Thread for Guys in Xiaflex Trial - Currently or Previously

[taurian]

Hmm, good question...I didn't register how this was done, I was looking at the ceiling at the time!  The Dr used a special metal instrument and I think it was applied to the top angle.  he certainly didn't carry out any calculation, unless he did it mentally.  The dorsal angle is sharper than the ventral angle, and probably easier to measure.  I'll pay more attention next time (next month) and will ask what the protocol is..

[/quote]

I have a question about how they measure the angle.  I have a plaque located on the top, and a digital photograph taken from the side shows the angle to be different on the top (concave) side vs. the bottom (convex) side.  The angle on the top side is always the largest of the two, and conversely, the angle on the bottom is the smallest.  It would seem reasonable to simply average the top and bottom angles, but I'm wondering if the doctors are only using one of the two angle measurements?
[/quote]

[Humorous3]

I have a question about how they measure the angle.  I have a plaque located on the top, and a digital photograph taken from the side shows the angle to be different on the top (concave) side vs. the bottom (convex) side.  The angle on the top side is always the largest of the two, and conversely, the angle on the bottom is the smallest.  It would seem reasonable to simply average the top and bottom angles, but I'm wondering if the doctors are only using one of the two angle measurements?

bigk,

The following quote from the study consent form may or may not fully answer your question.

"The study doctor will measure the severity of the curvature of your penis using a small device placed on the surface of the penis, called a goniometer (a ruler that measures angles), which allows the study doctor to measure the degree of curvature in your penis."  Then it goes on to mention injecting a drug to create an erection.  

From my observation, it is placed on the "inside" of the angle between the top and middle of the penis.  This would seem to "average" the angle.  Another thing is they don't have to induce a "full" erection to get an accurate measurement.  This benefits the patient as it lessens the time it takes to get flaccid again.  The doctor must wait until then to inject the Xiaflex.  

Humorous

[BSSS]

I have a question about how they measure the angle.  I have a plaque located on the top, and a digital photograph taken from the side shows the angle to be different on the top (concave) side vs. the bottom (convex) side.  The angle on the top side is always the largest of the two, and conversely, the angle on the bottom is the smallest.  It would seem reasonable to simply average the top and bottom angles, but I'm wondering if the doctors are only using one of the two angle measurements?

bigk,

The following quote from the study consent form may or may not fully answer your question.

"The study doctor will measure the severity of the curvature of your penis using a small device placed on the surface of the penis, called a goniometer (a ruler that measures angles), which allows the study doctor to measure the degree of curvature in your penis."  Then it goes on to mention injecting a drug to create an erection.  

From my observation, it is placed on the "inside" of the angle between the top and middle of the penis.  This would seem to "average" the angle.  Another thing is they don't have to induce a "full" erection to get an accurate measurement.  This benefits the patient as it lessens the time it takes to get flaccid again.  The doctor must wait until then to inject the Xiaflex.  

Humorous

Humorous,

Why do you think the dr. has to inject when flacid?  Any idea?  What would be the problem with injecting while erect?

BSSS  

[Ben]

BSSS i think it easier to target the plaque on a flacid penis (maybe there is another reason).

Does a Xiaflex trial volonteer with curve enhancement seen improvement in sensation ? with Ed quality ? with lenght and girth ?

By the way I think that the different result may be linked to the % of medecine involved. When a chemical lab test a pill, they use different dosage to evaluate the minimal dose to have an effect and the maximal dose after which unwanted effects are too frequent.

So some men may receive Xiaflex without any improvement while other men on Xiaflex may have huge swelling and bruising.
- I wish to thanks every man involved in those trials, may your efforts be rewarded-

[Humorous3]

Humorous,

Why do you think the dr. has to inject when flacid?  Any idea?  What would be the problem with injecting while erect?

BSSS  

BSSS,

I believe it's because the Dr. has to feel the plaque and get the location before injecting.  I think it would be difficult to find the plaque when erect.  Also, and this is just a guess, I think there would be a greater internal bleeding problem if he injected while erect.  

