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Dutasteride is indeed in phase 3 trials in KOREA


#1

There has been some debate on whether or not the phase three trial for
dutasteride is happening. I have confirmed the trial is happening, it is
taking place in Korea. Should be interesting.


#2

How did you “confirm” that it’s happening?

.


#3

» How did you “confirm” that it’s happening?
»
» .

Bryan, Dr. Rassman told me and I believe he got the info from a reliable collegue


#4

» » How did you “confirm” that it’s happening?
» »
» » .
»
» Bryan, Dr. Rassman told me and I believe he got the info from a reliable
» collegue

He originally posted the info on 12-20-07 and I contacted him to make sure he had accurate info.


#5

What do you mean by phase III?
Cheers

» » » How did you “confirm” that it’s happening?
» » »
» » » .
» »
» » Bryan, Dr. Rassman told me and I believe he got the info from a
» reliable
» » collegue
»
» He originally posted the info on 12-20-07 and I contacted him to make sure
» he had accurate info.
»
»


#6

» What do you mean by phase III?
» Cheers
»
»
» » » » How did you “confirm” that it’s happening?
» » » »
» » » » .
» » »
» » » Bryan, Dr. Rassman told me and I believe he got the info from a
» » reliable
» » » collegue
» »
» » He originally posted the info on 12-20-07 and I contacted him to make
» sure
» » he had accurate info.
» »
» »
boris, new drug applications that are filed with the U.S. FDA must go through 3 seperate clinical trials. For example, phase one trials basically just look at toxicology, side effects and not efficacy. Dutasteride had gone through phase 1 and 2 and they were preparing to go into phase three but suddenly stopped with no explanation. They now have decided to go forward and the trials are being done in Korea. Once the trial is completed they will study the data and possibly file an NDA with the FDA for approval for hairloss. It obviously can be prescribed off label right now, which is legal in the U.S… However the drug companies can’t market their drugs for off label use, thus the reason GSK wants to go through phase 3 trials. It appears from several studies that duta is more effective than finasteride.


#7

Hi rooster,

So your feedback please about the way you do it …the solution you use and the results ?!


#8

» Hi rooster,
»
» So your feedback please about the way you do it …the solution you use
» and the results ?!

Amilcar, finasteride does not disolve in water so you need an alcohol based solution. The easiest and most convenient way is to buy 5% minoxidil and drop 4 to 6 proscar tablets in the minoxidil and let it dissolve. That is proscar or 5mg finasteride. I have little to go on with ideal dosage recommendations, but i suspect the skin would minimize the full amount of finasteride in the solution to go systemic. there are 60ml of minoxidil in a bottle so at six pills each application would administer 1/2 MG of finasteride per ML. I’m also looking at possibly dutasteride. I actually recieved my order today. it is a .5mg solution of dutasteride. I would dillute that down to about .025 because the stuff systemically scares me.


#9

Yeah go slowly dude ! and watch you libido … make some records about your sexual performances if necessary…start with something like once /3 days or whatever …and according to your libido you can make decision about drug frequency…as for my question I dont tolerate that damn Minoxidil its smell make my heart beat faster…can I mix it with a lighter alcohol solution ?!


#10

» Yeah go slowly dude ! and watch you libido … make some records about your
» sexual performances if necessary…start with something like once /3 days
» or whatever …and according to your libido you can make decision about
» drug frequency…as for my question I dont tolerate that damn Minoxidil its
» smell make my heart beat faster…can I mix it with a lighter alcohol
» solution ?!

Yes any alochol is going to dissolve it. I would go with the most friendly for the skin as not to irritate.


#11

Thanks Rooster,
I wasnt aware that GSK stopped at phase III, why would that be? I was on propecia and I am now on Avodart, and Avodart is much more powerful than propecia. Avodart has shut down hair serum completely, incredible.
To me, I dont mind whether the FDA approves it for use in hairloss since I dont live in the US, but it would be interesting that they officially label avodart as probably the most potent hairloss drug up to now.

One final question, I dont swallow the pill, I have to wait until it dissolves on my mouth… Do you think it could loose its efficacy?
Could this be considered as topical dutasteride???

» » What do you mean by phase III?
» » Cheers
» »
» »
» » » » » How did you “confirm” that it’s happening?
» » » » »
» » » » » .
» » » »
» » » » Bryan, Dr. Rassman told me and I believe he got the info from a
» » » reliable
» » » » collegue
» » »
» » » He originally posted the info on 12-20-07 and I contacted him to make
» » sure
» » » he had accurate info.
» » »
» » »
»
» boris, new drug applications that are filed with the U.S. FDA must go
» through 3 seperate clinical trials. For example, phase one trials
» basically just look at toxicology, side effects and not efficacy.
» Dutasteride had gone through phase 1 and 2 and they were preparing to go
» into phase three but suddenly stopped with no explanation. They now have
» decided to go forward and the trials are being done in Korea. Once the
» trial is completed they will study the data and possibly file an NDA with
» the FDA for approval for hairloss. It obviously can be prescribed off
» label right now, which is legal in the U.S… However the drug companies
» can’t market their drugs for off label use, thus the reason GSK wants to
» go through phase 3 trials. It appears from several studies that duta is
» more effective than finasteride.


