Developmental drugs & treatments - Still in trial or not approved for Peyronies

[Ted Williams]

Regarding Non-U.S. patients:  

If you are in a European or westernized country you will likely be able to get the treatment.  The profit indicators for Auxillium require a world market to hit there expectations.  European clearance of new drugs is easier than the FDA.  It is possible, that if you are European, you will get the treatment before your U.S. counter-parts.  As for the validity of this drug, phase III of the approval may reveal something in the safety profile that will cause the drug to be withdrawn from the process.  That being said, the business indicators suggest that Auxillium is making swift moves to launch this drug immediately when it is approved.  Keep the faith, their stock is up, their moves indicate launch, their studies show success and the patients are now starting to say, "Not Bad!"  It is all good.  

All indicators suggest that this is not a bunch of bull.... It is the real deal.

Regards,


Ted.  

[Vernon21]

I agree. I think they are on to something and will push hard to get this drug available world wide as soon as they can.  We should remember it has already been used successfully in the past.

[bluth]

Is Xiaflex supposed to work even for calcified plaques?

I read online that two disqualifiers for people on trial where those that:
a) could not maintain an erection, and
b) those whose scares and calcified

I think the information was on Auxilian's homepage though I am not an expert, and am guessing others may be better informed than I.

[Ted Williams]

Hello Bluth:  

Xiaflex is a Collagenase.  It is an enzyme that digests collagen deposits.  We have collagenase naturally in our bodies.  It does not digest calcium.  Though I would not exclude the idea of Xiaflex as part of an over-all treatment for Peyronie's Disease.  Often times, the entire plaque is not calcified.  I hope this is helpful.  

Regards,

Ted.  

[seaside2]

I am bumping this up because of no response. Perhaps because it was somewhat buried in my post.

In any case, are there any side effects to Pentox that I need to be aware of?


We talked about Pentox and he is willing to give it to me for a few months as a trail. Before I start, I want to find out more about side effects. I checked out the various web sites but wanted to get feedback from real people. I am 64 years old and have a mild form of type 2 diabetes. Otherwise very good health, except for this darn Peyronies Disease stuff

[bluth]

Hello Bluth:  

Xiaflex is a Collagenase.  It is an enzyme that digests collagen deposits.  We have collagenase naturally in our bodies.  It does not digest calcium.  Though I would not exclude the idea of Xiaflex as part of an over-all treatment for Peyronie's Disease.  Often times, the entire plaque is not calcified.  I hope this is helpful.  

Regards,

Ted.

So in laymen's terms. Xiaflex can help people who have had Peyronie's for years or not?

Here is a link that Xiaflex may not be useful against calcified plaque's. http://www.curepeyronies.net/index04Xiaflex.html

There will be at least 2 screen out criteria. 1) Calcification of the scar tissue
area and 2) Failure to achieve an erection via injection.  This criterion makes
sense because calcification or hardening of the area will make it more difficult
for Xiaflex to soften the plaque.  

[George999]

I am bumping this up because of no response. Perhaps because it was somewhat buried in my post.

In any case, are there any side effects to Pentox that I need to be aware of?


We talked about Pentox and he is willing to give it to me for a few months as a trail. Before I start, I want to find out more about side effects. I checked out the various web sites but wanted to get feedback from real people. I am 64 years old and have a mild form of type 2 diabetes. Otherwise very good health, except for this darn Peyronies Disease stuff

Just always remember to take it with food.  If you don't it will give you some stomach upset and queasiness.  Other than that I have had no problem with it.  - George

[Ted Williams]

George999

Xiaflex should be considered for long-term Peyronie's.  So long as there is collagen present in the plaque, then Xiaflex stands a chance of disolving that plaque.