Humorous

[Chopsuey]

Hi Everyone,

Just finished my cycle three evaluations and there has been no improvement. I'm convinced that I am getting the placebo. I haven't seen any bruising or swelling and haven't had any improvement. Just received my 2 forth cycle injections, which seemed to hurt more than usual. Maybe because I think they're the placebo and aren't doing me any good? I'm grateful to be in the study, but it's difficult to go through when you're part of the 1/3 placebo group and you know you have to do the whole thing again once you finish phase three. If it's definitely the placebo, I won't see the real drug until the beginning of next year.  

[bigk]

I really sucks that you're probably getting the placebo, but considering that you have had zero improvement, I suppose it would be in all of our best interest if you really are getting the placebo.  Thanks for the update, and let's hope that the future will be far better than the present.

[Worried Guy]

The guys on the UK study seem to have some pretty bad swelling and bruising.  It is a shame if you are getting the placebo but at least you will know better after the study what the likely outcome of your treatment will be.  

[Chopsuey]

If I was only taking a pill or putting on a topical cream, it wouldn't be so bad. But damn, it's a lot of injections. Between the blood work, the injections for getting you up then making you go down, then the meds...then you find out it's just a placebo. I'll be ok...I was just really hoping this was all gonna work out this year.

[MikeSmith0]

I won't see the real drug until the beginning of next year.

I don't think we will see the real drug until the summer - at the earliest.  They won't be done with the regular Phase 3 study until March of 2012.  Then they have to analyze the data, re-enroll all the study sites again, ship out all the products, etc... though the learning curve is passed from phase 3, so maybe it won't take as long.  It's hard to know - but I don't think it will be before 1 year from now.  It's just insane that we could've basically been done now... but we won't even start for a year.  I can't believe I got Peyronies Disease to begin with and ended up in the placebo group.  <1% chance of both happening to the same person... amazing.

[BrooksBro]

Glass half-empty or half-full guys?  Some of us didn't even make it into the study.  We are sitting on the sidelines, watching and waiting, sometimes impatiently.

I won't see the real drug until the beginning of next year.

It's just insane that we could've basically been done now... but we won't even start for a year.  I can't believe I got Peyronies Disease to begin with and ended up in the placebo group.  <1% chance of both happening to the same person... amazing.

[BSSS]

I won't see the real drug until the beginning of next year.

I don't think we will see the real drug until the summer - at the earliest.  They won't be done with the regular Phase 3 study until March of 2012.  Then they have to analyze the data, re-enroll all the study sites again, ship out all the products, etc... though the learning curve is passed from phase 3, so maybe it won't take as long.  It's hard to know - but I don't think it will be before 1 year from now.  It's just insane that we could've basically been done now... but we won't even start for a year.  I can't believe I got Peyronies Disease to begin with and ended up in the placebo group.  <1% chance of both happening to the same person... amazing.

Don't want to sound like a broken record, but are you sure there will be another open label study after 03/2012?  I know phase III officially ends then, but recruitment has already begun for an open label study, and it looks to possibly be a sub-segment of phase III from what I saw.

[MikeSmith0]

Don't want to sound like a broken record, but are you sure there will be another open label study after 03/2012?  I know phase III officially ends then, but recruitment has already begun for an open label study, and it looks to possibly be a sub-segment of phase III from what I saw.

Recruitment for an open label study for people who had the placebo in Phase 2 was going on for a while.  It is considered its own "study" for FDA purposes and you will see it on clinicaltrials.gov.  That's not related to phase 3.  People in phase 3 are not finished yet.   The last patients were injected for the first time in March.  It is a 1 year study. Therefore, the study ends in March of 2012.   Participants in phase 3 have been told that they will get the real drug after the study ends which will be sometime after March of 2012.  

[MikeSmith0]

Glass half-empty or half-full guys?  Some of us didn't even make it into the study.  We are sitting on the sidelines, watching and waiting, sometimes impatiently.

I would be frustrated to be in your position too.

The main difference is that I can't be on any treatments right now (for a full year + then for the open label study - you cannot be on anything).  No traction, pentox, etc... so we are all giving this all up for 2 years, roughly.  I personally have only gotten worse since I stopped pentox and traction.  I have had no reaction to the injected substance in the study (no swelling) and no change in curve.  Also, its like 14 penile injections and a total of 17 doctor visits - for nothing other than the promise that in a year from today (most likely June) - I can START to get the real drug.  The FDA will probably have it on the open market shortly after that anyway.  With good enough insurance, it wouldn't be that expensive & the doctors can target more areas once it is on the market - and you can use traction and pentox.  In the trial, they can only target 1 area (one plaque) - and you can't take any drugs or use traction.  