#12

» Thanks Rooster,
» I wasnt aware that GSK stopped at phase III, why would that be? I was on
» propecia and I am now on Avodart, and Avodart is much more powerful than
» propecia. Avodart has shut down hair serum completely, incredible.
» To me, I dont mind whether the FDA approves it for use in hairloss since I
» dont live in the US, but it would be interesting that they officially label
» avodart as probably the most potent hairloss drug up to now.
»
» One final question, I dont swallow the pill, I have to wait until
» it dissolves on my mouth… Do you think it could loose its efficacy?
» Could this be considered as topical dutasteride???
»
»
»
» » » What do you mean by phase III?
» » » Cheers
» » »
» » »
» » » » » » How did you “confirm” that it’s happening?
» » » » » »
» » » » » » .
» » » » »
» » » » » Bryan, Dr. Rassman told me and I believe he got the info from a
» » » » reliable
» » » » » collegue
» » » »
» » » » He originally posted the info on 12-20-07 and I contacted him to
» make
» » » sure
» » » » he had accurate info.
» » » »
» » » »
» »
» » boris, new drug applications that are filed with the U.S. FDA must go
» » through 3 seperate clinical trials. For example, phase one trials
» » basically just look at toxicology, side effects and not efficacy.
» » Dutasteride had gone through phase 1 and 2 and they were preparing to
» go
» » into phase three but suddenly stopped with no explanation. They now
» have
» » decided to go forward and the trials are being done in Korea. Once the
» » trial is completed they will study the data and possibly file an NDA
» with
» » the FDA for approval for hairloss. It obviously can be prescribed off
» » label right now, which is legal in the U.S… However the drug companies
» » can’t market their drugs for off label use, thus the reason GSK wants
» to
» » go through phase 3 trials. It appears from several studies that duta is
» » more effective than finasteride.

Boris, no, letting it dissolve in your mouth doesn’t make it like a topical. in fact, it might lead to a stronger systemic dose. I would have to read the literature to see how the drug is affected by the digestive track and especially the liver. There is no need to let it dissolve in your mouth, of course it really doesn’t matter unless you keep it there long enough to systemically absorb through the walls of the inner mouth and especially under the tongue (which is something you might not want to do). Otherwise your probably just getting a bad taste.


#13

Hi!
The problem that I have is that I cant swallow pills, especially the size of avodart so I usually chew them, mix them with juice and just swallow it,it tastes very bad but that is not my concern.
Usually, I let it around my mouth for a little bit before I finally swallow it since the capsule is harder and is that last thing that dissolves.
So yes, it is going under the tongue, I know that many drugs especially valium, etc, is put under the tongue for a strong and fast body reaction, but I have not idea about avodart. I worry that I might be undergoing bad sideeffects that I could experience down the road. I know that on the label is says to swallow the pill, but I jsut cant.
Do you think I shall contact GSK directly??
Thanks greatly!

» » Thanks Rooster,
» » I wasnt aware that GSK stopped at phase III, why would that be? I was
» on
» » propecia and I am now on Avodart, and Avodart is much more powerful
» than
» » propecia. Avodart has shut down hair serum completely, incredible.
» » To me, I dont mind whether the FDA approves it for use in hairloss since
» I
» » dont live in the US, but it would be interesting that they officially
» label
» » avodart as probably the most potent hairloss drug up to now.
» »
» » One final question, I dont swallow the pill, I have to wait
» until
» » it dissolves on my mouth… Do you think it could loose its efficacy?
»
» » Could this be considered as topical dutasteride???
» »
» »
» »
» » » » What do you mean by phase III?
» » » » Cheers
» » » »
» » » »
» » » » » » » How did you “confirm” that it’s happening?
» » » » » » »
» » » » » » » .
» » » » » »
» » » » » » Bryan, Dr. Rassman told me and I believe he got the info from a
» » » » » reliable
» » » » » » collegue
» » » » »
» » » » » He originally posted the info on 12-20-07 and I contacted him to
» » make
» » » » sure
» » » » » he had accurate info.
» » » » »
» » » » »
» » »
»
» » » boris, new drug applications that are filed with the U.S. FDA must go
» » » through 3 seperate clinical trials. For example, phase one trials
» » » basically just look at toxicology, side effects and not efficacy.
» » » Dutasteride had gone through phase 1 and 2 and they were preparing to
» » go
» » » into phase three but suddenly stopped with no explanation. They now
» » have
» » » decided to go forward and the trials are being done in Korea. Once
» the
» » » trial is completed they will study the data and possibly file an NDA
» » with
» » » the FDA for approval for hairloss. It obviously can be prescribed off
» » » label right now, which is legal in the U.S… However the drug
» companies
» » » can’t market their drugs for off label use, thus the reason GSK wants
» » to
» » » go through phase 3 trials. It appears from several studies that duta
» is
» » » more effective than finasteride.
»
» Boris, no, letting it dissolve in your mouth doesn’t make it like a
» topical. in fact, it might lead to a stronger systemic dose. I would have
» to read the literature to see how the drug is affected by the digestive
» track and especially the liver. There is no need to let it dissolve in
» your mouth, of course it really doesn’t matter unless you keep it there
» long enough to systemically absorb through the walls of the inner mouth
» and especially under the tongue (which is something you might not want to
» do). Otherwise your probably just getting a bad taste.


