Xyosted is an FDA-approved, single-dose subcutaneous autoinjector containing testosterone enanthate in sesame oil for once-weekly testosterone replacement therapy (TRT) in adult men with hypogonadism. Approved in September 2018, it delivers the same seven-carbon testosterone ester used since 1953 in deep-muscle vials, but injects a smaller weekly dose under the abdominal skin through a hidden 27-gauge needle. Weekly subcutaneous dosing avoids deep gluteal injections and produces a flatter blood testosterone curve with smaller peak-to-trough swings.
This page summarizes what the FDA prescribing information, registration trials, and post-marketing studies report as of November 2026. It is for educational purposes only and is not medical advice.
| Property | Detail |
|---|---|
| Drug class | Androgen; anabolic-androgenic steroid (testosterone ester) |
| Brand / NDA | Xyosted (Antares Pharma / Halozyme), NDA 209863 (approved September 28, 2018); no generic as of November 2026 |
| Active ingredient | Testosterone enanthate (C₂₆H₄₀O₃, 400.59 g/mol) |
| Route | Subcutaneous in the abdomen only (avoid intramuscular or intravascular use) |
| Strengths | 50 mg/0.5 mL, 75 mg/0.5 mL, and 100 mg/0.5 mL in preservative-free sesame oil |
| Labeled dose | Start at 75 mg once weekly; adjust by 25 mg to keep 7-day trough testosterone at 350–650 ng/dL |
| Time to peak (median) | 11.9 hours at steady state (week 12) |
| Testosterone content | About 72% of ester weight (50 mg ≈ 36 mg, 75 mg ≈ 54 mg, 100 mg ≈ 72 mg testosterone) |
| US schedule | Controlled substance, Schedule III (21 CFR 1308.13) |
| WADA status | Prohibited at all times (Class S1.1, anabolic androgenic steroids) |
What it is
Xyosted pairs testosterone enanthate with a prefilled, single-use, pressure-assisted autoinjector (Xyosted label; Drugs@FDA, NDA 209863). Testosterone enanthate is the 17β-heptanoate ester of endogenous testosterone (C₂₆H₄₀O₃, 400.59 g/mol) (PubChem; Xyosted label). Unesterified testosterone weighs 288.4 g/mol (PubChem). Because the seven-carbon ester chain makes up about 28% of the weight, roughly 72% of each dose is active testosterone (about 36, 54, and 72 mg in the 50, 75, and 100 mg pens).
Each disposable pen holds 0.5 mL of clear, colorless to pale yellow, sterile testosterone enanthate solution in preservative-free sesame oil (Xyosted label). A spring mechanism pushes the viscous sesame oil through a 5/8-inch, 27-gauge needle into abdominal fat (Kaminetsky et al., Sex Med 2015).
In subcutaneous fat, the oil forms a depot. The ester itself is inactive until esterases cleave off the heptanoate group to release free testosterone (Xyosted label), which binds the androgen receptor and converts into:
- dihydrotestosterone (DHT), a stronger androgen formed by 5α-reductase in the prostate, skin, and hair follicles;
- estradiol, the primary estrogen formed by aromatase in fat, bone, and brain tissue.