Regards,

Ted

[George999]

Ted,  Concerning Xiaflex, I believe that Xiaflex may prove to be quite useful.  But at this point, Xiaflex is not approved for Peyronies.  Until it is, I would not recommend it.  The problem with injectable drugs is that success or failure often rests on the skills of the doctor or technician administering the injections.  I have known people who got pretty messed up with injections of cortisone, for example, simply because the doctor didn't know what he was doing.  I can't even imagine all of the things that could go wrong with something like Xiaflex.  I also want to see a long term track record on it first.  - George

[jackisback]

Bluth,

Auxillium choses the screenout criteria they do to maximize the potential of the trials. You must have a 30 degree curve to participate in the trials. This is not because people with small degrees have worse Peyronie's beyond the hope of being positively effected by Xiaflex, but because the drug is more likely to have a greater impact on the change in degrees as well as change in percentage of degrees of the penis after treatment if you started out with a larger deviation to begin with.

In the same vein, calcification is something they feel could make their numbers less impressive. They clearly feel that Xiaflex could be less effective against calcified plaques, but I doubt there is anything to suggest that it would be useless. And in fact, maybe some of the more scientific minded on this forum could back me up, but I believe it is hypothesized that calcification could even be reversedwith this drug.

Seaside, yes people do report various side-effects. None too serious that I know of, I've only heard of relatively minor things like acne and acid reflux. But this is a prescription drug, and given your Diabetes I would think you would like to clear it's safety with the doctor potentially prescribing it to you.

[bluth]

Thanks Ted and Jackisblack. Great answers as usual.

[Vernon21]

Ted,

I agree that it is an absolute must to see a skilled doctor that is very experienced in injecting Xiaflex for Peyronie's (such those selected to use it in the trials).  However, if Xiaflex was approved for another use before it is for Peyronie's, I would not hesitate to see one of those same highly qualified doctors if they would use it to treat Peyronie's as an off label use.

[Ted Williams]

Strong point Vernon:  

No rookie doctor is getting near me and mine.  How is the progress going?  You had your second injection, right?  Have you felt the plaques subside?  Has your curvature changed? Your updates are appreciated.  

Regards,


Ted

[Ted Williams]

Hey Vernon:  

Any updates on your progress?

Regards,

Ted.  

[ohjb1]

I am in the Xiaflex trials and have received 2 injections which completes my 1st of 3 treatment cycles. It has been 2 weeks and no change in my condition. Does anyone know if prior use of Xiaflex treatment has resulted in immediate change or was there a threshold point at which point a series of injections over time caused an improvement?  

[Old Man]

ohjb1:

If the trials are a double blind study group, it is possible that you are getting a placebo instead of the"real" stuff.

Old Man

[George999]

The good news for ohjb1 is that, as I understand it, if you end up with a placebo in a study that turns out to be successful, you end up first in line for the real thing at the completion of the study.  - George

[ohjb1]

George - I wish you were right, but as it turns out this is not the case. This is discouraging

[Iceman]

ohjb1 - whats discouraging - that its not working or that you are not first in line?? - if its not working thats absolutely BAD NEWS - and good news I guess if you are on a placebo - at least theres a bit of hope here...

[Ted Williams]

Hey ohjb1,

Stick with the study.  Yes, most folks that have been in the study have experienced immediate results.  Most notably, those being treated for Dupuytren's contraction have had immediate, noticeable changes in their condition.  It is likely that the doctors are not allowed to disclose anything regarding the trial and as it is a blind trial, they don't know if you are are receiving placebo or the real thing.  In most cases, when a study is done and success, along with safety, is obtained, they do an open-label portion of the study.  This is designed to show that the placebo patients, after failing at placebo, have now achieved success with the real drug.  It is a good piece of marketing that increases the number of successes in the trial and allows them to file it all together with the FDA for all of their future marketing material.  It just looks "sexy" to market a product that takes a failure and turns it into success.  Next, when there is a drug that represents the only certifiable treatment for a condition, then there is a duty for the doctors to then apply it to the placebo patients.  This is common in life threatening situations and may even apply in this situation.  

I appreciate your discouraged attitude.  I wouldn't want to go through what you are going through.  Be encouraged that others are reporting success and that past studies in Dupuytren's and in Peyronie's have shown success.  If there is absolutely no change in your condition, then you are likely receiving placebo and it is likely they will want to include you in an open-label portion of the study.  

No matter what... Stick With The Study!  Don't become "Lost To Follow-Up."  They don't call you when it is time to get the real thing if you are "lost to follow-up".  