#14

» Hi!
» The problem that I have is that I cant swallow pills, especially the size
» of avodart so I usually chew them, mix them with juice and just swallow
» it,it tastes very bad but that is not my concern.
» Usually, I let it around my mouth for a little bit before I finally
» swallow it since the capsule is harder and is that last thing that
» dissolves.
» So yes, it is going under the tongue, I know that many drugs especially
» valium, etc, is put under the tongue for a strong and fast body reaction,
» but I have not idea about avodart. I worry that I might be undergoing bad
» sideeffects that I could experience down the road. I know that on the
» label is says to swallow the pill, but I jsut cant.
» Do you think I shall contact GSK directly??
» Thanks greatly!
»
»
»
» » » Thanks Rooster,
» » » I wasnt aware that GSK stopped at phase III, why would that be? I
» was
» » on
» » » propecia and I am now on Avodart, and Avodart is much more powerful
» » than
» » » propecia. Avodart has shut down hair serum completely, incredible.
» » » To me, I dont mind whether the FDA approves it for use in hairloss
» since
» » I
» » » dont live in the US, but it would be interesting that they officially
» » label
» » » avodart as probably the most potent hairloss drug up to now.
» » »
» » » One final question, I dont swallow the pill, I have to wait
» » until
» » » it dissolves on my mouth… Do you think it could loose its efficacy?
»
» »
» » » Could this be considered as topical dutasteride???
» » »
» » »
» » »
» » » » » What do you mean by phase III?
» » » » » Cheers
» » » » »
» » » » »
» » » » » » » » How did you “confirm” that it’s happening?
» » » » » » » »
» » » » » » » » .
» » » » » » »
» » » » » » » Bryan, Dr. Rassman told me and I believe he got the info from
» a
» » » » » » reliable
» » » » » » » collegue
» » » » » »
» » » » » » He originally posted the info on 12-20-07 and I contacted him
» to
» » » make
» » » » » sure
» » » » » » he had accurate info.
» » » » » »
» » » » » »
» » » »
» »
» » » » boris, new drug applications that are filed with the U.S. FDA must
» go
» » » » through 3 seperate clinical trials. For example, phase one trials
» » » » basically just look at toxicology, side effects and not efficacy.
» » » » Dutasteride had gone through phase 1 and 2 and they were preparing
» to
» » » go
» » » » into phase three but suddenly stopped with no explanation. They now
» » » have
» » » » decided to go forward and the trials are being done in Korea. Once
» » the
» » » » trial is completed they will study the data and possibly file an
» NDA
» » » with
» » » » the FDA for approval for hairloss. It obviously can be prescribed
» off
» » » » label right now, which is legal in the U.S… However the drug
» » companies
» » » » can’t market their drugs for off label use, thus the reason GSK
» wants
» » » to
» » » » go through phase 3 trials. It appears from several studies that
» duta
» » is
» » » » more effective than finasteride.
» »
» » Boris, no, letting it dissolve in your mouth doesn’t make it like a
» » topical. in fact, it might lead to a stronger systemic dose. I would
» have
» » to read the literature to see how the drug is affected by the digestive
» » track and especially the liver. There is no need to let it dissolve in
» » your mouth, of course it really doesn’t matter unless you keep it there
» » long enough to systemically absorb through the walls of the inner mouth
» » and especially under the tongue (which is something you might not want
» to
» » do). Otherwise your probably just getting a bad taste.

Boris, I doubt they would tell you anything other than you should swallow the pill as instructed. I don’t think what your doing is a problem and i don’t think a few seconds in the mouth would cause extreme systemic absortion. The drug may pass the intestine and liver unaffected, if so, there is especially nothing to worry about. Even assumming the worst case scenrio that the drug went straight into you system i would imagine there is a several fold safety from toxicity. In volunteer studies of AVODART (dutasteride) soft gelatin capsules, single daily doses of dutasteride up to 40 mg/day (80 times the therapeutic dose) have been administered for 7 days without significant safety concerns. In clinical studies, doses of 5 mg daily have been administered to subjects for 6 months with no additional adverse effects to those seen at therapeutic doses of 0.5 mg. The drug is metobolized which does include liver metabolism. The half life of this drug is very long, i wouldn’t even think a daily dose would be needed, two to three doses per week may be plenty.


