Enclomiphene Citrate Cost vs. Alternatives in Class

What separates enclomiphene from the alternatives

Clomiphene citrate is FDA-approved only for ovulatory dysfunction in women who want to become pregnant. Its label has no male indication and states that no adequate or well-controlled studies show effectiveness in male infertility; testicular tumors and gynecomastia have been reported in men using it, with cause and effect unknown [1]. Clomiphene is a mixture of enclomiphene (trans) and zuclomiphene (cis); FDA cites a USP monograph giving 50 to 70 percent enclomiphene content [2].

Repros Therapeutics applied for Androxal in secondary hypogonadism; FDA's 2015 complete response said the phase 3 designs were not adequate to demonstrate clinical benefit and raised concerns about entry criteria, titration and bioanalytical method validation [2]. EMA's committee recommended refusing EnCyzix in January 2018, after four main studies in 588 patients; the reasons given were that testosterone rose but symptom improvement was not examined and that venous thromboembolism was a risk [3].

What the head-to-head trials show

Two parallel phase 3 trials, ZA-304 and ZA-305, ran 16 weeks in overweight men aged 18 to 60 with morning testosterone of 300 ng/dL or lower, comparing enclomiphene with AndroGel 1.62 percent. Testosterone rose in every treatment group; LH and FSH rose with enclomiphene and fell with the gel; sperm concentration stayed in the normal range on enclomiphene while spermatogenesis fell markedly on the gel [5].

A 2025 meta-analysis of randomized trials of clomiphene and enclomiphene combined found SERM therapy raised total testosterone above placebo by a mean 273.76 ng/dL (95% CI 191.87 to 355.66) with high heterogeneity, and found no significant difference versus testosterone gel [7].

Where compounding leaves sourcing

FDA's list updated 14 May 2026 places enclomiphene citrate 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 enforcement discretion, not approval and not a finding of safety or effectiveness [4]. In June 2022 FDA proposed not adding it to the allowed list, and the advisory committee voted 4 yes, 8 no [8]. Compounded enclomiphene is not FDA-approved or reviewed for safety, effectiveness or quality [9].

HealthRX.com offers enclomiphene by prescription.

Side effects and label warnings

The Clomid label covers the mixture, not enclomiphene alone. It lists visual symptoms such as blurring or flashes in 1.5 percent of patients in clinical studies; these are usually reversible, though prolonged and possibly irreversible cases have been reported. The label's contraindications include liver disease, uncontrolled thyroid or adrenal dysfunction and pituitary tumor [1].

In the enclomiphene trials the most frequent side effects were headache, hot flushes, nausea and muscle spasm. In ZA-302, headache occurred in 7 of 112 men on 12.5 mg versus 1 of 47 on placebo [10]. FDA's 2022 review listed cardiac and thromboembolic events, raised estradiol, raised PSA and raised hematocrit, and noted no long-term safety data [2].