How it differs from intramuscular testosterone enanthate
Both Xyosted and generic testosterone enanthate vials (first approved in 1953 as Delatestryl under NDA 009165) use the same ester in sesame oil, but differ in packaging, preservative, injection depth, schedule, and labeled uses (Xyosted label; generic IM label):
| Feature | Xyosted autoinjector | Generic IM testosterone enanthate vial |
|---|---|---|
| FDA application | NDA 209863 (approved September 28, 2018) | ANDA 091120 and others (reference NDA 009165, 1953) |
| Packaging | Single-dose prefilled 0.5 mL autoinjector | 5 mL multi-dose glass vial |
| Strengths | 50, 75, or 100 mg per 0.5 mL (100, 150, or 200 mg/mL) | 200 mg/mL (1,000 mg per 5 mL vial) |
| Carrier and preservative | Sesame oil; preservative-free | Sesame oil with chlorobutanol 5 mg/mL |
| Route and site | Subcutaneous into abdomen (27-gauge, 5/8-inch needle) | Deep intramuscular into gluteal muscle |
| Labeled schedule | 75 mg once weekly, adjusted to 50 or 100 mg weekly | 50–400 mg every 2–4 weeks |
| Labeled indications | Adult male primary or hypogonadotropic hypogonadism only | Male hypogonadism, delayed male puberty, and metastatic female breast cancer |
| Generic status | None approved as of November 2026 | Multiple generic vials marketed |
Traditional intramuscular (IM) dosing injects 100–400 mg every 2–4 weeks deep into the gluteus muscle, producing high, often supraphysiologic testosterone peaks in week 1 and low troughs by days 14–21 (Sokol et al., Fertil Steril 1982; Rey & Grinspon, Am J Mens Health 2020). Many clinicians and patients split generic testosterone cypionate or enanthate vials into off-label weekly subcutaneous doses with manual syringes (Spratt et al., JCEM 2017; Figueiredo et al., JCEM 2022). Xyosted remains, as of November 2026, the only FDA-approved subcutaneous testosterone ester product.
Labeled indication and limitations of use
Xyosted is indicated for testosterone replacement therapy in adult males with a deficiency or absence of endogenous testosterone (Xyosted label):
- Primary hypogonadism (congenital or acquired): testicular failure from cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, orchiectomy, Klinefelter syndrome, chemotherapy, or toxic damage from alcohol or heavy metals (low serum testosterone with elevated follicle-stimulating hormone, FSH, and luteinizing hormone, LH).
- Hypogonadotropic (secondary) hypogonadism (congenital or acquired): gonadotropin or luteinizing hormone-releasing hormone (LHRH) deficiency, or pituitary-hypothalamic injury from tumors, trauma, or radiation (low serum testosterone with normal or low LH and FSH).
Diagnosis requires morning serum testosterone below the normal range on at least two separate days (Xyosted label), matching the Endocrine Society guideline (Bhasin et al., JCEM 2018).
The label states two Limitations of Use:
- Safety and efficacy in men with “age-related hypogonadism” (late-onset hypogonadism) have not been established.
- Safety and efficacy in males under 18 years old have not been established; androgens can accelerate bone age and close growth plates early (Xyosted label).
Labeled dosing, administration, and monitoring
Starting dose and titration
Xyosted is injected once weekly on the same day each week (Xyosted label):
| Step | Labeled instruction |
|---|---|
| Starting dose | 75 mg subcutaneously in the abdomen once weekly |
| First lab check | Measure total testosterone trough (Ctrough, drawn 7 days after a dose) after 6 weeks |
| Ctrough below 350 ng/dL | Increase dose by 25 mg (from 75 mg to 100 mg) |
| Ctrough 350 to under 650 ng/dL | Maintain the same weekly dose |
| Ctrough 650 ng/dL or higher | Decrease dose by 25 mg (from 75 mg to 50 mg) |
| Follow-up checks | Re-measure Ctrough 6 weeks after any dose change and periodically on treatment |
Administration and usability
Patients inject only into the left or right abdomen at least 2 inches from the navel, avoiding bruised, tender, red, hard, scarred, tattooed, or stretch-marked skin, and avoiding intramuscular or intravascular injection (Xyosted label). The user twists off the cap, pinches abdominal skin, presses the pen down at a 90-degree angle until it clicks, holds while counting slowly to 10 (10 seconds), and verifies the viewing window is orange (Xyosted label).
In a usability study of 65 patients and caregivers across 123 simulated injections (50, 75, and 100 mg pens), 99 of 123 attempts (80.5%) delivered a full dose; 21 of the 24 use errors came from lifting the pen before holding at least 8 seconds (Arora et al., J Sex Med 2018). Store pens at 20°C–25°C (68°F–77°F), with excursions permitted at 15°C–30°C (59°F–86°F); do not refrigerate or freeze (Xyosted label).
