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.