So, the placebo group lost more (time, hope, painful penile injections, disease progression) than people are giving them credit for.  

Rather than seeing a positive outcome by now, we've seen nothing and will not see a positive outcome until December of 2012.  What do I do between now and December of 2012?  I can't do anything but watch it get worse.  I could take pentox and traction, etc...and they'd never know, in theory - but then if I happen to go under 30 degrees from all that, I'm excluded from the open label trial anyway...or I could just drop out entirely now.  It's just a bad situation.  I wouldn't care if I had a placebo pill - but I am getting like 14 shots in my dick... and some people get more if their erection doesn't go down or if they want to numb the area more ,etc.  And it's been discussed on other threads that needles in the tunica are not the safest thing...unless they actually contain some kind of medicine.

[Worried Guy]

It is really crap for you mike.  When you do get the real thing that should help and once it is certified the insurance can pay for your other plaques to finish off the job.  It will go quicker than you think.  It seems like a long way off now but it will soon come around.  

[Cisco Kid]

Does anyone know Doctors in the San Francisco Bay Area that are doing these xiaflex trials?  I talked to my uro and he said that since xiaflex is FDA approved for DC that I might find a doc that would use it for Peyronies off lable.  Anyone working this?

[Worried Guy]

Not sure about that!  I can imagine it costing a lot of money?

[MikeSmith0]

Does anyone know Doctors in the San Francisco Bay Area that are doing these xiaflex trials?  I talked to my uro and he said that since xiaflex is FDA approved for DC that I might find a doc that would use it for Peyronies off lable.  Anyone working this?

The trial locations are on clinicaltrials.gov.  They are finished enrolling people now since they reached their capacity.  Urologists will not be able to purchase it for you since the distribution channel for the drug is controlled.  It would also cost 5k per cycle, roughly, if you were able to buy it based on what OldMan's doc told him about purchasing it for Duputreyn's...it is not reimbursable by insurance since it is not FDA approved for peyronie's.  

[ronners]

It sucks sitting around waiting for this drug ... I can imagine it also sucks if you're in the trials and getting the placebo ... but we are where we are ... I might be way off, but my understanding is that once phase 3 trials are over there are no further trials planned - placebo participants just get the real drug as and when and the results are released to the relevant authorities for consideration.

There are open label trials going on at the moment for individuals in the EU (UK included) and I think Australia and some in the US - This will be finished before or at the same time as the closed label study (i.e. March 2012) ...

In all honesty Mike, if I was you, I would resume your previous treatments for the time being. I think concerns about dropping below 30% curvature are unfounded and you will get the drug anyhow - and even if Auxilium refused, as you've stated, if the drug works it will be on the open market a short while later ... clearly doing something will make you feel better emotionally at least ...

On a different topic, back to pricing - Xiapex has just been launched in the UK for Dupuytrens:

http://www.pjonline.com/news/new_dupuytren's_contracture_therapy

according to this article it will be sold for £650 per vial ($1050) ... It's not clear to me if this is the price to the consumer but it does indicate that there could be different pricing structures between Auxilium and Pfizer for this drug given the cost of the drug to physicians in the US is $3250 per vial for dupuytrens currently.

That should give people hope that we will see an affordable and realistic pricing structure for this treatment depending on the country and healthcare systems in place as opposed to shelling out $50k - $100k as some on this thread have suggested.

Lastly, in case people aren't aware there are some interesting reports coming back from guys in the open label UK trial about improvements / side effects / concerns etc. Worth a read ...

[MikeSmith0]

Lastly, in case people aren't aware there are some interesting reports coming back from guys in the open label UK trial about improvements / side effects / concerns etc. Worth a read ...

Really, where are these posted?  

The pricing in the UK will probably be cheaper...like Canada... the government buying / negotiation power works in your favor.  Though that is the extent of my international health system knowledge.

Are the open label trials in the EU and UK from phase 2 placebo patients?  I don't understand why anyone would sign up for a randomized trial when there is an open label one available.  In the USA, via clinicaltrials.gov, it's just very clear you cannot sign up for the open label trial (running now) w/o having been in phase 2.