Clinical monitoring
The FDA label recommends monitoring five areas (Xyosted label):
| Parameter | Labeled monitoring schedule and action |
|---|---|
| Total testosterone (Ctrough) | At week 6, 6 weeks after dose changes, and periodically; target 350 to under 650 ng/dL |
| Blood pressure | Confirm control before starting; check periodically and treat new or worsening hypertension |
| Hematocrit and hemoglobin | Check at baseline, then about every 3 months; hold if elevated and stop permanently if elevation recurs |
| Prostate (PSA and symptoms) | Screen for prostate cancer before starting and periodically; monitor benign prostatic hyperplasia (BPH) symptoms |
| Serum lipids | Check lipid profile periodically, particularly after starting therapy |
Pharmacokinetics
In a phase II study, 39 hypogonadal men washed out topical therapy and received 50 or 100 mg subcutaneous testosterone enanthate weekly for 6 weeks via the autoinjector alongside a 200 mg IM reference group (Kaminetsky et al., Sex Med 2015). Mean steady-state 7-day average testosterone (Cavg) at week 6 was 422.4 ng/dL on 50 mg and 895.5 ng/dL on 100 mg, showing dose-proportional exposure and narrower fluctuations than 200 mg IM dosing (Kaminetsky et al., Sex Med 2015).
In phase III, steady state was reached by week 6. Table 3 of the label reports week-12 pharmacokinetics over the 168-hour (7-day) interval in 137 patients on 50, 75, or 100 mg weekly (Xyosted label):
| Parameter at Week 12 (N = 137) | Arithmetic mean (SD) | Observed range (min–max) |
|---|---|---|
| Time-averaged concentration, Cavg (0–168 h) | 553 (127) ng/dL | 276–1,036 ng/dL |
| Maximum concentration, Cmax | 790 (215) ng/dL | 389–1,410 ng/dL |
| Time to peak, Tmax (median) | 11.9 hours | 6–168 hours (5.8–168.7 hours in text) |
| Minimum concentration, Cmin | 436 (109) ng/dL | 166–788 ng/dL |
| Area under the curve, AUC (0–168 h) | 92,955 (21,385) ng·h/dL | 46,432–173,987 ng·h/dL |
Intact testosterone enanthate reached a mean (SD) peak of 169 (68) ng/dL at week 12. In plasma, about 40% of testosterone binds sex hormone-binding globulin (SHBG), 2% is free, and 58% binds albumin and other proteins. Pre-dose at week 12, the mean DHT-to-testosterone ratio was 0.07 (normal range). About 90% of a dose is excreted in urine as conjugates and 6% in feces (Xyosted label).
Pivotal trial and clinical studies
52-week pivotal registration study (NCT02159469)
FDA approval rested on a 52-week, open-label, single-arm, dose-blinded trial in 150 hypogonadal men with two morning testosterone levels below 300 ng/dL (Kaminetsky et al., J Urol 2019; Xyosted label). Patients self-injected 75 mg weekly at 7:00 a.m. (± 2 hours) and adjusted to 50, 75, or 100 mg at week 7 based on week 6 trough levels:
| Endpoint (NCT02159469) | FDA label full cohort (N = 150) | Published completer analysis (Kaminetsky et al. 2019) |
|---|---|---|
| Week 12 Cavg (0–168 h) within 300–1,100 ng/dL | 90.0% (135 of 150 men) | 92.7% (mean 553.3 ± 127.29 ng/dL) |
| Week 12 Cmax below 1,500 ng/dL | 100% of men with week-12 PK (0% above 1,500 ng/dL) | 91.3% of all 150 enrolled (0 patients above 1,800 ng/dL) |
| Week 52 mean trough total testosterone | — | 487.2 ± 153.33 ng/dL |
| Patients reporting no injection pain | — | Over 95% |
26-week safety study (NCT02504541) and post-marketing cohorts
A second phase III study treated 133 hypogonadal men aged 18–75 for 26 weeks (113 completed), keeping trough testosterone at 300–650 ng/dL in 82.4% at week 12 and 83.2% at week 26, with mild pain in 1 patient across 965 assessed injections (Gittelman et al., J Sex Med 2019). Neither registration trial had a placebo or comparator arm.