Regards,


Ted.

[ohjb1]

To iceman - what is discouraging is that even if I (and the other 25% of trial participants) go through the entire trial and it turns out that the placebo was administered - the company will not offer Xiaflex.

To - Ted Williams. I have been advised verbally and in writing that Xiaflex will not be offered to those individuals who receive the placebo.  Therefore, what you have said in your recent email can not come to pass unless the company decides to change its policy.

[George999]

ohjb1,  You have to realize that they may be required to tell you that for legal reasons.  Life is full of these kinds of situations.  I really don't think that this means that they will actually not offer it to you.  I think that this means that they want to be legally clear of any implied obligation to offer it to you AND that such an offer may be contingent on your remaining for an extension of the study.  A lot of this stuff is what is known as legal "boilerplate".  Its intention is to protect the company in question in all circumstances and it indeed does not preclude the fact that they can change their policy later on down the line.  I think you should hang in there and hopefully these issues will all be worked out in the end.  - George

[ohjb1]

Thanks for your comments and words of encouragement.  In about a month I have to go back to the urologist and undergo some tests that will objectively determine whether or not there has been any improvement. Will get back to you then. Thanks again.

[Tim468]

Dear ohjb1

I cannot find a protocol for the trial that says whether or not there is an open label follow-on study that will follow the double blinded randomized clinical trial (RCT) for Xiaflex.

But, I want to put in a plug for good science right here and now. Even if you got placebo, and they do not do an open label study that gives you free drugs soon thereafter, your participation in this important research will help all of us soon find out if this is a viable treatment or not, and make it possible for this drug to come to market - where you and I both could benefit from it. You may end up being able to get it as a regular patient, and not in the study - but that will still happen because you were willing to participate in the research.

For that, I am grateful.

Tim

[jackisback]

Hi all,

I haven't been on in a while, but I saw some ruckus in another thread that briefly mentioned pirfenidone, which somehow I'd never heard of.

Anyways, for those who haven't heard of it, here's a very short (good for me) and interesting blurb. It's recently been approved in Japan, and it's on "fast track designation" in America.

http://www.bizjournals.com/sanjose/stories/2008/10/13/daily72.html

[j]

I must be missing something.  Auxilium will not do anything for study patients who received a placebo?  You're supposed to make all those trips and appointments at your own expense, and undergo an uncomfortable if not painful procedure - for nothing?  Or do you get a nice handshake at the end?

This isn't how I thought it was supposed to work.

[Old Man]

j:

Now you know why I don't participate in studies of any kind.

Old Man

[ohjb1]

J - i don't get it either.

You would think they would at least offer the drug to those who received the placebo and have completed the study.  Those who complete the study will receive $250 from the drug company.  

From what I can tell (and I maybe wrong) they do not have a great deal of patients signing up for the study.

 

[Tim468]

I still encourage those here to participate in clinical trials if offered the chance - it is the only way that science will move forward.

Most studies reimburse one for travel and/or pay them something. A too large of a reimbursement is seen as coercive.

Tim

[j]

I didn't know about the $250.   It's not a lot, but it's something.  It wouldn't be enough to get me to jump through all those hoops without knowing I'd get an actual injection of Xiaflex at the end.  

No doubt it was a simple financial calculation for Auxilium. It pains me to say I hope they succeed; because if they don't, we start all over and that means another 10 years.

[j]

I recently participated in a study at a nearby university for which I did an interview, had an MRI and was given $50; I'd have done it for nothing, and I may do more.  But what Auxilium is asking is, well, a bit less pleasant.  And they're expecting to make a lot of money.

[G.]

Hello,

First time I'm posting here - have been following the discussions on this board for a while, and want to say I'm very impressed with the quality of the discussion that goes on here.

What's prompting me to post now is the discussion about whether the latest Auxilium trials will include treatment for those men who fall into the placebo group.

I've just signed up/been screened for this study, not yet been treated, so I want to be circumspect in my comments - don't know how much comment is permitted by people participating in the study, and don't want to do anything to jeopardize my participation.

