CLINICAL STUDY OF PFS LAUNCHED AT UNIVERSITY OF MILANO

pfsfoundation.org/news/2061/

Clinical Study of Post-Finasteride Syndrome Launched
at University of Milano-Bicocca and University of Milano
Research Aims to Determine Why PFS Patients Develop Neurological and Psychological Dysfunction

SOMERSET, N.J., Dec. 9, 2014 – The Post-Finasteride Syndrome Foundation today announced the funding of a third clinical study on post-finasteride syndrome (PFS), this one a collaboration between the University of Milano-Bicocca and the University of Milano, both in Italy.
Drs. Cavaletti (left) and Melcangi (right): Collaborating on PFS research in Europe.
Drs. Cavaletti (left) and Melcangi (right):
Collaborating on PFS research in Europe.
Titled “Rare, but Serious and Persistent, Side Effects of 5α Reductase Inhibitors (5ARI): Why Do They Occur, in Which Patients, and What Can We Do to Treat or Prevent Them?” the research is being led by Guido Cavaletti, M.D., Ph.D., head of the Neuroimmunology Center at San Gerardo Hospital in the Milanese suburb of Monza, and Roberto Cosimo Melcangi, Ph.D., head of the Neuroendocrinology Unit in the Department of Pharmacological and Biomolecular Sciences at the University of Milano in Milan.
The objective of the study is to determine why PFS patients develop neurological and psychological dysfunction.
PFS has been reported to occur in men who have taken the prescription drug finasteride to treat hair loss (under the brand name Propecia and generics), or enlarged prostates (Proscar and generics).
Reported symptoms include loss of libido, erectile dysfunction, depression, suicidal ideation, anxiety, panic attacks, Peyronie’s disease, penile shrinkage, gynecomastia, muscle atrophy, cognitive impairment, severely dry skin, and tinnitus. The condition often has a life-altering impact on victims and their families, such as job loss and the breakup of marriages and romantic relationships, while also being linked to suicides.
On April 1, 2012, the U.S. Food and Drug Administration ordered drug manufacturer Merck to revise the labeling on Propecia to reflect mounting evidence that it can cause persistent sexual dysfunction. Of the 421 Propecia-related sexual dysfunction cases reviewed by the FDA in its probe, 14 percent lasted longer than three months after patients quit the drug.
Details of the University of Milano-Bicocca/University of Milano study are as follow:
Principal Investigator: Guido Cavaletti, M.D., Ph.D.
Principal Investigator: Roberto Cosimo Melcangi, Ph.D.
Institution of Collaborators: University of Modena, Italy.
Institution of Collaborators: University of Roma, Italy.
Title: Rare, but Serious and Persistent, Side Effects of 5α Reductase Inhibitors (5ARI): Why Do They Occur, in Which Patients, and What Can We Do to Treat or Prevent Them?
Objective: To study why the patient population of post-finasteride syndrome (PFS) patients develops neurological and psychological dysfunction, and to further characterize the sexual side effects of Propecia for hair loss.
Methods: To (i) clinically characterize sexual and psychological function, (ii) assess central and peripheral neurosteroid and hormonal levels, (iii) characterize 5-alpha reductase genomics, (iv) measure peripheral nerve function, and (v) evaluate testicular function of PFS patients.
Why This Study is Important

o This study will evaluate sexual and psychological function in patients with PFS.
o This study will focus on pathophysiological mechanisms of central and peripheral neurological dysfunction in patients with PFS.
o This study will assess fertility parameters in patients with PFS.
o This study will uncover the underlying biological mechanisms related to the wide array of symptoms in PFS patients.
o This study will seek to identify predisposing genetic factors in patients with PFS.
o This study will provide leads for the development of mechanism-specific therapeutic strategies.
Patient recruitment for the University of Milano-Bicocca/University of Milano study got under way in November 2014.

Excellent news. Great to see that the foundation is now going even deeper into clinical research. Glad that they have the money for these efforts.

2015 promises to be a good year for anyone suffering from PFS – and of course a bad year for Kenneth C. Frazier.

This is the best news I’ve heard for a long time!!!

Perfect way to end 2014 and look forward to 2015!!!

I want to save a huge thank you to the PFS foundation for they’re ongoing medical research, for without them we would have nothing!!!

This is also the perfect opportunity for anybody living in Europe to get involved and take part, no excuse, so to get involved, send your email to the studies organiser here…

Email: roberto.melcangi@unimi.it

Nothing but positive news lately. So glad to hear. Optimistic about the coming year. We’ve got this…

The PFS Foundation are heroes.

This news is such great Christmas present. :sunglasses:

I love the CVs of these guys. This is extremely high-caliber stuff. Their CVs are chock full of titles and phrases like ‘Head of the Experimental Neurology Unit’ and ‘has authored more than 200 peer-reviewed scientific publications’, and ‘senior consultant neurologist’. Lends a lot of weight to the work that will be undertaken.

Posted it on Reddit and it’s been well received. As I said there:

“It is in everybody’s interests that this study is a success. Would you prefer to know if a drug is safe for you or not? Only the PFS Foundation is trying to find that out. Not Merck.”

By the way please note:

“Please note that only patients residing in Italy are eligible for this study.”

So it’s important we try to reach out to those in Italy for now.

Yes, I noticed the line about Italian only. Have no idea how many patients are needed, but am assuming it’s in the 25-50 range. And I personally know of 10 PFS patients in Italy, so I imagine patient recruitment won’t be that hard.

Yeah my map has 10 people:

zeemaps.com/map?group=976852

Thanks for affirming. Maybe if the patient recruitment gets done quickly, the study could be published by the end of 2015.

Wouldn’t that be a neat trick – Baylor College of Medicine, Brigham and Women’s Hospital and University of Milan all drawing a “causal” relationship between finasteride and PFS in 2015.

Sweating yet, Kenneth C. Frazier?

Bill Cosby’s fate awaits you.

Big Thanks to the PFS foundation.

With all these studies in works it can only be a matter of time before Propecia is pulled off the market.

I had an email back from Prof. Roberto Melcangi, basically the hospital anaylsis is expensive and only free to those who are private citizens of Italy. We could do with knowing the costs involved. The objectives of this study sound promising providing they can get the required patient numbers and the sooner the better.

Someone in Europe mentioned that – unlike BCM and BWH, which started from scratch – Melcangi already has a bunch of PFS patients lined up.

So I’m hoping that’s true.

Italy has already done some studies so maybe it was just a case of contacting those again.

An Italian member at solvepfs (It123) has said this:

^^ Wow that’s some encouraging news! - if true, of course…

It would definitely explain everything. I wonder why just the CNS though? Maybe neurons are more sensitive/“adaptive” than other cells.

There are published studies on this forum that show the immune system can attack enzymes and hormones. Hopefully someone will make the researchers aware of this.

But everyone has told me this is permanent?

No, not everyone said this is irreversible, because it’s not. But it takes time and effort and you have to give up a lot of your bad habits in order to get better…what I still don’t understand is the rivalry between the users here, this is supposed to be a support forum, a place where we could help each other out while in times of darkness. Lately all I’ve seen is anger towards one another, or in your case completely ignoring someone who’s spent hours on end debating about theories and ways out of this mess. But no this is NOT permanent , and I can say that because I was once a complete shell of myself and now I am feeling tremendously better, so it is possible to improve one’s health situation.