Clinical Study of PFS Launched at Baylor College of Medicine

#1

pfsfoundation.org/news/clini … -medicine/

Clinical Study of Post-Finasteride Syndrome
Launched at Baylor College of Medicine

Research Aims to Determine Why Potentially Thousands of Men
Have Persistent Sexual Dysfunction After Quitting Finasteride

SOMERSET, N.J., Aug. 21, 2013 – The Post-Finasteride Syndrome Foundation today announced the funding of a second major clinical study on post-finasteride syndrome (PFS), this one at Baylor College of Medicine (BCM) in Houston, Texas.

Titled “Genetic and Epigenetic Studies on Post-Finasteride Syndrome Patients,” the research is being led by Mohit Khera, M.D., M.B.A., M.P.H., Assistant Professor of Urology in the Scott Department of Urology and Director of the Laboratory for Andrology Research, McNair Medical Institute at BCM.

The objective of the study is to determine why PFS patients develop sexual 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, 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.

On July 1, the PFS Foundation announced the funding of its first clinical PFS study, at Brigham and Women’s Hospital (BWH) in Boston, a teaching affiliate of Harvard Medical School. That study aims to identify causes of the condition at the molecular level.

Details of the BCM study are as follow:

Principal Investigator: Mohit Khera, M.D.

Institution: Baylor College of Medicine; St. Luke’s Episcopal Hospital and The Methodist Hospital.

Title: Genetic and Epigenetic Studies on Post-Finasteride Syndrome Patients

Objective: To study why the patient population of post-finasteride syndrome (PFS) patients develops sexual dysfunction.

Methods: To (i) evaluate sexual and psychological function, (ii) assess hormone levels, (iii) measure penile hemodynamic and sensory parameters, (iv) study androgen receptor genetics and gene expression, and (v) and determine gene expression patterns and profiles.

Why This Study is Important

This study will evaluate parameters of peripheral sexual function in patients with PFS.
This study will uncover the underlying biological mechanisms related to the wide array of symptoms in PFS patients which closely match those of the androgen deprivation syndrome.
This systematic investigation will help identify the genetic footprint of PFS and the array of deregulated androgen dependent functions.
This study will elucidate the hormonal, genetic and epigenetic molecular mechanisms of the PFS.
This study will provide leads for the development of mechanism-specific therapeutic strategies.
Patient recruitment for the BCM study got under way in July/August 2013.

Patients interested in participating in the study should email Yesenia S. Rodriguez, Administrative Coordinator for Dr. Khera: Yesenia.Rodriguez@bcm.edu

“Coupled with the Brigham and Women’s Hospital study, the Baylor research promises to pave the way for PFS therapies by uncovering the root causes of this condition that is likely affecting thousands of men worldwide,” 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. Mohit Khera

Specializing in andrology, sexual wellness and male reproductive medicine, Dr. Khera is Assistant Professor of Urology in the Scott Department of Urology and Director of the Laboratory for Andrology Research, McNair Medical Institute at the Baylor College of Medicine. He also serves on the board of directors of the Sexual Medicine Society of North America (SMSNA) and the executive council of the American Society of Andrology (ASA), while serving as Associate Editor of the Journal of Sexual Medicine. Dr. Khera earned his medical degree from The University of Texas Medical School at San Antonio. After finishing a six-year residency in urology at Baylor, he completed a one-year fellowship in male reproductive medicine and surgery with Dr. Larry I. Lipshultz. Dr. Khera edited the most recent edition of the book Urology and the Primary Care Practitioner, and in 2009 won the SMSNA Basic Science Award.

About Baylor College of Medicine

Baylor College of Medicine in Houston is recognized as a premier academic health science center and is known for excellence in education, research and patient care. It is the only private medical school in the greater southwest and is ranked as one of the top 20 medical schools for research in the country and number one in Texas by U.S. News & World Report. BCM is listed 17th among all U.S. medical schools for National Institutes of Health funding, and No. 2 in the nation in federal funding for research and development in the biological sciences at universities and colleges by the National Science Foundation. Located in the Texas Medical Center, BCM has affiliations with nine teaching hospitals. Currently, BCM trains more than 3,000 medical, graduate, nurse anesthesia, and physician assistant students, as well as residents and post-doctoral fellows. Follow BCM on Facebook and Twitter.

