Ranjith Ramasamy, MD, Director of Reproductive Urology at the University of Miami Health System talks about low testosterone, the signs, and a trial that is evaluating nasal testosterone and fertility.
Interview conducted by Ivanhoe Broadcast News in April 2019.
We’ve heard about low testosterone, but what does it mean and how many men are affected by this?
RAMASAMY: Low testosterone is a condition in which men will have a low serum testosterone level. When they check their blood test for testosterone, they could have a low level. And if this is checked twice and they have symptoms of low testosterone such as lack of energy, fatigue, improper sleep, weight gain, erectile dysfunction, or lack of libido, then together it’s a syndrome called hypogonadism in which men can get treatment for low testosterone. Now traditionally this was commonly diagnosed and screened in men who were older and terms like late onset hypogonadism was used. But now over the last 10 years we have identified that due to factors such as stress, obesity, and improper sleep habits, young men have been diagnosed with low testosterone. And so we’ve now identified at least one in three men between the ages of 30 to 50 appear to have low testosterone.
It is that common?
RAMASAMY: It’s a very common condition and some men go to their doctor to get their blood tested. Some men do not get it checked.
Right. Because there may be telltale signs for the person.
RAMASAMY: If they have lack of energy, they are experiencing weight gain, they are not able to have the same level of activity that they used to do in the past, then they are all signs of low testosterone and it’s best to get it checked with a simple blood test.
Right. Because like you’re saying, doctor, people may mistake it as, well I’m just tired.
RAMASAMY: It’s just normal. Yeah, you’re just tired or people attribute it to normal aging. And so therefore they don’t get it checked. But if you do get it checked, there are very good treatment options that are available for low testosterone. And men can actually start feeling better.
What were we looking at as far as treatments? Because we heard a little bit about patches, this kind of thing.
RAMASAMY: Right. Testosterone treatment can come in various forms. Unfortunately, the form that most men would like to take is pills and testosterone is not available as pills. It’s either available as injections or pellets that are placed in the office or gels that are applied on men once a day. Now all of these treatments will actually block hormones from the pituitary gland which are important for sperm production. Now older men often are not concerned about fertility and so therefore these are very good treatment options for men who have either completed their families or are not interested in future fertility. However in this young population of men, testosterone therapy is a contraceptive. So it cannot be used in men who have either not completed their family or are still interested in building their family. And so testosterone therapy should be used very cautiously in this young population of men who are still interested in having kids.
Up to this point there hasn’t been a very good treatment option for younger men with this condition.
RAMASAMY: Absolutely. The medications that are currently being used are off-label and are not FDA approved and are medications that were traditionally used in women to increase the egg count, and have been now transposed on to these young men to increase their own testosterone and sperm production.
That brings us to this new treatment that I’ll have you talk about, what it’s called, if it is FDA-approved, and why is it so different and why is it so exciting?
RAMASAMY: Correct. It’s a new treatment because we are now studying this for a new indication to be used in young men who want to preserve their fertility. It’s called Natesto. Just as it stands, it’s nasal testosterone. So it’s a gel that is applied in your nose two to three times a day. And men use it frequently and are able to sustain their production of hormones from the pituitary because long-acting testosterone will block your production of hormones from the pituitary whereas because this is used two to three times a day and it’s short-acting, it still preserves your hormones from the pituitary. And therefore maintains your sperm production. So this is a very good treatment option for young men to not only increase their testosterone, but at the same time maintain their fertility.
You’re dispensing it through the nose, nasally, it’s getting the testosterone into the system?
RAMASAMY: Absolutely. Just like many other medications that we’ve put through the nose, like medications that are used for allergies go through the nose and are absorbed systemically. It’s the same concept. It’s absorbed through the blood supply from the nose and men who have been on the drugs so far have very good testosterone levels.
So how does it work, doctor? You said you take it two to three times a day. Is there any other protocol with it?
RAMASAMY: No. They just use it through the nose and the nice aspect of this medicine is that you don’t have to use injections once a day which a lot of men are scared of using needles once a day. Or you don’t have to worry about transference. When they use gels on their skin, they are often worried about touching their wives, touching their kids, because you could potentially transfer testosterone onto other family members. Whereas using it up the nose, it’s a little cumbersome but truly does not affect transference and avoids the use of needles or invasive procedures.