Update: oh i see no placebo is being given in the UK...well i am forced to conclude the brutish have more common sense then?  In the USA for some reason, the FDA believes that we can think the plaque away.  That is truly amazing that one country's standards are in line with rational (and ethical) reasoning... and the USA is just typical FDA red tape nonsense...that a placebo is necessary even though there is no chance it will do anything based on 100s of years of Peyronies Disease research.
 http://www.peyronies-disease.co.uk/2011/02/xiaflex.html    

[Worried Guy]

https://www.peyroniesforum.net/index.php/topic,1558.msg30734.html#msg30734

[MikeSmith0]

https://www.peyroniesforum.net/index.php/topic,1558.msg30734.html#msg30734

wow - that was scary to read, though it wasn't that different from my verapamil experience w/ the pain, swelling, and brusing.  The doc doesn't pull that hard on the penis during modeling - in my case - he said there's a risk of hurting the tunica.  Also the informed consent even says the modeling is "gently" done.    

Well, i am definitely getting the placebo...after reading that reaction description.  

I will be interested to read their updates for sure.

[BSSS]

Don't want to sound like a broken record, but are you sure there will be another open label study after 03/2012?  I know phase III officially ends then, but recruitment has already begun for an open label study, and it looks to possibly be a sub-segment of phase III from what I saw.

Recruitment for an open label study for people who had the placebo in Phase 2 was going on for a while.  It is considered its own "study" for FDA purposes and you will see it on clinicaltrials.gov.  That's not related to phase 3.  People in phase 3 are not finished yet.   The last patients were injected for the first time in March.  It is a 1 year study. Therefore, the study ends in March of 2012.   Participants in phase 3 have been told that they will get the real drug after the study ends which will be sometime after March of 2012.  

well perhaps this link will explain it since I evidently didn't do a well enough job?  I hope that there are more studies to follow, but can't help but wonder if Auxillium has changed its mind re: open label study? The open label study explained here clearly shows it's part of phase III.  I hope that there will be another for those who are counting on it.

http://clinicaltrials.gov/ct2/show/NCT01243411?term=peyronie%27s&rank=1

[MikeSmith0]

well perhaps this link will explain it since I evidently didn't do a well enough job?  I hope that there are more studies to follow, but can't help but wonder if Auxillium has changed its mind re: open label study? The open label study explained here clearly shows it's part of phase III.  I hope that there will be another for those who are counting on it.

http://clinicaltrials.gov/ct2/show/NCT01243411?term=peyronie%27s&rank=1

This is very confusing...

"Study Start Date:   November 2010"

Why does it say that?  that was the start date of the people in phase 2 i believe...i dont see why theyd offer an open label study alongside a placebo controlled study -- someone would have to call one of these places to find out who is enrolling in these studies.  its very confusing online.

"Subjects who receive placebo in a previous Auxilium-sponsored study may enroll in this study provided they continue to meet the eligibility requirements."

but it doesn't say "only subjects who received a placebo" .... strange.

[bigk]

This is very confusing...

"Study Start Date:   November 2010"

Why does it say that?  that was the start date of the people in phase 2 i believe...i dont see why theyd offer an open label study alongside a placebo controlled study -- someone would have to call one of these places to find out who is enrolling in these studies.  its very confusing online.

"Subjects who receive placebo in a previous Auxilium-sponsored study may enroll in this study provided they continue to meet the eligibility requirements."

but it doesn't say "only subjects who received a placebo" .... strange.

I recall reading that the participants in the phase III study are "eligible for any subsequent open label studies", but it is not a promise that absolutly no matter what the placebo group will eventually get the real thing. It might not be a bad idea to talk to your urologist and ask that he find out whether or not there really will be a follow-on open label study that you can participate in.  I would make it clear to the urologist that you intend to drop out of the study if there is no promise of a follow-on open label study.  If there is no promise that you will eventually be able to enroll in an open label study, then there would be no reason what-so-ever for you to complete the study.  If they want good data with valid results for the placebo group, then they need to step up and promise that you will eventually get the real thing.  And if they are unwilling to do that, then if it were me, I would be tempted to wave the middle finger and say "I'm done"!

