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MikeSmith0

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Thread for Guys in Xiaflex Trial - Currently or Previously
« on: December 03, 2010, 09:20:32 PM »

I wanted to start a new thread specifically for this (and guys that have questions about it).  The other Xiaflex thread is 5 pages and has a lot of different topics going on.  I ended up qualifying for the trial because the hourglassing is gone and I am still over 30 degrees of curve.  The calcifications were very minor - though the plaque feels like bone - so i was concerned but the ultrasound showed very little dots of calcium that are not significant. 

Anyway, I am 99% sure I got the placebo... nothing happened at all that is remotely close to what happened in the Xiaflex / Duputreyn's study. However, I want to ask others if anything happened with them (either Phase 2 people who had the real drug or other Phase 3 people).   I put details from the Duputreyn's study below.  I really don't want to go through this for 13 months for nothing.  I can't even use fast size or take oral meds for 13 months to comply with the study.   I'm not sure I care that I'll be the first to get the "real drug" in the end - if I give up a year of my life to Auxillium when the traction device just started working a month ago.

But have any guys who have been in this trial had the reactions below?  Has anyone improved who was NOT on the placebo in phase 2 - or in phase 3?


All adverse reactions 98% vs. 51%
Peripheral Edema (swelling) 73% vs  5% Placebo
Contusion (bruise) 70% vs 3% Placebo  (will be higher in the penis than the hand - regardless of what was injected)
Injection Site Hemorrhage 38% vs. 3% Placebo
Injection Site Swelling 24% vs. 6% placebo
Lymphadenopathy (swollen lymph nodes) 13% vs. 0% placebo

https://www.xiaflex.com/docs/pi_medguide_combo.pdf

Also notice Xiaflex patients all have swelling:

Dupuytren › Xiaflex injection | Forum for Dupuytren's contracture
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Chopsuey

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Re: Thread for Guys in Xiaflex Trial - Currently or Previously
« Reply #1 on: December 04, 2010, 12:48:02 PM »

As I said in the other thread, I've had two injections and so far no swelling or reaction of any kind. I haven't started the modeling yet though and I heard that is when you may see more of the swelling. Not sure why...

My nurse thinks I may be getting the drug because of the difference she noticed in drawing it up in the syringe. She said both times she drew it up, it was harder to pull back and it has a slightly different consistency in the vial. Of course she said she wasn't supposed to say anything and she doesn't want me to get my hopes up too much in case it is the placebo. I saw the vial and the liquid had a slight gel look to it whereas she said the other vials were more like water. Of course time will tell whether I got the drug. I don't want to continue in the trial if I think it's the placebo, but they say I will get the drug as long as I complete the full study. I guess I'll just bite the bullet even if it isn't the drug and just go the whole way so I can get it in the end. Damn, it's a lot of needle sticks for nothing!
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MikeSmith0

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Re: Thread for Guys in Xiaflex Trial - Currently or Previously
« Reply #2 on: December 04, 2010, 02:08:17 PM »

Damn, it's a lot of needle sticks for nothing!

Yeah, for sure... and I really just started seeing results with Fastsize & some oral meds so I'd hate to stop all that for a year.  That's my concern too - and it is very inconvenient to get to the study center in my case (not like the other guy in phase 2 who flew there though!).  I can't stand the induced erections either - which they have to do to see your progress.  I've gotten over the awkwardness by now (as much as I can)... but it burns & then creates an ache that doesn't go away for a while.

I'll look at the syringe and see if it's more gel like... interesting observation.  Who knows though - the gel could be the placebo.  It might be hard to make a placebo that is also freeze dried that looks exactly like xiaflex.  I wonder what it even is... just saline?   They said they actually can't say what it is (if they even know).    

I had a morning erection after the night after the injection and it didn't hurt or anything.  I don't know what to make of that (I never even have morning erections - and they should certainly hurt after a penile injection!).  The doc did tell me straight out "you'll be pretty bruised - so just be prepared" - but there's nothing there... He also said my plaque was very thick and it was easy to get a "good injection" so maybe i'm less bruised since the needle hit fewer capillaries.  I suppose bruising is from the needle pass, not the drug...?  I wonder why there was so much more bruising with the xiaflex in dupuytren's contracture. 
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ronners

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Re: Thread for Guys in Xiaflex Trial - Currently or Previously
« Reply #3 on: December 05, 2010, 07:13:38 AM »

thanks for sharing your observations on the trials guys - Mike, I have been reading your different posts and thoughts on the study itself - I can appreciate that no one wants a series of pointless injections (placebo) into an already damaged old man ... but that is what you signed up for and presumably you knew the risks when you signed up ... Living in the UK, I can't help but feel very envious that you guys have access to a these trials - if this drug is signed off, it could be 2014-15 before it is distributed in Europe (still not available for dupuytrens over here yet) ... a year passes by in a shot (excuse the pun) so I think you should try be a little more positive bearing in mind you will be able to get the real drug either way at the end of the trial - If you're that concerned, just use the fastsize anyway...?

good luck and thanks for sharing
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MikeSmith0

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Re: Thread for Guys in Xiaflex Trial - Currently or Previously
« Reply #4 on: December 05, 2010, 04:45:33 PM »

thanks for sharing your observations on the trials guys - Mike, I have been reading your different posts and thoughts on the study itself - I can appreciate that no one wants a series of pointless injections (placebo) into an already damaged old man ... but that is what you signed up for and presumably you knew the risks when you signed up ... Living in the UK, I can't help but feel very envious that you guys have access to a these trials - if this drug is signed off, it could be 2014-15 before it is distributed in Europe (still not available for dupuytrens over here yet) ... a year passes by in a shot (excuse the pun) so I think you should try be a little more positive bearing in mind you will be able to get the real drug either way at the end of the trial - If you're that concerned, just use the fastsize anyway...?

