be achieved, a reduced
requirement for
stimulation to achieve and maintain an erection and an increase in frequency,
firmness and
duration of morning erections and an increase in frequency, firmness and
duration of
spontaneous erections. Any of these indicators, alone or in combination, can
be used as a
measure of effectiveness.
Administration to the cavernosal tissue encompasses injections directly into
the
cavernosal tissue, which is preferred for men who have previously been trained
on the proper
method for intracavernosal injections and are currently using intracavemosal
injections. For
men who are not skilled with IC injections, the preferred injection would be
injections to the
connective tissues, which surround the cavernosal tissue from where the active
agents of the
present invention, in a water-based or oil-based system, will diffuse into the
cavernosal
tissue. Through this route, generally less of the administered dose would be
delivered to the
cavernosal tissue than if it were injected directly into the cavernosal
tissue. Other routes of
administration considered to be administration to the cavernosal tissue
include urethral
suppositories, implantable sustained-release drugs or devices, and transdermal
devices or
vehicles which are directly in contact with or adhered to the penis, such as
patches, creams,
or lotions. Optionally, the transdermal devices or vehicles may be delivered
by a condom-
like device.
In preferred embodiments of the invention the pharmaceutical compositions are
administered to the penile and cavernosal tissue of the penis of a male
patient.
The pharmaceutical composition is administered to the patient in a
pharmaceutically
acceptable sterile dosage form to the tissues of the penis, which includes the
cavernosal
tissue. The composition may be administered topically by transdermal vehicles
or devices,
such as creams, lotions, or patches. The composition may be administered by
urethral
suppository, or parenterally using a needle, auto-injector, slow sustained
injection pump, high
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pressure jet injection device, microinfusion pump, or implantable sustained
release drug or
device. Sterile dosage forms include, but are not limited to, syringes and
needles, urethral
suppositories, or transurethral implants, ampoules or vials, or transdermal
vehicles or devices,
such as creams, lotions or patches.
The active ingredient can also be delivered to the penile and cavernosal
tissue
transdermally. A suitable delivery vehicle or device is situated in direct
contact with the skin
of the penis to effect delivery of the agent to the penile and cavernosal
tissue. The vehicle or
device may include agents which enhance the transdermal absorption rate or
agents which aid
in the absorption of the pharmaceutical composition into the cavernosal
tissue.
A particularly preferred transdermal device of the present invention is a
patch. A
patch is designed to adhere to or be brought into contact with the skin of the
penis so that the
pharmaceutical composition contained by the patch can be absorbed
transdermally and into
the penile and cavernosal tissue. The patch may also contain agents which
enhance, control,
or a combination of both, the transdermal absorption of the pharmaceutical
composition
and/or the absorption of the pharmaceutical composition into the penile and
cavernosal tissue.
Optionally, these agents can be applied in conjunction with the pharmaceutical
composition,
at a different time, and/or a different route of administration. The patch may
also include
adhesives specially designed to adhere to the often sensitive skin of the
penis.
Kits comprising pharmaceutical compositions of the invention formulated in
sterile
unit dosage forms suitable for administration to the penile tissue, including
instructions for
use in written, oral, videotape, compact disc, other digital electronic form,
or other recorded
media, are contemplated. Conveniently, a kit wherein the sterile unit dosage
forms are for oil
based depot injections and instructions for use are provided.
Thus, in a further aspect, the invention provides a kit comprising the above-
described
compositions and an instruction for using the combination in treating,
improving, curing or
preventing male erectile dysfunction.
The appropriate dosage and frequency of treatment may vary depending upon
desire
or need of the degree of enhanced erectile function sought. Other health
related factors
would also be considered. Men without need of great enhancement of their
erectile function
may not need maximal treatment.
The frequency of administration may be in the range of two to three times a
day for
intercavernosal injection, more preferably from 3 to 7 times a week, or as
infrequently as
CA 02762355 2011-12-16
monthly for delayed release formulations or topical administrations. The
patient's condition
should be monitored and the dosage adjusted, usually titrated upward, if
enhanced erectile
function is not achieved. Enhancement in erectile function may start
immediately, but the
major therapeutic effect may be expected to be achieved within 2 weeks to 6
months, more
often within 4 weeks to 3 months. This may be followed by a maintenance phase
during
which there are intermittent or less frequent administrations.
This may involve
administrations of at least quarterly, bimonthly, biweekly, weekly injections,
depending on
the route of administration.
DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS
In order that the invention may be better understood, preferred embodiments
will now
be described by way of example only with reference to the following examples.