[MikeSmith0]

I recall reading that the participants in the phase III study are "eligible for any subsequent open label studies", but it is not a promise that absolutly no matter what the placebo group will eventually get the real thing. It might not be a bad idea to talk to your urologist and ask that he find out whether or not there really will be a follow-on open label study that you can participate in.  I would make it clear to the urologist that you intend to drop out of the study if there is no promise of a follow-on open label study.  If there is no promise that you will eventually be able to enroll in an open label study, then there would be no reason what-so-ever for you to complete the study.  If they want good data with valid results for the placebo group, then they need to step up and promise that you will eventually get the real thing.  And if they are unwilling to do that, then if it were me, I would be tempted to wave the middle finger and say "I'm done"!

I agree. It's not right at all - but they set it up so that if you no longer meet the criteria (develop an isolated hourglass, are not in a relationship, curve under 30 degrees, stop responding to trimix, develop calcifications)  they will not let you in.  Zero guarantee...despite the fact that all their freaking needles may cause more calcifications - and you spent 17 days of your life having your penis manipulated & placebo injected into it.  They could care less... it's cheaper for them if you don't qualify for the open label drug study.  They can also pull the plug on the whole thing if the results are bad.  Patents let some drug companies be total pieces of sh*t.   There is zero reason they should exclude anyone (unless there is a danger from xiaflex in a particular peron's case) from the open label study if they wasted a year of their time in the placebo...but they will, I am sure.  

The urologist at the study center has no power in the situation.  One person complaining to 1 doctor will do nothing except potentially get the patient excluded for being difficult.  It's the classic "one person can't step on the tracks and stop a train" problem.  The study has already been designed with great effort between AUX and the FDA...and now it's on the tracks.. going along.  

To AUX's defense though, the reason that single people and gay people were excluded was bc the FDA made them do it.  This was not their idea.  The FDA really wants details about vaginal sex...I have no idea why.  If any other part of your body were deformed, I don't see why you need to put it in a vagina to validate that it is doing better.  (ok sorry i have a sick sense of humor rarely displayed here) but seriously... if you had some skin disease that required collagenase...and it was just a "cosmetic" disease really...is the FDA not going to approve it?  Any of the rosacea or acne drugs that went through the FDA were purely for cosmetic purposes and insurance pays on all of these... so it baffles me that you have to have a regular vaginal sex partner to be in the study.  Who knows what will be a year from now...especially with the sh*t peyronie's creates for one's sex life and relationship.  Maybe I'll hire a hooker if things go south so I can stay in the study.  

[ronners]

Why are you guy's assuming that Xiaflex for ex-placebo patients will have to be administered in a open label trial environment?? I can't recall reading or seeing this anywhere ... It seems pretty clear that the trials (open and closed label) have all started and will all finish in March 2012 ... If you are concerned about whether or not you will recieve Xiaflex as a placebo patient after March 2012 then I would suggest a simple email to the Auxilium contacts on the Trial's website might clear things up ... I would certainly be inclined to do this before pulling out of a trial ...

[bigk]

Why are you guy's assuming that Xiaflex for ex-placebo patients will have to be administered in a open label trial environment?? I can't recall reading or seeing this anywhere ... It seems pretty clear that the trials (open and closed label) have all started and will all finish in March 2012 ... If you are concerned about whether or not you will recieve Xiaflex as a placebo patient after March 2012 then I would suggest a simple email to the Auxilium contacts on the Trial's website might clear things up ... I would certainly be inclined to do this before pulling out of a trial ...

I agree with your suggestion.

[MikeSmith0]

Why are you guy's assuming that Xiaflex for ex-placebo patients will have to be administered in a open label trial environment?? I can't recall reading or seeing this anywhere ... It seems pretty clear that the trials (open and closed label) have all started and will all finish in March 2012 ... If you are concerned about whether or not you will recieve Xiaflex as a placebo patient after March 2012 then I would suggest a simple email to the Auxilium contacts on the Trial's website might clear things up ... I would certainly be inclined to do this before pulling out of a trial ...

It is written on the paper based informed consent... "if you receive a placebo in this study, you may be eligible to receive AA4500 in a follow up study after the completion of this study" is the exact wording.