good luck and thanks for sharing

Yeah... well I don't know what the right answer is and I've had some arguments w/ friends of mine too (and doctors who are friends) since I started suspecting I had the placebo.  It's not easy to deal with any of this...I've lost like 1/3rd of my dick size thanks to Peyronies Disease...which for me put me way below normal size since I was only average to start.  Some of it was just barely starting to normalize and come back in the last few months - finally.   So, now I have to stop all that.  You cannot use fast size or take any of the pills while in the study.  I would not even want to use fast size in case I am in the "real drug" group - and collagenase is doing its thing, dissolving the excess collagen & possibly gets into the tunica...and then while wearing fastsize I rip the tunica apart.  Yikes.  And who knows if / how collagenase would interact with pentox, etc... so I'm not taking that (and they tell you not to before starting the study).  

If I lived in the UK, I'd use fast size (or one of the other extenders) and take pentox, and L-arginine, pyncogenol, viagra / cialis, L-acetyl-carnitine, and ubiquinol.  It'll probably work just as good as xiaflex, which I think only had a 47% improvement rate in phase 2 anyway (i think this might be wrong but i cannot remember the number).   It sounds like the hand disorder has had more success...in that situation, they are manually releasing a collagen cord from the joint that they weaken with xiaflex...and the finger is naturally in motion all the time...I'm not sure how well it'll work with Peyronies Disease.  Plus, I think there is more going on than excess collagen production.  What about all the elastin that was destroyed in the tunica by Peyronies Disease?  That isn't coming back...right?  There are a lot of things I have been getting skeptical about with xiaflex for Peyronies Disease. 
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ronners

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Re: Thread for Guys in Xiaflex Trial - Currently or Previously
« Reply #5 on: December 05, 2010, 06:31:40 PM »

Mike - It's not an easy condition (I hate calling it a 'disease) to live with but at the end of the day you are obviously doing all you can to try and overcome the issue so try not to get down on yourself ...

In respect to Dupuytrens, yes the weakened cord is effectively snapped the day after treatment manually (after a night of non-movement) - one thing I would say is that looking at pics of the open hand surgery for Dups, the cords that develop in the hand are very thick and tough looking (i.e. they look much more significant than penile plaques) - whilst dupuytrens and peyronie's are totally different conditions, the fact that Xiaflex degrades the dupuytrens cord to such an extent that it can be snapped the day after treatment makes me feel that there is potential for improvement in peyronie's plaques - will it cure the condition? I'm not sure due to the elastin issue - will it improve the condition? I hope so by removing or degrading the collagen aspect of the plaque ... My understanding is that Phase 2 was more about the safety aspect of the drug as opposed to the end result - Phase 3 is where the drug company attempts to demonstrate significant and plausible results -

point taken on the fastsize - although I think it's unlikely based on the claims that xiaflex only targets the unhealthy tissue - you're in a better position to make that call though ...

I'm 29 years of age and use viagra / cialis - the other drugs (pentox / l'arginine etc) are not really prescribed by urologists in the UK - reason? my urologist (who is one of the UK's Peyronie's specialists) has suggested that he doesn't feel any sizeable or reliable trials have been conducted to date in relation to their efficiency but noted that the Xiafle trial was the biggest and most followed yet - hmmm! long topic but effectively the only option really in the UK is to live with it and take PD5 inhibitors or to go down the surgery route ... I'll take the first option thanks ... if I was in your shoes I would see this trial out - don't spend time worrying about if it's the placebo or not - you've got more chance that it is xiaflex than it isn't (2:1 ratio) and you'll get the real drug if you stick it out either way - if the drug turns out to help and people have good experiences on this forum then I will be paying to come and have treatment in the US rather than wait ...

good luck and I will follow your progress with interest ...
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Chopsuey

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Re: Thread for Guys in Xiaflex Trial - Currently or Previously
« Reply #6 on: December 05, 2010, 08:03:21 PM »

Hi guys,

I hope I didn't come off as negative when I expressed worry about possibly getting the placebo. I am actually very excited and feel lucky to be in the study. It's the newest and hopefully most effective treatment option out there right now. My only point is, if I am getting the placebo right now, not only do I have to wait a year to get the actual drug, I have potentially many injections to go through before getting the drug. However, I am willing to do that if it means getting improvement in size and curvature. Like Mike said, I too have lost size and was probably only average to begin with. Not exactly Johnny Holmes if you know what I mean. I would have liked to have an extra inch or two before this and now I've lost some of what I had not to mention gaining a double curvature. Great for the sef esteem...

Anyway, I will keep posting throughout my experience and most likely I will be able to figure out if I am getting the drug or not over the next couple of months. No improvement...no drug. We'll see...

Hang in there.
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ComeBacKid

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Re: Mikesmith
« Reply #7 on: December 05, 2010, 08:49:09 PM »

I think a specific thread for xiaflex trial patients could be beneficial, assuming it can't hurt t he study I think we should def go ahead and create one.  Would be nice to have some structure to it, like everyone involved list things like

Region of Country:
Number of injections:
Symptons:
Any noticed results to date:
Etc....

Comebackid
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Chopsuey

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Re: Thread for Guys in Xiaflex Trial - Currently or Previously
« Reply #8 on: December 06, 2010, 02:14:28 PM »

Saw my urologist today for my first modeling. He said the plaque definitely felt "softer" to him today. I hope that's a sign I'm actually getting the drug.