Wow. Any side effects so far – like anything that?
RAMASAMY: So patients who have had a history of allergies or sinusitis or rhinitis appeared to have a little bit more side effects with Natesto compared to other forms of testosterone therapy. So if you do have a history of those things you should let your doctor know that you have a history of those – because those could be exacerbated by Natesto. Beyond that, the regular side effects of testosterone therapy which is unique to all preparations – the FDA mandates that we discuss risks of blood clots as well as a risk of breast enlargement in men – that can happen – who are on testosterone therapy.
Let’s talk about the trial and how effective the medication has been. Does it work immediately? Does it take days or weeks?
RAMASAMY: Got it. Natesto is a short-acting testosterone. It acts fast and it clears from the system fast. As soon as you take Natesto the testosterone levels rise within one to two hours and it’s off the system within three to four hours. So it’s actually like an on-demand testosterone. And men often use it for on-demand activities such as going and exercising, working out, going for a run, or even sex for that matter. I think this is a new form of testosterone which can truly be used as an on-demand preparation rather than having testosterone levels high throughout the day. In the trial so far, we’re now looking at maintaining sperm production before and after Natesto administration. And after 40 patients we’ve completed the trial in about 20 patients and all of them have now preserved the sperm production. And so this is very exciting because so far all of the other testosterone therapies have basically blocked off men’s sperm production. And the fact that we’ve observed this so far is obviously a very exciting finding.
So this is part of a clinical trial that you are heading.
RAMASAMY: Correct.
Are you still enrolling patients and if the trial isn’t accessible to a person who sees this, is the medication available?
RAMASAMY: Sure. We’ve finished about 20 out of the 40 patients, so yes we are enrolling patients in the trial. The medication is actually FDA approved and has been in the market since 2012. So patients can certainly speak to their doctor, their internist, or the urologist about prescribing Natesto to them and it’s certainly available without participating in the trial.
Are you hearing from your patients? Doctor, what are you hearing from them?
RAMASAMY: The patients are very happy. So first I had reservations about having to take a medication through the nose two to three times a day. I didn’t think men would actually like it. But so far all the patients that have been on the trial are extremely happy. They’re very happy that they’re not worried about transferring the medication onto their partners, or their spouses, or kids and they’re very happy with the results. They’re able to lose weight. They get back to the gym. Obviously, their sex life has improved.
Some men feel, I’m manly. I don’t have this these problems. But this is a medical condition, right, doctor? You have to talk to your doctor. You have to get help.
RAMASAMY: Absolutely. Low testosterone is a condition that has been around for the last 25 years but because of a lot of the bad press it has received in terms of men’s health clinics administering testosterone therapy even without checking testosterone levels in men to see if it’s low or not, I think that has been a bad press about testosterone therapy in general. But if men truly have low testosterone levels checked in the morning on at least two separate blood draws, then you certainly want to investigate as to why you have low testosterone. And see if there are any other organic causes that could lead to low testosterone. And as long as the causes remain idiopathic and there is unknown cause, you should certainly discuss therapy with your doctor.
That makes sense. So doctor, if someone sees this. They’re interested in Natesto. Where can they find more information from you or nationally?
RAMASAMY: Sure. So they can go to clinicaltrials.gov and type in the word Natesto and they can have all of the information that is to do about the trial, the study coordinator and our information to reach us.
Is it covered by insurance?
RAMASAMY: So most insurance companies will cover Natesto. If they do cover Natesto, it’s a $10 copay per month. If it is not covered by insurance, it’s $200 per month.
END OF INTERVIEW
This information is intended for additional research purposes only. It is not to be used as a prescription or advice from Ivanhoe Broadcast News, Inc. or any medical professional interviewed. Ivanhoe Broadcast News, Inc. assumes no responsibility for the depth or accuracy of physician statements. Procedures or medicines apply to different people and medical factors; always consult your physician on medical matters.
If you would like more information, please contact:
Jose Boza, Public Relations
786-326-7988
Sign up for a free weekly e-mail on Medical Breakthroughs called
First to Know by clicking here
