Is “Enclomiphene Citrate” going to replace hCG in the USA?

[Nelson Vergel]

Enclomiphene never got approved by the FDA. The FDA is also looking at banning any compounding pharmacies from making it.

Repros Therapeutics Stock Plunges as FDA Advisory Panel Cancels Enclomiphene Review

www.biospace.com

Enclomiphene - A SERM That was Seeking FDA Approval for the Treatment of Hypogonadism

Repros Therapeutics Inc, made an attempt at making a SERM approved by the FDA for the treatment of secondary hypogonadism. Before I continue about how this process went, I’d like to provide some background on their SERM: enclomiphene citrate (brand name Androxal, later rebranded to EnCyzix).

thinksteroids.com

To be honest, after reading many posts on ExcelMale from guys who tried enclomiphene, I do not remember one saying that it increased their libido. Their bloodwork looked great on paper!

Past enclomiphene posts

 

[jacb]

To be honest, after reading many posts on ExcelMale from guys who tried enclomiphene, I do not remember one saying that it increased their libido. Their bloodwork looked great on paper!

Interesting, so if all the perimeters that we normally look for in our blood work were optimal, there must be something we have either overlooked or do not yet test for when it comes to improving libido.

I must say I miss hCG and was interested in hearing about the pros and cons of enclomiphene in case it was a viable option. It seems that before the judgment about its use has been agreed, it is already in danger of being removed from circulation (no pun).

I liked hCG because it:

1. Increased Penile sensitivity
2. Prevented testicular atrophy
3. Maintained the IT function of the testicles (long term testicular health)
4. Increased ejaculate for a more intense orgasm

I note that the FDA cancelled its revue in 2015 … Let’s hope that now HCG is difficult to obtain someone else make a new review application.

 

[Nelson Vergel]

Interesting, so if all the perimeters that we normally look for in our blood work were optimal, there must be something we have either overlooked or do not yet test for when it comes to improving libido.

Messing with estrogen receptors is not a good idea, in my point of view.

The role of estradiol in males: Implications for libido and testosterone replacement therapy.

Historically, when we think of sex hormones in men and women, we identify testosterone as the core regulator of orderly male growth and sexual function. In a similar fashion, we identify estrogens central to regulating sexual and reproductive function along with a host of non-reproductive...

www.excelmale.com

"Change in estradiol level was the best predictor not only of the change in bone density and sexual desire but also of the changes in hemoglobin and HDL cholesterol." From: Relation of Testosterone, Dihydrotestosterone, and Estradiol With Changes in Outcomes Measures in the Testosterone Trials - PubMed

Effect of Estradiol on Men's Libido

Descriptions of the roles of estradiol in men and its management in men on testosterone therapy.

www.discountedlabs.com

Study in mice:

" Our findings suggest testosterone activates male sexual behavior in part via conversion to estradiol in the brain." Brain Aromatase and the Regulation of Sexual Activity in Male Mice

 

[jacb]

Thanks Nelson

I guess we can’t have it all and it comes down to one’s priority’s .. You talk of Libedo and I listed my hCG liked items above.

It would appear that TRT is once again under attack. First, HCG then Enclomiphene availability/cost and now in my country Testosterone Cypionate is no longer available via GP’s. Having been replaced by Sustanon as the only option.

With TRT it feels like one is pushing water uphill with a sharp stick.
“Who’s Life is it Anyway”?

 

[Nelson Vergel]

Just to let you guys know.

Is enclomiphene being discontinued?

I received an email from empower saying the FDA is cracking down on enclomiphene, anyone have additional information?

www.excelmale.com

 

[jacb]

Thanks Nelson .... That link about the FDA and enclomiphene is hard going for a lay person ..... can you sum up the FDA's decision for us? Will it/has it been discontinued?

It seems that enclomiphene is effective in the right circumstance. I see that very definitely raises LH and FSH and to certain extent T' .... I don't believe that the link concerned itself with enclomiphene AND supplementary Testosterone at the same time?

 

[Nelson Vergel]

Compounded Enclomiphene will not be produced anymore. It was never approved by the FDA and they decided to ban it this week.

 

[madman]

Thanks Nelson .... That link about the FDA and enclomiphene is hard going for a lay person ..... can you sum up the FDA's decision for us? Will it/has it been discontinued?

It seems that enclomiphene is effective in the right circumstance. I see that very definitely raises LH and FSH and to certain extent T' .... I don't believe that the link concerned itself with enclomiphene AND supplementary Testosterone at the same time?

Recommendations

*After considering the information currently available, a balancing of the four evaluation criteria weighs against enclomiphene citrate being added to the 503A Bulks List. R

 

[tareload]

Just an observation to let members know how fortunate (really downright spoiled) they are to have a database of such comprehensive information all in one place. Obviously this is due in large part to @madman, @Cataceous and of course @Nelson Vergel among others. Incredible effort (words which doesn't come out of my lips very easily as a pathologic perfectionist). Thank you very much folks. Above and beyond the call of duty.