This doesn't mean the FDA will be waiting for this data.  They might be - but it's not clear.  They can probably go ahead and submit the FDA application all their data from March 2012 and the official end of phase 3... however, the additional 100~ guys who get the placebo will also ultimately go into the prescribing information in the end (65% experienced swelling, etc...)   Also, it is again a "study" because the FDA will not have approved it yet... they can take a long time to approve things - and they can't just say it's a "freebie drug we're gonna give out" ... they have to do it under the provisions of a study (informed consent, not FDA approved, investigational drug, no promise of anything, etc..)

Also, the people who got the placebo in phase 2 had to re-qualify for the open label drug.  They will not give it to anyone who doesn't meet the criteria.  Maybe it'll be different for post-phase 3 open-label... who knows.  

The phase 3 placebo guys are by far the most screwed group...they just opened an open label study of 300 men with NO placebo...concluding in 36 weeks (which is 3-4 months shorter than the placebo group).  So, we have to waste more time, we don't get the real drug, and we MAY get the real drug in a year.  I realize not qualifying at all is unfortunate but I am just comparing the people in the different studies.

[ronners]

t is written on the paper based informed consent... "if you receive a placebo in this study, you may be eligible to receive AA4500 in a follow up study after the completion of this study" is the exact wording.

Ah ... fair! Thanks for clarifying - From reading previous posts it seemed that placebo participants were guaranteed the study drug post trial. Realistically if the drug works the drug company will want to bring it to market ASAP to generate revenue. I think we can all agree on that. This would not involve waiting another 6-12 months for another open label study to be completed.

Also, it is again a "study" because the FDA will not have approved it yet... they can take a long time to approve things - and they can't just say it's a "freebie drug we're gonna give out" ... they have to do it under the provisions of a study (informed consent, not FDA approved, investigational drug, no promise of anything, etc..)

Do you know these things for sure? If I was you (i.e. convinced I was in Placebo group) I would be doing what I could to ascertain whether or not I would receive the xiaflex post trial. This would involve speaking to my urologist and the contacts at Auxilium. At least that you should give you some basis to make a decision to continue with the trial.

The phase 3 placebo guys are by far the most screwed group...they just opened an open label study of 300 men with NO placebo...concluding in 36 weeks (which is 3-4 months shorter than the placebo group).  So, we have to waste more time, we don't get the real drug, and we MAY get the real drug in a year.  I realize not qualifying at all is unfortunate but I am just comparing the people in the different studies.

Mike, at the moment we are all screwed here ... That is why we go onto a website to post stories about our bent willies! There are approximately 80,000 men in the UK with Peyronie's ... I would hazard a guess that alot of those people are as unhappy about their condition as you and I. However, only 10 have been allowed onto the open label London trial ... So at the moment you are certainly not on your own in missing out on a drug that might offer some relief. However, it is possible that you will have access to Xiaflex a lot sooner than the rest of us .. You should look at the bigger picture and appreciate that we are all screaming out for a solution here!

[MikeSmith0]

If I was you (i.e. convinced I was in Placebo group) I would be doing what I could to ascertain whether or not I would receive the xiaflex post trial. This would involve speaking to my urologist and the contacts at Auxilium. At least that you should give you some basis to make a decision to continue with the trial.

I already asked everyone.  They won't say anything concretely at this point.  It's a year away.  My doctor does not know the details and AUX is not providing details yet - either because they don't know or because they were told not to provide them.  What is really amazing is that the open label trial application was processed in november of 2010 (per the website) but when I asked an AUX representative on the phone if there would ever be an open label trial, her response was "no - the FDA requires a placebo group".  Either she lied, didn't understand the question, or didn't know... but even aside from that, the fact that the timing of the open label trial ended up right after everyone in the placebo study enrolled is more than convenient.  I dont think honesty is high on the priority list there...and so I would not believe anything they say anyway.  Until I am sitting in a room w/ a syringe of xiaflex, I will not believe that I am getting it.  If I don't respond well to trimix in a year, have more calcification, develop an hourlglass, or whatever else... I am 99% sure they will exclude me from the study.   I can't confirm this concern because they won't confirm it.  They just have not published the exclusion criteria yet.   However, they already did this with the phase 2 placebo subjects so I don't see why they'd change it now.  With that group, it was a 36 week study (with the standard exclusion criteria) so at least I won't have to go through another full year...and will be done at the end of 2012 if all goes well.  Given my luck this far, I don't foresee all going well.

