Testosterone
Androgenic steroid hormone (not a peptide)
Also known as: T, TRT (testosterone replacement therapy), Test, Testosterone Cypionate (Depo-Testosterone), Testosterone Enanthate, Testosterone Propionate, Testosterone Undecanoate (Aveed, Jatenzo, Tlando), Testosterone Suspension, Sustanon (mixed esters), Xyosted (SC testosterone enanthate autoinjector), AndroGel / Testim / Vogelxo (transdermal gel), Testopel (subcutaneous pellet)
Evidence level: FDA-approved drug
What it is
Testosterone is the body's main male sex hormone, driving muscle mass, libido, energy, and male sexual development. It's a steroid hormone, not a peptide. It's FDA-approved as a prescription drug for male hypogonadism (low testosterone), available as injectable esters such as cypionate and enanthate, gels, pellets, oral capsules, and a nasal spray. In the US it's a DEA Schedule III controlled substance, so it's legal only with a prescription. The gels and creams carry the most serious warning label US regulators issue, and it is not about the person using them: children have been virilized after touching the skin where someone else applied it. The ordinary injections do not carry that label. It's included here because it's often used alongside peptide protocols.
What the research found
Testosterone replacement therapy treats men with confirmed low testosterone plus symptoms, and it's FDA-approved for that use. Large trials and Endocrine Society guidelines support replacement in that group: the TTrials showed benefits on several measures, and the TRAVERSE trial found no increase in major cardiac events versus placebo in middle-aged and older men with hypogonadism. Those safety findings come from replacement-dose contexts and do not extend to the much higher supraphysiologic doses used outside medical care. One point gets garbled often enough to be worth stating plainly: US regulators dropped the heart-risk wording from the warning label in 2025, but they did not drop the warning label. Every gel and cream still carries one, for virilization in children who touch the skin where it was applied.
Status and regulatory position
DEA Schedule III controlled substance under the US Controlled Substances Act (per the Anabolic Steroid Control Act of 1990, expanded by the Anabolic Steroid Control Act of 2004 and the Designer Anabolic Steroid Control Act of 2014 — DASCA). Prescription required for legal use in the US; off-prescription or research-community supply outside an authorized prescriber relationship is illegal under federal law. FDA-approved for treatment of male hypogonadism (primary or hypogonadotropic) under multiple branded and generic NDAs across multiple ester forms and delivery routes (intramuscular, subcutaneous, transdermal, oral, pellet implant, nasal). WADA-banned in regulated sport — explicitly listed under Section S1.1 (Anabolic Androgenic Steroids) of the 2026 and 2027 Prohibited Lists, the strongest WADA prohibition tier. Boxed warning — formulation-specific, not molecule-wide. Like desmopressin, testosterone must never be described as carrying a boxed warning, or as not carrying one, without naming the formulation. Carries one: every marketed topical and transdermal product — gels, creams and skin solutions — carries secondary exposure to testosterone, because virilization has been reported in children secondarily exposed to someone else's application site; and Aveed (testosterone undecanoate, intramuscular) carries serious pulmonary oil microembolism (POME) reactions and anaphylaxis. Does not carry one: the ordinary intramuscular esters (cypionate/Depo-Testosterone, enanthate, propionate), the subcutaneous enanthate auto-injector (Xyosted), the oral undecanoates (Jatenzo, Tlando, Kyzatrex), the nasal gel (Natesto) and the pellet (Testopel). ⚠️ The FDA's 28 February 2025 class-wide action removed cardiovascular-risk language from within the boxed warning — it did not remove the boxed warning from testosterone. Reading "the boxed warning was removed" as "testosterone has no boxed warning" is wrong, and wrong in the direction that matters: the warning still standing is about harm to other people.
Safety
Testosterone is a DEA Schedule III controlled substance requiring a prescription, and use outside a prescribed relationship is illegal under US federal law; it is banned in WADA-tested sport, and treatment requires lab monitoring (for example of red-blood-cell count and estradiol). If you use a gel, a cream or a skin solution, it carries the most serious warning label US regulators issue — and the person it protects is not you. Children have been virilized after skin contact with someone else's application site, so keep the area covered, wash your hands, and keep children off unwashed skin. The long-acting undecanoate injection given in clinics carries a different one, for serious lung and allergic reactions during or just after the injection. The ordinary cypionate and enanthate injections, the oral capsules, the nasal gel and the pellet carry no such label. US regulators removed heart-risk wording from that label in 2025 — they did not remove the label. VialWise is a research and educational reference, not medical advice — consult a licensed professional.