#15

» » Hi!
» » The problem that I have is that I cant swallow pills, especially the
» size
» » of avodart so I usually chew them, mix them with juice and just swallow
» » it,it tastes very bad but that is not my concern.
» » Usually, I let it around my mouth for a little bit before I finally
» » swallow it since the capsule is harder and is that last thing that
» » dissolves.
» » So yes, it is going under the tongue, I know that many drugs especially
» » valium, etc, is put under the tongue for a strong and fast body
» reaction,
» » but I have not idea about avodart. I worry that I might be undergoing
» bad
» » sideeffects that I could experience down the road. I know that on the
» » label is says to swallow the pill, but I jsut cant.
» » Do you think I shall contact GSK directly??
» » Thanks greatly!
» »
» »
» »

Boris, the oral bioavailabity is 60%, which generally means that 40% of the dosage is lost in the digestive track and not systemically absorbed. You would have to hold the drug in your mouth for several minutes to get significant absorption in my opinion. Regardless, the safety profile at large doses such as 5MG shows little adverse reaction. So, I wouldn’t worry about the way you are taking the drug unless your body starts to tell you otherwise.
» » » » Thanks Rooster,
» » » » I wasnt aware that GSK stopped at phase III, why would that be? I
» » was
» » » on
» » » » propecia and I am now on Avodart, and Avodart is much more powerful
» » » than
» » » » propecia. Avodart has shut down hair serum completely, incredible.
»
» » » » To me, I dont mind whether the FDA approves it for use in hairloss
» » since
» » » I
» » » » dont live in the US, but it would be interesting that they
» officially
» » » label
» » » » avodart as probably the most potent hairloss drug up to now.
» » » »
» » » » One final question, I dont swallow the pill, I have to wait
» » » until
» » » » it dissolves on my mouth… Do you think it could loose its
» efficacy?
» »
» » »
» » » » Could this be considered as topical dutasteride???
» » » »
» » » »
» » » »
» » » » » » What do you mean by phase III?
» » » » » » Cheers
» » » » » »
» » » » » »
» » » » » » » » » How did you “confirm” that it’s happening?
» » » » » » » » »
» » » » » » » » » .
» » » » » » » »
» » » » » » » » Bryan, Dr. Rassman told me and I believe he got the info
» from
» » a
» » » » » » » reliable
» » » » » » » » collegue
» » » » » » »
» » » » » » » He originally posted the info on 12-20-07 and I contacted him
» » to
» » » » make
» » » » » » sure
» » » » » » » he had accurate info.
» » » » » » »
» » » » » » »
» » » » »
» » »
»
» » » » » boris, new drug applications that are filed with the U.S. FDA
» must
» » go
» » » » » through 3 seperate clinical trials. For example, phase one trials
» » » » » basically just look at toxicology, side effects and not efficacy.
» » » » » Dutasteride had gone through phase 1 and 2 and they were
» preparing
» » to
» » » » go
» » » » » into phase three but suddenly stopped with no explanation. They
» now
» » » » have
» » » » » decided to go forward and the trials are being done in Korea.
» Once
» » » the
» » » » » trial is completed they will study the data and possibly file an
» » NDA
» » » » with
» » » » » the FDA for approval for hairloss. It obviously can be prescribed
» » off
» » » » » label right now, which is legal in the U.S… However the drug
» » » companies
» » » » » can’t market their drugs for off label use, thus the reason GSK
» » wants
» » » » to
» » » » » go through phase 3 trials. It appears from several studies that
» » duta
» » » is
» » » » » more effective than finasteride.
» » »
» » » Boris, no, letting it dissolve in your mouth doesn’t make it like a
» » » topical. in fact, it might lead to a stronger systemic dose. I would
» » have
» » » to read the literature to see how the drug is affected by the
» digestive
» » » track and especially the liver. There is no need to let it dissolve
» in
» » » your mouth, of course it really doesn’t matter unless you keep it
» there
» » » long enough to systemically absorb through the walls of the inner
» mouth
» » » and especially under the tongue (which is something you might not
» want
» » to
» » » do). Otherwise your probably just getting a bad taste.
»
» Boris, I doubt they would tell you anything other than you should swallow
» the pill as instructed. I don’t think what your doing is a problem and i
» don’t think a few seconds in the mouth would cause extreme systemic
» absortion. The drug may pass the intestine and liver unaffected, if so,
» there is especially nothing to worry about. Even assumming the worst case
» scenrio that the drug went straight into you system i would imagine there
» is a several fold safety from toxicity. In volunteer studies of AVODART
» (dutasteride) soft gelatin capsules, single daily doses of dutasteride up
» to 40 mg/day (80 times the therapeutic dose) have been administered for 7
» days without significant safety concerns. In clinical studies, doses of 5
» mg daily have been administered to subjects for 6 months with no
» additional adverse effects to those seen at therapeutic doses of 0.5 mg.
» The drug is metobolized which does include liver metabolism. The half life
» of this drug is very long, i wouldn’t even think a daily dose would be
» needed, two to three doses per week may be plenty.


