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

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, insomnia, 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, MD, PhD.

Principal Investigator: Roberto Cosimo Melcangi, PhD.

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.

“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 Guido Cavaletti, MD, PhD

Dr. Cavaletti completed his post-graduate medical studies in Neurology (1989) at the University of Milan “Statale,” and his PhD 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, PhD

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.

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.

#     #    #

Contact

Philip Roberts
The Post-Finasteride Syndrome Foundation
proberts@pfsfoundation.org
(856)425-6046