Description

(Dual-Ester Testosterone Replacement Therapy for Sustained Androgen Support)

A Balanced, Long-Acting Androgen Solution for Optimized Male Hormone Replacement

Testosterone Cypionate/Enanthate 100 mg/mL Injection is a compounded blend of two long-acting testosterone esters—testosterone cypionate and testosterone enanthate—formulated for intramuscular (IM) administration. Each mL delivers 100 mg of total testosterone, offering a sustained-release profile with a balanced pharmacokinetic curve. This 5 mL sterile vial provides a total of 500 mg of testosterone and is suited for testosterone replacement therapy (TRT) in males with confirmed hypogonadism or androgen deficiency.

The combination of cypionate and enanthate esters provides gradual testosterone elevation, followed by a stable maintenance phase, minimizing peaks and troughs commonly seen with single-ester therapies. This dual-ester formulation is ideal for patients who require steady-state testosterone levels without the need for excessively frequent injections.

Key Features

• Contains 100 mg/mL total testosterone from a blend of testosterone cypionate and testosterone enanthate

• Supplied in a 5 mL sterile multiple-dose vial (total 500 mg testosterone)

• Supports physiological testosterone levels for men with primary or secondary hypogonadism

• Designed for intramuscular injection only (typically gluteal site)

• Long-acting profile reduces need for frequent dosing

• Compounded in a USP <797>-compliant sterile environment

• Preservative-free, endotoxin-tested, and ready for clinical administration

What Are Testosterone Cypionate & Enanthate?

Both cypionate and enanthate are long-acting testosterone esters commonly used in hormone replacement therapy. They are chemically similar, differing slightly in half-life and release curve:

• Testosterone Cypionate: Approximate half-life of 8 days

• Testosterone Enanthate: Approximate half-life of 4.5–5 days

By combining both esters, this formulation achieves a balanced onset and duration, supporting stable hormone levels, reduced injection site irritation, and improved adherence.

Clinical Applications

This injection is indicated in adult males with conditions associated with deficient endogenous testosterone, including:

1. Primary Hypogonadism

• Congenital or acquired testicular failure (e.g., Klinefelter syndrome, orchitis)

2. Secondary Hypogonadism (Hypogonadotropic Hypogonadism)

• Pituitary or hypothalamic dysfunction due to tumors, trauma, or genetic disorders

3. Andropause (Age-Related Testosterone Decline)

• Fatigue, low libido, muscle wasting, and cognitive decline due to declining hormone levels

4. Supportive Therapy in Transgender Hormone Treatment

• Used in female-to-male (FTM) transitions to induce and maintain masculinization

Benefits of Therapy

• Increases lean muscle mass and strength

• Reduces fat mass and insulin resistance

• Enhances libido, erectile function, and mood

• Improves energy, cognition, and sleep quality

• Supports bone mineral density and cardiovascular health

• Helps restore quality of life in testosterone-deficient individuals

Dosing and Administration

• Typical initial dose: 100–200 mg IM every 7–14 days, depending on patient profile

• Administered via deep intramuscular injection into the gluteus muscle

• Dosing interval and titration guided by serum testosterone levels, SHBG, estradiol, and symptom resolution

• Always administered under medical supervision as part of a monitored TRT plan

Monitoring Parameters

• Total and free testosterone levels

• Estradiol, hematocrit, and PSA (prostate-specific antigen)

• Lipid profile, liver function, and insulin sensitivity

• Blood pressure and cardiovascular risk markers

• Mood and symptom tracking (using ADAM or AMS questionnaires)

Side Effects and Considerations

While testosterone therapy is well tolerated in most men, potential side effects include:

• Erythrocytosis (elevated hematocrit)

• Estrogen-related effects: gynecomastia, fluid retention

• Acne or oily skin

• Testicular atrophy and infertility (suppressive effect on FSH/LH)

• Mood fluctuations in susceptible individuals

Mitigation strategies may include dose adjustment, aromatase inhibitors, or HCG co-therapy to preserve fertility.

Contraindications

• Known or suspected prostate or breast cancer in men

• Serious cardiac, hepatic, or renal impairment

• Polycythemia (hematocrit >54%)

• Uncontrolled sleep apnea

Storage and Handling

• Store at controlled room temperature (20–25°C / 68–77°F)

• Do not freeze

• Use a sterile syringe and needle for each administration

• Shake gently if precipitate forms

• Keep out of reach of children

• For intramuscular use only

Who Should Consider It?

• Adult males with clinically low testosterone and related symptoms

• Patients seeking a steady, long-acting testosterone option with less frequent dosing

• Individuals who experience instability with single-ester TRT

• FTM transgender individuals under supervised hormonal therapy

• Athletes and professionals under monitored medical programs (not for non-therapeutic enhancement)

Testosterone Cypionate/Enanthate 100 mg/mL Injection – 5 mL delivers dual-ester androgen support for individuals requiring sustained testosterone elevation with balanced pharmacokinetics. This formulation reflects a modern, clinically refined approach to hormone replacement, offering stability, flexibility, and improved patient outcomes.