If Propecia gets pulled off market, I'll pull a Virginia Beach

user394587

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Adverse Event Reporting in Clinical Trials of Finasteride for Androgenic Alopecia: A Meta-analysis​


Conclusions and relevance: Available toxicity information from clinical trials of finasteride in men with Androgenetic Alopecia is very limited, is of poor quality, and seems to be systematically biased. In a cohort of men prescribed finasteride for routine treatment of Androgenetic Alopecia, most would have been excluded from the pivotal studies that supported US Food and Drug Administration approval for Androgenetic Alopecia. Published reports of clinical trials provide insufficient information to establish the safety profile for finasteride in the treatment of Androgenetic Alopecia.



Hell, even Merck themselves admit not knowing what the long term effects are for younger men in their official FDA approval letter:


We need more studies, especially with younger men and long term, atleast 5+ years. Also done by endocrinologists, urologists and not some dermatologists who have a conflict of interest when it comes to fina.

That said, I still think everyone should be free to take what they want. Even if they succeed in banning fina for hairloss, people will get it through unofficial channels instead.

Just going to drop this here to avoid having the same discussion in two different threads.


Adverse Event Reporting in Clinical Trials of Finasteride for Androgenic Alopecia: A Meta-analysis​


Conclusions and relevance: Available toxicity information from clinical trials of finasteride in men with Androgenetic Alopecia is very limited, is of poor quality, and seems to be systematically biased. In a cohort of men prescribed finasteride for routine treatment of Androgenetic Alopecia, most would have been excluded from the pivotal studies that supported US Food and Drug Administration approval for Androgenetic Alopecia. Published reports of clinical trials provide insufficient information to establish the safety profile for finasteride in the treatment of Androgenetic Alopecia.



Hell, even Merck themselves admit not knowing what the long term effects are for younger men in their official FDA approval letter:


We need more studies, especially with younger men and long term, atleast 5+ years. Also done by endocrinologists, urologists and not some dermatologists who have a conflict of interest when it comes to fina.

That said, I still think everyone should be free to take what they want. Even if they succeed in banning fina for hairloss, people will get it through unofficial channels instead.

I think pretty much everyone can agree on this (bolded).

Claims here are frequently made like "you're inhibiting the second most important androgen in the body, how could you not experience side effects" or "look at all of these neurosteroids that are inhibited, most people will get side effects from this at some point".

The issue is that the outcome data we have relating to human finasteride usage does not support these claims. All of the studies indicate a relatively low side effect profile. The studies funded by the PFS foundation may lay the ground work for future areas of research, but they can't be used to make inference about the population of finasteride users because they suffer from extreme selection bias (IE, sampling finasteride users who already complained about persistent side effects).

I'm personally not a huge fan of finasteride either; I'd really rather not inhibit a significant portion of my DHT and neurosteroid production. With that said, the majority of people that take the medication seem to do so without issue, and I'll continue to do so until I experience side effects or a better alternative comes out (IE, pyrilutamide if it is successful).
 

user394587

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I don't agree with data showing a relatively low side effect profile because as concluded by the meta analysis of this available data; the data is limited, of poor quality, biased and far from sufficient to establish a realistic safety profile. Even Merck admits that it doesn't know what the long term side effects are for younger men. But yes we had this dicussion already so agree to disagree.

And I hope you will continue to have results with fina, I also hope we get some legit alternatives soon.
You're obviously free to have that opinion, but I haven't seen you comment on the studies funded by the PFS foundation. What is your opinion on those?

I don't see how you can come to the conclusion that the other existing literature is poor quality and then not for the studies associated with PFS, considering they have extreme selection bias, low sample sizes, questionable methodologies, and in some cases the lack of controls.

I'll also say that in addition to what I wrote earlier, I'd discontinue the medication if there was medical literature that was concerning enough, but at this stage I haven't observed that. Opinions will obviously vary here as different people have different comfort levels, this is simply my opinion. I don't agree with people who criticize others for choosing not to take it.
 