EXAMPLE 1
55 year old male on penis enlargement using traction combined with
intracavemosal
injections for 7 months. After I inch of growth in length of erect penis,
growth rate had
slowed and stopped and had been static for over 4 months.
After 3 months without any new additional growth, the patient was started on
topical
Verapamil 200mg/m1 resulting in new additional penile growth of 1-1.5/16th of
an inch
growth of the fully erect penis length in the first month on Verapamil and a
total of 6/16
inches of new growth over the first 3 months on topical Verapamil.
EXAMPLE 2
49 year old male with severe ED. Patient had previously experienced ongoing
spontaneous priapisms and had continuous erections for 3 months. But when
seen, patient
was totally impotent and unable to erect. The penis was a solid fibrotic mass
with extensive
fibrosis of the cavernosal system. No response to PDE5's or IC test doses.
During several
attempted IC injections by the inventor with extensive experience and skill in
the
intracavernosal injection technique, the physician was unsuccessful to achieve
an aspiration
which indicated that the needle had entered the cavernosal system. The skilled
physician was
unable to locate erectile tissues on several attempts prior to initiating
Verapamil and the
patient had profound erectile dysfunction with no response to maximal dose
PDE5's and
maximal dose intracavemosal injections. Patient started applying Verapamil
200mg/m1 0.1
ml 5-8 times a day to the penis. After one month, the patient was re-examined
and a dramatic
softening of the patient's fibrotic penis was noted, and the patient reported
his first
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spontaneous erection in months. After 3 months of topical Verapamil, the
patient's
spontaneous erections were now sometimes penetrable, and he was consistently
developing
penetrable erections with Viagra and Levitra with maximum firmness of 70-
75%. As
well, test doses of intracavernosal medication by the physician were now
frequently
15 EXAMPLE 3
46 year old male on penis enlargement using IC injections; initial growth rate
without
topical Verapamil was 1-2/16" per month for the first 4 months. Patient
started Verapamil
0.1 ml 5-6 times/day in the fifth month of treatment and growth rate increased
to 3-4/16" per
month and the active growth rate of the patient did not decelerate at 4-6
months. The patient
EXAMPLE 4
Patient with severe ED secondary to Peyronie's disease started on Verapamil
0.1 ml
of 200mg/m1 applied to penis 5-6 times per day. The inventor/physician noted a
dramatic
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EXAMPLE 5
62 year old male had extensive Peyronie's disease following several years of
IC
medications. The patient had developed these extensive masses of fibrotic
nodular plaques
throughout the entire penile shaft from 2001 through to 2008. During this time
that these
fibrotic changes were developing, the patients erectile dysfunction worsened,
and PDE5's
were no longer giving usable erections. The strength¨dose of intracavemosal
medication had
increased over 2,000 percent and now instead of erections lasting over 2 hours
to just prior to
starting topical Verapamil therapy, a dose 2,000 percent stronger was only
causing a soft
semi-erection for 5-10 minutes. The patient started on Verapamil 2mg/m1 0.5 ml
added to
each IC dose and topical Verapamil 200mg/m1 applied 5-6 times per day. Within
one month
there was dramatic shrinkage of multiple plaques in the penis. After 3 months
there were
only three small plaques of 1-3mm diameter left and an estimated reduction of
plaque volume
by 95- 98% after 4 months of active treatment which remained stable for
several months after
stopping the topical Verapamil. As well, the patient experienced a dramatic
improvement in
erectile function such that the volume of intracavemosal medications were
reduced by 40
percent and now instead of a brief semi-erection, the erectile response to
this reduced dose
was now staying hard and usable for 1 to 1 'A hours.
EXAMPLE 6
39 year old male on penis enlargement using traction combined with
intracavernosal
injections stopped growing. For three months there was no further increase in
his penis length
measurements despite adequate biomechanical stimulation. The patient added on
drop of a
0.01 percent by weight PGF2alpha aqueous solution applied topically to the
skin of the penis
at mid shaft 2-6 times per day. When the patient returned in four weeks he
experienced 1.5-
2/1 6ths of an inch growth. After three months there had been 6.5-7/16th of an
inch of new
growth in the erect length of the penis.
Although this disclosure has described and illustrated certain preferred
embodiments
of the invention, it is to be understood that the invention is not restricted
to those particular
embodiments. Rather, the invention includes all embodiments which are
functional or
mechanical equivalence of the specific embodiments and features that have been
described
and illustrated.
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