Thread for Guys in Xiaflex Trial - Currently or Previously

[GS]

All,

I log in pretty much every morning and read all the new posts.  If I know anything about any of the posts, I respond with my opinion.  If I don't, I garner whatever information I can from the posts and log in again the next morning.  If there is a particular drug or therapy mentioned, I go to whatever website I can find and research the item.

I've been doing this for close to 3 years; I've become comfortable with my VED; I've switched from COQ10 to Ubiquinol; I'm taking Vitamin D, low dose Viagra and L-arginine everyday along with my regular vitamins and prescriptions, including Pentox.

Other than getting the Xiaflex injections, I don't know what else I can do or can be done or said.  I think our Forum has been extremely valuable to me and to all the others; how else would we all know about all the new information.  But, we are talking about a disease with no known cure and there is very little that can actually be done.

I also think there is a lot of good done by talking about it and knowing we are not alone in our struggles.  As they say, "misery loves company".

These are just my initial thoughts on the efficacy of our forum and I will continue on as long as the forum is here.  I look forward to hearing others' thoughts and ideas.

GS  

[crashbandit]

All,

I log in pretty much every morning and read all the new posts.  If I know anything about any of the posts, I respond with my opinion.  If I don't, I garner whatever information I can from the posts and log in again the next morning.  If there is a particular drug or therapy mentioned, I go to whatever website I can find and research the item.

I've been doing this for close to 3 years; I've become comfortable with my VED; I've switched from COQ10 to Ubiquinol; I'm taking Vitamin D, low dose Viagra and L-arginine everyday along with my regular vitamins and prescriptions, including Pentox.

Other than getting the Xiaflex injections, I don't know what else I can do or can be done or said.  I think our Forum has been extremely valuable to me and to all the others; how else would we all know about all the new information.  But, we are talking about a disease with no known cure and there is very little that can actually be done.

I also think there is a lot of good done by talking about it and knowing we are not alone in our struggles.  As they say, "misery loves company".

These are just my initial thoughts on the efficacy of our forum and I will continue on as long as the forum is here.  I look forward to hearing others' thoughts and ideas.

GS

That sums up how I feel about using the forum very nicely. Additionally, I really like how the icons light up next to the different forum sections when a new post is posted within any the threads. Maybe some of the threads could be combined.

Such as, combining Progression of peyronies, congenital curvature or Peyronies Disease and causes of Peyronies Disease. Also, On the light side and open questions or general comments could go together. Maybe the off topic section could be in the open discussion as well. Doing these changes wouldn't help me or someone that's been around for awhile but it might with newbies and not feeling overwelmed.

[fubar]

I agree with the latest statements made here in this thread.Most importantly I agree with worriedguy. .Come back yes we need more moderators , not my job.

I would however nominate worriedguy? He is honest and true in nature.I like those attributes in a person.

Please consider him as a moderator. I think he would be a wise choice.Or maybe newguy personally I think the best choice as moderator.Have much respect for newguy, knows how to handle the challenge.

Just my two cents if you are looking for leaders in tactic moderation then newguy is your man.Will he except the challenge do not know. He definately stands out from the crowd.

Fubar

[Worried Guy]

Fubar, thanks for the compliment.  I did not mean to be rude before and have been guilty of posting off topic myself.  I believe this trial is important and I like to know as much about it as I can. That was my gripe.  

I would be interested in helping out, but have never really done anything like this.  This forum helped me so much in the early stages when I felt very down and people like yourself, Newguy, George, GS, Oldman and so many others helped me realise that my life was not over and there is light at the end of the tunnel. I want to help others now.  I've still not had this blasted disease for a year yet.

I'm also short on time at the moment with staying away for work. wifi can be very expensive in hotels so I don't have access during the week. This staying away is playing havoc with my VED routine. I'm having to share a room some weeks to keep cost down during these hard times and I don't feel comfortable taking the VED with me.  I'm not sure how much time I will have and this is one of the reasons why I've not been on here much.  

I will have a chat with comebackid to see what it entails

[fubar]

Worriedguy

Dont sweat the small stuff.Yes this whole ordeal can be tough finding time to use the ved and time just to put things in perspective. I'm having a bit of turmoil this week with it all.You are absolutely right about topic and where it should be.But it did take time to relize we can not change outcome.And brothers need to make that connection and they do not think all the time.I like to pm mostly that way I'm not desturbimg the forum.But like you said we all make that mistake.Dealing with this dish we did not order.