Anyway, the physician and his research coordinator both told me verbally that everyone who gets the placebo in this trial, will then be offered the real treatment, at the end of the trial, free of charge or course.
Also, in the written consent form I had to sign, it said that if you are in the placebo group, at the end of this study, you will be offered the chance to participate in a further study.

So yes, it will be a pain if I end up in the placebo group, but my understanding is that I'll get the treatment either way, either now or later.

Not sure why different doctors might be communicating a different message.  It would be worth re-checking the consent form you signed; it should be the same for all the different study groups.

Again, just want to express my appreciation for the good work people are doing on this forum.

G.

[jon]

I recently participated in a study at a nearby university for which I did an interview, had an MRI and was given $50; I'd have done it for nothing, and I may do more.  But what Auxilium is asking is, well, a bit less pleasant.  And they're expecting to make a lot of money.

Who cares? I'd gladly do it for free if there were a location near me, if for no other reason than to do what I can to get this treatment to market. I simply cannot fathom the mindset behind refusing to participate in the study because you might get the placebo, or you might not get the actual drug if you are given the placebo, or they're not offering enough money. It just seems so completely contrary to your own interests to not participate if you qualify, and there isn't an undue travel burden.
I turned 30 this year, and peyronie's has been affecting me since I was 22. I'm sorry, if I sound somewhat bitter, but when almost a third of your life has been jacked up because of this, and a solid half of your sexual life thus far has been negatively affected, my sympathy levels are pretty low for anyone in a position to move the process along but don't because of what ifs and maybes.
Cry me a F^@$!ng river about maybes and ifs about placebos and not being paid enough. Let's have just a little bit of self serving altruism and get the damn thing to market and in the hands of our doctors so we can all be treated if it's shown to work.

[ohjb1]

Jon - speaking of cry me a river. You are big talker, but apparently you didn't try to get into the study. I live quite a ways from the study site and am traveling there, also require at least one overnight stay each time.

What has stopped from enrolling in study?  I believe there are still open slots at some centers.  When can we expect to hear your updates from study participation?  

[Old Man]

jon:

If this means anything to you, I have had Peyronies Disease for over 55 years now. So, I admire your position about studies, but they are just not for everyone. I have tried to get into several study groups without success. There was always some little something the leaders/companies wanted that I did not qualify for, so good luck to those are interested and can become part of them. They are just not for me, especially at my advanced age compared to others here.

Old Man

[j]

jon, you're basically right. If I looked at it purely logically I'd have to agree that it would be to my advantage to participate on any terms.  What annoyed me was the fact that Auxilium is a very well-financed for-profit company that clearly can afford to give a real injection to every patient.  And according to G. that's what they're going to do, so my previous comments are moot.

[Old Man]

j:

Another aspect of any study is to get FDA approval of the product, there has to be volumes of paperwork, laboratory reports, results of those with the actual medicine and those who took a placebo. All of this eats up capital and resources, so the companies have to be careful of what they do, etc.

I know first hand about production of a product as part of my career was with an aircraft engine builder.
They sold engines to the government and you would not believe the paperwork, trials and tests that we had to do just get their final approval.

Just my 2 cents.

Old Man

[jon]

Jon - speaking of cry me a river. You are big talker, but apparently you didn't try to get into the study. I live quite a ways from the study site and am traveling there, also require at least one overnight stay each time.

What has stopped from enrolling in study?  I believe there are still open slots at some centers.  When can we expect to hear your updates from study participation?  

cost prohibitive. I'm in DFW. Show me a study location within a 10 hour drive of me, and I'll be there. I looked into flying to SF, Chicago, Norfolk, Miami, Hartford, etc.. and I'm looking at a minimum of 300/rt + hotel+ car rental. Now I don't know about you, but I don't have that kind of money to shell out every 6 weeks. If I did, again I would be there. The only thing preventing me from enrolling is cost. Which if you read what I posted, I quite clearly said "if you qualify, and there isn't an undue travel burden."

But like I said, show me a study site within a 10 hour drive of me, and fwiw I can make it to Birmingham, AL in 10 hours, and believe you me, I'll be there.

[G.]