#16

Rooster,
What do you mean by the oral bioavailability? So in my case I guess that less than 40% is lost right? Do you have any studies regarding dutas been systemically absorved and whether it increases its efficacy.
Since I have to wait until the capsule completely dissolves, what if I let the dutas on my mouth longer…
Thanks amigo!

»
» Boris, the oral bioavailabity is 60%, which generally means that 40% of
» the dosage is lost in the digestive track and not systemically absorbed.
» You would have to hold the drug in your mouth for several minutes to get
» significant absorption in my opinion. Regardless, the safety profile at
» large doses such as 5MG shows little adverse reaction. So, I wouldn’t
» worry about the way you are taking the drug unless your body starts to
» tell you otherwise.
» » » » » Thanks Rooster,
» » » » » I wasnt aware that GSK stopped at phase III, why would that be?
» I
» » » was
» » » » on
» » » » » propecia and I am now on Avodart, and Avodart is much more
» powerful
» » » » than
» » » » » propecia. Avodart has shut down hair serum completely,
» incredible.
» »
» » » » » To me, I dont mind whether the FDA approves it for use in
» hairloss
» » » since
» » » » I
» » » » » dont live in the US, but it would be interesting that they
» » officially
» » » » label
» » » » » avodart as probably the most potent hairloss drug up to now.
» » » » »
» » » » » One final question, I dont swallow the pill, I have to
» wait
» » » » until
» » » » » it dissolves on my mouth… Do you think it could loose its
» » efficacy?
» » »
» » » »
» » » » » Could this be considered as topical dutasteride???
» » » » »
» » » » »
» » » » »
» » » » » » » What do you mean by phase III?
» » » » » » » Cheers
» » » » » » »
» » » » » » »
» » » » » » » » » » How did you “confirm” that it’s happening?
» » » » » » » » » »
» » » » » » » » » » .
» » » » » » » » »
» » » » » » » » » Bryan, Dr. Rassman told me and I believe he got the info
» » from
» » » a
» » » » » » » » reliable
» » » » » » » » » collegue
» » » » » » » »
» » » » » » » » He originally posted the info on 12-20-07 and I contacted
» him
» » » to
» » » » » make
» » » » » » » sure
» » » » » » » » he had accurate info.
» » » » » » » »
» » » » » » » »
» » » » » »
» » » »
» »
» » » » » » boris, new drug applications that are filed with the U.S. FDA
» » must
» » » go
» » » » » » through 3 seperate clinical trials. For example, phase one
» trials
» » » » » » basically just look at toxicology, side effects and not
» efficacy.
» » » » » » Dutasteride had gone through phase 1 and 2 and they were
» » preparing
» » » to
» » » » » go
» » » » » » into phase three but suddenly stopped with no explanation. They
» » now
» » » » » have
» » » » » » decided to go forward and the trials are being done in Korea.
» » Once
» » » » the
» » » » » » trial is completed they will study the data and possibly file
» an
» » » NDA
» » » » » with
» » » » » » the FDA for approval for hairloss. It obviously can be
» prescribed
» » » off
» » » » » » label right now, which is legal in the U.S… However the drug
» » » » companies
» » » » » » can’t market their drugs for off label use, thus the reason GSK
» » » wants
» » » » » to
» » » » » » go through phase 3 trials. It appears from several studies that
» » » duta
» » » » is
» » » » » » more effective than finasteride.
» » » »
» » » » Boris, no, letting it dissolve in your mouth doesn’t make it like a
» » » » topical. in fact, it might lead to a stronger systemic dose. I
» would
» » » have
» » » » to read the literature to see how the drug is affected by the
» » digestive
» » » » track and especially the liver. There is no need to let it
» dissolve
» » in
» » » » your mouth, of course it really doesn’t matter unless you keep it
» » there
» » » » long enough to systemically absorb through the walls of the inner
» » mouth
» » » » and especially under the tongue (which is something you might not
» » want
» » » to
» » » » do). Otherwise your probably just getting a bad taste.
» »
» » Boris, I doubt they would tell you anything other than you should
» swallow
» » the pill as instructed. I don’t think what your doing is a problem and
» i
» » don’t think a few seconds in the mouth would cause extreme systemic
» » absortion. The drug may pass the intestine and liver unaffected, if so,
» » there is especially nothing to worry about. Even assumming the worst
» case
» » scenrio that the drug went straight into you system i would imagine
» there
» » is a several fold safety from toxicity. In volunteer studies of AVODART
» » (dutasteride) soft gelatin capsules, single daily doses of dutasteride
» up
» » to 40 mg/day (80 times the therapeutic dose) have been administered for
» 7
» » days without significant safety concerns. In clinical studies, doses of
» 5
» » mg daily have been administered to subjects for 6 months with no
» » additional adverse effects to those seen at therapeutic doses of 0.5
» mg.
» » The drug is metobolized which does include liver metabolism. The half
» life
» » of this drug is very long, i wouldn’t even think a daily dose would be
» » needed, two to three doses per week may be plenty.