In post-marketing urology clinics, a 6-week cohort of 110 men (mean age 40.3 years) showed mean trough testosterone rising from 246.6 ng/dL (SD 113.3) to 538.4 ng/dL (SD 209.3), with 101 of 110 (91.8%) exceeding 300 ng/dL and 0 exceeding 54% hematocrit (Choi et al., Int J Impot Res 2022). A 12-week two-institution study of 234 hypogonadal men compared 100 mg weekly IM testosterone cypionate against 100 mg weekly Xyosted: trough testosterone rose from 313.6 to 536.4 ng/dL on IM cypionate and from 246.6 to 552.8 ng/dL on Xyosted (multivariable p = 0.057), while Xyosted was independently associated with lower post-therapy hematocrit (p below 0.001) and lower estradiol (p below 0.001) (Choi et al., J Urol 2022).
The boxed warning on blood pressure and its 2025 removal
When approved in September 2018 following an October 2017 FDA Complete Response Letter, Xyosted carried a Boxed Warning (WARNING: BLOOD PRESSURE INCREASES) stating it could raise blood pressure and increase the risk of major adverse cardiovascular events (MACE: non-fatal myocardial infarction, non-fatal stroke, and cardiovascular death) (2018 Xyosted FDA label). That warning rested on 24-hour ambulatory blood pressure monitoring (ABPM) in the 26-week study (Gittelman et al., J Sex Med 2019; Xyosted label):
| Subgroup (Baseline to Week 12, 24-hour ABPM) | Mean systolic BP change (95% CI) | Mean diastolic BP change (95% CI) |
|---|---|---|
| All patients with valid ABPM recordings (n = 62) | +3.9 mm Hg (1.4 to 6.4) | +1.5 mm Hg (0.4 to 2.6) |
| Men on antihypertensive therapy (n = 33) | +3.9 mm Hg (0.19 to 7.7) | +1.3 mm Hg (−0.37 to 3.0) |
| Men with no hypertension history (n = 28) | +4.1 mm Hg (0.43 to 7.8) | +1.9 mm Hg (0.055 to 3.7) |
Clinic blood pressure at week 26 rose by a mean of 3.4 mm Hg systolic (125.6 to 129.0 mm Hg) and 1.8 mm Hg diastolic (78.2 to 80.0 mm Hg) (Gittelman et al., J Sex Med 2019). In the 52-week study, 10% of men started or increased blood pressure medication (Xyosted label).
In TRAVERSE, a randomized trial in 5,246 randomized (5,198 treated) hypogonadal men aged 45–80 with cardiovascular disease or high risk using daily testosterone gel (mean follow-up 33 months, mean treatment 22 months), MACE occurred in 7.0% (182 men) on testosterone versus 7.3% (190 men) on placebo (hazard ratio 0.96, 95% CI 0.78–1.17) (Lincoff et al., NEJM 2023; Xyosted label). Class-wide ABPM studies also confirmed small blood pressure increases across all testosterone routes (FDA 2025 Safety Communication).
Following the FDA’s February 28, 2025 class-wide directive, Xyosted’s Boxed Warning was removed in March 2025 (Xyosted label; FDA 2025 Safety Communication). Blood pressure increases remain a standard warning in Section 5.4 (not recommended in uncontrolled hypertension), and the label reports TRAVERSE rates for venous thromboembolism (1.7% vs 1.2%, including pulmonary embolism 0.9% vs 0.5% and deep vein thrombosis 0.6% vs 0.5%), non-fatal arrhythmias warranting intervention (5.2% vs 3.3%), atrial fibrillation (3.5% vs 2.4%), acute kidney injury (2.3% vs 1.5%), and bone fracture (3.5% vs 2.5%) (Xyosted label).