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user394587

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The meta analysis study analyzing the available data has nothing to do with the PFS foundation. The data being of poor quality,... is the conclusion of these researchers, not me. (of course I agree)

Now concerning the studies funded by PFS foundation, well if it's done by independent researchers who only care about objective data and real unbiased science I see no problems with it. Also who else will fund more research into this? For example their last study is done by

And there is a TON of medical literature showing the importance of DHT , dangers of 5ar inhibitors and all of the effects it has on your body. I posted a ton in that other big thread.

Anyway, said it many times anyone is free to take what they want imo. But the mechanism of how these drugs work are not understood and risks are downplayed on hairloss forums (for obvious reasons of course)

It is what it is, I can post tons of studies it won't convince anyone who already decided to take fina.
You don't think there's anything wrong with people taking the results of studies that have low sample sizes and extreme selection bias, and using that information to make inference about the entire population of finasteride users?
 
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user394587

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Sure but I also have a problem with people quoting studies done by dermatologists with conflicting interests and studies done on older men to prove fina is safe.
I don't think I've ever seen you post here criticizing the methodology of the studies done on PFS, or people extrapolating their results to the entire population of finasteride users, but I'll take your word for it.

You won't see any large, long term studies conducted on finasteride from researchers outside of dermatology and urology because the only thing finasteride is prescribed for is Androgenetic Alopecia and BPH. The larger studies that are conducted by urologists will only focus on older age groups because that's their target demographic for drug prescriptions.

My point is that you're going to be at an impasse here. In all likelihood, the research that you'd like to see done will not occur. The larger studies done on finasteride in the opinion of some researchers has poor safety evaluations and conflicts of interest. The studies done on PFS, as noted in the limitations section in said studies, have high selection bias, small sample sizes and a lack of evidence to prove causation.

Where does that leave you? The bottom line is that unless you're in a position where you can have multiple hair transplants and have the donor hair to support it, your only option for treating hair loss that will be successful in the long term is finasteride or dutasteride.

I'd like to see a better alternative come out as well, but I'm always going to remain skeptical until I see the medical literature in front of me. Pyrilutamide has gained a lot of traction here, but how can you be sure it's safe? It's a topical AR antagonist with a binding affinity high enough to compete with DHT. If it ends up going systemic to a notable degree either immediately or slowly in the long term, what side effect profile will that have? You're also going to run into the exact same problem with newer medications; the only people who have the incentive to research it are dermatologists and the pharmaceutical companies developing it.

It would be ideal if medications like this had to go through more rigorous testing by sources that have no conflict of interest and were required to be conducted by researchers who specialize in the same scientific field that the medication's mechanism of action is associated with (IE, endocrinologists). You and I both know the likelihood that happens is incredibly small. So the people that consider pyrilutamide as a treatment will ultimately have to make a similar decision compared to finasteride, except they won't have 23+ years worth of research (poorly conducted or otherwise), physician prescribing experience and anecdotes to base their decision on.
 
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Pacho

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Adverse Event Reporting in Clinical Trials of Finasteride for Androgenic Alopecia: A Meta-analysis​


Conclusions and relevance: Available toxicity information from clinical trials of finasteride in men with Androgenetic Alopecia is very limited, is of poor quality, and seems to be systematically biased. In a cohort of men prescribed finasteride for routine treatment of Androgenetic Alopecia, most would have been excluded from the pivotal studies that supported US Food and Drug Administration approval for Androgenetic Alopecia. Published reports of clinical trials provide insufficient information to establish the safety profile for finasteride in the treatment of Androgenetic Alopecia.



Hell, even Merck themselves admit not knowing what the long term effects are for younger men in their official FDA approval letter:


We need more studies, especially with younger men and long term, atleast 5+ years. Also done by endocrinologists, urologists and not some dermatologists who have a conflict of interest when it comes to fina.

That said, I still think everyone should be free to take what they want. Even if they succeed in banning fina for hairloss, people will get it through unofficial channels instead.
lets be real here: if the study wouldnt have you prefered outcome ("everybody will get horrible sideeffects eventually!!") you would say its manipulated, cant be trusted and we are back to square 1

like 10 year studies like this will always be fake to you

so whats the point
 

jamesbooker1975

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Just going to drop this here to avoid having the same discussion in two different threads.




I think pretty much everyone can agree on this (bolded).

