Clinical Study of Post-Finasteride Syndrome Launched at University of Milano-Bicocca

[Grammaton Cleric]

http://www.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.

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. Patients interested in inquiring about participation in the study can email Dr. Melcangi at roberto.melcangi@unimi.it Please note that only patients residing in Italy are eligible for this study.

About Guido Cavaletti, M.D., Ph.D.

Dr. Cavaletti completed his post-graduate medical studies in Neurology (1989) at the University of Milan “Statale,” and his Ph.D. in Neurosciences (2001) at the University of Milan Monza. He is currently Professor, senior consultant neurologist and Head of the Neuroimmunology Center, San Gerardo Hospital, Monza, Italy, as well as Head of the Experimental Neurology Unit at the Department of Surgery and Translational Medicine, University of Milano-Bicocca, Monza. Professor Cavaletti serves on the board of directors of the Peripheral Nerve Society and has authored more than 200 peer-reviewed scientific publications (H-index = 35) that include two recent articles on altered neurosteroid levels in the spinal fluid of PFS patients.

About Roberto Melcangi, Ph.D.

Dr. Melcangi received his Ph.D. degree in Chemistry and Pharmaceutical Technology from the University of Milano in 1982. He is currently Professor of Neuroendocrinology and Head of the Neuroendocrinology Unit in the Department of Pharmacological and Biomolecular Sciences in the University of Milano, Italy, and serves on the editorial board of Frontiers in Aging Neuroscience. With 158 peer-reviewed publications (H-index = 39), Dr. Melcangi is a leading authority in the field of neuroendocrinology and neuroactive steroids, and he is the organizer of the International Meeting on Steroids and the Nervous System held in Turin, Italy. Dr. Melcangi recently published two articles on altered neurosteroid levels in the spinal fluid of PFS patients.

“This thorough examination of PFS from an endocrinological perspective will no doubt expand our understanding of the condition while helping guide medical science toward effective therapies,” said PFS Foundation CEO Dr. John Santmann.

In July 2013, the PFS Foundation announced the funding of its first clinical PFS study, at Brigham and Women’s Hospital in Boston, Mass., a teaching affiliate of Harvard Medical School. That study aims to identify causes of the condition at the molecular level.

In August 2013, the foundation announced the funding of its second PFS study, at Baylor College of Medicine in Houston, Texas, designed to determine why PFS patients develop sexual dysfunction.

About the PFS Foundation

Headquartered in Somerset N.J., the Post-Finasteride Syndrome Foundation was established in July 2012 as a 501(c)(3) organization, with private grants from families in the U.S. and abroad. Tax-deductible financial donations to the nonprofit organization can be made via PFSFoundation.org, which also houses patient-recruitment information on active clinical studies, published research, research goals, and media reports about PFS.

About Dr. John Santmann

Dr. Santmann brings three decades of medical experience to the PFS Foundation. An Emergency Department physician by training, he spent two years in residency at Norfolk General Hospital in Norfolk, Va., after completing his internship at Alameda County Medical Center in Oakland, Calif. From 1988 to 1999, he practiced at both community- and academic-based medical centers in Missouri and New Jersey, including the Robert Wood Johnson Medical Center in New Brunswick, N.J. In recent years, Dr. Santmann has worked in the field of healthcare information technology. He earned his M.D. from Washington University School of Medicine in St. Louis and his B.A., in biophysics, from The Johns Hopkins University.

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[burtandernie]

Well we cant fix your hair loss or offer any viable alternatives, but we can find faults and problems with finasteride the only current thing that works at all. It must be fun to find faults or side effects in existing treatments without putting forth any viable alternatives or anything better which is much harder to do.
Hey though thanks for pointing out problems with the only existing treatment and reminding me there are no options but to risk these sides

[Notcoolanymore]

Well we cant fix your hair loss or offer any viable alternatives, but we can find faults and problems with finasteride the only current thing that works at all. It must be fun to find faults or side effects in existing treatments without putting forth any viable alternatives or anything better which is much harder to do.
Hey though thanks for pointing out problems with the only existing treatment and reminding me there are no options but to risk these sides

It's what this guy does. I have gotten into it with him a few times on ***. His only contribution to the hair loss forums is creating fear. Just about every one of his posts will include links to propeciahelp and pfs websites. He has absolutely no input on possible treatments or cures. His only objective is to scare guys into not treating their hair loss.

[burtandernie]

I guess I just would rather see a new treatment or research into new approaches verses just saying what we have causes such and such problems. Yeah we know internal drugs have issues but its all there is which is why people still use it

[Aonyx262]

Every single drug on the market has side effects. Like Spencer says frequently, it's a very safe drug. DHT is pretty useless past puberty. I've not had any since sides since starting finasteride or Dutasteride... I bet if I thought about it hard enough I would feel "tingling" in my penis... If I had so much anxiety about getting an erection, I probably wouldn't get one. I'm sure people have side effects... But let's be real, PFS likely doesn't exist.

[Munkynutz]

I agree with you guys. It probably doesn't exist. It could be any number of other completely unrelated things.

14/421 is like 3.3% of people too, although when it comes to ED and a bunch of other sexual disorders how much of that could have come from smoking, unhealthy eating, other medications, psychological disorders.... It's impossible to say really.

[gettingback]

Please read carefully... It's 14%! And as I'm also suffering from severe sides after quitting finasteride, I can tell you that this thing is real. I don't say fin is bad, because obviously it helps a lot of hairloss sufferers, but I can also be very dangerous for some. Including myself.. Btw. I'm not smoking, nor having bad eating habits and the only other thing I'm using is min 5%. Have a nice day, be lucky if you don't get fin related sides, and please accept that there are people who suffer after taking fin. It is what it is... and we should be respectfull and see both sides of the coin.

[Willhunter]

I'm using min 15% and want to know if the results of the following research conducted are already known? You know 15 is quiet strong, do I need to worry? It's always like that, they announce some kind of provocative research and stop providing the public with any results. If they have troubles with crafting a research they can be consulted by any assignment writing company, like I do as a computer science student. In such cases it's always nice to pay someone to do my coding homework whereas assignmentcore.com knows exactly how good programming must look like.