Disclosures
⚠️ boxed warning — and it is formulation-specific. Testosterone does not carry one boxed warning; some formulations carry one and most do not, so the formulation has to be named either way. Topical and transdermal products — gels, creams, skin solutions — carry secondary exposure to testosterone: virilization has been reported in children secondarily exposed to another person's application site. Aveed (undecanoate, IM) carries a boxed warning for serious pulmonary oil microembolism and anaphylaxis. The ordinary cypionate/enanthate injections, Xyosted, the oral undecanoates, Natesto and Testopel carry none. ⚠️ The FDA's February 28, 2025 action removed the cardiovascular-outcomes language from testosterone's boxed warnings.[⁹] It did not remove boxed warnings about other risks: topical products still carry the secondary-exposure warning, and Aveed still carries its POME and anaphylaxis warning. Products whose boxed warning was about blood-pressure increases, such as Xyosted, had it removed in their July 2025 label updates, and blood pressure now sits under Warnings and Precautions.[⁶] See the per-formulation table in the About section.
⚠️ Testosterone is a DEA Schedule III controlled substance and is FDA-approved as a prescription drug for male hypogonadism. Information in this entry is informational, not medical advice. Always confirm dose calculations with the in-app calculator and consult appropriate professional guidance before any protocol decisions. Use of testosterone outside a prescribed therapeutic relationship is illegal under US federal law and carries criminal as well as health-related consequences.
⚠️ Testosterone is not a peptide. This entry exists in the Vialwise library because researchers running peptide protocols frequently use TRT (testosterone replacement therapy) or research-community testosterone alongside peptide stacks (CJC-1295/Ipamorelin, BPC-157/TB-500, AOD-9604, GLP-1 agonists). The compound is a 19-carbon steroid hormone, not a peptide — produced naturally in the testes (and adrenals/ovaries) and synthesized commercially in multiple ester forms. Mechanistically, pharmacologically, and regulatorily it sits in a different category from the rest of the Vialwise library. Researchers should be explicit with themselves about which compound class they are using and the corresponding regulatory and safety considerations.
⚠️ DEA Schedule III. Prescription required. Testosterone has been a Schedule III controlled substance under the US Controlled Substances Act since the Anabolic Steroid Control Act of 1990.[⁸] The schedule was expanded by the Anabolic Steroid Control Act of 2004 (effective January 20, 2005 — eliminated the prior "muscle growth" requirement and added 59 specific substances) and by the Designer Anabolic Steroid Control Act of 2014 (DASCA) (closing the chemical-modification loophole for designer derivatives). Possessing, distributing, or using testosterone outside an authorized prescriber relationship is a federal criminal offense in the US, distinct from the regulatory environment of unapproved peptides like BPC-157 or TB-500. State laws also apply; some states have additional restrictions. Researchers in jurisdictions outside the US face different regulatory environments.
⚠️ Multiple ester forms with substantially different pharmacokinetics. Do not confuse them. Testosterone is sold in multiple ester forms with substantially different half-lives, peak/trough profiles, dosing intervals, and delivery routes. The most common are: - Testosterone cypionate (Depo-Testosterone) — IM oil-based injection, half-life ~8 days, typical TRT dose weekly - Testosterone enanthate — IM oil-based injection (and subcutaneous via Xyosted autoinjector), half-life ~4.5 days, typical TRT dose weekly ( starting for SC enanthate via Xyosted) - Testosterone propionate — IM oil-based injection, half-life ~0.8 days (~20 hours), requires more frequent dosing (every 1–3 days) — uncommon in modern TRT but encountered in research-community use - Testosterone undecanoate — IM (Aveed, dosed every 10 weeks after loading) and oral (Jatenzo, Tlando), much longer half-life - Testosterone suspension — water-based, no ester, very short acting; primarily research/legacy use - Transdermal gel/cream (AndroGel 1.62%, Testim, Vogelxo, compounded creams) — daily application, different absorption profile - Subcutaneous pellet (Testopel) — implanted every 3–6 months - Mixed-ester products (Sustanon 250) — combinations of propionate, phenylpropionate, isocaproate, decanoate; not FDA-approved in the US but encountered in research/international contexts The dosing patterns, delivery routes, and pharmacokinetic profiles for each ester are not interchangeable. Researchers should be explicit with themselves about which ester they are using, in what formulation, by what route, and at what dose interval. This entry treats each ester as a related but distinct preparation and flags inline where dosing claims apply to one ester vs another.