I'm in it a year and a half I have ups I have Downs.I have times when everything I have learned I question over and over again.I am sure the guys long standing have felt the same.speacialy when half of their post answer the same questions over and over.

This Peyronie's is definatley a hard road , newguy once told me it is our particular challenge. I can't tell you exactly how I felt about his statement but it is much better than challenging a missle to the face.

Fubar

[agent0]

when is this drug coming out! im tired of waiting. this drug seems to be the only thing thats keeping me move foward. im tired of my penis being numb, and im tired of this hard lump being in my penis. please if anybody hears when the drug is coming out please post it here.

[jw1441]

I listened to the last conference call.  They said final data from phase 3 trial will be out the beginning of the second quarter of 2012.  My guess is that the drug would be out after that if there are no insoluble problems.  

[mike67]

JW1441
Thanks for giving us this info. From what you know , when it is finally introduced, would it be Global ( US / Canada / U.K . Pacific Rim , Europe etc etc  for example) or would each country require their own Food & Drug authorities to approve it for distribution before we can all take advantage of it? That could take awhile.
Mike67

[MikeSmith0]

The FDA still has to review it...which could take a long time.  I have looked up the Dupuytren's trials to get an idea, below.  Also, I saw a youtube video of a trial participant who reported her last injection was in August of 2008 (in a phase 3 trial).  more on her below.

Here's some of the study info:

Joint I (Phase 3)
Study Start Date:   October 2007
Study Completion Date:   April 2009
Primary Completion Date:   October 2008 (Final data collection date for primary outcome measure)

Study Start Date:   December 2007
Study Completion Date:   May 2009
Primary Completion Date:   November 2008 (Final data collection date for primary outcome measure)

Cord II (Phase 3 - non US)
Study Start Date:   August 2007
Study Completion Date:   January 2009
Primary Completion Date:   September 2008 (Final data collection date for primary outcome measure)

The "primary completion date"  (when patients have their last visits) is estimated to be March of 2012 for the Peyronies Disease studies, and  for some reason the study completion date is supposed to also be in March, though it looks like it usually gets delayed based on the above.  It appears that patients were done with their trials in the fall of 2008 (which coincides with the woman in the youtube video who finished in August 2008) and the FDA approved in in Feb of 2010.  This is very fast (17 months)...and we can hope that it may be even faster given that the drug is already on the market.   Then again, with this being in unknown territory (not many approved penis injections out there) - who knows.  

So, my guess is that it will be on the market 12-18 months after March of 2012, which would be March of 2013 - September 2013.  

Then, let's see the fun begin with insurance companies covering each 4k injection + doctor's fees... easily $30-40,000 per patient.

As for the woman who recorded her trial experience... the cord came back a year later.  I don't know if this means anything that serious - it could have been another cord, or it might have returned after the NA procedure... but its not a good sign.  I don't think it will affect approval, but in 2020, we'll know if it actually works in the long term:
http://www.youtube.com/watch?v=_hJHVsl9nzw

[BSSS]

just had my second follow up visit; no injections, only an exam by the doctor. Not much to report, seems there's no change since the last report, but there were no measurements taken either.

[bummedout]

Hello all,

I haven't posted in a while, but I've had Peyronie's Disease for almost 4 years now.  I'm pretty much just waiting for the final results and an FDA approval of Xiaflex before I go back to any doctor in the hopes for a successful treatment.  I don't know if you guys have seen, but they're advertising Xiaflex like it's Viagra now for Dupuytren's Contracture.  Anyway, I was just wondering for the guys that have been through the trials, and who have had success or at least partial success, if they could give up some names of Doctors that treated them (preferably in the NY/NJ area).  I'd like to go see a doctor that has had success in doing this procedure, as I suspect that the drug itself as well as the doctor injecting it are equally important.  I myself had a doctor inject my penis with something that caused the majority of my problem now, so I'm very cautious.  My plaques seem very hard so I'm really not even sure if I'd be eligible, but speaking with a doctor who has experience, might help me figure things out.  So thanks in advance for anyone that can give me a reference.  In the mean time though, I get to disappoint the girl I'm seeing this week as I'm probably going to have to explain all this crap to her.  I wonder if she'll stick around?

bummed

[Ben]

I know a lot of women who prefer oral sex to penetration. I was aware of it before Peyronie. There is a lot to do to please a woman, touching, kissing... Give her pleasure, don't depreciate what you can do. Sex is 80 % emotionnal 20 % physical.

