Clomiphene and enclomiphene: Drugs, not dietary supplements
What is clomiphene?
Clomiphene is a selective estrogen receptor modulator (SERM) used in female fertility prescription drugs such as Clomid. SERMs are a class of drugs that affect how estrogen functions in the body. Clomiphene is approved by FDA “…for the treatment of ovulatory dysfunction in women desiring pregnancy.” It is not approved for men for any condition. However, it is sometimes used off-label for male infertility and other conditions. “Off-label” is when an FDA-approved drug is prescribed for an unapproved use. Clomiphene is on the DoD Prohibited Dietary Supplement Ingredients List and is listed in Section 4 (Hormone and Metabolic Modulators) of the World Anti-Doping Agency (WADA) Prohibited List.
What is enclomiphene?
Enclomiphene (also a SERM) is a component of clomiphene. It has been studied in clinical trials as a treatment for conditions including low testosterone, hypogonadism, and type 2 diabetes. However, as of 2021, development of enclomiphene as a drug has been discontinued for all medical purposes. By itself, enclomiphene is an investigational drug and has not been approved by FDA for any use. As an unapproved drug, enclomiphene is on the DoD Prohibited List and is also listed in Section 4 of the WADA Prohibited List.
How are these substances being marketed in products?
It is illegal for either clomiphene or enclomiphene to be sold as a dietary supplement. However, products containing these drugs are currently available on the market advertised for use as testosterone boosters. They may be labeled as dietary supplements with a Supplement Facts label. Or, they may be labeled as “research chemicals” with a “Research Facts” label, or they may have “for research use only” or as “not for human consumption” listed on the label. None of these appear to be legitimate consumer products. Also, be aware that neither drug is an acceptable dietary supplement ingredient.
Can enclomiphene be legally prescribed?
While enclomiphene is not an FDA-approved drug, it can be prescribed and sold legally through compounding pharmacies to individuals with a valid prescription. Compounding pharmacies are those that combine, mix, or alter ingredients in order to create medications tailored to the needs of individual patients. According to guidance from FDA, drug substances that are components of FDA-approved drugs are eligible for compounding under section 503A of the Federal Food, Drug, and Cosmetic Act.
What should I do if I have been prescribed clomiphene or enclomiphene?
Speak with your military healthcare provider who can determine whether you can take either of these drugs. Service Members should use providers at their installation’s Medical Treatment Facility (MTF) whenever possible. These providers will be more knowledgeable about their service-specific policies regarding the use of these medications. Service Members should ensure all their medications are recorded in their military health record and work with their military Primary Care Provider to ensure their record is updated to reflect any missing prescription medications.
Posted 22 April 2025
