Comment from Corey R

I am writing as a patient who is prescribed Enclomiphene Citrate. I have experienced significant therapeutic and life changing benefits from this medication. My LH, FSH, total and free testosterone as well as Estradiol have increased into the physiologic range and my life has changed for the better. I sleep better, I can build muscle easier and my mood is stable. I heavily support Enclomiphene’s inclusion on the FDA’s 503A Bulk Substances List. Enclomiphene is an effective option for testosterone support because it doesn't contain the side effects or risks associated with other therapies including Clomid monotherapy. For patients with low baseline testosterone levels and for those who do not want to downregulate their HPTA and fertility, Enclomiphene displays a very safe and individualized alternative, even superior to Clomid. Clomid works by agonizing and antagonizing Estrogen receptors in the brain while Enclomiphene purely antagonizes those receptors. This, in my opinion, is the biggest reason I believe Enclomiphene is superior and patients see less side effects from this medication. If you are agonizing and antagonizing receptors in the Hypothalamus and Pituitary Gland with Clomid, these actions will cancel each other out and you'll see more side effects from the other isomer Zuclomiphene. I believe this is why more patients on Clomid see side effects related to vision, mood changes etc. The goal of a SERM monotherapy is to stimulate natural testosterone production and minimize side effects. If this medication were to become unavailable due to its exclusion from the 503A bulk list, it would significantly impact my ability to maintain stable and effective hormone levels and quality of life. My wife and I also want to have the option to have a child one day. It will force individuals to either return to their lower baseline levels or explore other therapies with their physicians such as Testosterone Replacement Therapy which will downregulate natural production. While I understand the FDA’s responsibility to ensure safety and efficacy, I hope that consideration will be given to patients who rely on medications like Enclomiphene when they are responsibly compounded by qualified pharmacies.