Side effects and safety profile
Adverse reactions in clinical trials
Across 283 men in the 52-week (N = 150) and 26-week (N = 133) trials, adverse reactions in at least 2% of patients were (Xyosted label):
| Adverse reaction | 1-year study (N = 150) | 6-month study (N = 133) |
|---|---|---|
| Hematocrit increased | 21 (14.0%) | 11 (8.3%) |
| Hypertension | 19 (12.7%) | 3 (2.3%) |
| Prostate-specific antigen (PSA) increased | 18 (12.0%) | 4 (3.0%) |
| Injection-site bruising | 10 (6.7%) | 5 (3.8%) |
| Headache | 8 (5.3%) | Below 2% |
| Injection-site hemorrhage | 5 (3.3%) | 8 (6.0%) |
| Blood creatine phosphokinase increased | 5 (3.3%) | 5 (3.8%) |
| Back pain | 5 (3.3%) | Below 2% |
| Prostatitis | 4 (2.7%) | 4 (3.0%) |
| Urinary tract infection | 4 (2.7%) | 4 (3.0%) |
| Acne, blood testosterone increased, cough, peripheral edema, injection-site erythema | 4 (2.7%) each | Below 2% |
| Fatigue | 3 (2.0%) | 3 (2.3%) |
| Abdominal pain, arthralgia, hematuria, polycythemia, sleep apnea syndrome | 3 (2.0%) each | Below 2% |
| Insomnia, nausea | Below 2% | 3 (2.3%) each |
Hematocrit, injection sites, PSA, mood, and fertility
- Polycythemia: Across both trials (N = 283), mean hemoglobin rose 1.0 ± 1.1 g/dL at 6 months and 1.1 ± 1.4 g/dL at 1 year; mean hematocrit rose 3.8 ± 3.4% at 6 months and 5.4 ± 3.4% at 1 year. Twelve of 283 men (4.2%) reached a hematocrit of 55% or higher, and polycythemia was judged medically significant in 1.8% (2018 Xyosted FDA label). Across 29 randomized trials (3,393 men), IM enanthate/cypionate raised hematocrit by +4.0% (95% CI 2.9–5.1) vs placebo, compared with +3.0% for gels and +1.6% for IM testosterone undecanoate (Nackeeran et al., J Urol 2022). The Endocrine Society advises holding testosterone if hematocrit exceeds 54% (Bhasin et al., JCEM 2018).
- Injection-site reactions: Occurred in 36 of 283 patients (12.7%), including bruising, hemorrhage, erythema, and induration; 0% discontinued due to injection-site reactions (2018 Xyosted FDA label).
- PSA elevations: A PSA rise of at least 1.4 ng/mL above baseline or an absolute PSA above 4.0 ng/mL led to discontinuation in 4.6% of the 283 patients (Xyosted label).
- Depression and suicidality: Section 5.15 warns that 2 of 283 patients discontinued for depression and 2 additional patients had suicide attempts (1 completed suicide, 1 incomplete attempt), totaling 4 men (1.4%) (Xyosted label).
- Spermatogenesis and fertility: Exogenous testosterone suppresses pituitary LH and FSH, halting sperm production. In a WHO study of 200 mg weekly IM testosterone enanthate in 271 healthy men, 65% became azoospermic within 6 months (mean 120 days) (WHO Task Force, Lancet 1990). Across 30 contraceptive studies (1,549 men), recovery to 20 million sperm/mL occurred in 67% by 6 months, 90% by 12 months, 96% by 16 months, and 100% by 24 months after stopping (Liu et al., Lancet 2006), though the label warns fertility impairment may be irreversible (Xyosted label).
