Clinical study of post-finasteride syndrome launched

pfsfoundation.org/news/clini … affiliate/

Clinical Study of Post-Finasteride Syndrome Launched at Brigham and Women’s Hospital (a Harvard Medical School Teaching Affiliate)

Study Aims to Identify Causes at Molecular Level of Condition Potentially Affecting Thousands of Men Worldwide.

SOMERSET, N.J., July 1, 2013 – The Post-Finasteride Syndrome Foundation today announced the funding of a major clinical study on post-finasteride syndrome (PFS) at Brigham and Women’s Hospital (BWH), a teaching affiliate of Harvard Medical School.

Titled “A Preliminary, Hypothesis-Generating Investigation of the Post-Finasteride Syndrome: Description of the Phenotype, and Elucidation of the Hormonal, Genetic and Epigenetic Mechanisms”, the study is being led by Shalender Bhasin, M.D., Director of the Research Program in Men’s Health: Aging and Metabolism at BWH.

The objective of this systematic investigation will be to determine whether there is a syndromic constellation of signs, symptoms and hormone levels that characterize PFS.

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, Peyronie’s disease, penile shrinkage, gynecomastia, muscle atrophy, cognitive impairment, severely dry skin, and depression. 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.

Methods of the BWH study are as follows:

  • Evaluate sexual, psychological and cognitive function
  • Assess hormone levels and metabolic parameters
  • Identify epigenetic interactions with the androgen receptor (AR) and gene expression of AR-dependent genes
  • Perform magnetic resonance imaging of the brain in a group of subjects consisting of PFS patients, former asymptomatic users of finasteride for male pattern hair loss, and age matched controls

The PFS Foundation believes this study will:

- Help establish PFS as a bona fide condition
- Help uncover some of the underlying biological mechanisms of PFS
- Elucidate the hormonal, genetic and epigenetic mechanisms of PFS
- Provide leads for the development of mechanism-specific therapeutic strategies

Patient recruitment is now underway.

“This study promises to be an important step in our progress toward better understanding post-finasteride syndrome,” said PFS Foundation CEO Dr. John Santmann.

On April 11, 2012, the 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.

About Dr. Shalender Bhasin

Dr. Bhasin is an internationally recognized reproductive endocrinologist with expertise in androgen biology who is director of the Men’s Health Unit, Division of Endocrinology, Diabetes & Metabolism in the Department of Internal Medicine at BWH. He has served in many national and international leadership positions, including Chair of the American Board of Internal Medicine: Endocrinology & Metabolism Subspecialty Board, Chair of the Endocrine Society’s Expert Panel on Androgen Deficiencies in Men, and Associate Editor of the Journal of Clinical Endocrinology & Metabolism.

About Brigham and Women’s Hospital

Brigham and Women’s Hospital (BWH) is a 793-bed nonprofit teaching affiliate of Harvard Medical School and a founding member of Partners HealthCare. Founded in 1980, BWH has more than 3.5 million annual patient visits, is the largest birthing center in New England and employs nearly 15,000 people. Through investigation and discovery conducted at its Biomedical Research Institute (BRI), BWH is an international leader in basic, clinical and translational research on human diseases, more than 1,000 physician-investigators and renowned biomedical scientists and faculty supported by nearly $640 million in funding. For the last 25 years, BWH ranked second in research funding from the National Institutes of Health (NIH) among independent hospitals.

About the PFS Foundation

Headquartered in Somerset N.J., the Post-Finasteride Syndrome Foundation was established in July 2012 as a 501©(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 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.

Fantastic!

Great News!! And thank you to the Foundation!

I also found this link, looks like a way to sign up??

ziptrials.us/study/brigham-and-w … ess-study/

Wow – Harvard Medical School is on the case.

One could not ask for a more reputable organization to show definitive cause between finasteride and PFS.

Thank you, PFS Foundation for make this happen.

Also - is this Awor’s good news? Or is there even more good news? God knows we need as much good news as we can get…

I was expecting something more significant we are still along way from anything approaching a cure. I’m sorry to be downbeat but I find it hard to keep going, if I thought their was a cure just around the corner it might make life more bearable.

We have to concentrate on laying proper foundations for the process which will eventually lead to a treatment. No one know how near or far that will be but without investigating it thoroughly with the right people we will never get there. I have thought in the last couple of years it could be anything from five to ten years but at least we will be doing something constructive to get there, otherwise carrying on with the same scattergun approach will mean we will be more or less in the same place in a decade. Be thankful you arrived here now when things are getting going and not a decade ago.

Very good news!

This is fantastic news, but I also was hoping that something more significant with clinical results was around the corner. IMO, Traish and Malangi seemed to have more of a grip on this with the startling findings of three patients with severely depleted 5ar metabolites in the CNS, even Irwig’s findings of alcohols affect with PFS patients.

Give it a rest Finatruth.

Second Amendment- Its ok to have ambition and strive for the best, even through this horrible time I have a major business and litigate in court several days a week. Its ok to have expectations and demand things. Its ok to be wishful for things. I am sure you are out of work and miserable, but I am sure you were both of those things before propecia. If you were the guy i saw on TV, there is no way propecia gave you that terrible personality.

And would giving it a rest also mean forgeting about the findings at the conference in Italy? Where there is smoke there is fire.

Oh wow, you hurt my feelings.

I am not trying to hurt your feelings, my point is why do you care if you get better or not?

It was sarcasm. Back on topic.

Yes, this is the good news. With your continued support, more good news should follow in the future. I fully understand that everyone is looking for a direct route to a cure. However, we need to learn to walk before we can run. In our case, as I have said countless times before, we need to fully understand the problem before we can try to fix it. Many have probably realized by now that it isn’t Google and educated guessing that is going to give us this understanding. The only way to get there is through basic science research.

This excellent study is the result of the hard work of a team of individuals, who have contributed in different ways to make this happen. We all hope that the discovery which will result from the scientific process will shed some light onto our problem, and that this knowledge will eventually help us manage PFS more effectively. Until then, I hope that everyone clearly sees the benefit of what the Foundation is doing, and that each and everyone will continue to support it to the best of his ability on the road ahead.

Godspeed to us all.

This is EXCELLENT news, it is the ONLY route to any kind of significant treatment. Do we know (estimate?) when this study will take place? And do we know how many men they are looking to have participate? Thanks!

Awor -

This is truly good news, not just for those of us suffering, but also to those who are unaware of the potential risks associated with this poison. I have seen numerous doctors over the past 12 months, all of which are currently clueless of what this garbage can do. I hope this study not only finds a treatment or cure, but raises the awareness of the general public and medical community.

Thanks to you and all of those involved up to this point.

Donation forthcoming.

Awesome.

Some coverage already showing up:

pharmaceuticalonline.com/Doc … pital-0001