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

Joined
Dec 18, 2018
Messages
2,207
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



enclomifene1.PNG
 

Tristan Loscha

Member
Thread starter
Joined
Dec 18, 2018
Messages
2,207
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.
 

Attachments

  • encyzix-epar-public-assessment-report_en.pdf
    4.4 MB · Views: 3
  • questions-answers-refusal-marketing-authorisation-encyzix-enclomifene_en.pdf
    72.6 KB · Views: 1

hei

Member
Joined
Jun 7, 2019
Messages
227
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

Member
Thread starter
Joined
Dec 18, 2018
Messages
2,207
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.
 
Last edited:
Similar threads
Thread starter Title Forum Replies Date
Drareg Dr Hodkinson,Chairman Of The Royal College Of Physicians And Surgeons Committee In Ottawa On COVID Articles & Scientific Studies 5
E Do You Use Medicinal Mushrooms / And Shilajit? Supplements, Pharmaceutical Drugs 14
E Cordyceps Sinensis 5-Alpha-Reductase Assay Of Medicinal Mushrooms Scientific Studies 70
AlphaCog List Of Medicinal Tree Barks Supplements 1
D Medicinal, Nutritional Value Of Citrus Skins Diet, Recipes 2
haidut Amazing Medicinal Properties Of Beta-lapachone (β-lapachone) Supplements 22
haidut Amazing Medicinal Properties Of Emodin Cascara Sagrada 39
Makrosky Medicinal uses of L-Lysine Articles & Scientific Studies 5
R Suppliers Thread - Supplements, heatlth foods, pharmaceuticals, other products Supplements, Pharmaceutical Drugs 1
A Cheap Vitamin C products, any contamination risk? Ask For Help or Advice 8
F Indus Civilization People Ate Mainly Meat and Dairy Products Scientific Studies 1
ursidae Healing Power Of Animal Products? Where? Ask For Help or Advice 39
johnwester130 Erythritol Better Than Xylitol For Teeth Products And Mouthwash Oral Health 4
B Anti-Peat Collagen Supplements Are TOXIC WASTE PRODUCTS Debate - Anti-Peat 22
Brundle Would The Optimal Peat Diet Be Mostly Raw Animal Products And Fruit? Diet 38
B Tocopherol-based Products Gone Rancid? Supplements, Pharmaceutical Drugs 4
J Safe Hair Products To 'hold' Hair Body Care 0
T New NDT Products From Pimpom Natural Dessicated Thyroid 20
Lewis Acid Evaluation Of Natural Products On Inhibition Of (COX-2) & Nitric Oxide Scientific Studies 0
A Harmful Additives Or Contaminations In Cheap Vitamin Products? Ask For Help or Advice 5
A Idealabs Products Ask For Help or Advice 7
Hitchens Rahua Hair Products. Seems Peat Friendly Hair & Nails 0
N Cold/flu Type Symptoms After Eating Flour, Wheat, Products In High Amount? Symptoms, Causes 4
Francisco Best Aspirin Products? Ask For Help or Advice 5
A Idealabs Products Recommendation Ask For Help or Advice 3
B Iodine In Dairy Products Concerns Ask For Help or Advice 0
S Introduction To Your Products IdeaLabs 4
lyfe Are All Otc Aspirin Products Safe For Daily Use? Aspirin 12
C About To Experiment With A2 Milk After Over 20 Years Of No Dairy Products Milk 9
Makrosky Recent Study : Shielding Methods And Products Against Man-made Electromagnetic Fields: Protection Ve Radiation 3
Beastmode Vitamin E Experience With ADM Products? Vitamins 5
C Can Someone Please Tell Me How I Can Buy These Products? I Dont See A Button To Buy Them. Thank You! IdeaLabs 1
J Cleaning Products Ask For Help or Advice 12
G Allergic Reaction To All NDT Thyroid Products Supplements, Pharmaceutical Drugs 4
G Which IdeaLabs Products Have Boosted Androgens Best In Your Experience? Hormones 29
Lokzo Copper Induced Oxidation Of Serotonin: Analysis Of Products And Toxicity Scientific Studies 0
bistecca Is Enough Emphasis Placed On Healthy Animal Products? Diet 2
goodandevil Invoking Peat's Name: Ethics Of Promoting Products IdeaLabs 86
T Consuming High-fat Dairy Products Found To Make Lung Function In Smokers Even Worse Scientific Studies 3
KalosKaiAgathos Free E-book Sized Guide On Cannabis-based Products Supplements, Pharmaceutical Drugs 0
S Blood Work After Using IdeaLabs Products Experiments 58
S How To Buy Products At Idealabs? IdeaLabs 2
marcar72 What About Sprouted Bread Products? Vegetables, Grains, Legumes, Fiber 8
michael94 "Anti-aging Products And Services Is A Multi-billion Dollar Industry" Miscellaneous Health Discussions 0
biggirlkisss Taking Out Greek Yogurt All Dairy Products Ask For Help or Advice 3
yerrag Melania Trump Bans Monsanto Products From The White House Breaking News 48
Elize Haidut Products Digestion 7
Westside PUFAs Don Matesz To Eat Animal Products Again The Ray Peat Forum Lounge 4
S Ketogenic Diet And Lipolysis: Supplements / IdeaLabs Products To AVOID Or TAKE Weight 20
M Discount On Thorne Products -Vitamin K2, Etc Suppliers 1

Similar threads

Top