- Other warnings, contraindications, and interactions: The label also warns of venous thromboembolism, edema, gynecomastia, sleep apnea, hypercalcemia, and hepatic adenomas reported with long-term IM testosterone enanthate. Xyosted is contraindicated in male breast cancer, known or suspected prostate cancer, pregnancy, and hypersensitivity to testosterone enanthate or sesame oil. It interacts with insulin (lowering blood glucose), warfarin (altering INR), corticosteroids (fluid retention), and drugs that raise blood pressure (Xyosted label).
Schedule III status, misuse, and sports ban
In the US, Xyosted is a Schedule III (CIII) controlled substance under the Controlled Substances Act (21 CFR 1308.13(f)). Section 9 warns that abuse of testosterone and other anabolic-androgenic steroids at supratherapeutic doses is linked to cardiac arrest, myocardial infarction, cardiomyopathy, heart failure, stroke, hepatotoxicity, and severe psychiatric reactions including mania, psychosis, and aggression (Xyosted label). Section 10 notes a published report of acute injectable testosterone overdosage reaching 11,400 ng/dL, implicated in a stroke. Abrupt cessation after high-dose abuse can cause withdrawal symptoms lasting weeks to months, including depression, fatigue, insomnia, decreased libido, and hypogonadotropic hypogonadism (Xyosted label).
Under the WADA 2026 Prohibited List, testosterone enanthate is prohibited at all times under Class S1.1 (anabolic androgenic steroids).
Key takeaways
- Same ester, subcutaneous autoinjector delivery. Xyosted delivers testosterone enanthate in preservative-free sesame oil (50, 75, or 100 mg per 0.5 mL) once weekly into abdominal fat via a hidden 27-gauge needle, rather than deep into the gluteal muscle every 2–4 weeks.
- Trough-guided weekly titration. Therapy starts at 75 mg weekly and adjusts in 25 mg steps based on a 7-day trough blood draw at week 6, targeting a trough of 350–650 ng/dL.
- Flatter pharmacokinetic curve. In the pivotal 52-week trial, 90% of all 150 enrolled men (92.7% of week-12 completers) achieved a 7-day average testosterone of 300–1,100 ng/dL (mean 553 ng/dL, mean peak 790 ng/dL, mean trough 436 ng/dL), and none exceeded 1,500 ng/dL at week 12.
- Boxed warning removed in March 2025, but blood pressure still rises. On 24-hour ambulatory monitoring, Xyosted raised systolic/diastolic blood pressure by an average of 3.9/1.5 mm Hg at 12 weeks, and 10% of men in the 1-year study started or increased blood pressure medication. Following TRAVERSE and class-wide ABPM studies, the FDA removed Xyosted’s boxed warning in March 2025 while keeping blood pressure increases as a class-wide warning.
- Hematocrit, PSA, mood, and fertility require monitoring. Hematocrit rose to 55% or higher in 4.2% of trial participants, PSA increases led to discontinuation in 4.6%, depression or suicide attempts occurred in 1.4%, and exogenous testosterone suppresses sperm production.
Sources
- Antares Pharma. Xyosted (testosterone enanthate) injection, for subcutaneous use, prescribing information (revised July 2025). DailyMed; Drugs@FDA, NDA 209863.
- US Food and Drug Administration. Xyosted (testosterone enanthate) injection original approval prescribing information (NDA 209863, September 2018). FDA Label PDF.
- US Food and Drug Administration. FDA issues class-wide labeling changes for testosterone products. February 28, 2025. FDA.
- Hikma Pharmaceuticals USA. Testosterone enanthate injection, USP, prescribing information (revised June 2025). DailyMed; Drugs@FDA, ANDA 091120.
- US Food and Drug Administration. Delatestryl (testosterone enanthate), NDA 009165. Drugs@FDA.
- National Center for Biotechnology Information. Testosterone enanthate, PubChem CID 9416; testosterone, PubChem CID 6013. PubChem CID 9416; PubChem CID 6013.
