Does Aetna (CVS Health) Cover Enclomiphene Citrate?

Why there is no approved enclomiphene product

FDA has not approved enclomiphene for any indication. FDA's advisory-committee presentation from June 8, 2022 states that no FDA-approved drugs contain enclomiphene as the active ingredient.[1]

The sponsor, Repros Therapeutics, submitted a new drug application for Androxal for secondary hypogonadism in fertile men. In 2015 Repros announced a complete response letter from FDA, which, as summarized by FDA, said the design of the phase 3 studies was not adequate to demonstrate clinical benefit and raised concerns about study entry criteria, titration and bioanalytical method validation. No FDA approval has followed.[1] A 2026 British Society of Sexual Medicine position statement says the manufacturer discontinued development in 2021.[7]

Europe took a similar path. EMA's committee adopted a negative opinion on 25 January 2018 recommending refusal of marketing authorisation for EnCyzix (enclomifene), for hypogonadotropic hypogonadism in overweight men with a BMI of at least 25. The reasons given were that the studies showed higher testosterone but did not look at whether symptoms such as bone strength, weight gain, impotence or libido improved, and that there is a risk of venous thromboembolism. That review rested on 4 main studies in 588 patients.[5]

What compounding status means

FDA's list, updated May 14, 2026, places enclomiphene citrate in Category 1, 'Bulk Drug Substances Under Evaluation'; it is not on FDA's final list of bulk substances that can be used in compounding.[3] FDA says it does not intend to take action against a compounder using a Category 1 substance if the conditions in its guidance are met, but that is an enforcement-discretion policy, not an approval and not a finding that the product is safe or effective.[3]

At the June 8, 2022 meeting of FDA's Pharmacy Compounding Advisory Committee, FDA proposed that enclomiphene citrate not be added to the list of allowed bulk substances. The committee voted 4 yes, 8 no, 0 abstain. Members who voted no cited a lack of clinical efficacy evidence, and one said more studies are needed.[4] Enclomiphene is not on FDA's list of bulk substances that raise significant safety risks.[2]

Is clomiphene citrate the same question?

No. Clomiphene citrate is a mixture of two geometric isomers, enclomiphene (trans) and zuclomiphene (cis), so enclomiphene is not simply clomiphene.[1] Per FDA, the USP monograph gives enclomiphene content of clomiphene as 50 to 70 percent.[1]

Clomiphene citrate is FDA-approved, but only for ovulatory dysfunction in women who desire pregnancy, and its label has no male indication.[6] The label states that there are no adequate or well-controlled studies demonstrating the effectiveness of clomiphene citrate in the treatment of male infertility, and that testicular tumors and gynecomastia have been reported in males using clomiphene, with cause and effect not known.[6] Use of clomiphene in men with low testosterone is off-label.[6] A request for clomiphene therefore concerns a different drug with a different approval status.