As for xiaflex and good uro, can't help.

[ohno]

Try Dr. Gilbert in Great Neck Long Island on Northern Blvd.

[LWillisjr]

Hey all. I've been travelling for about 3 weeks and have been off the boards during this time. So trying to catch up on all the activity.

I had my annual check with Dr. Levine yesterday. We had  conversation about the Xiaflex trials (among other things). Just wanted to share that he did mention that for the men who did respond to Xiaflex that thy have seen good improvement. But it seems that the percentage of men who do respond is smaller than expected. He also said it would take time to compile the data and that it would be the end of next year before anything conclusive.

I know many would like something more positive and sooner than this, but just wanted to share this with the group.

[MikeSmith0]

. We had  conversation about the Xiaflex trials (among other things). Just wanted to share that he did mention that for the men who did respond to Xiaflex that thy have seen good improvement. But it seems that the percentage of men who do respond is smaller than expected.

I think this is because of the highly restrictive study design.  Instead of injecting all plaque or all the way along a distributed plaque, they would only put it in one spot.  So, this won't dissolve the plaque.  When doctors are free to do things how they want - and target multiple plaques or entire plaques, results will probably be better.  I just hope this doesnt force the company to do an entirely new study...which will delay this 2 yrs.

[ThisWontWork]

I have participated in the open-label Xiaflex Phase 3 trial. I´m not convinced that this is the solution to Peyronies disease. At the screening I had a deviation of 70° to the left. Last week I had my FU2 meeting -examination. The doctor found the deviation approx 60°. The accuracy of the measurement could be questioned.

I have come to the conclusion that the drug must be modified. The "half-life" of the drug must be extended to at least 7-10 days and the capability to diffuse in the plaque-tissue must be much better.

[UK]

Thiswontwork.

Are you in the US or UK trials?
How do you know you are not in the placebo group?
Is this after all cycles of the trials?

[ThisWontWork]

Thiswontwork.

Are you in the US or UK trials?
How do you know you are not in the placebo group?
Is this after all cycles of the trials?

Read my post - I participated in the OPEN_LABEL trial - that means I got the real stuff. This is after all 4 cycles. I´m not in US or UK - I´m in another EU-country - that´s enough.
Sorry if I get you all disappointed but why should I hide the truth. Remember that this drug is not new. In the early 80-ties "Gelbard" performed some trials and after that nothing happend until now. Why? I think you all know what this about ..... $$$$$$$$$

[MikeSmith0]

Thiswontwork.

Are you in the US or UK trials?
How do you know you are not in the placebo group?
Is this after all cycles of the trials?

Read my post - I participated in the OPEN_LABEL trial - that means I got the real stuff. This is after all 4 cycles. I´m not in US or UK - I´m in another EU-country - that´s enough.
Sorry if I get you all disappointed but why should I hide the truth. Remember that this drug is not new. In the early 80-ties "Gelbard" performed some trials and after that nothing happend until now. Why? I think you all know what this about ..... $$$$$$$$$

These are the reasons why I've heard it hasn't worked that well so far:
1.  Need to use it with traction in the weeks between injection to force the scar to break apart more (similar to the snapping done in the dupuytren's patients...too dangerous to "snap" the penis in Peyronies Disease since the scar is not separate from the tendon)
2.  Plaques can be extensive and in multiple locations, but the study will only allow 1 injection in 1 location of 1 specific dose. (was this the case with you?)
3.  The body might just make more scar tissue over time (we need better drugs to suppress this)...long after the study is over
4.  Injection might not be deep enough bc doctor is worried to cause a penile fracture.  This would injure the skin quite a bit..which has happened to some people... does nothing to the plaque.  What happened during your injections?  Any skin damage / blistering?