 

[Nelson Vergel]

@readalot Thanks a lot, man. It means a lot coming from you. We owe it to @madman who is a mad man when it comes to catching ALL studies that are published regarding men's health. @Cutaceous and others like you also keep this forum's quality high.

 

[jacb]

Recommendations

*After considering the information currently available, a balancing of the four evaluation criteria weighs against enclomiphene citrate being added to the 503A Bulks List. R

Thanks Madman

Not being from the USA I had no idea what the
"503A Bulks List" was.

To clarify, hCG and now Enclomiphene have been banned by the FDA from being produced by compounding pharmacies.

Both these products will continue to be produced by "Big Pharma", but prices will almost certainly significantly increase.

It remains to be seen if Enclomiphene replaces hCG + T' use outside of the USA.

 

[tareload]

Both these products will continue to be produced by "Big Pharma", but prices will almost certainly significantly increase.

FYI...never FDA approved in US.

Enclomifene - Wikipedia

en.wikipedia.org

Androxal (enclomiphene): What is it and is it FDA approved? - Drugs.com

Androxal (enclomiphene citrate) is a new drug in development for the treatment of hypogonadism. Androxal information includes news, clinical trial results and side effects.

www.drugs.com

 

[jacb]

FYI...never FDA approved in US.

Yet compounding pharmacies produced it and now they don’t following the latest ruling. By inference that looks like you can do what you like unless it’s black listed!

 

[Nelson Vergel]

Yet compounding pharmacies produced it and now they don’t following the latest ruling. By inference that looks like you can do what you like unless it’s black listed!

The ruling was this week.

 

[jacb]

The ruling was this week.

I do understand that Nelson, but previously Readalot had said “FYI...never FDA approved (Enclomiphene) in US”. My point was even without previous FDA approval, compounding pharmacy’s had been producing it. This made it appear to those of us who are not familiar with the US system, that you can do what you like in compounding terms, until you are expressly banned from doing it by the FDA.

Either way it causes those of us on TRT another problem since Enclomiphene and hCG have now both been removed from compounding pharmacies and this greatly pushes up the cost of our treatment.

I did note what “Low T Nation“ had to say about the effect on the testicles of long term treatment with only Testosterone (no HCG or Enclomiphene) in their latest video.

Whats is left in the affordable medicine cupboard now?

 

[jacb]

The Pharmacy Compounding Committee (PCAC) debate and vote that was held on the 8 June 2022, regarding Enclomiphene and allowing or not allowing it to be produced by compounding Pharmacies can be found here. The vote (following the debate) was taken at minute 2:16:10.

The video is not very stimulating, but for those of us who are not familiar with the USA system, the audio track gives great insight into how the decision was made. A decision which greatly effects the cost and options re our TRT treatment. Enclomiphene has now suffered the same fate as hCG.

 

[tareload]

Yet compounding pharmacies produced it and now they don’t following the latest ruling. By inference that looks like you can do what you like unless it’s black listed!

Note my response was to your quote above. Enclomiphene will not continue to be produced by big Pharma. It was never produced by big pharma as it was not approved by FDA. Hence the difference between hCG and enclomiphene. hCG continues to be produced by pharma companies.

 

[jacb]

Note my response was to your quote above. Big pharma will not continue to be produced by big Pharma. It was never produced by big pharma as it was not approved by FDA. Hence the difference between hCG and enclomiphene. hCG continues to be produced by pharma companies.

Hi Readalot

I read "Big pharma will not continue to be produced by Big Pharma" as "Enclomiphene, will not continue to be produced by Big Pharma" .. I hope this is correct.

In the USA I understand that only Big Pharma will now produce hCG.

Enclomiphene will now only be produced outside of the USA. EG: Non USA Product En-Clofert

Is this correct?

 

[tareload]

Hi Readalot

I read "Big pharma will not continue to be produced by Big Pharma" as "Enclomiphene, will not continue to be produced by Big Pharma" .. I hope this is correct.

In the USA I understand that only Big Pharma will now produce hCG.

Enclomiphene will now only be produced outside of the USA. EG: Non USA Product En-Clofert

Is this correct?

My apologies for typo. I corrected. Yes thanks.

Also see EU situation:

EnCyzix | European Medicines Agency (EMA)

www.ema.europa.eu

 

[jacb]

Also see EU situation:

EnCyzix | European Medicines Agency (EMA)

www.ema.europa.eu

It dosnt seem to be going Enclomiphen’s way … maybe more studies in time would help? But who is going to do them?

It remains to be seen what the likes of the UK, NZ, India do.