#17

By the way rooster, in the studies you cite, how did the people take those doses of 40mg?
I am taking a dose of 1mg but that requires to take in 2 pills, any way I can increase the dose with just one pill?
Thanks.

» » » Hi!
» » » The problem that I have is that I cant swallow pills, especially the
» » size
» » » of avodart so I usually chew them, mix them with juice and just
» swallow
» » » it,it tastes very bad but that is not my concern.
» » » Usually, I let it around my mouth for a little bit before I finally
» » » swallow it since the capsule is harder and is that last thing that
» » » dissolves.
» » » So yes, it is going under the tongue, I know that many drugs
» especially
» » » valium, etc, is put under the tongue for a strong and fast body
» » reaction,
» » » but I have not idea about avodart. I worry that I might be
» undergoing
» » bad
» » » sideeffects that I could experience down the road. I know that on
» the
» » » label is says to swallow the pill, but I jsut cant.
» » » Do you think I shall contact GSK directly??
» » » Thanks greatly!
» » »
» » »
» » »
»
» Boris, the oral bioavailabity is 60%, which generally means that 40% of
» the dosage is lost in the digestive track and not systemically absorbed.
» You would have to hold the drug in your mouth for several minutes to get
» significant absorption in my opinion. Regardless, the safety profile at
» large doses such as 5MG shows little adverse reaction. So, I wouldn’t
» worry about the way you are taking the drug unless your body starts to
» tell you otherwise.
» » » » » Thanks Rooster,
» » » » » I wasnt aware that GSK stopped at phase III, why would that be?
» I
» » » was
» » » » on
» » » » » propecia and I am now on Avodart, and Avodart is much more
» powerful
» » » » than
» » » » » propecia. Avodart has shut down hair serum completely,
» incredible.
» »
» » » » » To me, I dont mind whether the FDA approves it for use in
» hairloss
» » » since
» » » » I
» » » » » dont live in the US, but it would be interesting that they
» » officially
» » » » label
» » » » » avodart as probably the most potent hairloss drug up to now.
» » » » »
» » » » » One final question, I dont swallow the pill, I have to
» wait
» » » » until
» » » » » it dissolves on my mouth… Do you think it could loose its
» » efficacy?
» » »
» » » »
» » » » » Could this be considered as topical dutasteride???
» » » » »
» » » » »
» » » » »
» » » » » » » What do you mean by phase III?
» » » » » » » Cheers
» » » » » » »
» » » » » » »
» » » » » » » » » » How did you “confirm” that it’s happening?
» » » » » » » » » »
» » » » » » » » » » .
» » » » » » » » »
» » » » » » » » » Bryan, Dr. Rassman told me and I believe he got the info
» » from
» » » a
» » » » » » » » reliable
» » » » » » » » » collegue
» » » » » » » »
» » » » » » » » He originally posted the info on 12-20-07 and I contacted
» him
» » » to
» » » » » make
» » » » » » » sure
» » » » » » » » he had accurate info.
» » » » » » » »
» » » » » » » »
» » » » » »
» » » »
» »
» » » » » » boris, new drug applications that are filed with the U.S. FDA
» » must
» » » go
» » » » » » through 3 seperate clinical trials. For example, phase one
» trials
» » » » » » basically just look at toxicology, side effects and not
» efficacy.
» » » » » » Dutasteride had gone through phase 1 and 2 and they were
» » preparing
» » » to
» » » » » go
» » » » » » into phase three but suddenly stopped with no explanation. They
» » now
» » » » » have
» » » » » » decided to go forward and the trials are being done in Korea.
» » Once
» » » » the
» » » » » » trial is completed they will study the data and possibly file
» an
» » » NDA
» » » » » with
» » » » » » the FDA for approval for hairloss. It obviously can be
» prescribed
» » » off
» » » » » » label right now, which is legal in the U.S… However the drug
» » » » companies
» » » » » » can’t market their drugs for off label use, thus the reason GSK
» » » wants
» » » » » to
» » » » » » go through phase 3 trials. It appears from several studies that
» » » duta
» » » » is
» » » » » » more effective than finasteride.
» » » »
» » » » Boris, no, letting it dissolve in your mouth doesn’t make it like a
» » » » topical. in fact, it might lead to a stronger systemic dose. I
» would
» » » have
» » » » to read the literature to see how the drug is affected by the
» » digestive
» » » » track and especially the liver. There is no need to let it
» dissolve
» » in
» » » » your mouth, of course it really doesn’t matter unless you keep it
» » there
» » » » long enough to systemically absorb through the walls of the inner
» » mouth
» » » » and especially under the tongue (which is something you might not
» » want
» » » to
» » » » do). Otherwise your probably just getting a bad taste.
» »
» » Boris, I doubt they would tell you anything other than you should
» swallow
» » the pill as instructed. I don’t think what your doing is a problem and
» i
» » don’t think a few seconds in the mouth would cause extreme systemic
» » absortion. The drug may pass the intestine and liver unaffected, if so,
» » there is especially nothing to worry about. Even assumming the worst
» case
» » scenrio that the drug went straight into you system i would imagine
» there
» » is a several fold safety from toxicity. In volunteer studies of AVODART
» » (dutasteride) soft gelatin capsules, single daily doses of dutasteride
» up
» » to 40 mg/day (80 times the therapeutic dose) have been administered for
» 7
» » days without significant safety concerns. In clinical studies, doses of
» 5
» » mg daily have been administered to subjects for 6 months with no
» » additional adverse effects to those seen at therapeutic doses of 0.5
» mg.
» » The drug is metobolized which does include liver metabolism. The half
» life
» » of this drug is very long, i wouldn’t even think a daily dose would be
» » needed, two to three doses per week may be plenty.


