Dutasteride in phase 3

[Guy Legend]

Phase 3 trials to occur in South Korea.

http://www.clinicaltrials.gov/ct/show/N ... 16?order=7

The dose is .5 mg and they are excluding guys who are thinning globably, are taking finasteride or Saw palmetto, minoxidil, etc.

 

[hair today gone tomorrow]

when they say thinning globally do they mean diffused thinners or do they mean another type of hairloss not associated with Androgenetic Alopecia....like something along the lines of a Telogen Effluvium or alopecia areata

 

[Guest]

when they say thinning globally do they mean diffused thinners or do they mean another type of hairloss not associated with Androgenetic Alopecia....like something along the lines of a Telogen Effluvium or alopecia areata

no they are talking about men with something like that OR something like diffuse UNPATTERNED alopecia, i believe, where men even lose a solid amount of hair in the very bottom of the back of their head and the very bottom of their sides, in the normally safe NW7 region.

i am sure that they will include diffuse patterned thinners like myself who are diffusing but still have thick back and sides.

 

[Bryan]

I don't think it has anything to do with patterned versus unpatterned loss, I think all they want to do is test the drug for VERTEX balding (as opposed to frontal balding).

I find a couple of issues quite interesting:

1) Judging from that short blurb, all they're apparently testing is just the standard dutasteride dose of 0.5 mg/day. I suspect that Glaxo isn't too keen on the idea of people using larger doses than that.

2) Why on earth are they "re-inventing the wheel"?? Why are they simply duplicating (for the most part) a trial that they already performed a few years ago??

Bryan

 

[Cassin]

Now that...is an "I'll be damn."


Here's to hair int:

 

[Guest]

I don't think it has anything to do with patterned versus unpatterned loss, I think all they want to do is test the drug for VERTEX balding (as opposed to frontal balding).

I find a couple of issues quite interesting:

1) Judging from that short blurb, all they're apparently testing is just the standard dutasteride dose of 0.5 mg/day. I suspect that Glaxo isn't too keen on the idea of people using larger doses than that.

2) Why on earth are they "re-inventing the wheel"?? Why are they simply duplicating (for the most part) a trial that they already performed a few years ago??

Bryan

bryan, isn't phase III different from phase II in that it's a much larger amount of subjects? perhaps they are doing this to confirm that side effect %'s are low and that there's nothing unsafe about it.

 

[Bryan]

bryan, isn't phase III different from phase II in that it's a much larger amount of subjects?

Yes. That's why I can't figure out why they're referring to this new one as a "phase III" trial. Doesn't make any sense.

perhaps they are doing this to confirm that side effect %'s are low and that there's nothing unsafe about it.

Well, that's already been thoroughly tested in other dutasteride trials, including the earlier one for male pattern baldness and the ones for BPH. But whatever...

Bryan

 

[Guest]

i didn't realize that the number of subjects wasn't increased for this one. i guess this doesn't bring us any closer to fda approval for avodart then, does it?

 

[Bryan]

i didn't realize that the number of subjects wasn't increased for this one. i guess this doesn't bring us any closer to fda approval for avodart then, does it?

I don't see how it could, considering that this new trial is only going to have 150 test subjects, compared to the 416 that were in the earlier trial, and both of them are/were for only 6 months duration. I thought it was some kind of joke when I first saw that bit about the new one supposedly being a "phase III" trial.

Bryan