Claims here are frequently made like "you're inhibiting the second most important androgen in the body, how could you not experience side effects" or "look at all of these neurosteroids that are inhibited, most people will get side effects from this at some point".

The issue is that the outcome data we have relating to human finasteride usage does not support these claims. All of the studies indicate a relatively low side effect profile. The studies funded by the PFS foundation may lay the ground work for future areas of research, but they can't be used to make inference about the population of finasteride users because they suffer from extreme selection bias (IE, sampling finasteride users who already complained about persistent side effects).

I'm personally not a huge fan of finasteride either; I'd really rather not inhibit a significant portion of my DHT and neurosteroid production. With that said, the majority of people that take the medication seem to do so without issue, and I'll continue to do so until I experience side effects or a better alternative comes out (IE, pyrilutamide if it is successful).
hahaha, here we go again. you are inhibitin 8 NATURAL hormones by inhibitin alpha reductase at least a 70 % inhibition.. You can't do that even with Cholesterol even if it is high.
 

user394587

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hahaha, here we go again. you are inhibitin 8 NATURAL hormones by inhibitin alpha reductase at least a 70 % inhibition.. You can't do that even with Cholesterol even if it is high.
At this point I'm assuming that you're ignoring what I write.

If you bothered to take the time to actually read what I write, I actually agree with you that inhibiting these processes is concerning.

Having said that, the outcome data we have doesn't seem to indicate that doing so causes many problems for the majority of people for up to ten years. There is a conflict of interest and poor safety methodology in some cases, however, you'd have to assume that the study participants elected not to mention that they were experiencing deleterious side effects in every single one of these studies. I find that a bit far-fetched.

These studies are all we have to base our opinions on, unless you consider anonymous anecdotes to be reliable. The biochemistry surrounding finasteride indicates areas where potential problems can occur, but the outcome data does not seem to reinforce this. If there was even a single large study with proper design that reinforced the theoretical pitfalls of finasteride, I wouldn't even consider taking it.

The studies on PFS indicate that a subset of men who take the medication experience persistent deleterious side effects. They don't indicate what the incidence of this is or what any of the risk factors are. They're also not represtative of the average finasteride user due to extreme selection bias, among other things I've mentioned 100 times over at this point. You'd also have to assume that every single dermatologist or hair transplant specialist that prescribes finasteride frequently is morally bankrupt or scientifically illiterate. I'm sure some of them are, but not all of them.

Regardless, it seems that you're not even willing to have a discussion, because you haven't addressed a single point that I've made. Unless you consider the "Merck propaganda" or "You are inhibiting the production of these hormones/neurosteroids" lines that you've repeated probably over 50 times at this point to be constructive commentary. So lets stop wasting each other's time.
 
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jamesbooker1975

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At this point I'm assuming that you're ignoring what I write.

If you bothered to take the time to actually read what I write, I actually agree with you that inhibiting these processes is concerning.

Having said that, the outcome data we have doesn't seem to indicate that doing so causes many problems for the majority of people for up to ten years. There is a conflict of interest and poor safety methodology in some cases, however, you'd have to assume that the study participants elected not to mention that they were experiencing deleterious side effects in every single one of these studies. I find that a bit far-fetched.

These studies are all we have to base our opinions on, unless you consider anonymous anecdotes to be reliable. The biochemistry surrounding finasteride indicates areas where potential problems can occur, but the outcome data does not seem to reinforce this. If there was even a single large study with proper design that reinforced the theoretical pitfalls of finasteride, I wouldn't even consider taking it.

The studies on PFS indicate that a subset of men who take the medication experience persistent deleterious side effects. They don't indicate what the incidence of this is or what any of the risk factors are. They're also not represtative of the average finasteride user due to extreme selection bias, among other things I've mentioned 100 times over at this point. You'd also have to assume that every single dermatologist or hair transplant specialist that prescribes finasteride frequently is morally bankrupt or scientifically illiterate. I'm sure some of them are, but not all of them.