In response to the ComeBacKid.
- I'm from Maryland
- Two injections with the drug (I hope) so far.
- No pain, curve up and to the right  47 degrees
- Too soon for results, other than my doc saying the plaque "felt softer".
- Don't usually need any drugs to achieve an erection, although Viagra makes it even better.
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Humorous3

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Re: Thread for Guys in Xiaflex Trial - Currently or Previously
« Reply #9 on: January 10, 2011, 02:53:05 AM »

I've completed the first two shots of Cycle 2.  As with Cycle 1, the first injection went well.  Several hours after the second shot my penis started swelling and turning dark red.  Later on it was swollen about 100% and was red to dark red to purple.   After 1-2 days the swelling was mostly gone. 

Although I thought there was some slight improvement over the past six weeks, I didn't want to get my hopes up until I was measured.  Well, the good news is there was about a 10 degree reduction.  So, combining that with the swelling and bruising from the second injection of each cycle, I think it's safe to say I am probably receiving the study drug. 

Humorous
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bigk

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Re: Thread for Guys in Xiaflex Trial - Currently or Previously
« Reply #10 on: January 10, 2011, 07:15:28 PM »

Humorous:  I really appreciate you taking the time to post the results of your participation in the study.... please keep the reports coming!
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MikeSmith0

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Re: Thread for Guys in Xiaflex Trial - Currently or Previously
« Reply #11 on: January 10, 2011, 08:07:51 PM »

Sounds great Humorous!  10 degrees is a bonus for cycle 1.  Did you notice a size change at all?

One other question...does your shot burn when you get it?  Or, are you numb before anyway?

I'll let you guys know my update soon too.  I never had bruising or redness so far... but there may have been curve changes - it's a little hard to say due to erection quality issues.  I've heard that cycle 1 doesn't produce a ton of change for most guys.  They can't put too much in each injection since the chemical is so strong.  They use the same dose for dupuytren’s (0.58 mg)... which lets the doc just snap the collagen cord the next day.  Kind of crazy...and Xiaflex can't "tell the difference" between the bad and good collagen. It will dissolve it all - till the drug is used up by the cells (hence the penile fracture risk in the informed consent...and I think my doctor commented about it being harder to inject in plaques that are very thin).  It's the same collagenase that dissolves your tissues during gangrene - so it doesn't discriminate against good collagen.  There's an interesting story on the history of Xiaflex here...not sure if it's been posted to this forum yet.  It's been 50+ years since it was isolated...hard to believe the lag time...!  If Peyronies Disease was as prevalent as diabetes, we'd be on our 10th generation of xiaflex-like compounts (if you're interested in medical history - it's quite amazing what insulin went through in the last 100 years too - from the days when your mom would inject you (as a kid) at home with self-sharpened reusable needles!)


http://www.nytimes.com/2010/03/16/business/16hand.html  (xiaflex history)
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MikeSmith0

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Re: Thread for Guys in Xiaflex Trial - Currently or Previously
« Reply #12 on: January 11, 2011, 07:22:08 PM »

My Update after 2 Shots + Measurement at 6 weeks + 2 More shots (will update in when this last injection series has taken effect and i can have 100% erections again - they ask you not to for safety right after):

I would appreciate any thoughts (from all posters) on some of this - since there are conflicting things here.

- Curve went down but it's not easy to measure & is slightly worse on one side (sort of slanted - from the start though)... so there may be a little measurement error.   It went down over 10 degrees per their notes.  However, measurement difficulty & personal observation makes me think it is around 8-10 degrees - 6 weeks after series 1 injections.

- Plaque is unchanged in size (which makes it is odd how the curve went down)... and seems equally firm... though it may be softening on the border with the tunica...hard to know.  Hard to explain curve changes with equal plauqe - but then again, it's hard to track what is going on with the plaque begins and ends also.

- Size is probably unchanged...again hard to tell - erection quality varies.  I think I saw more size gains on traction than I have with this so far.

- Dent is unchanged.  The dents used to be on both sides but went away with traction (and possibly some oral meds) a few months prior to the study while I was in a more active phase (9 mos or so post onset).
 
Injection

- Burns for 10 seconds (as it is being injected) and then little else happens.  There are minor pains later on but maybe a 2 on a scale of 1-10.   Injection appears to be more of a gel - not watery.  (Don't know if placebo would burn like this)

- No major side effect so far (weird for actual drug - which makes me think it is placebo - but I did apparently have a curve reduction...so who knows.)

Concern:

- My "hinge effect" seems to be getting worse (maybe).  I can bend my penis somewhat easily even when it is fully erect... this started from day 1 with Peyronies but if part of the hard plauqe is softening / dissolving, the existing tunica isn't repairing itself yet...making quite a hinge effect... I have to see how this plays out - i dont always notice it.  If I am 100% (aka taking cialis) it's not as bad.
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marktx

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Re: Thread for Guys in Xiaflex Trial - Currently or Previously
« Reply #13 on: January 12, 2011, 06:23:05 PM »

I just got called by my urologist to see if I was interested in being in the study. I go next week for the initial testing. From reading the study criteria, I think I will qualify.

I have a couple of questions for those who have already started.  What is the modeling? Is it done in the flaccid state?  Also, does the erection inducing injection hurt?  How long does the erection last? Do you have to get another injection to reduce the erection?
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MikeSmith0

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Re: Thread for Guys in Xiaflex Trial - Currently or Previously
« Reply #14 on: January 12, 2011, 07:07:25 PM »

I just got called by my urologist to see if I was interested in being in the study. I go next week for the initial testing. From reading the study criteria, I think I will qualify.