#18

» By the way rooster, in the studies you cite, how did the people take those
» doses of 40mg?
» I am taking a dose of 1mg but that requires to take in 2 pills, any way I
» can increase the dose with just one pill?

All that’s commercially available is just the standard 0.5 mg capsule. The much larger doses (like 40 mg) that were used in the approval process have nothing to do with the commercial capsule, those were experimental doses of essentially the pure chemical.

BTW, if you have trouble swallowing capsules, chewing them first is perfectly acceptable, provided you can tolerate the awful taste! I’ve heard the taste is terrible! :slight_smile:

Also, you don’t need to worry about excessive absorption of the drug by holding it in your mouth. Systemic absorption by that route (directly through tissues in the mouth) is almost certainly very negligible. There was a study about five years ago which measured the blood levels of vitamin B-12 when using the so-called “sublingual” tablets, and it was found that they had no improvement in B-12 absorption than just ordinary tablets which were swallowed in the normal way. There’s no doubt in my mind that it’s the same way with Avodart capsules.

.


#19

» By the way rooster, in the studies you cite, how did the people take those
» doses of 40mg?
» I am taking a dose of 1mg but that requires to take in 2 pills, any way I
» can increase the dose with just one pill?
» Thanks.
»
»
»
»
» » » » Hi!
» » » » The problem that I have is that I cant swallow pills, especially
» the
» » » size
» » » » of avodart so I usually chew them, mix them with juice and just
» » swallow
» » » » it,it tastes very bad but that is not my concern.
» » » » Usually, I let it around my mouth for a little bit before I finally
» » » » swallow it since the capsule is harder and is that last thing that
» » » » dissolves.
» » » » So yes, it is going under the tongue, I know that many drugs
» » especially
» » » » valium, etc, is put under the tongue for a strong and fast body
» » » reaction,
» » » » but I have not idea about avodart. I worry that I might be
» » undergoing
» » » bad
» » » » sideeffects that I could experience down the road. I know that on
» » the
» » » » label is says to swallow the pill, but I jsut cant.
» » » » Do you think I shall contact GSK directly??
» » » » Thanks greatly!
» » » »
» » » »
» » » »
» »
» » Boris, the oral bioavailabity is 60%, which generally means that 40% of
» » the dosage is lost in the digestive track and not systemically absorbed.
»
» » You would have to hold the drug in your mouth for several minutes to
» get
» » significant absorption in my opinion. Regardless, the safety profile
» at
» » large doses such as 5MG shows little adverse reaction. So, I wouldn’t
» » worry about the way you are taking the drug unless your body starts to
» » tell you otherwise.
» » » » » » Thanks Rooster,
» » » » » » I wasnt aware that GSK stopped at phase III, why would that be?
»
» » I
» » » » was
» » » » » on
» » » » » » propecia and I am now on Avodart, and Avodart is much more
» » powerful
» » » » » than
» » » » » » propecia. Avodart has shut down hair serum completely,
» » incredible.
» » »
» » » » » » To me, I dont mind whether the FDA approves it for use in
» » hairloss
» » » » since
» » » » » I
» » » » » » dont live in the US, but it would be interesting that they
» » » officially
» » » » » label
» » » » » » avodart as probably the most potent hairloss drug up to now.
» » » » » »
» » » » » » One final question, I dont swallow the pill, I have to
» » wait
» » » » » until
» » » » » » it dissolves on my mouth… Do you think it could loose its
» » » efficacy?
» » » »
» » » » »
» » » » » » Could this be considered as topical dutasteride???
» » » » » »
» » » » » »
» » » » » »
» » » » » » » » What do you mean by phase III?
» » » » » » » » Cheers
» » » » » » » »
» » » » » » » »
» » » » » » » » » » » How did you “confirm” that it’s happening?
» » » » » » » » » » »
» » » » » » » » » » » .
» » » » » » » » » »
» » » » » » » » » » Bryan, Dr. Rassman told me and I believe he got the
» info
» » » from
» » » » a
» » » » » » » » » reliable
» » » » » » » » » » collegue
» » » » » » » » »
» » » » » » » » » He originally posted the info on 12-20-07 and I contacted
» » him
» » » » to
» » » » » » make
» » » » » » » » sure
» » » » » » » » » he had accurate info.
» » » » » » » » »
» » » » » » » » »
» » » » » » »
» » » » »
» » »
»
» » » » » » » boris, new drug applications that are filed with the U.S. FDA
» » » must
» » » » go
» » » » » » » through 3 seperate clinical trials. For example, phase one
» » trials
» » » » » » » basically just look at toxicology, side effects and not
» » efficacy.
» » » » » » » Dutasteride had gone through phase 1 and 2 and they were