Also, I found it interesting to hear that elastin is irrelevant...that just causes a counter-force on the erection.  You just need to dissolve the collagen to cure peyronie's.  Collagen lets the skin stretch, elastin brings it back - but you don't "need" elastin in the same way.

It's very expensive for a pharmaceutical company to take a drug to market for a non-life-threatening disease...that's partly why it took 30 years since Gelbard first started.  There is no money in it - with only a small % of men having Peyronies Disease.  It probably only became profitable after the invention of viagra - since many more men in older ages are noticing Peyronies Disease with their cured ED.  

[UK]

Not disappointed. In fact I don't believe a word you say. You are new poster turned up out of the blue so you have your own agenda. But that's just my opinion.

In fact I have heard really positive stuff about this round of trials, not just on this forum. There have been some immense improvements and some not so good. Don't worry Auxilium will know exactly why - they will even know if it was a particular doctor being better than another, from their averages being better than others across their pool of patients and learn and adapt techniques from that. A ton of data is gathered from each participant.

[ronners]

Read my post - I participated in the OPEN_LABEL trial - that means I got the real stuff. This is after all 4 cycles. I´m not in US or UK - I´m in another EU-country - that´s enough.
Sorry if I get you all disappointed but why should I hide the truth. Remember that this drug is not new. In the early 80-ties "Gelbard" performed some trials and after that nothing happend until now. Why? I think you all know what this about ..... $$$$$$$$$
[/quote]

No need to be patronising - The majority of posters here are considered and not stupid enough to blindly think that a drug in testing is going to solve all their problems. Drugs companies make drugs and sell them ... big deal ... if it's proven to be effective I'll buy it

Disappointed? Disappointed that the drug did nothing for you ... probably not as disappointed as you - glad that several other posters here have seen positive results and happy for them. Looking forward to seeing the full trial results which should be available sometime in the next 6 months  

[Humorous3]

I completed my final followup visit last month, which was at week 52.  There was an injection and curvature measurement which was 28 degrees.  This was only 2 degrees less than the last measurement (May 2011), so I won't revise my totals.  The goniometer, (a ruler that measures angles, which allows the study doctor to measure the degree of curvature in your penis), is far more subjective than objective IMO.  Therefore, I will discount the 28 degrees and stick with the earlier readings of 30 degrees.

To recap, the total was a 30 degree reduction (started at 60 - ended at 30 = 30).  So, averaging over four cycles, that's 7-8 degrees per cycle (although in reality, there was one cycle where there was no change).  

I am pleased with the reduction, of course, but would have liked to end below 15 degrees.  (Who wouldn't, right?)  

Humorous

[Humorous3]

Thiswontwork,

In your first post you stated "Last week I had my FU2 meeting -examination."  (I'm assuming "FU2" means 'followup #2'.)  Your second post said "This is after all 4 cycles."  Please clarify for those of us in the USA.   Thanks.  

Humorous

[ThisWontWork]

Thiswontwork,

In your first post you stated "Last week I had my FU2 meeting -examination."  (I'm assuming "FU2" means 'followup #2'.)  Your second post said "This is after all 4 cycles."  Please clarify for those of us in the USA.   Thanks.  

Humorous

2 injections separated by at least 24 hours but not more than 72 hours, repeated after 42 days (± 5 days) for up to 4 treatment cycles (ie, total of up to 8 injections per subject)

add 3W. in front of > clinicaltrials.gov/ct2/show/NCT01243411?term=Peyronie%E2%80%99s&rank=1

look under    Assigned Interventions

I hope I made it clear the meaning of "cycles".

[veryworriedguyuk]

Do you have any information of any other current trails taking place within the UK?

[MikeSmith0]

To recap, the total was a 30 degree reduction (started at 60 - ended at 30 = 30).  So, averaging over four cycles, that's 7-8 degrees per cycle (although in reality, there was one cycle where there was no change).  

Did you have any size increase in length or girth?  Was this an issue when Peyronies Disease progressed for you?  Or was size never a problem?  Peyronies Disease has caused worse size issues than curve issues for me...so any insight would be great.  Thank you.