I have a couple of questions for those who have already started.  What is the modeling? Is it done in the flaccid state?  Also, does the erection inducing injection hurt?  How long does the erection last? Do you have to get another injection to reduce the erection?

Modeling is done in the flacid state.  They stretch your penis for a few minutes - gently.  There is no attempt to break any plaque or do anything uncomfortable.  It takes place the day after your 2nd erection.   Then you have to do it yourself at home for a few minutes day.  

The injection to induce erections tends to burn for a few seconds. You can't feel the needle (it's very thin).   I think they have the option of giving prostaglandin, papaverine, or trimix... I don't remember exactly.   Some burn more than others and some take longer to work - or wear off ... I am not an expert on this but your doc will probably have a preference for 1 over another depending on how you respond in the screening visit so you should ask him about it.  The erection can last from 15 minutes to several hours.  A 4+ hour erection is bad for you - but also unusual - and probably only would happen if the dose was too high.  In my case, the opposite happens... I get erect from the shot, but the erection starts to go away as soon as the doctor walks back in the office (they leave for 10-15 minutes until the medicine starts to work).   So, your mind can actually affect an erection that was locally induced.  Everyone's different with this though.

If you have an erection that is not showing any signs of going down, they will give you the shot to make it go away.  But, usually they'll just give you time to let it go away on its own or not give you such a high dose to begin with.  If you live nearby, you can probably go home and just go back if the erection won't go down.  The nurse told me they prefer not to use the anti-erection injection because of its side effects.  
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BSSS

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Re: Thread for Guys in Xiaflex Trial - Currently or Previously
« Reply #15 on: January 14, 2011, 12:58:06 AM »

I just got called by my urologist to see if I was interested in being in the study. I go next week for the initial testing. From reading the study criteria, I think I will qualify.

I have a couple of questions for those who have already started.  What is the modeling? Is it done in the flaccid state?  Also, does the erection inducing injection hurt?  How long does the erection last? Do you have to get another injection to reduce the erection?

Modeling is done in the flacid state.  They stretch your penis for a few minutes - gently.  There is no attempt to break any plaque or do anything uncomfortable. It takes place the day after your 2nd erection.   Then you have to do it yourself at home for a few minutes day.  

The injection to induce erections tends to burn for a few seconds. You can't feel the needle (it's very thin).   I think they have the option of giving prostaglandin, papaverine, or trimix... I don't remember exactly.   Some burn more than others and some take longer to work - or wear off ... I am not an expert on this but your doc will probably have a preference for 1 over another depending on how you respond in the screening visit so you should ask him about it.  The erection can last from 15 minutes to several hours.  A 4+ hour erection is bad for you - but also unusual - and probably only would happen if the dose was too high.  In my case, the opposite happens... I get erect from the shot, but the erection starts to go away as soon as the doctor walks back in the office (they leave for 10-15 minutes until the medicine starts to work).   So, your mind can actually affect an erection that was locally induced.  Everyone's different with this though.

If you have an erection that is not showing any signs of going down, they will give you the shot to make it go away.  But, usually they'll just give you time to let it go away on its own or not give you such a high dose to begin with.  If you live nearby, you can probably go home and just go back if the erection won't go down.  The nurse told me they prefer not to use the anti-erection injection because of its side effects.  

Mike,

What does the 2nd erection mean, or why does it take place?
Also, are you told to have sexual relations during the study?

Thanks,
BSSS
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Humorous3

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Re: Thread for Guys in Xiaflex Trial - Currently or Previously
« Reply #16 on: January 14, 2011, 02:28:48 AM »

Sounds great Humorous!  10 degrees is a bonus for cycle 1.  Did you notice a size change at all?

One other question...does your shot burn when you get it?  Or, are you numb before anyway?

Mike,

I haven't noticed a size change but if there is I think it would be slight.  Congratulations on your 10 degree change also. 

If you're referring to the Xiaflex shots, it is slightly painful (the burning sensation you mention) when the Dr actually injects the medicine.  The second shot (on the second day) was more painful.  However, concerning the papaverine injection, it's not bad at all.  I barely feel it. 

On the first visit I declined the anesthetic because it didn't seem logical to me to get an injection to prevent pain during a second injection.  In other words, if the first shot is going to be painful, why opt for two shots? 

Humorous


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MikeSmith0

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Re: Thread for Guys in Xiaflex Trial - Currently or Previously
« Reply #17 on: January 14, 2011, 02:49:44 AM »

Mike,

What does the 2nd erection mean, or why does it take place?
Also, are you told to have sexual relations during the study?

Thanks,
BSSS

Sorry, that was a typo.  I meant to write "the day after your 2nd injection".    There are 4 injection "cycles" in the study.  Each cycle has 2 total xiaflex injections (1-3 days apart depending on any swelling that has to subside) and then modeling another 24 hrs later after injection 2.  So, each cycle requires 3 visits (or 4 visits if they do your curve measurements on a separate day from the xiaflex injection - they have to induce an erection every cycle to see what the curve is doing & measure it...and then wait for it to go down - then inject xiaflex - so that might push the whole cycle to 4 visits).
 
You are supposed to refrain from sexual activity for 2 weeks after the first shot.  I didn't really get into what "sexual activity" meant with the staff - so I just left things alone the first time.   However, I still had erections in the morning.  So, I couldn't help that & I don't think they thought that was an issue.  It didn't hurt either.