» » » preparing
» » » » to
» » » » » » go
» » » » » » » into phase three but suddenly stopped with no explanation.
» They
» » » now
» » » » » » have
» » » » » » » decided to go forward and the trials are being done in Korea.
» » » Once
» » » » » the
» » » » » » » trial is completed they will study the data and possibly file
» » an
» » » » NDA
» » » » » » with
» » » » » » » the FDA for approval for hairloss. It obviously can be
» » prescribed
» » » » off
» » » » » » » label right now, which is legal in the U.S… However the drug
» » » » » companies
» » » » » » » can’t market their drugs for off label use, thus the reason
» GSK
» » » » wants
» » » » » » to
» » » » » » » go through phase 3 trials. It appears from several studies
» that
» » » » duta
» » » » » is
» » » » » » » more effective than finasteride.
» » » » »
» » » » » Boris, no, letting it dissolve in your mouth doesn’t make it like
» a
» » » » » topical. in fact, it might lead to a stronger systemic dose. I
» » would
» » » » have
» » » » » to read the literature to see how the drug is affected by the
» » » digestive
» » » » » track and especially the liver. There is no need to let it
» » dissolve
» » » in
» » » » » your mouth, of course it really doesn’t matter unless you keep it
» » » there
» » » » » long enough to systemically absorb through the walls of the inner
» » » mouth
» » » » » and especially under the tongue (which is something you might not
» » » want
» » » » to
» » » » » do). Otherwise your probably just getting a bad taste.
» » »
» » » Boris, I doubt they would tell you anything other than you should
» » swallow
» » » the pill as instructed. I don’t think what your doing is a problem
» and
» » i
» » » don’t think a few seconds in the mouth would cause extreme systemic
» » » absortion. The drug may pass the intestine and liver unaffected, if
» so,
» » » there is especially nothing to worry about. Even assumming the worst
» » case
» » » scenrio that the drug went straight into you system i would imagine
» » there
» » » is a several fold safety from toxicity. In volunteer studies of
» AVODART
» » » (dutasteride) soft gelatin capsules, single daily doses of
» dutasteride
» » up
» » » to 40 mg/day (80 times the therapeutic dose) have been administered
» for
» » 7
» » » days without significant safety concerns. In clinical studies, doses
» of
» » 5
» » » mg daily have been administered to subjects for 6 months with no
» » » additional adverse effects to those seen at therapeutic doses of 0.5
» » mg.
» » » The drug is metobolized which does include liver metabolism. The half
» » life
» » » of this drug is very long, i wouldn’t even think a daily dose would
» be
» » » needed, two to three doses per week may be plenty.
boris, you don’t need to take two pills just one. This drug is potent at what it does at .5mg. There will be no added benefit for an extra dose. The drug at .5mg is amazingly effective at erradicating DHT. There is a really long half too, the drug can stay in your system for 8 months with a half life generally accepted to be in excess of four weeks. I wouldn’t take the extra pill, even though it won’t hurt you based on what I’ve read in the literature.


#20

» » By the way rooster, in the studies you cite, how did the people take
» those
» » doses of 40mg?
» » I am taking a dose of 1mg but that requires to take in 2 pills, any way
» I
» » can increase the dose with just one pill?
»
» All that’s commercially available is just the standard 0.5 mg capsule.
» The much larger doses (like 40 mg) that were used in the approval process
» have nothing to do with the commercial capsule, those were experimental
» doses of essentially the pure chemical.
»
» BTW, if you have trouble swallowing capsules, chewing them first is
» perfectly acceptable, provided you can tolerate the awful taste! I’ve
» heard the taste is terrible! :slight_smile:
»
» Also, you don’t need to worry about excessive absorption of the drug by
» holding it in your mouth. Systemic absorption by that route (directly
» through tissues in the mouth) is almost certainly very negligible. There
» was a study about five years ago which measured the blood levels of
» vitamin B-12 when using the so-called “sublingual” tablets, and it was
» found that they had no improvement in B-12 absorption than just ordinary
» tablets which were swallowed in the normal way. There’s no doubt in my
» mind that it’s the same way with Avodart capsules.
»
» .

Bryan, I don’t know how you can compare b-12 absorption to dutasteride without knowing the molecular size and weight of each. It appears that dutasteride readily crosses the dermis. duta 528 daltons, b-12 breaks the 500 dalton rule by 2.5 times with over a 1300 dalton weight.