⚠️ TRT (replacement) vs supraphysiologic / research-community use are pharmacologically and regulatorily distinct. The published RCT efficacy and safety data for testosterone (Bhasin 2018 Endocrine Society guidelines,[¹] TTrials,[²] TRAVERSE[³]) is overwhelmingly from TRT contexts — adult men with documented hypogonadism (low total testosterone confirmed on multiple morning measurements, plus consistent symptoms), receiving doses titrated to the mid-normal physiologic range. Research-community supraphysiologic use — doses targeting peaks of 1500–3000+ ng/dL — operates outside the published RCT evidence base for both efficacy and safety, and is also outside any FDA-approved indication, prescribing label, or DEA Schedule III prescription authority. The TRAVERSE cardiovascular-safety conclusions in particular ("non-inferiority to placebo on MACE in middle-aged and older men with hypogonadism")[³] do not generalize to the supraphysiologic-dose research-community use pattern. Researchers should be explicit with themselves about which dose context applies and what evidence base supports their specific use.
Quick reference
| Compound class | 19-carbon steroid hormone (not a peptide). Endogenous; synthesized commercially in multiple ester forms. |
|---|---|
| Boxed warning | Formulation-specific. Topical/transdermal gels, creams and solutions carry secondary exposure to testosterone (virilization in children who contact an application site). Aveed (undecanoate IM) carries POME and anaphylaxis. Ordinary IM esters, Xyosted, oral undecanoates, Natesto and Testopel carry none. The FDA's 2/28/2025 action removed cardiovascular language from within the warning, not the warning itself. |
| Common vial sizes (injectable, US) | Depo-Testosterone cypionate: and multidose vials. Generic enanthate: or. Propionate:. (All oil-based — cottonseed oil for cypionate; sesame oil typical for enanthate. Not lyophilized — no reconstitution required; vials come pre-mixed at fixed mg/mL concentration.) |
| Frequency | Cypionate or enanthate: weekly or every-2-weeks IM (weekly is increasingly preferred for stability); weekly SC. Propionate: every 1–3 days. Undecanoate: 10 weeks (Aveed). Transdermal gel: daily. Pellet: every 3–6 months. |
| Half-life | Cypionate IM: ~8 days. Enanthate IM/SC: ~4.5 days. Propionate IM: ~0.8 days (~20 hours). Undecanoate (oral): ~1.5 hours but with prolonged absorption profile; (IM): ~33 days. Transdermal: short — produces near-physiologic diurnal pattern with daily application. |
| Route | Intramuscular (most common — cypionate, enanthate, undecanoate, propionate, suspension); subcutaneous (Xyosted enanthate autoinjector + research-community SC use of standard cypionate/enanthate); transdermal (gel, cream); oral (undecanoate); pellet implant; nasal (Natesto, less common). |
| Onset of action | Subjective effects (libido, energy, mood, body composition) typically reported within 2–6 weeks of consistent TRT-range dosing; full effect generally observed by 3–6 months. Lab markers (T levels) reach steady state within ~5 half-lives (~6 weeks for cypionate weekly dosing). |
In depth
Testosterone is the principal endogenous androgen in humans, produced primarily by Leydig cells in the testes (with smaller contributions from the adrenal cortex and, in females, the ovaries). It is a 19-carbon steroid hormone, not a peptide — it is included in this library because researchers running peptide protocols frequently use testosterone alongside peptide stacks. Synthetic testosterone for therapeutic and research use is most commonly produced as an ester (a fatty-acid chain attached to the 17β-hydroxyl group) which slows release from oil depot injections; the unmodified molecule has a very short systemic half-life (minutes), which is why most preparations use ester forms.