1 Like
Could someone convince Dr. Khera leave a single post here?
#2

Hadn’t seen this – but thanks for posting.

So now it’s Harvard AND Baylor studying PSF. Those are some heavy hitters.

Will be curious to see what significant contributions to science they make on this front.

#3

Fantastic: thanks again to everyone in the Foundation involved in setting up this second major study, and also to peopel who have donated to the Foundation. I can’t wait to hear the results and it’s so good to know leading experts are looking into the problem.

#4

wonderful news. I hope we get results as quickly as possible…

#5

This is great news.

Thanks to anyone and everyone involved.

#6

More great news!

I just can’t wait until the fMRI’s studies at Bringham Women’s Hosipital, I think they are going to find something very eye opening.

#7

Hi Fina

We both share the same opinion on PFS been neurological in origin, I’m intregued to know what you think might be found from fMRI scans?

I’m convinced something is wrong with us and I firmly believe it all revolves around the hypothalamus.

#8

Hang in there guys…the calvary is coming!

#9

I believe there has been a shift in estrogen/progesterone in the brain at the receptor site and the brain metabolism has been severly altered.

#10

Keep donating - look at what we are beginning to achieve. This is huge. Keep going.

#11

yes, lets reward the foundation! I am going to do another donation drive for the foundation set for Monday night!!

#12

Major thumbs up. Keep on donating. Any ways of setting up a fund to help offset the travel costs for ppl participating in these studies? Since I took Saw Palmetto I can’t participate, but would love to be able to help those that can…

#13

Good idea about fundraiser. This time, try reaching to friends and family with the link to new release…

pfsfoundation.org/news/clini … -medicine/

…and let them know their donations are going to a good cause.

#14

This would at least explain my loss of thirst, appetite and desire for anything relating to food or drink including alcohol and before my crash I would describe myself as a moderate drinker, now nothing!!!

#15

14% is huge. I guarantee as soon as a more effective treatment for MPB hits the market, the fallout of millions of users discontinuing the drug will be colossal. Really find it hard to believe there aren’t any celebrity cases of PFS. You’d think it’d almost be compulsory for any mainstream actor who shows the first signs of hair loss.

#16

14% of the 421 reported cases had sides lasting more than 3 months. That’s 59 people.

All of the doctors that have studied his problem have stated in interviews ‘1 in 1000’ as a figure.

There is no evidence to suggest anything but a very, very rare problem.

#17

Tom Hanks took Propecia back in his Davinci Code days. Below from the New York Post’s Page Six column. I am guessing he just couldn’t stand the drug so he got off it.

The New York Post
May 24, 2006

MIRACLE GROW

THE final secret of “The Da Vinci Code” - the mystery of Tom Hanks’ long, college-professor hair - may be out. Top dermatologists believe the two-time Oscar-winner (above), whose hairline has headed north in recent years, popped the hair-growth drug Propecia to get his locks back. “The drug gives new hair the look Hanks is now sporting,” said one expert. “I haven’t a clue,” the actor’s flack, Leslee Dart, responded. But Hanks did cryptically reveal to Entertainment Weekly that he’d worked with a “hair chemical expert.” Well, at least he didn’t wig out.

#18

I just noticed that two media outlets are running coverage of Baylor College of Medicine’s PFS study:

-The Examiner, which notes “It’s an important study”

-PharmaBiz.com, which bills itself as “India’s most comprehensive pharma portal”)

Full coverage here:

The Examiner
examiner.com/article/men-exp … de?cid=rss

PharmaBiz.com
pharmabiz.com/NewsDetails.as … 7281&sid=2

Please click on each link so the editors see that people are reading. And please leave a comment as well. Particularly on The Examiner story, it’s important for the author to see your feedback firsthand.

#19

How about the Harvard one?

Any media coverage that one do you know?

#20

Yes, I see the PFS Foundation has posted this on its media awareness page:

pharmaceuticalonline.com/doc … pital-0001