Pharma-Grade Enclomiphene now available
- Thread starter Marco N Cognito
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These are two separate things. FDA approval means that a drug has been shown to be safe and effective in treating a particular condition, and it may be manufactured and marketed. The approval process is long, difficult and expensive.
Off-label prescribing refers to an unapproved use of an approved drug. Once a drug is approved then healthcare providers are given discretion in prescribing it for purposes other than what was used to gain approval: "... when they judge that it is medically appropriate for their patient."
Ostensibly, unapproved drugs such as enclomiphene and ipamorelin can be prescribed when they are compounded, thus falling less under the FDA's jurisdiction:
[1]
There has been new regulation subsequent to these remarks, which created a new category of compounding pharmacies, still not quite manufacturers, but now subject to FDA inspections and quality standards. Some details here.
I won't claim this clears everything up, but it at least gives a sense of the regulatory environment.
Marco N Cognito
Member
In those whose E2 is already low or low normal, I would be concerned that enclomiphene (being a pure estrogen receptor antagonist) might push them over the edge, further reducing E2 to unhealthy levels. Therefore, what about cycling low dose clomiphene concurrently to effectively keep the E2 levels from further supression? Thoughts?
Maybe taking DHEA to raise E2 if necessary and therefore avoid introduction of zuclomiphene isomer back into the mix? However, contra this thought, see Castaneda's post on High estrogen / SHBG. He says his experience with taking DHEA results in no E2 increase, but higher E1, carrying SHBG higher, and therefore binding more E2.
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There is one guy on the PeakT site who has obtained enclomiphene from Tailor Made via his local TRT doctor.
The usual problem with Clomid is too much estrogenic action, not to little. I'd expect enclomiphene alone to stimulate plenty of intratesticular aromatization via the increase in LH. But if not, isn't zuclomiphene a rather poor choice for an estrogen replacement? The long half-life is grossly mismatched with the 10-hour half-life of enclomiphene. If a guy's estradiol is that low wouldn't it make more sense to take estradiol directly? However, boosting estrogen exogenously works against the enclomiphene, at least to some extent.
I am very interested in Enclomiphene, and a patient of Defy. If this medication does come available I would be on this in a heart beat. I truly believe this medication will help my conditions.
If Defy finds a way to bypass any legal rights and start clinical trials I will volunteer and take this medicine lol.
If Defy finds a way to bypass any legal rights and start clinical trials I will volunteer and take this medicine lol.
Or just find a doc who will write the enclomiphene prescription using Tailor Made Compounding Pharmacy.
Has anyone been successful with using this pharmacy yet? I can provide this information to my doctor, but I do not want to waste his time or pose any risk his license.
Marco N Cognito
Member
How long have you been on it and can you tell any difference from TRT and clomid thus far?
If you go read the thread at peaktestosterone.com it will answer your questions.
Tailor Made, I assume? They're the only ones I know that dispense it. Let us know how it works out. Would be great if you did baseline labs before and track it from there. I'm curious to know if it will yield any subjective benefits similar to frank T, but doubt it, as the only difference from regular clomiphene is the absence of the estrogenic zuclomiphene ester.
Yes Tailor Made, 25mg EOD to start with total quantity of 45x capsules. The cost was $130.
I do have baseline labs, once I have more data (more time) I can start a new thread and upload all my findings.
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