I am not sure what the 2 week reasoning is because if the collagenase is going to make the penis vulnerable to injury for 2 weeks (if it dissolves the collagen)... how is that confined to 2 weeks?  That would be permanent.  So, maybe it has something to do with swelling or not letting the drug get out of where it was injected.   An erection might spread the collagenase out I suppose...but it's probably done working after a day.  

Humorous - thanks for letting me know.   We might both be getting the real thing!
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MikeSmith0

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Re: Thread for Guys in Xiaflex Trial - Currently or Previously
« Reply #18 on: January 15, 2011, 03:53:54 AM »

Videos of a woman going through Xiaflex injections for Dupuytren's contracture were posted on Youtube a few years ago.  I just found them.  I thought some of you might be interested:

http://www.youtube.com/watch?v=29RLwrkSWEc&NR=1

Her side effects were nothing like what I experienced (though I might be getting placebo)...and at the same dose, this really makes no sense.  It appears that the collagenase dissolved a part of her skin (see the later video).  Her swelling and bruising are really bad.  I don't think anyone has reported anything like this in the penis... I don't understand how it is so radically different when it is the same chemical.  I think there's a lot less margin for error in the penis yet the dose is the same and the injection is the same...as far as I know.

She also says that her DC returned in recent times, despite going through all that.  I'm not sure what to make of this.  I wonder if DC patients take pentox or if I'll be on that forever post-xiaflex & have to use a traction device for the next 30 years..
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ronners

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Re: Thread for Guys in Xiaflex Trial - Currently or Previously
« Reply #19 on: January 15, 2011, 09:10:06 AM »

Mike - I think it's important to bear in mind that whilst they are related, the two conditions are in two totally different parts of the body - what follows with one does not necessarily follow with the other ...

It seems reasonable to assume that much of the swelling and bruising shown in the video is down to the manual manipulation that needs to occur with Dupuytrens after the injection in order to snap the chord - this is clearly quite a traumatic and painful event; other treatment videos suggest similar results ... it's quite normal to assume that the hand would swell and react after an event like this ... whilst you have detailed the modelling aspect of the peyronie's trials, this is quite clearly not on a par with the manual snapping of the chord that needs to take place after xiaflex treatment for dupuytrens ...

I think it's also more likely that repeated injections into the same area could cause the skin damage - the subject talks of bleeding in the video and this is more likely to be as a result of repeated injections into the same site  as opposed to her skin being dissolved from the inside out ... either way, she seems very happy with the results ...

as you know the drug was only approved for dupuytrens last year - long term trials are not yet complete although it is thought that xiaflex will reduce but not eradicate recurrence
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Chopsuey

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Re: Thread for Guys in Xiaflex Trial - Currently or Previously
« Reply #20 on: January 16, 2011, 02:26:38 PM »

Hi everyone,

I just went through my second phase of injections last Thursday and Friday. The evaluation showed a 10 degree reduction in curvature...better than I expected. I have an indentation on the right side of my penis that seemed to get worse, so my uro is injecting closer to that area than previously. He seems to think there are positive changes happening. I hope so. When he injected me this time, it hurt even more than the first time. When he hits plaque, there is resistance so he has to push harder for it to go in, causing more pain. Overall tolerable, but no fun. I don't think there is any change in size, just some reduction in curvature. I'm looking forward to see what changes occur in this cycle.
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Humorous3

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Re: Thread for Guys in Xiaflex Trial - Currently or Previously
« Reply #21 on: January 16, 2011, 05:35:14 PM »

Chopsuey,

It's great to hear your results from Cycle 2. Isn't it strangely coincidental that of the three of us that have reported so far (You, Mike Smith0 and I), each reported a 10 degree change from Cycle 1.

I thought there was at least one other guy in the Phase 3 trial reporting on his progress but after looking over the comments below I couldn't find him.  Do you know of anyone else reporting here? 

Was your penis bruised or swollen after the Cycle 1 or 2 injections?  (Mine was but Mike's wasn't.)  Thanks. 

Humorous
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ronners

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Re: Thread for Guys in Xiaflex Trial - Currently or Previously
« Reply #22 on: January 16, 2011, 07:34:19 PM »

Guys,

Also just interested to know if any of you in the study group noticed any change in the size or firmness of your plaque / scar tissue??

Thanks for your efforts so far in posting ...
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Ticker

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Re: Thread for Guys in Xiaflex Trial - Currently or Previously
« Reply #23 on: January 17, 2011, 09:39:29 AM »

Goodmorning everyone,I have not posted here in a long time but read often.I am going in Wednesday for my blood test,EKG,Measurements,etc.etc. I am one of the people that has gone through the test and received the placebo.I will keep everyone posted as to any changes and/or results.Ticker 
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Ticker

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Re: Thread for Guys in Xiaflex Trial - Currently or Previously
« Reply #24 on: January 17, 2011, 09:50:48 AM »

FYI, The doctors office referes to this as the "Auxilium 802 Trial"
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Chopsuey

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Re: Thread for Guys in Xiaflex Trial - Currently or Previously
« Reply #25 on: January 17, 2011, 06:58:42 PM »

Hi Humorous,

I didn't notice any swelling or bruising after any of my injections. Just slightly red at the injection sites, though that didn't last too long. They said today that the more stretching I do on my own, the better the results will be.
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MikeSmith0

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Re: Thread for Guys in Xiaflex Trial - Currently or Previously
« Reply #26 on: January 18, 2011, 02:38:21 AM »

Mike - I think it's important to bear in mind that whilst they are related, the two conditions are in two totally different parts of the body - what follows with one does not necessarily follow with the other ...