[MUSICMAN]

This is a test to see if my posts go through. I have had some computer problems. It seems that some are a little disapointed in the "Xiaflex" results. Have you read my story under the "Improvement" board under the heading "Suscess"???    Musicman

[saramon]

Hi Everyone

Have just completed my penultimate followup prior to Christmas which involved a measurement, I'll never get used to those injections.

Just to recap from my previous post back in September where I reported the following changes over the course of the trial:

Cycle 1:   8° change, no change in length
Cycle 2:   2° change, no change in length
Cycle 3: 10° change, no change in length  
Cycle 4:   0° change, no change in length

This time the Doc measured a further 2° improvement and mentioned that he was seeing ongoing improvement in a number of other patients in the followup period.

The measurement process is not a precise science but hopefully he has enough practice to be consistent.

He also reiterated that he could no longer detect any plaque which he seemed to think was significant.

So overall improvement now at 22° leaving me with a 28° curvature.

One more follow up in 6 weeks so will report the conclusion of my experience after that.

Thanks
S.

[Kempenstein]

Hope someone can help and advise.

I contacted David Ralph's clinic in Harley Street at the end of September. I was absolutely over the moon when I received a telephone call from one of the nurses almost straight away saying that it was my lucky day as there were a few spaces that had become available on a trial which was to begin the first or second week of October. She said she would get back to be with a date and time for a screening appointment.

I heard nothing so emailed her. She called me to say the trial dates had been delayed a bit but would contact me with an appointment very soon.

A month went by and I contacted her by email for an update.

I received an email asking me to answer five screening questions which I replied to with answers.

I heard nothing and emailed again to check that they had received my answers. They said they had. This was early November.

Since then I have heard absolutely nothing. I am frustrated because time is ticking by and am scared of calcification. Also having a demo of a VED pump at my hospital, I was advised to await using it until I had this trial as they thought Dr Ralph would not like me having alternative treatment.

Does anyone here know what is going on? Any advice how I should proceed?

[nycsurfer]

Hey there. My piece of not-so-good news is I just got through with the Xiaflex trial last month and I came out looking even WORSE (!) than when I went in both with the hourglassing and curvature.  Had high hopes and now not too sure WHAT to do...

[ohjb1]

to nycsurfer.  where you in the clinical trial where you may have received the placebo?  

My impression from reading the informed consent is that Auxillium's position is that any significant or long term adverse events are not due to the drug, but from improper administration of the drug.  

unfortunately, I also had a negative experience with the clinical trial.    

[Humorous3]

To recap, the total was a 30 degree reduction (started at 60 - ended at 30 = 30).  So, averaging over four cycles, that's 7-8 degrees per cycle (although in reality, there was one cycle where there was no change).  

Did you have any size increase in length or girth?  Was this an issue when Peyronies Disease progressed for you?  Or was size never a problem?  Peyronies Disease has caused worse size issues than curve issues for me...so any insight would be great.  Thank you.

Mike,

I never measured girth, nor did the study, so I can't answer concerning that.  I did have a 4.5-5.0 cm increase in length.  As the curve decreased, the length increased, which I think was a natural process.

Humorous

[james1947]

Humorous
Thank you for the encouraging answer. 4.5 to 5 cm is what I have lost to Peyronie's
James

[veryworriedguyuk]

You say that you have come off worse due to the trial. Could you explain your before and after situation and what process you went through?

[ComeBacKid]

I've lost size as well from this mess.  Before my foreskin only covered half the head of my penis, I lost so much size that it covered it completely.  Now that I'm on pentox my penis has regained size, straightened out, I have more "full" erections, and better erections, and my penis overall is softer, this stuff really works, I'd advise people to try it before trying other permanent stuff.  My penis lost a lot of girth, and the pentox has restored this, to the point that it looks pumped all the time, like pumped with a VED, except I'm not using one currently.  I notice with the pentox is makes it hard to go to the bathroom right away, and reaching orgasm is more challening, although the feeling is slightly numbed, but when you quit pentox it goes away.  I'm going to stay on this stuff, and reload with another prescription, I'm getting ready to go from two pills a day to three, I've taken three a day a few times, but then I feel hot and sweaty all the time, you can tell the side effects really go up from 2-3 pills, I may push it to 4 a day at some point , but I haven't decided.  Either way, the pentox has restored my size, this drug is awesome!