Regardless, it seems that you're not even willing to have a discussion, because you haven't addressed a single point that I've made. Unless you consider the "Merck propaganda" or "You are inhibiting the production of these hormones/neurosteroids" lines that you've repeated probably over 50 times at this point to be constructive commentary. So lets stop wasting each other's time.
Dude, the " outcome " ?! Most studies where sponsoredpatrocinate by Merck ! What the hell are you talking about ? The only ignorant is you if you think that you can cut 70% of Natural hormones in a normal range in the body and there will not be side effects.
 

user394587

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Dude, the " outcome " ?! Most studies where sponsoredpatrocinate by Merck ! What the hell are you talking about ? The only ignorant is you if you think that you can cut 70% of Natural hormones in a normal range in the body and there will not be side effects.
Did I ever make the claim finasteride has "no side effects"?
 

user394587

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Did I ever told you that you claim that finasteride has " no side effects " . You are telling that just a few have it and are not much important, lol .
It's more than just a few. The range of side effects reported in studies is actually quite broad. This meta-analysis https://pubmed.ncbi.nlm.nih.gov/27475241/ alongside https://pubmed.ncbi.nlm.nih.gov/25830296/ is evidence enough of that.

For example, this study is completely free of influence from pharmaceutical companies and reports a side effect rate of 6% https://pubmed.ncbi.nlm.nih.gov/21910805/. The sample size is only 118, but it was conducted over 10 years.

I'm not trying to downplay side effects. I'm basing what I say off the scientific literature that's available.

There are claims being made that the incidence of persistent side effects from finasteride are high. The reality is that there is no clinical data to support this. If you read the studies sponsored by the PFS foundation, none of them make this claim, they clearly state that the incidence of persistent side effects cannot be established.

There is one study that has estimated an incidence of persistent side effects https://pubmed.ncbi.nlm.nih.gov/28289563/. It pertains to persistent erectile dysfunction (PED), and the incidence is 0.8 to 1.4% depending on the way you interpret their results. For other types of persistent side effects, no studies to date have been published that examine critical masses of patient records (https://www.pfsfoundation.org/frequently-asked-questions/). The studies funded by the PFS foundation indicate there are men who experience persistent side effects with an unknown incidence, and they may not recover over a period of a few years. This is concerning, but it's hard to say how concerning it is when we don't have an estimate of how many men develop persistent side effects beyond the aforementioned study.

What you're saying has merit in that most of the larger clinical trials were sponsored by Merck and GSK, and these pharmaceutical companies have a financial incentive to produce favorable side effect profiles. Clinical trials such as this require significant funding. Who else is going to pay for it? I'd prefer it too if these clinical trials didn't involve pharmaceutical companies, but this isn't the reality of the economics at play.

I also don't dismiss the point you make about inhibiting DHT systemically, alongside other neurosteroids/hormones of varying importance. This is concerning to me, and it's why I put off my decision to take the medication for 4 months to research it. My point is simply that based on the scientific literature, most people do not seem to experience side effects. This isn't my opinion, it's just what exists in the literature.

At the end of the day, people will need to make a personal decision as to whether or not taking finasteride is worth the risk for them. I based mine off the present scientific literature. If I see larger clinical trials arise that provide compelling evidence against finasteride, I'll elect not to take it. At this time, I don't feel as if the evidence that exists against finasteride is compelling. This is a personal decision, and I don't fault anyone for disagreeing with me. The healthier option is not to take any drugs, accept your genetic lot in life, and shave your head. I obviously don't fall in that camp, and for me taking finasteride is worth the risks.

To each their own.
 
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Micky_007

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Dude, the " outcome " ?! Most studies where sponsoredpatrocinate by Merck ! What the hell are you talking about ? The only ignorant is you if you think that you can cut 70% of Natural hormones in a normal range in the body and there will not be side effects.

Fully agree.

It's really common sense.
 

Micky_007

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hahaha, here we go again. you are inhibitin 8 NATURAL hormones by inhibitin alpha reductase at least a 70 % inhibition.. You can't do that even with Cholesterol even if it is high.

Exactly and there have been several studies showing how bad this is. All @user394587 is looking at is the bought-off studies paid off By Big Pharma to fool people.

