ANDROXAL - Latest Update

Marco N Cognito · Dec 31, 2014

Still got a ways to go before FDA approval, but it looks like injections and gels will eventually become phased out with a TRT agent exhibiting a significantly lesser side effect profile that actually enhances HPTA, and most importantly, induces ENDOGENOUS production of both total and free T in those with secondary hypogonadism via stimulation of both LH and FSH:
http://www.zacks.com/stock/news/158927/repros-gains-on-positive-updates-on-the-status-of-androxal
http://reprosrx.com/androxal.php

Other research re Androxal:
http://www.ncbi.nlm.nih.gov/pubmed/19204885
http://www.ncbi.nlm.nih.gov/pubmed/23530575
http://www.tunedsports.com/steroid-...e-future-of-testosterone-replacement-therapy/
http://www.fertstert.org/article/S0015-0282(04)01521-3/abstract
http://www.livescience.com/47094-clomid-treat-low-testosterone.html

I would suspect, but am not certain, that since enclomipheme citrate (Androxal) is an estrogen receptor antagonist, and excess estrogen (specifically E2) is amongst the primary facilitators of thrombotic (blood clots) and other untoward cardiovascular events that have been reported in a small percentage of both men and women using the current exogenous TRT agents (i.e. injections, gels, pellets), those of us with a history of either familial (genetic) or idiopathic (unknown origin) thrombophilia may finally have us an agent free of risk as long as we stick to physiologic replacement levels.

tmckenzie · Dec 31, 2014

Marco N Cognito said:
Still got a ways to go before FDA approval, but it looks like injections and gels will eventually become phased out with a TRT agent exhibiting a significantly lesser side effect profile that actually enhances HPTA, and most importantly, induces ENDOGENOUS production of both total and free T in those with secondary hypogonadism via stimulation of both LH and FSH:
http://www.zacks.com/stock/news/158927/repros-gains-on-positive-updates-on-the-status-of-androxal
http://reprosrx.com/androxal.php

Other research re Androxal:
http://www.ncbi.nlm.nih.gov/pubmed/19204885
http://www.ncbi.nlm.nih.gov/pubmed/23530575
http://www.tunedsports.com/steroid-...e-future-of-testosterone-replacement-therapy/
http://www.fertstert.org/article/S0015-0282(04)01521-3/abstract
http://www.livescience.com/47094-clomid-treat-low-testosterone.html

I would suspect, but am not certain, that since enclomipheme citrate (Androxal) is an estrogen receptor antagonist, and excess estrogen (specifically E2) is amongst the primary facilitators of thrombotic (blood clots) and other untoward cardiovascular events that have been reported in a small percentage of both men and women using the current exogenous TRT agents (i.e. injections, gels, pellets), those of us with a history of either familial (genetic) or idiopathic (unknown origin) thrombophilia may finally have us an agent free of risk as long as we stick to physiologic replacement levels.

I hope gels etc are not phased out. Those of us with ess would be screwed.

Marco N Cognito · Dec 31, 2014

tmckenzie said:
I hope gels etc are not phased out. Those of us with ess would be screwed.

I have a partially empty sella which was diagnosed as an incidental finding on an MRI test some years back. However, as it turns out, my pituitary is still functional as I still respond to secretagogues like sermorelin. Unless you have documented ESS and/or are truly hypopituitary, I would not think this would be a problem.

tmckenzie · Dec 31, 2014

Yep. Unfortunately it is documented. Reconfirmed this week. Had an mri to look for a tumor as igf and gh are way too high.

Marco N Cognito · Oct 11, 2015

Update: "The company anticipates an FDA approval decision by November 30, 2015 for Androxal, a potential treatment for secondary hypogonadism. The FDA is also planning to hold an advisory committee (ADCOM) meeting to discuss the approvability of Androxal, on November 3, 2015."
Read more: Repros Therapeutics Inc. Poised To Move Higher (RPRX) http://www.investopedia.com/stock-a...nc-poised-move-higher-rprx.aspx#ixzz3oHqvWptn

HarryCat · Oct 30, 2015

Looks like Androxal is in trouble:

Repros Therapeutics Announces Cancellation of FDA Advisory Committee Meeting to Review Enclomiphene for the Treatment of Secondary Hypogonadism

THE WOODLANDS, Texas, Oct. 29, 2015 (GLOBE NEWSWIRE) -- Repros Therapeutics Inc.® (Nasdaq:RPRX) today announced that the Division of Bone, Reproductive and Urologic Products of the U.S. Food and Drug Administration (FDA) has cancelled the scheduled November 3, 2015 advisory committee to review the Company's New Drug Application (NDA) for its enclomiphene product candidate, formerly known as Androxal®, due to questions that arose late in the review regarding the bioanalytical method validation that could affect interpretability of certain pivotal study data.
The FDA has expressed its willingness to work with Repros to address these questions. The FDA accepted the NDA for review on April 1, 2015 and later assigned a Prescription Drug User Fee Act (PDUFA) goal date of November 30, 2015.