It seems reasonable to assume that much of the swelling and bruising shown in the video is down to the manual manipulation that needs to occur with Dupuytrens after the injection in order to snap the chord - this is clearly quite a traumatic and painful event; other treatment videos suggest similar results ... it's quite normal to assume that the hand would swell and react after an event like this ... whilst you have detailed the modelling aspect of the peyronie's trials, this is quite clearly not on a par with the manual snapping of the chord that needs to take place after xiaflex treatment for dupuytrens ...

I think it's also more likely that repeated injections into the same area could cause the skin damage - the subject talks of bleeding in the video and this is more likely to be as a result of repeated injections into the same site  as opposed to her skin being dissolved from the inside out ... either way, she seems very happy with the results ...

as you know the drug was only approved for dupuytrens last year - long term trials are not yet complete although it is thought that xiaflex will reduce but not eradicate recurrence

Right, well I just meant that in the first video she posted (just after the injection - no snapping) she had really bad swelling and brusing.  She posted one a few days later after the manipulation to snap the cord...which she said was horrendously painful because in the trial, they were not allowing lidocaine.  These were on different days.  She was extremely swollen and bruised from the shot alone.   At least that's what I understood from her videos.  I just think the penis would show similar swelling and bruising to the hand - that's all.  For all I know, maybe it does cause that, and I am getting the placebo...and Humorous is getting the real thing & having the real reaction.  Certainly, my penis looked quite a bit like her hand after verapamil shots - so that kind of reaction isn't out of the question for injections to this part of one's anatomy.

About recurrence - she only mentioned that vaguely in the video description - and it is also over 2 years later.  So, I am not sure that we know it truly "came back" or if it's a new cord or what.  It seems like DC may be more of a progressive condition but it's hard to say.  Peyronies Disease may be equally progressive... and so I wonder if xiaflex even does work, could the plaques come back?  I think doctors are trying to be optimistic about the body's ability to heal the area once the plaque is dissolved but Peyronies Disease is a healing disorder to begin with - so that optimism may be too strong.   It's less risky & traumatic than surgery, certainly...so for that reason - I'd take this any day.  If it is a progressive disease, then maybe people with it will have to be on pentox for life after xiaflex.

You're right - the bleeding in the DC youtube video was probably from the needle.  Her description was just a little macabre about the whole thing. 

Anyway, Ronners - I dont think i noticed any plauque change... but I don't really know if I am comparing it effectively to November.  It's possible that it is softer on one side.   It is hard to compare to my own memory since the changes aren't really that noticable.   The plaques are all there, probably the same size - but maybe softer in 1 spot (but again I might not be getting xiaflex). 
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ronners

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Re: Thread for Guys in Xiaflex Trial - Currently or Previously
« Reply #27 on: January 19, 2011, 05:23:29 PM »

Mike - I think DC is definitely more of a progressive condition - it regularly affects more than one finger and at different speeds too (i.e. contracture in one finger is more progressed than contracture in others) ... I suppose with 'traditional peyronie's' (whatever that is!!) the disease tends to stabilise one the acute phase is passed ... with peyronie's you only have the one 'finger' to worry about although I think I would prefer Dupuytrens if I had been given the choice ...

anyhow, here is some auxilium data about recurrence rates for your info: http://www.checkorphan.org/grid/news/treatment/auxilium-pharmaceuticals-announces-two-year-recurrence-rate-of-19-3-for-joints-treated-with-xiaflex-r

It would appear that with Dupuytrens at least, the recurrence rate with xiaflex is lower than with the two other forms of treatment (NA and Surgery) - remember that Xiaflex is being touted as a treatment and not a cure ...

Hard to say about the swelling after injection and I get where you're coming from - whilst you could say it's odd that you reacted after Verapamil but not with the xiaflex (or placebo), at the end of the day different people react differently to different drugs at different times ... so I guess time will tell - either way I'm really pleased that you and the others have seen some mild improvements so far and it's great that you are taking the time to post the details here for us to read - there is the possibility of open label trials for Xiaflex in the UK with Pfizer (who are marketing the drug in the EU) and so I am going to speak to my uro and see if I can get involved (I may not qualify as my plaque is not always palpable) ...
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BSSS

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Re: Thread for Guys in Xiaflex Trial - Currently or Previously
« Reply #28 on: January 19, 2011, 06:48:05 PM »

Hi Humorous,

I didn't notice any swelling or bruising after any of my injections. Just slightly red at the injection sites, though that didn't last too long. They said today that the more stretching I do on my own, the better the results will be.

if that's the case is a VED too much for this purpose?
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MikeSmith0

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Re: Thread for Guys in Xiaflex Trial - Currently or Previously
« Reply #29 on: January 19, 2011, 09:24:42 PM »

BSSS,

I am pretty sure they ask you not to use pumps during the study... maybe double check with the doc or see if it is on the informed consent.  I think it's more of an issue of control (over varibles that lead to improvement) than of any side effects happening.
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Humorous3

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Re: Thread for Guys in Xiaflex Trial - Currently or Previously
« Reply #30 on: January 20, 2011, 02:33:56 AM »

BSSS,

When Chopsuey mentioned "stretching" below, he was referring to modeling which we are supposed to do during our Phase 3 trial.  This is done by using your hand and bending/stretching your penis in the area where the plaque is.  We were provided with an instruction card.  Basically, I put my thumb on one side and my index finger on the opposite side (and just slightly higher than the thumb).  Then I bend my penis in the opposite direction of the curve.  Hold for 30 seconds, release for 30 seconds, and repeat that three times.  This is done in the flaccid state.

Concerning using a VED, I'm sure that is forbidden during the trial.  Like Mike said, they don't want anyone using or doing anything unauthorized that might change the outcome.

