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Testosterone Replacement, Low T, HCG, & Beyond
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<blockquote data-quote="Cataceous" data-source="post: 248782" data-attributes="member: 38109"><p>It's speculation. In <a href="https://thinksteroids.com/articles/enclomiphene-serm-seeking-fda-approval-treatment-of-hypogonadism/" target="_blank">this detailed article</a> Peter Bond reaches the same conclusion:</p><p></p><p style="margin-left: 20px"><em>Importantly, the only endpoints were testosterone, LH, and FSH levels, and sperm concentration. Clinically relevant endpoints, such as sexual desire, erectile function, fatigue/vitality, etc. were not investigated. Seemingly also not in the other (published) trials. Or, perhaps, they were investigated, but simply never reported in the study results because the results were disappointing. And I think it might’ve been the latter, as the FDA did not approve the drug for the treatment of secondary hypogonadism, because there was a lack of measurable symptomatic improvement [10]. The EU equivalent of the FDA, the EMA, also refused the marketing authorisation for enclomiphene some time later, with similar concerns:</em></p> <p style="margin-left: 20px"></p> <p style="margin-left: 20px"><em>“The CHMP [Committee for Medicinal Products for Human Use] noted that although the studies showed an increase in testosterone levels with EnCyzix [enclomiphene], they did not look at whether EnCyzix would improve symptoms such as bone strength, weight gain, impotence and libido. In addition, there is a risk of venous thromboembolism (problems due to the formation of blood clots in the veins) with the medicine.”</em></p></blockquote><p></p>
[QUOTE="Cataceous, post: 248782, member: 38109"] It's speculation. In [URL='https://thinksteroids.com/articles/enclomiphene-serm-seeking-fda-approval-treatment-of-hypogonadism/']this detailed article[/URL] Peter Bond reaches the same conclusion: [INDENT][I]Importantly, the only endpoints were testosterone, LH, and FSH levels, and sperm concentration. Clinically relevant endpoints, such as sexual desire, erectile function, fatigue/vitality, etc. were not investigated. Seemingly also not in the other (published) trials. Or, perhaps, they were investigated, but simply never reported in the study results because the results were disappointing. And I think it might’ve been the latter, as the FDA did not approve the drug for the treatment of secondary hypogonadism, because there was a lack of measurable symptomatic improvement [10]. The EU equivalent of the FDA, the EMA, also refused the marketing authorisation for enclomiphene some time later, with similar concerns:[/I][/INDENT] [INDENT][I][/I][/INDENT] [INDENT][I]“The CHMP [Committee for Medicinal Products for Human Use] noted that although the studies showed an increase in testosterone levels with EnCyzix [enclomiphene], they did not look at whether EnCyzix would improve symptoms such as bone strength, weight gain, impotence and libido. In addition, there is a risk of venous thromboembolism (problems due to the formation of blood clots in the veins) with the medicine.”[/I][/INDENT] [/QUOTE]
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