There are so many people on this very forum alone and every other hairloss forum that complains of sides that are often permanent. You even got people on websites like Hairlosscure2020, Follicle Thought, etc always in the comments section talking about how they had sides on Finasteride when the topic of initial conversation wasn't even about Finasteride. It is highly common. So common that you can not even go online and not hear about people who haven't experienced side effects on Finasteride.

Even multiple dermatologists I went to said in her experience Finasteride users do quite often get sides but they don't like to tell patients about the side effects before prescribing it because they don't want to scare people away.

It's a business for even Dermatologists. Imagine you go to a dermatologist and they be straight honest with you for a change and tell you look:

" There's only 2 FDA approved treatments, Minoxidil rarely works unless accompanied by Microneedling but Microneedling is not FDA approved for Hairloss so I don't tell my patients to use it, and then we have Finasteride that blocks the 2nd most important hormone in males, can have a cascade effect on your hormones, cause you ED that could be permanent, low libido, low sperm count, depression, possibly never have kids, etc etc" - you would get almost NO one going to take the stuff prescribed from a Dermatologist especially the Finasteride.

However, hairloss is a business for Dermatologists and hair loss surgeons. There's a reason they will understate the sides, especially when hairloss patients make a large % of their salary.

That's also a big reason how it's so easy for Big Pharma to hit that 2 million annual prescriptions of Finasteride and why that number doesn't mean sh*t because most often dermatologists don't tell you the bad side of Finasteride in such detail as any sane person would be scared off.

Since there are tens of millions of Balding people every year in the US, and millions of those see a dermatologist soon after they notice hairloss, dermatologists almost as a reflex just downplay Finasteride sides and quickly prescribe finasteride to almost everyone experiencing hairloss. That's how they are so easily able to hit that 2 million prescriptions a year and that is why that number doesn't mean sh*t about the safety or efficacy.

Also, most people who get sides don't even report it, even to their dermatologists. They just stop use. They don't report it because:

1) Fear of embarrassmet as men
2) The complaint process to actually register their side effects as a statistic is far longer, tedious and inconvenient in comparison than those who simply can say they just responded positively or didn't have any sides and so don't even have to register their experience as a statistic.

That is the reason these statistics of how many people actually got side effects are Farrrrrrr lower than what they actually should be.
 
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user394587

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Exactly and there have been several studies showing how bad this is. All @user394587 is looking at is the bought-off studies paid off By Big Pharma to fool people.

There are so many people on this very forum alone and every other hairloss forum that complains of sides that are often permanent. You even got people on websites like Hairlosscure2020, Follicle Thought, etc always in the comments section talking about how they had sides on Finasteride when the topic of initial conversation wasn't even about Finasteride. It is highly common. So common that you can not even go online and not here about people who haven't experienced side effects on Finasteride than.

Even multiple dermatologists I went to said in her experience Finasteride users to quite often get sides but they don't like to tell patients about the side effects before prescribing it because they don't want to scare people away.

It's a business for even Dermatologists. Imagine you go to a dermatologist and they be straight honest with you for a change and tell you look:

" There's only 2 FDA approved treatments, Minoxidil rarely works unless accompanied by Microneedling but Microneedling is not FDA approved for Hairloss so I don't tell my patients to use it, and then we have Finasteride that blocks the 2nd most important hormone in males, can have a cascade effect on your hormones, cause you ED that could be permanent, low libido, low sperm count, depression, possibly never have kids, etc etc" - you would get almost NO one going to take the stuff prescribed from a Dermatologist especially the Finasteride.

However, hairloss is a business for Dermatologists and hair loss surgeons. There's a reason they will understate the sides, especially when hairloss patients make a large % of their salary.

That's also a big reason how it's so easy for Big Pharma to hit that 2 million annual prescriptions of Finasteride and why that number doesn't mean sh*t because most often dermatologists don't tell you the bad side of Finasteride in such detail as any sane person would be scared off.

Since there are tens of millions of Balding people every year in the US, and millions of those see a dermatologist soon after they notice hairloss, dermatologists almost as a reflex just downplay Finasteride sides and quickly prescribe finasteride to almost everyone experiencing hairloss. That's how they are so easily able to hit that 2 million prescriptions a year and that is why that number doesn't mean sh*t about the safety or efficacy.