Humorous
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BSSS

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Re: Thread for Guys in Xiaflex Trial - Currently or Previously
« Reply #31 on: January 20, 2011, 04:23:01 PM »



thanks guys for the info re: VED and the trial.  I'd be tempted too much to use the VED and pop that sucker straight! :)  j/k  May be too much chance of injury and all using it.

BSSS
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restore

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Re: Thread for Guys in Xiaflex Trial - Currently or Previously
« Reply #32 on: January 20, 2011, 05:49:39 PM »

Can any of the particpants in the study have tried injectable verapamil in the past?  Or is that not allowed.
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BrooksBro

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Humorous3

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Re: Thread for Guys in Xiaflex Trial - Currently or Previously
« Reply #34 on: January 21, 2011, 02:00:49 AM »

Can any of the participants in the study have tried injectable verapamil in the past?  Or is that not allowed.

It's OK as long as it was more than three months ago. 

For all the criteria follow the link provided by BrooksBro in the mesage between this one and yours. 

Humorous
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ronners

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Re: Thread for Guys in Xiaflex Trial - Currently or Previously
« Reply #35 on: January 23, 2011, 06:56:39 AM »

Found this online which details how Xiaflex should be prepared and administered to patients suffering from Dupuytrens Contracture:

https://www.xiaflex.com/docs/pi_medguide_combo.pdf

What's relevant is that there is a paragraph 2.3 a) which states that the Xiaflex solution should be clear and not cloudy ... this might be useful info for the guys doing the trials and wondering whether or not they're on the placebo
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Tim468

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Re: Thread for Guys in Xiaflex Trial - Currently or Previously
« Reply #36 on: January 29, 2011, 03:31:12 PM »

I don't think that any study would be so obvious that you could tell at a glance which was which (at least in a double blinded test).

One study I participated in we had to add quinine to the placebo to make it taste as bitter as the real drug tasted. Same would go for cloudy/clear differences.

Tim
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52, Peyronies Disease for 30 years, upward curve and some new lesions.

ronners

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Re: Thread for Guys in Xiaflex Trial - Currently or Previously
« Reply #37 on: January 29, 2011, 06:57:37 PM »

@Tim468

I hear ya - it's just a few of the guys here have commented below on the difference in appearance and consistency of the study drug they have been given - as well as their body's reaction to the drug / placebo ... It's quite an intrusive study given the amount of injections involved so I think the info is relevant ...

I have also heard that there is likely to be upcoming Xiaflex (AA4500) trials in the UK ... I am meeting my Uro in March so will post details as and when I have them

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MikeSmith0

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Re: Thread for Guys in Xiaflex Trial - Currently or Previously
« Reply #38 on: January 30, 2011, 06:14:42 PM »

I have had zero changes... zero.  No improvement in curve... no increase in size... nothing.  At best, I am getting the placebo.  At worst - I am getting the drug but it doesn't work.  I may have scar tissue in the septum or under the corporal bodies which is not being touched by the xiaflex.  As I've said before - I have not had any side effects at all - so I am probably getting the placebo.  I won't know until a year from now.

I have noticed - possibly - that the dorsal plaque may be thinner... but this could be my imagination.  I have taken photographs under identical conditions before I began the study and also 2 weeks after my second injection cycle.  The photographs are identical.

My photographs (over the past year) have revealed that the only reason my hourglass deformity went away is because I LOST girth in the rest of my penis... not from xiaflex... but just because I am super lucky.  The hourglass area is still less malleable than the rest of the penis.  There is some kind of scar tissue running along the tunica in that area....though it is not plaque-like. I don't know if that can ever be resolved.
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George999

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Re: Thread for Guys in Xiaflex Trial - Currently or Previously
« Reply #39 on: January 30, 2011, 07:44:11 PM »

Well ... just as an outsider looking in ... it appears to me that Auxillium is pretty excited about Xiaflex for Peyronie's.  That doesn't really fit with the drug having no positive effect on some patients.  It may not fix everything back to normal, but it has got to have some positive effect in a reasonably dependable way for them to be moving forward with it at the pace they seem to be.  - George
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bigk

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Re: Thread for Guys in Xiaflex Trial - Currently or Previously
« Reply #40 on: January 30, 2011, 10:16:03 PM »

MikeSmith0:  For the sake of all of us, lets hope that you really are getting the placebo instead of the real thing.  You mentioned that it would be a full year before you find out what you got, but I was under the impression that participants would find out just as soon as the injection cycle was finished??  Or are they intent on maintaining secrecy throughout the entire study?
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MikeSmith0

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Re: Thread for Guys in Xiaflex Trial - Currently or Previously
« Reply #41 on: January 30, 2011, 11:08:38 PM »

I do not have a definite calendar on when they will reveal what group I was in.    There are 4 visits after the injections are done - and they wont reveal before those 4 visits are completed.  Believe me ill be the first to post here as soon as I know if I had the placebo or not.

4 injections with zero side effects and zero results likely means i am getting the placebo.  Collagenase is no joke of a chemical...it's a very strong substance.  To not have a side effect would be unusual.  100% of xiaflex recipients in the hand studies had side effects (see the full prescribing information on the xiaflex website).  I am pi$$ed bc this has rearranged my calendar for nearly 8 months - work time, vacation time, everything... these visits are very difficult on my schedule.  And then i dont get the real drug until 2012 and have to go through it all again.  In the meantime, i cant even use pentox or traction!

