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Does Medicare Advantage Cover Enclomiphene Citrate?

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At a glance

  • FDA status / No FDA-approved drug contains enclomiphene as an active ingredient [1]
  • Europe / EMA committee recommended refusing marketing authorisation for EnCyzix, 25 January 2018 [3]
  • FDA compounding list / Category 1, bulk substances under evaluation, updated 14 May 2026 [4]
  • FDA advisory committee vote / 4 yes, 8 no on adding it to the allowed bulk list, June 2022 [5]
  • Approved relative / Clomiphene citrate is approved for ovulatory dysfunction in women, with no male indication [6]
  • What phase 3 measured / Testosterone, LH, FSH and sperm counts, not symptom relief [1]

Approval status and clinical evidence

FDA's advisory committee materials state that no FDA-approved drug contains enclomiphene as an active ingredient [1]. Sponsor Repros Therapeutics filed a new drug application for enclomiphene (Androxal) for secondary hypogonadism; in 2015 the company announced a complete response letter which, as summarized by FDA, said the phase 3 study design was not adequate to demonstrate clinical benefit and raised concerns about entry criteria, titration and bioanalytical method validation [1]. EMA's committee adopted a negative opinion on 25 January 2018 recommending refusal of marketing authorisation for EnCyzix, based on four main studies in 588 patients: testosterone rose, but the studies did not examine whether symptoms improved, and the committee cited a risk of venous thromboembolism [3].

The phase 3 trials tracked testosterone, LH, FSH and sperm counts, not symptom or quality-of-life improvement, and both FDA and EMA identified that as a gap [1][3].

What compounding status does and does not mean

Enclomiphene citrate is not on FDA's final list of bulk substances that can be used in compounding. FDA's list, updated 14 May 2026, places it in Category 1, 'Bulk Drug Substances Under Evaluation'. 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; that is an enforcement-discretion policy, not an approval and not a finding that the product is safe or effective [4]. At the 8 June 2022 meeting of FDA's Pharmacy Compounding Advisory Committee, the committee voted 4 yes, 8 no on adding enclomiphene citrate to the allowed bulk list, with members who voted no citing lack of clinical efficacy evidence [5].

Clomiphene citrate is approved, but for a different use

Clomiphene citrate is a mixture of two isomers, enclomiphene (trans) and zuclomiphene (cis); per FDA, the USP monograph gives enclomiphene content of clomiphene as 50 to 70 percent [1]. Clomiphene citrate (Clomid and generics) is FDA-approved for ovulatory dysfunction in women desiring pregnancy. Its label has no male indication and states that there are no adequate or well-controlled studies demonstrating effectiveness in male infertility; testicular tumors and gynecomastia have been reported in males using clomiphene, with cause and effect not known [6]. Male use for low testosterone is off-label.

Frequently asked questions

Is enclomiphene FDA-approved?
No. No FDA-approved drug contains enclomiphene as an active ingredient, and EMA's committee recommended refusing marketing authorisation for EnCyzix in January 2018. [1][3]
Does Medicare Advantage cover compounded enclomiphene?
Coverage is set by each plan, and FDA's records do not address it. What FDA does say is that compounded enclomiphene products are not FDA-approved and have not been reviewed by FDA for safety, effectiveness or quality. [2]
Does FDA allow compounding with enclomiphene citrate?
It is not on FDA's allowed bulk list. FDA places it in Category 1, under evaluation, and says it does not intend to act against a compounder using it if its guidance conditions are met; the 2022 advisory committee voted 4 yes, 8 no on adding it. [4][5]
Is clomiphene citrate covered for low testosterone in men?
Clomiphene is approved only for ovulatory dysfunction in women, and its label says effectiveness in male infertility has not been shown in adequate studies; male use is off-label. [6]

References

  1. U.S. Food and Drug Administration. U.S. Food and Drug Administration
  2. Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks | FDA. Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks | FDA
  3. Official web page. Official web page
  4. U.S. Food and Drug Administration. U.S. Food and Drug Administration
  5. U.S. Food and Drug Administration. U.S. Food and Drug Administration
  6. U.S. National Library of Medicine, DailyMed. Clomid (clomiphene citrate) tablets, Cosette prescribing information. Clomid (clomiphene citrate) tablets, Cosette label
  7. Official web page. Official web page
Evidence overview for Does Medicare Advantage Cover Enclomiphene Citrate?