Endogenous role. Testosterone is essential for male sexual development, fertility, muscle and bone maintenance, erythropoiesis (red blood cell production), libido and sexual function, and broader metabolic and CNS effects. Endogenous serum levels in healthy adult men typically range 300–1000 ng/dL (with diurnal variation — morning peak is highest). Levels decline gradually with age (~1% per year after age 30 in many men), but pathologic hypogonadism (consistently low T plus symptoms) is distinct from age-related decline. The Bhasin 2018 Endocrine Society guidelines define hypogonadism as "symptoms and signs consistent with testosterone deficiency AND unequivocally and consistently low serum testosterone concentrations" — both clinical and laboratory criteria are required.[¹]
Regulatory status (US). Testosterone has been a DEA Schedule III controlled substance under the US Controlled Substances Act since the Anabolic Steroid Control Act of 1990. The legal definition of "anabolic steroid" was expanded by the Anabolic Steroid Control Act of 2004 (effective January 20, 2005) and the Designer Anabolic Steroid Control Act of 2014 (DASCA).[⁸] Testosterone is FDA-approved for treatment of male hypogonadism (primary or hypogonadotropic, congenital or acquired) under multiple NDAs spanning multiple ester forms and delivery routes — Depo-Testosterone (cypionate IM, ANDA 085635, since the 1950s), Xyosted (enanthate SC autoinjector, NDA 209863, approved 2018), AndroGel (transdermal 1% and 1.62%), Testim, Vogelxo, Aveed (undecanoate IM, every-10-weeks dosing), Jatenzo and Tlando (oral undecanoate), Natesto (intranasal), Testopel (subcutaneous pellet), among others. Each branded product has its own FDA-approved indication, dosing, and labeling — they are not interchangeable.[⁵][⁶]
Regulatory status (sport — WADA). Testosterone is explicitly listed in Section S1.1 (Anabolic Androgenic Steroids) of the 2026 and 2027 WADA Prohibited Lists, the strongest WADA prohibition tier. This is a fundamentally different prohibition category from the peptides covered elsewhere in this library (which sit in S2 under Peptide Hormones, Growth Factors, Related Substances, and Mimetics). Testosterone is prohibited at all times — in-competition and out-of-competition — for all athletes under WADA jurisdiction.[⁷][¹²] The catch-all clause in S1.1 also covers "other substances with a similar chemical structure or similar biological effect(s)" — closing the loophole for novel anabolic-steroid analogues.
Common research interests. Testosterone is one of the most widely used research peptides — although it is not technically a peptide. The most common contexts: - TRT (testosterone replacement therapy) — adult men with diagnosed hypogonadism. This is the FDA-approved use case and the use case supported by the largest body of RCT evidence.[¹][²][³] - Performance / research-community supraphysiologic use — outside FDA approval, outside DEA prescription authority, and outside the published RCT efficacy/safety data; widely encountered in athletic and bodybuilding contexts. Typically targets supraphysiologic testosterone levels over multi-week or multi-month cycles. - Transgender masculinization (gender-affirming hormone therapy) — adult and adolescent transmasculine populations; FDA-off-label but widely practiced under specialist supervision; dose ranges typically overlap with TRT. - Anti-aging / "men's health" clinic use — a controversial use case where TRT is prescribed in older men based on age-related decline rather than diagnostic criteria meeting the Endocrine Society's definition of hypogonadism. The Bhasin 2018 guidelines explicitly recommend against routine TRT in men with age-related decline alone, in the absence of consistent symptoms and unequivocally low serum testosterone.[¹]
Stacking with peptide protocols (the reason this entry exists in Vialwise). Researchers using peptide stacks frequently combine testosterone with one or more of: GH-secretagogue blends (CJC-1295/Ipamorelin), regenerative peptides (BPC-157, TB-500), GLP-1 / GIP / glucagon agonists (semaglutide, tirzepatide, retatrutide) for body-composition cycles, and AOD-9604 for additional fat loss. Each of these stack pairings has its own rationale and risk profile (see the relevant entries' Stacks sections for details).
Boxed warnings — per formulation. Testosterone has no single answer here, and a blanket statement in either direction is wrong.
| Formulation / route | Boxed warning on the current US label |
|---|---|
| Topical and transdermal — gels, creams, skin solutions (Testim, Vogelxo, and the generic testosterone gels and solutions) | YES — secondary exposure to testosterone. Virilization has been reported in children who were secondarily exposed. Children should avoid contact with unwashed or unclothed application sites. |
| Testosterone undecanoate intramuscular injection (Aveed) | YES — serious pulmonary oil microembolism (POME) reactions and anaphylaxis, during or immediately after the injection. |
| Ordinary intramuscular esters — cypionate (Depo-Testosterone), enanthate, propionate | No boxed warning. |
| Subcutaneous enanthate auto-injector (Xyosted) | No boxed warning. |
| Oral undecanoate (Jatenzo, Tlando, Kyzatrex) | No boxed warning. |
| Nasal gel (Natesto), pellet (Testopel) | No boxed warning. |
The takeaway that matters: if you use a topical gel, cream or skin solution, the boxed warning on that product is about the people who touch you — children in particular. Keep the application site covered, wash your hands after applying, and do not let a child contact unwashed skin. This is a preventable third-party harm, which is why it is stated here rather than left to the label.