I just double-checked the wording of the consent agreement, and I was partly wrong:  it says you "may" be asked to be in an additional study - it doesn't say "will" - I guess there's a world of difference between "may" and "will"!

In my case, the doctor and research coordinator were very emphatic that I would get the treatment no matter what - and I've known this doctor for a while and trust him, so I'm going to go with that.  Plus, I haven't even had a treatment yet, and if I'm not in the placebo group, then the issue will be moot for me personally.

I don't know anything about clinical trials, and thought they had to be done consistently, but in this case, it sounds like they may be funding some doctors to give further treatment to the placebo group after the completion of the study, while not funding other doctors

So ohjb1, sorry to say you may be right, if you have it in writing from the doctor and Auxilium that the placebo group doesn't get further treatment.

This is complicated - on the one hand, I think it's wrong if some placebo patients will get further treatment, and others won't - particularly if this is being done to save $$.  On the other hand, clinical trials must be very expensive, and we all have a vested interest in Auxilium surviving so that this treatment (if it works) gets to market.  If I'm reading their financial statements right (and I guess my reading skills are now in question), they have yet to record a net profit, so they are essentially burning funding - and not every start-up company survives, even if they have good products.
I also think it's important to try to help others by participating in the study, but I don't have to incur the expense of flying in, so it's easy for me to say.

It still comes down to a personal decision whether or not to participate.

Good luck.

G.

[jon]

I'd like to add a mea culpa:
The last time I check clinicaltrials.gov, there was no site close to me. There is now one in Houston. I'll be calling Monday.

[Ted Williams]

Hello folks,  

Regarding those concerned about whether a man will receive Xiaflex after the study if they are in the Placebo group; I feel confident it will be so.  Everyone, put your "Cover-Your-Ass-Hats" on.  The difference between "you will receive Xiaflex" and "you may receive Xiaflex" is about liability.  No study would guarantee the out-come such that they would confidentally offer the product to all participating.  Patients always respond differently to things and if you happen to be an unfortunate placebo patient who also develops severe side effects as a result of the injection itself, then it is highly unlikely that you would be called back.  If the needle is bad for you then the study is not serving you well by guaranteeing that you also get the product.  

This study is being designed for success.  Typically, in a study like this the design will be 2:1.  This is 2 Xiaflex to 1 Placebo.  This product has been projecting success for a long time in all of the previous studies.  The best way to raise capital for a company is to put some bright hope on the Horizon.  Xiaflex is that and will transform this company if successful; when successful!  To maximize the show for the FDA and for the investor public, creating a "success narrative" by showing how previously failed patients responded to the treatment is an ideal way to market the product while fulfilling the requirements of a double-blind-randomized placebo controlled study.  

As for the $250 and what Auxillium should or should not pay you, this is another liability thing.  If they paid each patient a sizable sum, then it could be viewed as an intrusion on the study.  Its like paying people to donate blood.  Pay for blood and you get junkies saying they are virgins that never booted black tar heroine with prostitutes.  If you make the process lucrative, then you may get folks entering the study that are guided by less altruistic motivations.  I'm not saying they would inflict themselves with Peyronies, but they will lie about anything subjective that makes a requirement to enter or measure the study.  

Stay confident and "STICK WITH THE STUDY!"  Lost-to-follow-up patients don't get to be considered for the open-label portion of a study.  

This is a great product on deck.  It has a strong chance of meeting all the requirements FDA approval.  We will likely all be taking this injection.  

Best wishes,


Ted Williams

[ohjb1]

Ted - the study design is 3:1.  I don't think the $250 is an issue for anyone.  