Also, most people who get sides don't even report it, even to their dermatologists. They just stop use. They don't report it because:

1) Fear of embarrassmet as men
2) The complaint process to actually register their side effects as a statistic is far longer, tedious and inconvenient in comparison than those who simply can say they just responded positively or didn't have any sides and so don't even have to register their experience as a statistic.

That is the reason these statistics of how many people actually got side effects are Farrrrrrr lower than what they actually should be.
People can review the literature and make decisions themselves. I could care less whether or not someone decides to take finasteride.

It just annoys me when people (not implying you) advocate to see finasteride outright banned for all hairloss indications when there's a lot of people that benefit from it.
 

user394587

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That's why the PFS foundation is raising money so actual doctors who understand how hormones work like endocrinologists can conduct studies to get a deeper look.

They're working with Melcangi, a respected endocrinologist from an italian university.

But who knows if they can raise enough money for bigger and longer studies... Maybe they can get some serious money in the future.
It's within everyone's best interest that longer studies with proper methodologies are conducted. Assuming the medication isn't outright banned if or when these studies are conducted, it will allow people to make more informed decisions.
 

jamesbooker1975

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One of the best articles I found about finasteride is this one :
https://www.leoandlongevity.com/post/the-problem-with-finasteride
"Note that there are other, less well-known effects of androgen deprivation. For example, the observed reduction in erection quality in finasteride-treated patients has led academics to question whether the androgen-deprivation may be aging men prematurely. Consequent to androgen deprivation, post-finasteride patients exhibit upregulated androgen receptor density in penile skin tissue up to 8 years after discontinuation of the treatment[26], and androgen receptors were found to be upregulated in other tissues, including the prostate[27]. Hypoandrogenism is thought to cause fibrosis in the corpora cavernosa of penile tissue through collagen fiber deposition and the inhibition of nitric oxide synthases[28][29]. Moreover, 5AR inhibition induced smooth muscle cell apoptosis in the corpora cavernosa in rats[30], leading researchers to speculate that it could cause fibrosis and apoptosis in human penile tissue."


"Hypoandrogenism is thought to cause fibrosis in the corpora cavernosa of penile tissue through collagen fiber deposition and the inhibition of nitric oxide synthases "

Now, you got it @user394587 ?
 

user394587

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One of the best articles I found about finasteride is this one :
https://www.leoandlongevity.com/post/the-problem-with-finasteride
"Note that there are other, less well-known effects of androgen deprivation. For example, the observed reduction in erection quality in finasteride-treated patients has led academics to question whether the androgen-deprivation may be aging men prematurely. Consequent to androgen deprivation, post-finasteride patients exhibit upregulated androgen receptor density in penile skin tissue up to 8 years after discontinuation of the treatment[26], and androgen receptors were found to be upregulated in other tissues, including the prostate[27]. Hypoandrogenism is thought to cause fibrosis in the corpora cavernosa of penile tissue through collagen fiber deposition and the inhibition of nitric oxide synthases[28][29]. Moreover, 5AR inhibition induced smooth muscle cell apoptosis in the corpora cavernosa in rats[30], leading researchers to speculate that it could cause fibrosis and apoptosis in human penile tissue."


"Hypoandrogenism is thought to cause fibrosis in the corpora cavernosa of penile tissue through collagen fiber deposition and the inhibition of nitric oxide synthases "

Now, you got it @user394587 ?
You know that the person who posted this article takes finasteride, right? He's on TRT concurrently, so this more than likely will reduce the likelihood of side effects.

Regardless, I've read Leo's content on the matter, and he offers useful information. This is a perfect example of why we need properly conducted clinical trials to assess things such as this.
 
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WaccWaccWacc

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Studies exist. More than 1. To say none are of any credibility is ignorant and biased.

At the end of the day who cares? Prior to taking finasteride everyone has made their choice. If you got the sh*t end of the stick, you cannot complain because many do not suffer and we all went into it with the same uncertainty.

It doesn’t take a billion dollars to run a simple study. You don’t have to play it out like it is completely unknown that finasteride is relatively safe. Believe it or not the FDA process for approval is not easy by any means.

The FDA is also not the only federal agency to have approved finasteride.
 
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