TPrime365™ Sublingual Testosterone Optimization: Enclomiphene 25mg | Spermidine 10mg | Boron 10mg | Vitamin C 10mg

Administered sublingually—placed under the tongue and allowed to dissolve and absorb through the sublingual mucosa. Do not chew or swallow the troche/tablet. Avoid eating, drinking, or rinsing the mouth for 10–15 minutes after administration to maximize mucosal absorption. Sublingual delivery bypasses hepatic first-pass metabolism, enhancing bioavailability of enclomiphene.

Enclomiphene 25 mg is the standard clinical dose for secondary hypogonadism based on pharmacodynamic studies, which showed a non-dose-dependent steady-state plateau at 25 mg/day. This formulation is dosed once daily or per prescriber instruction.

• Assess serum LH, FSH, total testosterone, and free testosterone at baseline before initiation
• Recheck hormone levels at 4–6 weeks to assess HPG-axis response
• Final dosing schedule, duration, and follow-up are prescribed by the clinician

• Enclomiphene: The trans-isomer of clomiphene that acts as a pure estrogen receptor antagonist (unlike the cis-isomer zuclomiphene, which is partially estrogenic). Antagonizes hypothalamic and pituitary estrogen receptors, preventing negative feedback by endogenous estradiol. This increases GnRH pulsatility and downstream LH and FSH secretion. Elevated LH stimulates Leydig cells to produce testosterone; elevated FSH supports spermatogenesis—unlike exogenous TRT, which suppresses both.
• Spermidine: A naturally occurring polyamine found in spermine-rich foods; promotes cellular autophagy (clearance of damaged organelles), mitochondrial biogenesis, and anti-aging cellular processes. In the male reproductive system, spermidine is present in high concentrations in semen and supports sperm motility and function. Its role in systemic hormone optimization is an area of ongoing research.
• Boron: Inhibits microsomal enzymes responsible for hydroxylation of steroids, specifically those catabolizing testosterone and vitamin D. Supplemental boron (6–10 mg/day) has been shown to increase free testosterone within one week by reducing SHBG, decreasing estradiol conversion, and slowing testosterone catabolism.
• Vitamin C: Acts as an essential cofactor in collagen hydroxylation and dopamine-beta-hydroxylase reactions. In the testes, ascorbic acid at high concentrations protects Leydig cells from oxidative damage and supports steroidogenesis by maintaining the redox state of key cytochrome P450 enzymes (including StAR and CYP11A1) involved in testosterone synthesis.

TPrime365™ targets men with secondary (hypogonadotropic) hypogonadism—characterized by low-to-normal LH/FSH and low testosterone—where stimulation of the intact HPG axis is preferable to exogenous testosterone, particularly in men who wish to preserve fertility. Enclomiphene has demonstrated consistent increases in testosterone into the normal range without significantly suppressing spermatogenesis.

Monitoring parameters:

• Serum LH, FSH, total testosterone, free testosterone, estradiol at baseline and 4–6 weeks
• SHBG (to contextualize free testosterone changes, especially with boron)
• Semen analysis if fertility preservation is a goal
• Ophthalmic evaluation if visual changes occur (clomiphene-class compounds can cause visual disturbances)
• Liver function tests periodically (enclomiphene is hepatically metabolized)

Contraindications:

• Hypersensitivity to enclomiphene or clomiphene-class compounds
• Liver disease or hepatic dysfunction (enclomiphene)
• Unexplained uterine bleeding or ovarian cysts (if used in females)
• Active thromboembolism (estrogen receptor modulation may affect clotting)

Warnings & Precautions:

• Visual disturbances: clomiphene-class SERMs can cause blurred vision, scotomata, or phosphenes; discontinue and evaluate if visual changes occur
• Mood changes: estrogen receptor modulation may affect mood in some patients
• Testicular pain or enlargement: infrequently reported with SERM therapy
• Boron at >20 mg/day may impair male fertility—doses in this formulation (10 mg) are within established tolerable upper intake levels
• Enclomiphene is not FDA-approved for any indication; use is off-label/investigational

Drug Interactions:

• Exogenous testosterone or anabolic steroids: antagonize enclomiphene's stimulatory effect on the HPG axis; concurrent use is counterproductive
• Drugs affecting estrogen receptors (tamoxifen, other SERMs): pharmacodynamic interaction

Common Side Effects: Hot flushes, mood changes, visual disturbances (less common than with zuclomiphene), and testicular discomfort. B vitamins, boron, and vitamin C have favorable tolerability at these doses.

Store sublingual troches or tablets at room temperature (15–25°C) in a cool, dry location, protected from heat, humidity, and direct light. Do not refrigerate or freeze unless specifically instructed. Keep in the original sealed packaging until use. Use within the beyond-use date assigned by Genesis Compounding.

How is this different from testosterone replacement therapy (TRT)?

Exogenous TRT replaces testosterone from an outside source but suppresses the body's own HPG axis, causing testicular atrophy and infertility. Enclomiphene works by stimulating your own pituitary and testes to produce more testosterone endogenously—preserving fertility and testicular function.

Why is boron included?

Boron inhibits the enzymes that break down testosterone in the body, and it reduces SHBG (the protein that binds testosterone and makes it inactive). This results in higher free (bioavailable) testosterone levels for a given total testosterone level.

What does spermidine do?

Spermidine is a natural polyamine that promotes cellular autophagy (self-cleaning of damaged cells) and supports mitochondrial function. It is present in high concentrations in semen and testicular tissue, where it supports cellular health and sperm function.

Is enclomiphene FDA-approved?

Enclomiphene is not currently FDA-approved for any indication; it is in an investigational status for male hypogonadism. This compounded sublingual preparation is a 503A patient-specific product by Genesis Compounding.

How long before I see results?

LH and FSH typically rise within 1–2 weeks. Testosterone levels usually reach therapeutic ranges within 4–6 weeks. Your prescriber will check labs at that interval to assess response.