[BSSS]

well all these reasons/concerns about placebo vs open label, etc. are why I posted what I did.  I'd rather be informed about what's going on and not be given some empty promise about getting the real thing. My second round of injections are coming up in the not too distant future and if I feel afterwards as if I am receiving the placebo, I think I'll have to have some definitive answers re: open label to continue.

For those of you not enrolled yet, it looks like one of the doctors participating and currently recruiting in the open label part of phase III is the well known Dr. Levine.

Sign up while you can!!

[MikeSmith0]

I'd rather be informed about what's going on and not be given some empty promise about getting the real thing. My second round of injections are coming up in the not too distant future and if I feel afterwards as if I am receiving the placebo, I think I'll have to have some definitive answers re: open label to continue.

Great - please post what you find out if you can get any information.

If you had no reaction to your first cycle, you're getting the placebo.  It's 100% guaranteed to create swelling...as evidenced by xiaflex for duputreyn's prescribing information  (100% have swelling) and by the UK open label guys...all had swelling - if not to the first shot than at least to the 2nd.  

I think the urologists & nurses are counseled by Auxilium to deal with patients who suspect they are in the placebo group - to keep repeating the same line "well some people have swelling and some don't - and it doesn't even correlate to their curve reduction" verbatim.  When something is a script, it becomes obvious (we're not dealing with trained actors).  They know who the placebo patients are by reactions from cycle 2.  "Double blind" would have to be "double blind-folded" for anyone to believe that the doctors don't know 100% who is getting placebo.  They're not told by AUX but they know if someone penis doubles in size and turns red from swelling - that's not a placebo patient.  Someone who has no reaction & never has curve reduction - well, let's take a wild guess.

[saramon]

Hi Chaps

I have been through the cycle of injections for the trial in Australia (Sydney) and now the first followup to check progress.

My results show an improvement in the bend by 8 degrees (with a starting angle of 50 degrees) so assume I am not getting the placebo.

No increase in length reported yet.

Start 2nd round of injections this week.

Thanks
Saramon

[newguy]

It's heartening to see positive results from people all over the world (UK, US, Australis etc). Of course all treatment types have their benefits, but to see improvements so fast really is very positive. Maybe future rounds of treatment will result in the curvature becoming almost unnoticable? Either that or new multi pronged treatment regimens will start to appear (xiaflex then ved/traction, with oral treatments throughout the whole process etc). Exciting times ahead. Keep posting guys!

[bigk]

Question for the guys in the study:  How often and for how many weeks to you perform modeling after the 2nd injection?

[Humorous3]

Hi Chaps

I have been through the cycle of injections for the trial in Australia (Sydney) and now the first followup to check progress.

My results show an improvement in the bend by 8 degrees (with a starting angle of 50 degrees) so assume I am not getting the placebo.

No increase in length reported yet.

Start 2nd round of injections this week.

Thanks
Saramon

Saramon,

Good to hear of your improvement.  Did you have any reaction (swelling, bruising, etc.) to the first series of shots?  

After this next series, please post your reaction to those shots also.  Thanks and good luck.

By the way, I had similar results after my first series of shots.  I started with a 60 degree curve and had a 10 degree improvement at the end of Phase 1/beginning of Phase 2.

Humorous

[Humorous3]

Question for the guys in the study:  How often and for how many weeks to you perform modeling after the 2nd injection?

bigk,

My understanding is we are supposed to start after the swelling goes away and do it until the next injection.  

Humorous

[bigk]

Question for the guys in the study:  How often and for how many weeks to you perform modeling after the 2nd injection?

bigk,

My understanding is we are supposed to start after the swelling goes away and do it until the next injection.  

Humorous

How many times per day do you perform modeling, and how many repetitions each time?

[saramon]

Hi Humorous

No swelling, just some minor bruising at the injection site, I get more bruising from the modelling.

Hi Bigk

Modelling done at least once per day (stretching when flaccid, bending against the curve when erect), I don't think you stop from here on until end of trial, the Doc wants me to do it at least 75% of the time.

