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(EU) Committee for Medicinal Products for Human Use (CHMP) Assessment report: EnCyzix (Enclomifene)

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Treatment of hypogonadotropic hypogonadism (secondary hypogonadism) in adult men aged ≤60 years with a body mass index (BMI) ≥25 kg/m2 which has been confirmed by clinical features and biochemical tests in patients which have not responded to diet and exercise



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Tristan Loscha

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Application rejected based on grounds of lack of shown evidence in regards to clinical endpoints, which is opposed by the divergent position, which sees benefit of increased serum testosterone as canonical and already proven in the literature elsewhere.
 

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hei

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They also claimed that "there is a risk of venous thromboembolism (problems due to the formation of blood clots in the veins) with the medicine"

But, according to their documentation, this was suffered by 5/1403 (0.35%) of recipients, 3 being morbidly obese and all having high estrogen, advancing age, and poor health. They said that because none were recorded in the control groups they can't rule out that the drug is dangerous, but the control groups were so much smaller that it's unlikely to see even a single case even if they occur at the same rate.
1608259052759.png
 

Tristan Loscha

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They also claimed that "there is a risk of venous thromboembolism (problems due to the formation of blood clots in the veins) with the medicine"

But, according to their documentation, this was suffered by 5/1403 (0.35%) of recipients, 3 being morbidly obese and all having high estrogen, advancing age, and poor health. They said that because none were recorded in the control groups they can't rule out that the drug is dangerous, but the control groups were so much smaller that it's unlikely to see even a single case even if they occur at the same rate.
View attachment 20755

Very true, i feel that the Benefit/Risk ratio is overall favorable, as long as causes of the hypogonadism are addressed, which were almost always obesity related in the cohorts, with the subsequent excess aromatization events located in the adipose storage and hypothalamic suppression of release of gonadoliberin and/or gonadotropins. Enclomifene and Tamoxifen are quite similar in their anti estrogenism, whilst clomiphene possesses both isomers, zuclomifene, which is a agonistic ligand of the E alpha/beta receptors, and Enclomifene, which is more thoroughly antagonistic. I think similar benefit can be derived from tamoxifen usage.
 
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