Repros Initiates Two Head to Head Studies of Androxal(R) Versus the Leading Topical T

[Nelson Vergel]

It is very interesting to me that the endpoints of this study do not include improvement in sexual function. Clomiphene has shown not to improve it! Androxal is a clomiphene (Clomid) isomer (since Clomid is a generic, the company changed the molecule a tiny bit to patent it and get approval)

"The primary endpoint of the study is the comparison of Androxal to the topical gel from the perspective of normalizing testicular function. As such, men must exhibit 24 hour average testosterone levels in the normal range (300-1040 ng/dL), and an average of two sperm counts at the end of the study must remain above the lower bound of the 95% confidence interval for normal male fertility (15 million/mL). Based on results from previous Repros studies, the Company believes the two trials are suitably powered (90% power, alpha=0.05) to demonstrate the key difference between restoration of normal testicular function with Androxal versus the T replacement-induced suppression of male reproductive organ activity."

http://www.marketwatch.com/story/re...tosterone-gel-2014-01-08?reflink=MW_news_stmp

Previous post on excelmale about this company: https://www.excelmale.com/forum/thr...-studies-for-clomiphene-drug?highlight=repros

 

[Nelson Vergel]

THE WOODLANDS, Texas, April 30, 2014 (GLOBE NEWSWIRE)

Repros Therapeutics Inc.(R) (Nasdaq:RPRX) today announced that it has received guidance from the Food and Drug Administration (FDA) regarding primary endpoints for the two studies, ZA-304 and ZA-305, that Repros is currently conducting of Androxal(R) against a leading approved testosterone gel. The FDA stated that sperm concentration reductions should take into consideration recognized thresholds for fertility treatments, and also that the clinical significance of the degree of sperm concentration decline between the beginning and end of the treatment period is important, as it may represent an adverse effect on fertility, even if sperm concentration stays in the normal range. To address these issues, the FDA recommended, "Show that the enclomiphene-treated men are significantly more likely to maintain normal sperm concentrations compared to those treated with your testosterone active control. Also show that the enclomiphene-treated men have a significantly smaller decline in total sperm concentrations as compared to your testosterone active control. This approach would involve a co-primary efficacy endpoint. Both components of the co-primary efficacy endpoint should show statistically significant and clinically relevant differences (you will need to justify the clinical relevance of the observed differences). Other important endpoints should include other semen parameters, testosterone concentrations and comparisons between your product and placebo and between testosterone and placebo. If there are no meaningful differences between your product and testosterone or between testosterone and placebo, we will question the utility of your product."
The FDA further stated that, rather than a cutpoint of 15 million sperm/mL, a 10 million sperm/mL, which is recognized as the threshold for needing invitro fertilization, and a 20 million sperm/mL, which is recognized as the threshold for needing intrauterine insemination in infertile couples, might be more clinically relevant cutpoints for defining low sperm counts and thresholds below which an absolute negative effect on spermatogenesis could be substantiated. While the FDA strongly recommended in its guidance that the Company resubmit the revised protocols before initiating the trials, the Company instead has substantially enrolled the trials and plans to continue to engage the FDA, during the conduct of the trials and before unblinding the data, in discussion of the specifics of the spermatogenesis endpoints in order to meet FDA expectations. The Company notes that men enrolled into the study are clearly hypogonadal and fertile as determined by central laboratory assessments. These criteria have been consistently referenced in FDA correspondence. Furthermore, the Company believes, based on its experience with Androxal(R) and exogenous testosterone products, that the studies are well powered to meet any permutation of the comparative sperm endpoints outlined in the FDA guidance.

 

[txmx]

So far in Repros studies, the benefit of expensive brand name Androxal pill over cheap generic clomiphene pill that performs the same function is.......nothing? They really need to explore any subjective benefit to be found by doing away with the zuclomiphene isomer of clomiphene. That's the money shot. Otherwise Androxal serves no purpose, unless T gel users are unaware of clomiphene availability.

 

[Nelson Vergel]

The FDA sends the maker of enclomiphene back to drawing board