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.