Sorry ive just been in a bad mood since i finally took the 2 pics and compared them.  it's really wearing me out already.  over a year of this at my age & how much size i lost is a sick enough joke already. 
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George999

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Re: Thread for Guys in Xiaflex Trial - Currently or Previously
« Reply #42 on: January 30, 2011, 11:53:09 PM »

The silver lining will be if it DOES work when you do get it a few years out.  The bummer would be if, after all of this, the drug turns out to be a failure when it comes to treating Peyronie's.  But I think the odds are that this thing WILL work and that in the two years you are waiting, they will really get the treatment fine tuned enough to be spectacularly effective.  At that point you should be able to combine it with Pentox, Ubiquinol, VED or whatever else you want to throw at the stuff.  But sorry they are keeping you in the dock for so long.  - George
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crashbandit

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Re: Thread for Guys in Xiaflex Trial - Currently or Previously
« Reply #43 on: January 31, 2011, 12:44:01 AM »

 And then i dont get the real drug until 2012 and have to go through it all again.  In the meantime, i cant even use pentox or traction!

What would prevent you from just using traction and pentox, even while during the trials? I know they ask you not too but how would they know other wise? I guess you wouldn't want to throw off their statistics either.
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Humorous3

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Re: Thread for Guys in Xiaflex Trial - Currently or Previously
« Reply #44 on: January 31, 2011, 01:35:31 AM »

MikeSmith0:  For the sake of all of us, lets hope that you really are getting the placebo instead of the real thing. 

Bigk,

Please clarify your post for those of us who don't understand why you hope Mike is getting the placebo. 

Humorous
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bigk

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Re: Thread for Guys in Xiaflex Trial - Currently or Previously
« Reply #45 on: January 31, 2011, 09:05:06 AM »

If it's not working for him, then it would be logical to hope that he's receiving the placebo instead of the real thing.  Just imagine how dissappointing it would be for everyone reading this thread to realize that he received the real thing and the result was zero improvement?
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ohjb1

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Re: Thread for Guys in Xiaflex Trial - Currently or Previously
« Reply #46 on: January 31, 2011, 05:46:01 PM »

I was in the prior stage of the Xiaflex trial and received the placebo, no change in my condition. 

While currently discussing curvature change on this forum,  I would like to point out that in the prior stage of the trial, approx 35% of the men who were in the Xiaflex-modeling group did not achieve the goal, i.e., a 25% improvement in the curvature. However, those who did receive Xiaflex did do better overall as a group than the the placebo group. 

Although Xiaflex does seem to be a somewhat effective treatment, it is not a miracle cure and no one know why some men improve and others do not.   
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MikeSmith0

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Re: Thread for Guys in Xiaflex Trial - Currently or Previously
« Reply #47 on: February 01, 2011, 09:04:02 PM »

And then i dont get the real drug until 2012 and have to go through it all again.  In the meantime, i cant even use pentox or traction!

What would prevent you from just using traction and pentox, even while during the trials? I know they ask you not too but how would they know other wise? I guess you wouldn't want to throw off their statistics either.

Right - they wouldn't know - the risk is that if i am getting the real drug and I combine it with traction or pentox, I could have a serious side effect.   And yeah it would screw up the stats in the study - which is a small group as it is.   They have 200 on the drug and 100 on placebo as far as I know... so small numbers of people screwing around can throw it off.

Yeah BigK - I hope at this point that I am getting the placebo too.  If these are the results from the real drug, then I am really screwed.  I think it'll still be FDA approved and it'll still be better than verapamil... but it'll just be interesting to see what insurance does.  3-4k a shot is not an easy sell...and that's just the drug fee.  The docs and facilities will charge on top of that.  If you need 4 shots... is your insurance really gonna pay 15k?  It will be a battle Royale... but I guess most of these are won by the patients in the end.  MS and CF have very expensive drugs out there...and HIV does as well - and those are for life.  I hope insurance doesn't try to screw people on this.
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MikeSmith0

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Re: Thread for Guys in Xiaflex Trial - Currently or Previously
« Reply #48 on: February 01, 2011, 09:24:41 PM »

I was in the prior stage of the Xiaflex trial and received the placebo, no change in my condition.  

While currently discussing curvature change on this forum,  I would like to point out that in the prior stage of the trial, approx 35% of the men who were in the Xiaflex-modeling group did not achieve the goal, i.e., a 25% improvement in the curvature. However, those who did receive Xiaflex did do better overall as a group than the the placebo group.  

Although Xiaflex does seem to be a somewhat effective treatment, it is not a miracle cure and no one know why some men improve and others do not.  

This was actually explained to me - in theory at least.  Basically, if your scar tissue wraps around your corpora cavernosa  and is in the septum, then collagenase is not going to be very effective.   I am talking about people who have scar tissue 360 degrees around the corpora - and is not thick enough to be injected everywhere.  They might benefit a little from dissolving the top plaque (if it dissolves) but the bottom scar tissue probably cannot be injected safely due to the urethra.  Also, hourglassing is caused by a lot of plaque in multiple locations - some of which is also too thin to inject - so i dont think they'll ever be able to  cure hourglassing w/ this.   They excluded people w/ hourglassing from the trial - so they have some issue with it... though I don't know exactly what that was.

OHJB - Are you getting the open-label product now?  Are you still in the study?  They told me if i was getting the placebo, i would ultimately get the real thing.  I would assume you had the same deal in phase 2?  

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ohjb1

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Re: Thread for Guys in Xiaflex Trial - Currently or Previously
« Reply #49 on: February 01, 2011, 09:37:58 PM »

yes mike, they have kept their word. I will be evaluated shortly and if there are no problems, I will be in the open label study, which means I will get the Xiaflex.
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