[despise]

Hello everyone! I am a 17 year old male living in Glendale Los Angeles. I didn't see a introduction forum. Would be good to have one to help introduce all the people that are newly diagnosed. I'f you do have one sorry just didn't see one. I have been living in hotels with my father for the past 4 years so money has been tight. I had to go to the local free clinic. They setted a appointment up for the sylmar hospital to have a urologist check me out. I't took a long frusterating wait but eventually I got in. He was UCLA doctor that volunteers on his free time for the people who can't afford urologist. I was having a lot of issues with my pee being blocked and coming out irregular. i also have a very low output of pee. pee little bits and sometimes i have to flex my muscle to get the rest out. even doing that i feel burning in my penis like the pee isn't coming out and is stuck in there. I was also having a lot of issues with my erections curving left and downward. He checked me out and said he could see nothing wrong except for the penile whole looked small so it was blocking my pee. I was acourse angry cause my penis was destroyed and this guy was telling me there was nothing wrong with it. I'm 17 and I haven't even been able to get a hard on in the past 2 weeks. It's very uncomfortable flacid and is always hard. Sometimes it bends to the left and then even to the right less often. So we decided to go to Healthy Kids to help me out. They got me into a Urologist last night. He was a good one from USC and he did a thurough but painful examination. Also pushed back up my hemoroid. That wasn't so pleasent haha. He confirmed my worse fears. I have Peyrnoies disease. I am only 17 so I must be a very rare case right? He told me it wasn't from injury but I think he was just trying to be nice. I had a lot of mental depression and basically I physically destroyed my penis beyond the limit. After I masterbated 5 times one day I felt a very sharp pain. I was already having problems with the Peyrnoies but I made it a lot worse that night. Even after my erections were massively curved, painful, and even short I still continued to minupulate it and saw the resolts. It just got worse everytime I pushed my figurouse masterbation. I think I was kind of torturing myself kind of like what cuters do. I didn't enjoy the painful masterbation but I didn't care I just wanted to get off one more time. Sex addict to my hand for sure. Now I haven't masterbated in maybe 3 weeks. Experienced some painful pre mature ejeaculation wet dreams twice. I haven't even had a errection once yet other then those wet dreams. I am 17!!! this is insane =( Now im ready to recover. Im quiting cigs and im going to start working out everyday! I need as much as help as I can get. Please guys realise my agony and do everything you can. I love you all for being so strong and living with this. This disease is truely a tough thing to have to live with but Im happy to see many people can being strong and fighting it! So can you guys please help me out with this? Im so young and ive been through nothing but misery my entire life. I use to live in a happy mansion in Agoura Hills untill my parents broke up. Found out my mom was scitzophrenic bi polar. Dad lost his job at Guitar Center and we lost our house. Me and my sister moved in with our dad. Now my moms homeless. I got out of juvy from a crime and drug past 2 years ago. I thought I could change my life around. I have always had problems with masterbation. I started when i was 8 humping the floor. When i got a girlfriend when i was 14 I tried to have sex but couldn't maintain a errection because i was masterbating none stop everyday. I tried to have sex with her again and I failed. Ive tried to have sex 2 times after that and I failed again. 4 times I have tried to have sex from age 14 to 17. Now I have this! I am a atractive guy and have a lot of friends. Life is getting to hard to bear anymore. All these beautiful girls I want I cant have. I need to fight this guys! Will you guys promise to help me? Ill do anything to be happy like I was when I was a kid.

[Tim468]

I just wanted to put up a post about randomized clinical trials (RCT) and how they are designed. RCT's are not done to "help people", they are done to prove if a drug is going to be able to help anyone at some point down the road.

First, the design has to be done to detect a difference between a drug and placebo if one actually exists. This is not so simple. For instance, testing drugs on someone who is barely bent, or so severely bent, that he falls outside the "normal" range of usual Peyronie's, means that an improvement may be impossible to see. If, for example, I entered a study and had a 15 degree bend upwards and dents, then how are they going to measure "improvement"? Less dents? How will they quantify that?

I have seen pictures of improvement from treatments for Peyronie's and thought that there was NO difference even when they claimed it existed - it looked like faulty measuring technique. What if I am not as hard? Will that lead to a difference in angulation? This study shows "improvement", but when I look at the measures, I see some variability in how they measure the angle of deformation, and it also looks like the patient is not as hard for the "after" shot.

http://www.scielo.br/scielo.php?pid=S1677-55382004000300004&script=sci_arttext

So coming up with rigorous methods for selection of patients, and for ways of measuring progress is vital to doing a good study. Old Man may have been ineligible for studies in the past because of another medical problem, or the degree of angulation - there are lots of reasons that folks are excluded from studies.

