Enclomiphene is a medication used to manage male hormonal imbalances. While it is a component of an FDA-approved medication, enclomiphene itself does not hold standalone approval from the U.S. Food and Drug Administration.
Understanding Enclomiphene’s Regulatory Status
Enclomiphene has not received standalone FDA approval. It is derived from clomiphene citrate, an FDA-approved medication known as Clomid. Clomid contains both enclomiphene and zuclomiphene isomers. While Clomid is approved for female infertility, its use in men for low testosterone is considered off-label.
The approval process for standalone enclomiphene was halted in 2015. The FDA issued a Complete Response Letter, stating that the design of the Phase 3 studies was inadequate to demonstrate clinical benefit. Despite these regulatory hurdles, enclomiphene remains a subject of ongoing discussion.
How Enclomiphene Works
Enclomiphene functions as a selective estrogen receptor modulator (SERM), primarily affecting the hypothalamic-pituitary-gonadal (HPG) axis. It works by blocking estrogen receptors in the hypothalamus and pituitary gland. This blockade reduces the negative feedback that estrogen typically exerts on these glands, leading to an increase in the secretion of gonadotropin-releasing hormone (GnRH) from the hypothalamus.
The increased GnRH then stimulates the pituitary gland to release higher levels of luteinizing hormone (LH) and follicle-stimulating hormone (FSH). LH, in turn, signals the Leydig cells in the testes to produce more testosterone, while FSH supports spermatogenesis, the process of sperm production. This mechanism allows enclomiphene to stimulate the body’s natural testosterone production.
This approach differs from traditional testosterone replacement therapy (TRT), which directly introduces external testosterone. TRT can suppress the body’s natural testosterone production and may reduce or halt sperm production, affecting fertility. Enclomiphene, by stimulating endogenous production, maintains or improves sperm counts while increasing testosterone levels, making it a suitable option for men who wish to preserve fertility.
Accessing Enclomiphene and Its Primary Application
Despite not having standalone FDA approval, enclomiphene can be legally prepared and dispensed by compounding pharmacies with a valid prescription. Compounding pharmacies create customized medications, allowing access to enclomiphene in specific formulations. This ensures preparation according to a physician’s guidance and dosage requirements.
Enclomiphene’s primary medical application is the treatment of low testosterone in men, specifically secondary hypogonadotropic hypogonadism. This condition occurs when the hypothalamus or pituitary gland are not sending adequate signals to the testes. Common symptoms include low libido, reduced energy, and mood changes. Enclomiphene helps restore hormonal balance by addressing these signaling pathway issues, promoting the body’s own testosterone synthesis.