Martin - A Personal Journey Through a Clinical Trial
It's not everyday that one gets the opportunity to be part of something, that not only will help your own future, but to help the future of others too.
I was asked to take part in a clinic trial for a new testosterone replacement product. MD-Lotion. Manufactured by Acrux Pharma Pty Ltd, here in Melbourne. I was the perfect candidate for I had lost one of my testicles to cancer in 1994, then the other to atrophy in 2002. So bar the single prosthesis I had fitted after the second one was removed, I no longer have the bits to produce my own.
Testosterone replacement comes in a number of forms. There are the patches, simular to the type to give up smoking. Injections, either two or twelve weekly. Implants, simular to the size of a tic-tac, laid under the skin in either the stomach or rump and the gel. This is the type I am on, rubbed on daily, to the arms, shoulders and torso.
But why is testosterone so important for a male? Simply it is the balance hormone, responsible for mood, libido, body growth and the maintenance of bone structure. Without it, libido becomes zero; mood can swing from complacency to aggression and back again in a moment. Energy levels dramatically reduced. Lack of sleep, depression, night sweats and day-time hot flushes. And what with the inability to concentrate, there is the long term result of Osteoporosis
December 10th 2008
This day was the last day I was able to apply my life-line to sanity. I was now fully aware of the symptoms that I might experience during the next thirty days. I say might because how this would affect one person, may not necessarily be the same for another. An appointment had been made for me at the Monash Medical Centre in eight days time to have my first of many blood tests. This prior week was a wash out period of all testosterone in my body. I normally plod along at a level around the fourteen mark, [Australian levels range from seven being low to a high of thirty]. Mine after one week, were below one and it would be another three weeks before I would be able to have my first dose of the new product.
The first three days I felt exceptionally good despite being flat out at work. No change in mood, libido or energy. The fourth day was the start of a downhill path. I was getting home more tired than usual, and although erections were as good as ever, my sleep patterns started to become erratic. My tiredness also took a different turn as I felt the strength in my muscles was being sapped out. By the tenth day the hot flushes and the night sweats were constant. Mood was fine, though I was always making a constant effort to keep it in check. Sleep was becoming a luxury and any erection was short lived. My weight had also dropped two and a half kilos with no change of diet to put it to.
At the two week mark, tiredness was constant. I started becoming aloof, just wanting to be on my own and avoiding interaction with other people. I no longer had to keep myself in check which I put down to being just too tired to react. I would cat nap whenever the opportunity became available and the only erections that happened were when my wife and I would cuddle up for a morning lie in. But they were nothing to write home about. Emotionally I was not as bad as I had expected, though my own desire for isolation probably helped me there. By the end of December I started to experience two strange body reactions. One was waking up feeling that my body wanted to scream, yet I was calm and peaceful. The other, my penis started to hurt at night. Although being only partially erect it was a feeling simular to the outward expression of an orgasm, but the opposite in an inward manner. I spoke to my endocrinologist about these two incidents, plus the weight loss and he could give no logical reason.
January 7th 2009
This was the last day of nil testosterone replacement. I posted an email, part of which read:
Tomorrow I go for a blood test and then my first dose of the new product. I almost feel like a junkie hanging out for a fix. I just long to feel so much better. To be able to sleep at night. To dream the dreams of a normal person. To not have hot flushes when someone I care for gets to close to me. To make love to my wife who has been my partner, best friend and soul mate for near forty years and to not feel as I now do, like someone that is collapsing within themselves.
Looking back now, that is exactly how I felt. That I was collapsing within myself. At least I knew the time-frame of what I had to do to be part of this project. I wonder how the guys of not so long ago survived, with only the ignorance of the medical professionals on their side.
By the eleventh of January I had been taking the MD-Lotion for three days and I was feeling much better. This came in liquid form, via a plunger bottle, which gave a specific dosage. The bottle’s cap had a flexible insert simular to an eye bath. The cap was filled and the liquid lotion rubbed under the armpit. I had to have two doses, so the operation was duplicated and rubbed under the other arm. No mess, dry and done in seconds. I was starting to sleep most nights and was pleasantly on the fourth morning, woken with an erection that yelled not only a ‘Good Mourning’ but a definite ‘I’m back’ the hot flushes reduced as with the night sweats. But not completely. I felt that the dosage I was been given was not sufficient for me though any dosage up or down would be rectified on the first of my overnight stays in the Alfred Hospital. This is when I found out having some dosage had a problem I had not bargained. I became impatient, intolerant and inwardly aggressive. It took constant self checking and even then I lost out a couple of times.
Unfortunately I had a problem. The varicose veins I had on my right leg became much worse. I had done nothing about them previously, as I had had them for years. Part an inheritance from my mother and part smashing up my leg in a motorcycle accident. My leg was scanned when a blood clot, the size of an egg, appeared behind the knee.
Thrombophlebitis is not something to be mucked around with and certainly not to be left till the trial ended at the end of May. Of course I had to inform the trial organisers of the impending surgery and, rightly, they told me that I would not be able to continue. But that would not be until after an overnight stay in the Alfred hospital in Melbourne. So in the afternoon of Wednesday 20th of January I checked in to be prepared for a 24 hour blood testing. This was to be done every four hours through the next day, starting at 6.30 am and the last being at the same time on the Friday morning. I had become a lab rat. And a very interesting experience it was too. A shunt was put in my arm so they had ‘blood on tap’ I remember being woken up early hours on the Friday morning and just saying, help yourself, then going back to sleep. I will add though that all samples were taken EXACTLY at four hour intervals. Not a second before or a second after. Exactly thirty minutes after I was allowed to eat. This reminds me. The staff were wonderful, but the food was TERRIBLE. I said to one of the nurses that the kitchen wasn’t locked to keep us starving patients from helping themselves, but to stop what was inside from escaping. There must have been at least two dozen of us. I was the only one testing the MD-Lotion. The others, mainly back-packers were trialling other products. I bumped into guys from Ireland, France, the States and Canada. A couple were Aussies returning home but in need for a feed, a bed for a few nights and some cash. By seven o’clock on the Friday morning I was back in the open air, making my way home. Also I was back on the Testogel, which I applied straight after my final blood test.
I felt sad that I was not able to complete something that I had agreed to, yet glad that I could get my leg fixed, no longer be in discomfort and get on with my life. The only duty I then had left, was to attend the Monash Medical Centre a week later, to hand in the psychosexual questionnaire I had to fill in daily, hand back the remaining MD-Lotion and tidy up some odd paperwork.
The conclusion of it all is that I am glad I was able to take part in this clinical trial. The suggestions I was given as to how I might feel, being totally off testosterone replacement therapy for thirty days, certainly opened my eyes a touch wider and very much helped. It also gave me a much clearer insight as to who I was. I will be on some form of testosterone replacement for the rest of my life, so I feel that the best I got out of this trial, is the knowledge that there will also be something better being developed. For any of you who might one day consider doing as I did, do it knowing that one day you will be part of something that will improve another person's, or even your own, way of life. For now, as I have mentioned, I am back on the Testogel. I used to think it was the bee’s knees. Now I think it is a long winded, messy pain in the neck.
Boy I can’t wait for the new product to hit the market!
Martin [Melbourne Australia]
Martin Yalden [Melbourne Australia]
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