Almost all important studies have follow-on studies called "open label" that give all patients a shot at real treatment. This is not done if the first part shows no benefit - hence the disclaimer "may participate" in future studies. Also, if you had an adverse event, or if your penis changed shape for other reasons, you might then become ineligible for study. You can NEVER guarantee participation in a follow-on study. It was my understanding that Auxullium was planning to do an open label study after the initial study; they did that for their DP studies.

My point is that we should be trying actively to participate in drug trials. All of us can decide for ourselves if we want to participate in any particular study. I will not do Xiaflex because I do not have heaped up plaque, but in stead have dents and small areas of fibrosis and contraction. I am also very uncertain that an injection would be good FOR ME - I would not have participated in Verapamil injection studies either. I would have gladly participated in studies of Pentox, verapamil cream, oral supplements, etc. I am not sure I would qualify, as my disease has never been "stable" as defined by no changes for a long period of time.

The worst thing for them to do would be to include folks with minor changes that would not easily show improvement, and thus wash out the statistical significance of treatment, and thus lead to the drug not getting approved. That is a real possibility of a poorly designed trial. A famous vitamin C study that showed "no effect" used a daily dose of 250 mg - it is still widely cited as proof that supplemental C is of "no value", while better but smaller studies continue to show the opposite.

Let's help this company do a good study and volunteer when we can, and help move it forward. If we do not qualify because we are too severely or too mildly affected, well, lets stand by and hope for a good outcome and future availability of a drug that might help all of us.

Tim

[Tim468]

I think that you need to focus on your mental health. You seem to have already learned that altering your behavior has helped you out socially (ie gotten you out of Juvy), but if you can find more social and mental health support, you will be helping yourself greatly. Finding a source of therapy to help you cope with not only a urologic problem but also with enormous family stress would be to the good. Many young people with terrible situations have moved ahead and out of them and so can you.

For now, I would focus on a few healthy things. First, getting a healthy erection daily is probably good for you. Doing this without porn, or sex involved is better, as you do not need to inject any other obsessive thinking into the picture, and what we all want is a healthy loving sex life some day anyway, right? So if your hope and desire is to one day be in a loving sexual relationship with the girl of your dreams, don't become the guy she would never like (a porn obsessed wanker!). Many of us have added a daily erection to our life using the VED, but you might be able to get hard - ALONE - without one. Please postpone getting sexual with a girl for just a little while.

If you can find a way to get regular erections, then you will get a much better idea of what is going on with your penis. A bend to the left, but sometimes to the right is NOT typical for Peyronie's Disease. It is typical for erectile dysfunction, and the most common reason for that at your age is anxiety - which it seems that you have a lot of. So by removing performance anxiety from the picture by chosing not to perform (just for a while!!) should help you get a much better idea of what you penis does when it gets hard.

If it turns out that you have a real bend to the left and down that is new and not just something that appears on the way to a normal straight erection (sometimes the two sides of a penis get hard at different rates leading to temporary bending), then you can start to treat it. You are in LA and you should be able to be seen by members of the UCLA department of urology. You might have to finagle free care - but it might well be that a member of that department can see you. Perhaps the visit to the USC urologist is all that you need. What you have not said is what the urologist recommended for you.

I recommend getting a VED. Also, talk to your Dad if you have not yet done so and tell him what is happening. He can help you purchase a VED, and if too expensive, he can help you make a cheap one using the techniques discussed here by Angus on the Child Boards. I bet that with a VED and time, you may regain a lot of length and straightness.

I commend you on stopping smoking - that is a good one for you and not something a person struggling so much financially should be spending money on anyway. Now develop some healthy habits for your sexuality and masturbate gently, not furiously or repeatedly. With time and more confidence, the sex with girls part will happen just fine.