- Kaminetsky J, Jaffe JS, Swerdloff RS. Pharmacokinetic profile of subcutaneous testosterone enanthate delivered via a novel, prefilled single-use autoinjector: a phase II study. Sex Med. 2015;3(4):269–279. PubMed.
- Arora S, Moclair B, Murphy K, Jaffe JS, Kaminetsky JC. Summative usability evaluation of the SCTE-AI device: a novel prefilled autoinjector for subcutaneous testosterone administration. J Sex Med. 2018;15(12):1707–1715. PubMed.
- Kaminetsky JC, McCullough A, Hwang K, Jaffe JS, Wang C, Swerdloff RS. A 52-week study of dose adjusted subcutaneous testosterone enanthate in oil self-administered via disposable auto-injector. J Urol. 2019;201(3):587–594. PubMed.
- Gittelman M, Jaffe JS, Kaminetsky JC. Safety of a new subcutaneous testosterone enanthate auto-injector: results of a 26-week study. J Sex Med. 2019;16(11):1741–1748. PubMed.
- Choi EJ, Xu P, El-Khatib FM, Kavoussi PK, Yafi FA. Post-market safety and efficacy profile of subcutaneous testosterone enanthate-autoinjector: a cohort analysis. Int J Impot Res. 2022;34(5):467–470. PubMed.
- Choi EJ, Xu P, Barham D, El-Khatib FM, Yafi FA, Kavoussi PK. Comparison of outcomes for hypogonadal men treated with intramuscular testosterone cypionate versus subcutaneous testosterone enanthate. J Urol. 2022;207(3):677–683. PubMed.
- Spratt DI, Stewart II, Savage C, et al. Subcutaneous injection of testosterone is an effective and preferred alternative to intramuscular injection: demonstration in female-to-male transgender patients. J Clin Endocrinol Metab. 2017;102(7):2349–2355. PubMed.
- Figueiredo MG, Gagliano-Jucá T, Basaria S. Testosterone therapy with subcutaneous injections: a safe, practical, and reasonable option. J Clin Endocrinol Metab. 2022;107(3):614–626. PubMed.
- Sokol RZ, Palacios A, Campfield LA, Saul C, Swerdloff RS. Comparison of the kinetics of injectable testosterone in eugonadal and hypogonadal men. Fertil Steril. 1982;37(3):425–430. PubMed.
- Rey RA, Grinspon RP. Androgen treatment in adolescent males with hypogonadism. Am J Mens Health. 2020;14(3):1557988320922443. PubMed.
- Lincoff AM, Bhasin S, Flevaris P, et al. Cardiovascular safety of testosterone-replacement therapy. N Engl J Med. 2023;389(2):107–117. PubMed.
- Nackeeran S, Kohn T, Gonzalez D, et al. The effect of route of testosterone on changes in hematocrit: a systematic review and Bayesian network meta-analysis of randomized trials. J Urol. 2022;207(1):44–51. PubMed.
- Bhasin S, Brito JP, Cunningham GR, et al. Testosterone therapy in men with hypogonadism: an Endocrine Society clinical practice guideline. J Clin Endocrinol Metab. 2018;103(5):1715–1744. PubMed.
- World Health Organization Task Force on Methods for the Regulation of Male Fertility. Contraceptive efficacy of testosterone-induced azoospermia in normal men. Lancet. 1990;336(8721):955–959. PubMed.
- Liu PY, Swerdloff RS, Christenson PD, Handelsman DJ, Wang C. Rate, extent, and modifiers of spermatogenic recovery after hormonal male contraception: an integrated analysis. Lancet. 2006;367(9520):1412–1420. PubMed.
- Drug Enforcement Administration. Schedules of controlled substances: Schedule III, anabolic steroids. 21 CFR 1308.13(f). eCFR.
- World Anti-Doping Agency. World Anti-Doping Code International Standard: Prohibited List 2026. WADA.