Two new phase 3 clinical trial by Tennessee Medical Center in Knoxville USA have shown positive results for a drug which aims to replace Testosterone Replacement Therapy.
Enclomiphene Citrate has been branded as ‘Testosterone Restoration Therapy’ – but aiming to achieve in a pharmaceutical product what natural testosterone boosting supplements have been doing for years using natural products.
Much like steroids, one of the (many) problems with TRT is that when synthetic testosterone is introduced into the body, the body stops producing it’s own. Often the body will resume it’s own natural production once the therapy or course is complete. Sometimes it won’t.
When the body is not producing it’s own testosterone sperm count will drop, as the body requires it’s own testosterone to create sperm. One of the side effects of TRT is that it can therefore lead to infertility.
This new product works in the same way to drugs designed to help women ovulate – it encourages the body to produce it’s own testosterone and therefore maintain sperm count.
The results of the clinical trials have been extremely positive. The team of researchers conducted a five month long study on overweight men with low test. They were split between patients receiving TRT in the form of Androgel and patients receiving the new Enclomiphene Citrate. 152 subjects in total were used, there were 4 groups (including a placebo group).
Both sets of subjects receiving the full dosages had normal test levels after 16 weeks – but the Androgel subjects had marked reductions in sperm count whilst the Enclomiphene Citrate subjects did not.
The trials themselves were textbook quality (read our article on clinical trials for more info);
And crucially there doesn’t seem to be any evidence of the kind of conflicts of interest and sham trials that bedevil the natural test boosting market. This is shaping up well.
There are numerous natural ingredients which are particularly effective on overweight men, or men with low test – it will be interesting to see what effect Enclomiphene Citrate has on men with a normal body weight / sperm count.
Or more extreme still, athletic guys who build muscle and have normal test levels.
Will this product be able to boost test production past the norms, and will it end up being abused in the same way steroids are?
The other question (which will be at the forefront of the minds of supplement companies doing natural test boosters) is – how much will this therapy cost. The supplement manufacturers will surely be hoping it’s priced through the roof.
And there’s no reason why it wouldn’t be, pharmaceutical companies are not renowned for their charitable pricing structures, and the main competitor Androgel is extremely expensive. Why would a more effective competitor with less risk and fewer side effects need to be cheaper?
Time will tell how this new product is branded and marketed. However that assumes it ever gets there. As this FDA info page on clinical trials explains, they will still have another phase of trials to go through, and the phase 4 trial can take anywhere between 1 and 4 years to complete.
At stage 3 only 25-30% of drugs ever make it fully through to market.
So whatever happens with Enclomiphene Citrate, it won’t be on the shelves in the immediate future.