Reported side effects
Commonly reported
- Erythrocytosis / elevated hematocrit — most common dose-limiting side effect; the AndroGel label says it would be appropriate to re-evaluate hematocrit 3 to 6 months after starting and then annually, and that increases may require lowering or discontinuation of testosterone.[¹⁴] SC enanthate produces lower hematocrit elevation than IM cypionate at the same dose.[⁴]
- Secondary exposure — topical and transdermal only, and it happens to other people. Virilization has been reported in children who came into contact with an application site on someone using a testosterone gel, cream or skin solution. This is the boxed warning on every marketed topical/transdermal product, and it is the one adverse effect in this entry whose victim is not the person taking the drug. Labeling directs that children avoid contact with unwashed or unclothed application sites.
- Increased blood pressure — In 2025 FDA added a class-wide warning that testosterone can raise blood pressure, after required postmarket ambulatory blood-pressure monitoring studies "confirmed an increase in blood pressure with use of all testosterone products, class-wide."[⁹] Labels direct prescribers to monitor blood pressure periodically, especially in men with hypertension.[⁶]
- Acne, oily skin, increased body/facial hair — dose-related; typically more prominent with supraphysiologic doses
- Estradiol elevation — testosterone is aromatized to estradiol; mild elevation is normal and beneficial in most men, but symptomatic hyperestrogenism (gynecomastia, water retention, mood changes) is dose-dependent
- Suppressed endogenous testosterone production / testicular atrophy — exogenous testosterone suppresses LH and FSH via negative feedback, leading to reduced endogenous T production and reduced testicular size. Reversible after discontinuation in most men but recovery can take months.
- Reduced fertility / sperm production — hypothalamic-pituitary-testicular axis suppression reduces spermatogenesis. TRT is not recommended for men actively trying to conceive. The Bhasin 2018 guidelines specifically address this.[¹]
- Mood and behavioral changes — variable. Some men report improved mood and energy on TRT (TTrials reported small mood improvements);[²] others report irritability, particularly at supraphysiologic doses or with rapid level fluctuations.
- Site reactions — IM injection site pain or swelling; SC injection site reactions; transdermal gel skin irritation; pellet implant site reactions.
- Acute changes around injection — for IM ester injections, some men report a "pre-injection low" before re-dosing as serum levels drop near trough.
Serious
- Severe acute chest pain, shortness of breath, leg swelling — possible pulmonary embolism (TRAVERSE reported elevated PE rate in the TRT group)[³]
- Acute palpitations, irregular heartbeat — possible atrial fibrillation (TRAVERSE reported elevated AF rate in the TRT group)[³]
- Sudden severe headache, vision changes, weakness — possible stroke
- Acute abdominal pain, decreased urine output — possible acute kidney injury (TRAVERSE reported elevated AKI rate)[³]
- Unexplained leg swelling, redness, pain — possible deep vein thrombosis
- Severe psychiatric changes (mania, severe aggression, psychosis) — particularly with supraphysiologic doses
- Markedly elevated hematocrit with symptoms (headache, dizziness, blurred vision)
- New-onset erectile dysfunction or worsening BPH symptoms
Contraindications and warnings
Absolute contraindications (per FDA labels and Bhasin 2018):[¹][⁵][⁶]
Known or suspected prostate cancer or breast cancer in men — testosterone can drive growth of androgen-sensitive cancers
Untreated severe sleep apnea — testosterone can worsen sleep apnea; should be managed before initiating TRT
Severe cardiac, hepatic, or renal disease — exercise caution; balance against established benefit
Pregnancy (testosterone can virilize a female fetus)
Active fertility goals — TRT suppresses spermatogenesis; should not be used in men actively trying to conceive
Elevated hematocrit — the AndroGel label says to check hematocrit before starting, and that increases may require lowering or discontinuation of testosterone[¹⁴]
Recent (within 6 months) cardiovascular event — caution; TRT initiation should typically be delayed and balanced against other clinical needs
Pediatric use — generally contraindicated outside specialist settings; testosterone can prematurely close growth plates and disrupt normal pubertal development
Active breast cancer (in women) — even off-label transgender use should be reconsidered in this context
Warnings:
Pregnancy and lactation: contraindicated — virilization risk to fetus; testosterone is excreted in milk.