Just some general observations:

During my modelling demo from the doc a snap was felt by him and me when he was bending against the curve, the plague appears to be broken in half which is what he expected as he described the injection as a chemical scalpel.

The curve is remeasured so that the next round of injections are placed at the next greatest point of curve.

I don't find the injections to bad but it tends to sting for a couple of minutes after.

The trial goes for 4 cycles with about 1 month between cycles plus some followup stuff later (haven't checked into this yet).

Thanks

[Humorous3]

Hi Humorous

No swelling, just some minor bruising at the injection site, I get more bruising from the modelling.

Saramon,

Doesn't your modeling card say "Gently stretch..."?  and "Gently attempt to straighten..."?  I don't think gentle modeling should produce more bruising. You may want to check with the study nurse or doctor about that.  

For your information, I have been through the first four cycles of the Phase 3 study which includes modeling.  

Humorous

[Worried Guy]

saramon, you are expected to bend your erection?  I'm not sure I like the sound of that!  Could this not cause another injury?  Just gently I assume?

[fubar]

Your dick stretches on its own during the night. Regardless of any protocol.how much modeling can make a difference? You are already altered for now?

Fubar

[saramon]

Hi Worried Guy

Yes - it is bent against your erection but as Humorous states it is done gently.

I can say that I am far less "vigorous" than the Doctor was and the bruising occurred on the head of the penis so have adjusted my technique (he managed to snap the plaque during the first modelling demonstration).

Hi Fubar, I think the stretching is to "model" the reforming scare tissue to a more normal shape but will ask for more information about this tomorrow when I have my next session.

I did ask what replaces the dissolved scare tissue and his answer was "hopefully less scare tissue".

[Humorous3]

Saramon - Are you saying that your doctor manipulated (bent) your penis while erect? If so, did they give you another shot of trimex? This does not sound right at all.

ohno,

It is proper to model/bend an erect penis. Here is what the Home Modeling Instruction sheet says: "If you obtain a spontaneous erection, gently attempt to straighten the penis during spontaneous erections; hold for 30 seconds in a more straightened position, but not so forcefully as to produce any pain or discomfort."

Having done it during the Phase 3 study, it's not as bad as it sounds, so there's no need for papaverine/trimix, etc., IMO.  

Humorous

[saramon]

2nd cycle completed which includes:

1. Remeasure curvature of erect penis
2. 2 rounds of injections (around .5 mils each)
3. 1 modelling session

Some bruising at the injection site was still visible the day after the injections.

I asked what the modelling was expected to achieve and the response was that the injections make the plague pliable so the modelling is to attempt to reshape the penis to a more normal shape. During this modelling you could experience plague rupture.

All modelling done by the doctor is in the flaccid state and is a little bit uncomfortable (both stretching and bending 3 x 30 seconds each).  

I find the injections sting quite a bit and more uncomfortable than the erection injection.

Cycle 3 due first week of June.

[Ben]

I think that modelling is less dangerous and more efficient with a stretcher. The stretching force can be soft but within a few hours could for sure do the job.
I remember a friend was aggravated by a urologist who pulled his penis forcefully.
Handling a medium tension for one or two hours sounds wiser to me than do it manually.

[newguy]

I think that modelling is less dangerous and more efficient with a stretcher. The stretching force can be soft but within a few hours could for sure do the job.
I remember a friend was aggravated by a urologist who pulled his penis forcefully.
Handling a medium tension for one or two hours sounds wiser to me than do it manually.

I guess they decide on a method in these studies and go with it. It's at least a positive sign that they realise that stretching can be useful. Maybe techniques will develop over time based on what works or doesn't work in conjunction with xiaflex. I'm quite pleased with the reports we're hearing so far. A year or so back, the rumblings seemed to suggest that xiaflex might not be all that useful, but now we're hearing some positiv stuff coming through, which is great. Keep the reports coming guys!

[Worried Guy]

Hello saramon, so after your second cycle how are things looking?  Any improvements?

[saramon]

Hi Worried Guy

I think there is some improvement but won't really know until the next set of measurements are taken (at the end of May).

I did ask if the doctor thought the treatment would be effective in my case and he was pretty definite and positive about an improvement, provided I was on the drug and not the placebo.

PS.. I spelt plaque as plague (dangers of spell checking without wearing glasses), sorry for any confusion