Men's Hormone Optimization Support
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Enclomiphene Capsules

Capsule Formulation

Compounded enclomiphene citrate capsules, prepared in Chino, CA to a prescriber's order for men with secondary hypogonadism. Not an FDA approved drug.

Reviewed by Linda Pungpravat, Compounding Pharmacist, RPh Mixwell Compounding Pharmacy, Chino, CA

  • USP <795> compliant
  • USP <800> hazardous drug lab
  • PCCA member

Clinical Advantages

  • Custom strength available
  • Dye free option
  • Non sterile preparation

How It Works

What is Enclomiphene Citrate?

Enclomiphene citrate is a compounded oral capsule of enclomiphene, one of the two isomers that make up clomiphene citrate. It is a selective estrogen receptor modulator that blocks estrogen receptors in the brain. Prescribers order it for men with secondary hypogonadism, meaning low testosterone caused by weak signaling from the pituitary rather than by the testes.

How it works

  1. Enclomiphene blocks estrogen receptors in the hypothalamus and pituitary, so the brain reads estrogen as low and raises luteinizing hormone (LH) and follicle stimulating hormone (FSH) [2][3].
  2. Higher LH prompts the testes to make more of the body's own testosterone, and FSH supports sperm production [2][3].
  3. Clomiphene citrate is a mixture of enclomiphene and zuclomiphene. Enclomiphene is the single isomer that blocks estrogen receptors [3].
  4. Because the body keeps making its own testosterone, sperm production was preserved in the trials, unlike with topical testosterone. Testosterone products can lower or stop sperm production [2][5].

When prescribers choose it

  • Urologists and reproductive endocrinologists treating men with secondary hypogonadism who want to keep sperm production intact
  • Men's health clinics whose patients want to avoid testosterone gels or injections
  • Prescribers who monitor testosterone, LH, and FSH and adjust the dose by the results

Clinical Details

What does the evidence show?
  • No enclomiphene product is FDA approved. The FDA lists enclomiphene citrate in Category 1 of its bulk drug substance categories, which means it can be compounded under the agency's interim policy while it is evaluated. That status can change [1].
  • Kim and colleagues (2016, BJU International) reported two parallel randomized, double blind, placebo controlled phase 3 trials in overweight men aged 18 to 60 with secondary hypogonadism. Two doses of enclomiphene were compared with 1.62% testosterone gel. Enclomiphene raised testosterone and preserved sperm counts, unlike the topical testosterone [2].
  • Wiehle and colleagues (2014, Fertility and Sterility) ran a randomized phase 2 trial comparing enclomiphene, topical testosterone, and placebo. Enclomiphene stimulated testosterone production while preventing the drop in sperm concentration seen with topical testosterone [3].
  • The phase 3 trials gave 12.5 mg or 25 mg once daily for 3 months. Effects over longer periods have not been established in these trials [4].

Findings come from the cited studies and do not promise any individual outcome.

Why is it compounded, and how is it typically used?

Why it is compounded

No enclomiphene product is approved in any strength, so a prescriber who wants it orders it compounded. It is eligible for compounding only because the FDA currently lists it in Category 1 of its interim policy, and the FDA can move a substance to another category [1].

Dosage forms and strengths

  • Capsules of 6.5 mg, 12.5 mg, or 25 mg, set by the prescriber. The phase 3 trials used 12.5 mg and 25 mg [4]
  • Dye free and filler conscious versions on request, including lactose free and gluten free
  • Quantities matched to the prescriber's monitoring schedule

Dosing, blood test monitoring, and duration are the prescriber's decision.

How Mixwell prepares it

Mixwell compounds these capsules in Chino, California under USP 795 standards for non sterile preparations [6]. Our pharmacist confirms the strength and any ingredients to exclude with the prescriber before compounding. Batch records document every preparation, and finished capsules ship across California.

Safety information

Enclomiphene has no FDA approved labeling, so there is no official list of warnings. The phase 3 trials lasted 3 months and measured testosterone, LH, FSH, and sperm counts [2][4]. Prescribers monitor those results, and semen analysis when fertility matters. Effects over years of use have not been established.

Testosterone products can lower or stop sperm production, and enclomiphene is used partly to avoid that [5]. It is not a form of testosterone, and it works only in men whose testes can respond to a higher LH signal. Patient selection, dosing, monitoring, and duration are the prescriber's responsibility.

References
  1. U.S. Food and Drug Administration. Bulk drug substances nominated for use in compounding under section 503A of the FD&C Act, categories. FDA
  2. Kim ED, McCullough A, Kaminetsky J, et al. Oral enclomiphene citrate raises testosterone and preserves sperm counts in obese hypogonadal men, unlike topical testosterone: restoration instead of replacement. BJU Int. 2016. doi:10.1111/bju.13337
  3. Wiehle RD, Fontenot GK, Wike J, Hsu K, Nydell J, Lipshultz L. Enclomiphene citrate stimulates testosterone production while preventing oligospermia: a randomized phase II clinical trial comparing topical testosterone. Fertil Steril. 2014;102(3):720 to 727. doi:10.1016/j.fertnstert.2014.06.004
  4. Phase III study to evaluate morning testosterone normalization in overweight men with secondary hypogonadism. ClinicalTrials.gov NCT01532414. ClinicalTrials.gov
  5. ANDROGEL (testosterone gel) 1.62%. Prescribing information. Drugs.com label
  6. United States Pharmacopeia. General Chapter 795, Pharmaceutical Compounding: Nonsterile Preparations. USP NF. Official November 1, 2023.

What to include on the prescription

  • APIs and strengths
  • Base or vehicle
  • Quantity
  • Directions for use
  • Refills
  • Allergies or dye free needs
Call (909) 378-7301 Fax (909) 378-7071

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Compounded in Chino, CA. Delivered across California.

  • Chino
  • Chino Hills
  • Ontario
  • Pomona
  • Diamond Bar
  • Rancho Cucamonga
  • Eastvale
Mixwell Compounding Pharmacy 13788 Roswell Ave, Ste 158, Chino, CA 91710
(909) 378-7301

Compounded medications are not reviewed or approved by the FDA. Dispensed only with a valid prescription. Mixwell is a non sterile pharmacy and does not prepare sterile products or injectables. Compounded preparations are not presented as superior to commercially available products, and nothing here promises a specific result. Mixwell does not accept insurance. Call for pricing.

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Want to learn more about Enclomiphene Capsules

Are you a healthcare provider or patient in Chino, Chino Hills, Ontario, Eastvale, Rancho Cucamonga, or Upland? Mixwell Pharmacy provides specialized pharmaceutical support throughout San Bernardino, Los Angeles, and Orange Counties. Contact our Chino laboratory to learn how we facilitate customized Enclomiphene Capsulesfor practitioners across Southern California.

(909) 378-7301

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