Tim

[George999]

Guys, we are really blessed on this forum to have health care professionals like Tim and Ted posting here.  I hope that all of you who are concerned about the Xiaflex trials will read their posts carefully.  These are the people who have the expertise to know what they are talking about.  I think you can take their insights to the bank in terms of trust.  On the other hand, I can certainly understand why travel expense will preclude participation for many.  But I really DO believe that Xiaflex will likely form an important function in the emerging Peyronie's toolkit and the more guys who take part in the trial the better off we will ALL be in the long run.  - George

[George999]

Welcome despise!  First of all, I agree completely with Tim's post.  I hope you have already read it carefully and that you will follow up on it.  I would also recommend that you simply try to relax and take time to read over the threads on this forum.    I would recommend that you begin with the "child boards".  These are a compilation of the best posts from the regular forum with the new reader in mind.  They will give you an opportunity to learn more about Peyronies.  And knowledge is power!  I am confident that with all the information available on this site, you will be able to get this condition under control and eventually beat it!  So hang in there, there are a lot of people here pulling for you and wishing you the best.  Also, another good place to go when you feel like you need help is the "Coping with Peyronies" thread on the main board.  Here you will always find other guys available to encourage you and point you in the right direction when it comes to dealing with Peyronies.  But it is really important that you first visit the child boards, that way you will be up to speed on the basic stuff and ready to get real time help on the more complicated issues.  I wish you the best young man, you have a great future ahead of you, so don't let this thing drag you down.  - George

[jackisback]

Hey Despise,

I am young like you. I'm 22, i first noticed this at age 20.  Yes, it sucks that you have gotten this so young. If you had to get it at all, it would be ideal that it would happen in your 40's and 50's after the days of your youth were behind you. But I will say that you still have a hope, and a situation that puts you in a better spot than say, me. In 2-3 years this Xiaflex may likely be available to all sufferers of Peyronie's disease, and at such time you'll only be 19 or 20. Make no mistake about it, Xiaflex is a real, concrete hope with a lot of money and medical studies being pumped into it.  I think that even if you have long term, serious peyronie's you still have hope of living your 20's in sexual normalcy given the potential of medical advancements to be made available within the next few years.

For now however, I don't think anyone needs to tell you that you need to be more careful in the future and lay off of more aggressive and abrasive forms of masturbation. I think this caused my problems as well, and I too humped the floor as a child (as funny as that sounds). There are many things you will find frustrating and ironic about your condition. One is that it may make you very stressed out and depressed, yet if you take most anti-depressants it will likely be bad for your sexual condition. I have recently started taking 25 mg of Trazodone to help me sleep at night after reading on this forum that it is one of the few of those types of drugs that can actually help erections rather than impairing them. It has helped me sleep a lot better, which probably makes the next day easier to cope with.

[UK]

Hi Everyone. I am new to the forum but have read most of it over the last few months. I'm 39 from the UK, had this devastating disease for 4 years, currently on Pentox for last 4 weeks (late I know but giving it a go).

I have a couple of questions on treatments that I hope fit under this category and would appreciate your advices on.

1) Xialflex being the enzyme Colleganese is currently being injected. EMDA has been shown to be able to transport Verapamil into the Tunica so could that happen with Colleganese? Whilst I would take the needles if it would help I was just wondering could there be another option as a 1st line treatment.

2) If Xiaflex was succesful, one way or another we are looking at 2 years. If you underwent traction  in the meantime and that succeeded in stretching the plaque so it was thinner would that negatively impact a possible future Xiaflex injection in that the plaque was not as concentrated? Ideally disolving as much plaque as possible and remodelling into healthy tissue is the preferred outcome so would not want to jeopardise the current situation if 2 years out a viable treatment was available.

[Hawk]

Welcome to the forum UK.

I am probably drawing a momentary blank but I am not familiar with EMDA or studies conclusively establishing that it, DMSO or anything else transports Verapamil into the tunica.  Whether DMSO (which I am familiar with) transports anything is based primarily on the molecular weight of the substance involved.  I do not have the weight at my finger tips nor do I know the molecular weight of Colleganese.  Beyound molecular weight I am sure there could be many other considerations from the absence of needle perforation of the plaque to interaction of the substance with DMSO and even control over depth of transport.

I personally doubt that traction could have a negative impact on future Colleganese use but in reality, only a clinical trial could establish this and I doubt that we are likely to ever see that.  I would certainly suspect Colleganese and traction used together would give better results than either used alone but these are just my thoughts.