For prescribers managing secondary hypogonadism in men — particularly those who want to preserve fertility — enclomiphene has drawn clinical interest as an oral option. Mixwell Compounding Pharmacy in Chino, CA prepares compounded enclomiphene capsules pursuant to a valid prescription, to the strength each prescriber specifies. This article explains what enclomiphene is, its evidence, and its important regulatory status.
🧬 What Is Enclomiphene?
Enclomiphene (enclomiphene citrate) is a selective estrogen receptor modulator (SERM). It is the trans-isomer of clomiphene citrate — the SERM long marketed as Clomid, which contains both the enclomiphene and zuclomiphene isomers.
🔬 The mechanism
By modulating estrogen receptors at the hypothalamus and pituitary, enclomiphene can influence the release of LH and FSH — the signals that drive the testes to produce testosterone and support sperm production.
👶 The fertility distinction
Because it works through the body's own hormonal axis rather than supplying testosterone directly, enclomiphene has been studied specifically in men who want to raise testosterone while maintaining sperm production. The prescriber determines suitability.
❓ How does enclomiphene differ from testosterone replacement?
Testosterone replacement therapy (TRT) supplies testosterone from outside the body, which can suppress the body's own production and, in many men, reduce sperm counts. Enclomiphene works differently: it acts on the hypothalamic-pituitary axis to stimulate the body's own testosterone production, which is why it has been studied in men who wish to preserve fertility. Whether either approach is appropriate is a clinical decision made by the prescriber.
📚 The Evidence Base
Enclomiphene has been studied in men with secondary hypogonadism. In published randomized trials, oral enclomiphene was reported to raise serum testosterone into the normal range while maintaining sperm counts, in contrast to topical testosterone (Wiehle et al., 2014; Kim et al., 2016). However, these trials were relatively small and of limited duration, long-term safety data are limited, and formal drug development for enclomiphene was discontinued without FDA approval. Prescribers weigh this evidence, along with each patient's goals and clinical picture, when considering treatment options.
Mixwell compounds to your prescription. The prescriber determines whether compounded enclomiphene is appropriate for a given patient based on individual evaluation.
⚠️ Important regulatory status — please read
Enclomiphene is not an FDA-approved drug. No FDA-approved enclomiphene product exists. It has been studied but was not approved through the FDA new-drug process.
It is compounded pursuant to a valid, patient-specific prescription. Compounders may prepare enclomiphene because it is a component of clomiphene citrate, an FDA-approved medication. Enclomiphene's status for compounding has been reviewed by the FDA and remains an area of ongoing regulatory attention; it is not on the FDA 503A bulks list.
Promotion must be truthful and accurate. Under federal law, prescription drug promotion — including for compounded drugs — must be truthful, non-misleading, and accurate. Nothing here is a promise of results.
FDA recommends that patients talk with their healthcare professional about their specific circumstances before taking any medication.
⭐ For Your Practice & Your Patients
🩺 For Prescribers
- Compounded to your specified strength (commonly prescribed as oral capsules)
- Prepared pursuant to a patient-specific prescription
- Direct pharmacist access for formulation questions
- Clinical and prescribing decisions remain yours
👤 For Patients
- Prepared only with a valid prescription from your provider
- Made by a licensed compounding pharmacy team
- Talk with your prescriber about whether it's right for you
- Used exactly as your prescriber directs
🚀 How to Send a Prescription
- Specify the strength, dosage form, quantity, and Sig on your patient-specific prescription.
- Fax or e-prescribe to Mixwell Compounding Pharmacy in Chino, CA.
- Call (909) 378-7301 to confirm the formulation and current turnaround time.
- Your patient picks up at our Chino pharmacy, or we can deliver — we serve patients across California.
❓ Frequently Asked Questions
Is enclomiphene FDA-approved?
No. There is no FDA-approved enclomiphene product. It has been studied in clinical trials but was not approved through the FDA new-drug process. It is prepared by compounding pharmacies pursuant to a valid, patient-specific prescription.
Why can a pharmacy compound enclomiphene if it isn't approved?
Compounders may prepare enclomiphene because it is a component of clomiphene citrate, an FDA-approved medication. Its status for compounding has been reviewed by the FDA and remains an area of ongoing regulatory attention. A valid, patient-specific prescription is required.
How is enclomiphene different from TRT?
TRT supplies testosterone from outside the body and can suppress the body's own production and sperm counts. Enclomiphene acts on the hypothalamic-pituitary axis to stimulate the body's own testosterone production, which is why it has been studied in men who wish to preserve fertility. The prescriber decides what is appropriate.
What form does compounded enclomiphene come in?
It is commonly prescribed as oral capsules, compounded to the strength the prescriber specifies. We compound to your prescription.
Should I ask my provider before taking it?
Yes. FDA recommends that patients talk with their healthcare professional about their specific circumstances before taking any medication, including compounded medications.
Does Mixwell accept insurance?
Mixwell does not accept insurance. Call (909) 378-7301 for current pricing.
Questions About Compounded Enclomiphene?
Mixwell Compounding Pharmacy
13788 Roswell Ave, Ste 158 · Chino, CA 91710
PCCA Member · CA Licensed · USP <795> · Non-Sterile Compounding · Delivery Across California
📞 Call (909) 378-7301References: Wiehle RD, Fontenot GK, Wike J, et al. Enclomiphene citrate stimulates testosterone production while preventing oligospermia: a randomized phase II clinical trial comparing topical testosterone. Fertil Steril. 2014;102(3):720-727. | Kim ED, McCullough A, Kaminetsky J. Oral enclomiphene citrate raises testosterone and preserves sperm counts in obese hypogonadal men, unlike topical testosterone. BJU Int. 2016;117(4):677-685. | U.S. Food and Drug Administration. Bulk Drug Substances Used in Compounding Under Section 503A of the FD&C Act; Pharmacy Compounding Advisory Committee proceedings. | Educational information for licensed prescribers; not a substitute for clinical judgment, and not a promise of results. Reviewed by Mixwell Compounding Pharmacy compounding team, Chino, CA.