Comebackid

[james1947]

ComeBacKid
I would like to ask you: how long time on Pentox until some improvement can be seen.
James

[infiniti]

Hi guys,
Is pentox readily available via a UK GP ?

[ComeBacKid]

Almost immediately I had better "fuller" erections, and a bigger flaccid hang.  The softening of the penis, takes time, at least two months before you start to notice that, I imagine getting rid of the plaque, or doing whatever it is doing takes time on the drug.  The side effects start immediately unfortunately, but they aren't so bad you want to quit taking it, but you do notice them.

Comebackid

[restore]

Comebackid, I can attest to the same results you have described for myself on pentox.  I can't even feel the plaque lump anymore in my flaccid penis.  My hourglass has completely gone away, and my girth has returned.  There is still a slight upward turn in my erection, but not a problem.  At the base of a hard erection, there are two small noticeable "impressions".  They are are two lines along the shaft that are about 2mm long, side by side.  I hope they too will eventually go away.  I think that is the only thing that is keeping me from being straight out as I used to be before peyronies.  

My pain has gone away, but have to say I still have some pain when during missionary intercourse my wife begins to move her pelvic area forwards and backwards when she approaches climax.  It really helps her be fulfilled and I do not begruge her that.  She is worried she shouldn't do it, because it might be doing harm to me.  But, I just immediately after sex, go into my bathroom and take about 3 Advils to hopefully ward off anymore damage.

My only treatment is pentox 3 times a day, and low-dose Cialis 2mg daily.

[james1947]

Combackid and restore
Thank you for the input, very encouraging
James

[ComeBacKid]

Restore,

Do you notice like I a different kind of pain.  The peyronies pain is like an ache, I had that for years.  Now that I'm on pentox a second time I feel a sharp pinpoint pain, but it coincides with my peyronies getting better.  I only feel it when on the pentox and felt it before.  Its random and not daily.  I believe it is the plaque breaking down, or changing, or something.  The "worsening" peyronies pain is more of a dull ache, I had that before I went on pentox the first time and then it stopped when I started the pentox.  Hell, I don't know whats going on but my condition is improving, so thats good enough for me!  I got bottles of this stuff, I'm going to "take it like candy," as Iceman would say!

Comebackid

[restore]

Comebackid,

 yes, your experience sounds like mine.  

I wonder if the pentox will be a maintenance thing from now on.  That is, I don't want to feel like I beat this thing, and then it return again at 55, or 60, or 70.  

If it is a maintenance procress from now on, I'm okay with that.  It's inexpensive and relatively safe.

[james1947]

Could participants on the Xiaflex Trial give some input to the forum on they progress, good or bad?
Thanks
James

[Worried Guy]

Yeah the Xiaflex trial seems to have gone very quiet!?  Any news guys?  The Trial in UCHL London must have finished.  There were a few guys on here participating!

[MUSICMAN]

I have finsihed my Xiaflex Trial III as I am sure most other in that phase have. You can read my story under "Improvement", "Suscess" Musicman. I wish more would report how they did. I did hear that there will be some kind of trial about how long the drug remains in a persons body, but don't know much about that.  I do feel that the drug will come to market but have no idea when that will be.

[james1947]

Musicman
Thank you for the post. Your results are amazing. Hope the Xiaflex will be available soon and not cost too much.
James

[bummedout]

Musicman,

Great to hear about your success!!

Who was the doctor that injected you?

[nycsurfer]

i completed the xiaflex trial last month and the condition did not improve. Might have even gotten worse.  Wish i had better news to report.  Thanks guys.

[james1947]

After reading again carefully the topic I begin to believe and hope I am right that the successes or failures cases in the Xiaflex trial are connected to how the Xiaflex was injected and the stretching done.
I hope we will get more input from friends that participated in the trials, not too many are active on the forum.
Have somebody knowledge about when the trial results will be released?
James

[ThisWontWork]

After reading again carefully the topic I begin to believe and hope I am right that the successes or failures cases in the Xiaflex trial are connected to how the Xiaflex was injected and the stretching done.
I hope we will get more input from friends that participated in the trials, not too many are active on the forum.
Have somebody knowledge about when the trial results will be released?
James

Jan 2013