Is Enclomiphene FDA Approved?
Introduction
For men with low testosterone, enclomiphene citrate has been a game changer, causing a 1.5-2.5X testosterone boost without the testicular shutdown, shrinkage, infertility, and dependence of dated alternatives. Though enclomiphene is a component of the FDA-approved medication Clomid, there is a lot of confusion around whether or not enclomiphene itself is approved by the FDA or even legal. Let’s set the record straight.
Read on to understand enclomiphene’s FDA status, explore safety considerations, and find out how you can safely buy enclomiphene online.
Key takeaways
- Enclomiphene is a component of the FDA-approved medication Clomid, which is one of the most popular fertility drugs for women and commonly used off-label to treat low testosterone in men.
- Though enclomiphene itself is not FDA approved, the medication is allowed to be legally prepared by a compounding pharmacy when prescribed by a physician.
- In 2022, a vote was conducted to exclude the medication from the FDA bulks list, but as of 2023, the list has not been updated nor has enclomiphene been added to the “do not compound” list.
- Until updates are made to the FDA bulks list, compounding pharmacies will continue to legally fulfill prescriptions indefinitely when they are prescribed by a physician.
About enclomiphene
Enclomiphene citrate is the purified isomer of the FDA-approved medication Clomid, which is a selective estrogen receptor modulator (SERM) and one of the most popular fertility drugs for women. It is also commonly used off-label to treat low testosterone in men. Enclomiphene works by blocking estrogen to amp up the production of the hormones luteinizing hormone (LH) and follicle stimulating hormone (FSH), signaling the body to make more testosterone.
When it comes to enclomiphene’s efficacy, the research is solid. Studies show taking enclomiphene can restore normal testosterone levels in hypogonadal men in as little as 14 days. And when compared to testosterone replacement therapy (TRT), which is typically the first-line treatment for low testosterone, enclomiphene has been found to be just as effective at increasing testosterone while maintaining sperm concentration, whereas many subjects become oligospermic while on TRT.
But raising testosterone isn’t just about tracking the numbers. The results of increasing testosterone via SERMs has resulted in more lean body mass, improved sexual performance, and even better productivity. This study found enclomiphene treatment led to an increase of ~5 lb. of lean body mass in as little as 12 weeks. And this research shows increasing testosterone with SERMs successfully “increased libido, sexual potency, and a general sense of well-being.” Lastly, anecdotal reports show taking enclomiphene helps to increase energy and focus, which makes sense when you look at the data connecting testosterone and motivation.
Who is enclomiphene for?
Enclomiphene is for anyone who wants to experience the benefits of more testosterone without negatively impacting their fertility. You don’t necessarily have to have low T levels to take enclomiphene. This medication is also beneficial for those looking to optimize their testosterone for better gym performance, a higher sex drive, and enhanced energy. As a prescription medication, enclomiphene requires a preliminary health assessment, in which your doctor will decide if the medication is right for you.
Enclomiphene FDA status
Though it is derived from the FDA-approved medication Clomid, enclomiphene itself is not FDA-approved. Its approval process was halted in 2015, when the FDA stated that the design of enclomiphene Phase 3 studies was no longer adequate to demonstrate clinical benefit. The FDA had also noted concerns regarding study entry criteria, titration, and bioanalytical method validation.
But as a component of the FDA-approved medication Clomid, the medication has been nominated for use in compounding under Section 503A of the Federal Food, Drug, and Cosmetic Act. This means it is allowed to be legally prepared by a compounding pharmacy when prescribed by a physician.
In June 2022, a vote was conducted by the Pharmacy Compounding Advisory Committee about excluding the medication from the 503A Bulks List, but as of 2023, the list has not been updated nor has enclomiphene been added to the “do not compound” list.
Is enclomiphene legal?
Until updates are made to the FDA bulks list, compounding pharmacies will continue to legally fulfill prescriptions indefinitely when they are prescribed by a physician. But different states have different regulations. If you are considering ordering enclomiphene from Maximus, please note that we currently serve all U.S. States, except Alabama, Alaska, Indiana, and the District of Columbia. Maximus also does not serve U.S. Territories or Freely Associated States. And if any updates are made to the FDA bulk drugs list, we are committed to working with our partners and patients to update our treatment protocols and maintain continuity of care.
When it comes to obtaining enclomiphene without a prescription, it may not be illegal, but it is highly risky. Medications obtained from unknown sources are unregulated and put you at risk for unwanted side effects and serious health concerns.
Is enclomiphene safe?
When prescribed by a physician, enclomiphene is safe and generally well-tolerated. The most common side effects were considered minimal in phase II and phase III clinical trials, and included headache (3.3%), nausea (2.1%), diarrhea (1.9%), common cold (1.7%), hot flush (1.7%), joint pain (1.2%), dizziness (1%).
When it comes to contraindications, enclomiphene is not prescribed to people with a pre-existing risk for blood clots or those taking blood thinners. People with a history of heart disease should also avoid taking enclomiphene, due to a slight risk of cardiac events.
If Clomid is FDA approved, why not take Clomid?
We’ve mentioned a few times that enclomiphene is a component of the FDA-approved medication Clomid. So why not just take Clomid? Well, there are a few key differences to consider between these two testosterone-boosting medications.
Though Clomid contains enclomiphene, which blocks estrogen, it also contains zuclomiphene, which increases estrogen. Due to its mixed estrogenic and antiestrogenic effects, Clomid has been linked to a number of undesirable side effects like emotional dysregulation, enlarged breasts, irritability, and anxiety. Even more, researchers have concluded that when it comes to the intended outcomes of the medication, “zuclomiphene contributes little” while staying in the system far longer than enclomiphene. There is also some evidence that zuclomiphene can negatively impact the male reproductive tract, causing a significant reduction in the size of testes, Leydig cell loss, an absence of sperm in the seminiferous tubules, and a reduction in size of the epididymis.
When isolated from Clomid, enclomiphene is just as successful in raising testosterone levels with fewer side effects, a shorter-half-life, and a far lower risk of compromising your reproductive system.
Where to buy enclomiphene
Purchasing enclomiphene at a traditional retail pharmacy is one way to ensure the product is safe and legitimate. You can also order enclomiphene from Maximus, which is not just a product, but a protocol. With Maximus, you’ll work with a licensed doctor to review your medical history, establish your goals, and test your baseline levels to devise a personal plan for optimizing your T levels. You’ll also have access to live coaching and the Maximus community for more insights into how to improve your testosterone and overall health. And follow-up lab tests ensure the protocol is working for you.
Learn more about how to safely purchase enclomiphene.
The bottom line: Enclomiphene is not approved by the FDA, but it is a component of the FDA-approved medication Clomid.
As a component of the FDA-approved medication Clomid, enclomiphene is allowed to be legally prepared by a compounding pharmacy when prescribed by a physician. For now, it is safe and legal to obtain a prescription of enclomiphene from a licensed doctor and is recommended for those looking to optimize their T levels without compromising their fertility.