Concurrent use of warfarin and other anticoagulants — testosterone can potentiate warfarin effects; monitor INR closely.
Concurrent use of insulin or oral hypoglycemics — testosterone can affect glucose metabolism; monitor glucose carefully when initiating or adjusting TRT.
Increased blood pressure (FDA class-wide warning, 2025). In 2025 FDA added a class-wide warning that testosterone can raise blood pressure, after required postmarket ambulatory blood-pressure monitoring studies "confirmed an increase in blood pressure with use of all testosterone products, class-wide."[⁹] Labels direct prescribers to monitor blood pressure periodically, especially in men with hypertension.[⁶]
Cardiovascular language removed FROM the boxed warning (FDA, 2/28/2025) — the boxed warning itself was not removed. Following the TRAVERSE cardiovascular-safety results[³] and required postmarket blood-pressure studies, FDA issued class-wide testosterone labeling changes "removing language from the Boxed Warning related to an increased risk of adverse cardiovascular outcomes for all testosterone products", adding the TRAVERSE results to all labels and a class-wide blood-pressure warning, while retaining the "Limitation of Use" language for age-related hypogonadism.[⁹] In June 2026, FDA asked manufacturers to remove that limitation of use, saying it is "no longer warranted"; labels change as each manufacturer updates them.[¹¹] ⚠️ This is not the same as testosterone having no boxed warning. The FDA notice says nothing about the secondary-exposure or POME boxed warnings, and both still stand. This reflects the current FDA regulatory posture for TRT-range use and does not extend to supraphysiologic-dose research-community use.
If you use a transdermal gel, cream or solution, the boxed warning on that product applies to the people around you. Virilization has been reported in children who contacted an application site. Cover the site, wash your hands after applying, and keep children off unwashed skin. The injectable walkthrough in this entry does not cover that risk, because injectables do not carry it.
Boxed warnings are formulation-specific — see the per-formulation table in the About section. Topical/transdermal products carry secondary exposure to testosterone; Aveed (undecanoate IM) carries POME and anaphylaxis; the ordinary IM esters, Xyosted, the oral undecanoates, Natesto and Testopel carry none.
Regulatory note (US): Testosterone is a DEA Schedule III controlled substance — possessing, distributing, or using testosterone outside an authorized prescriber relationship is a federal criminal offense.[⁸]
Regulatory note (sport): Testosterone is explicitly listed in Section S1.1 of the WADA 2026 and 2027 Prohibited Lists (Anabolic Androgenic Steroids), prohibited at all times.[⁷][¹²] Researchers competing in any WADA-tested sport will test positive on standard testing protocols.
Transgender hormone therapy contexts: TRT for masculinization in transmasculine populations is widespread but technically off-label; specialist supervision (endocrinology, primary care with experience, or gender-affirming clinic) is the standard of care.
Key terms
- Androgen
- A male sex hormone (such as testosterone) that supports male sexual development and traits like muscle and bone maintenance.
- Controlled substance
- A drug regulated by the government (in the US, scheduled by the DEA) because of its potential for misuse; requires a prescription for legal use.
- Testosterone replacement therapy (TRT)
- Medically supervised use of testosterone to treat men with diagnosed low testosterone.
- Estradiol
- The main form of estrogen; relevant in men because some testosterone is converted to estradiol.
Sources
- Bhasin S, Brito JP, Cunningham GR, Hayes FJ, Hodis HN, Matsumoto AM, Snyder PJ, Swerdloff RS, Wu FC, Yialamas MA. (2018). Testosterone Therapy in Men With Hypogonadism: An Endocrine Society Clinical Practice Guideline. The Journal of Clinical Endocrinology & Metabolism, 103(5):1715–1744.(PMID 29562364)
- Snyder PJ, Bhasin S, Cunningham GR, Matsumoto AM, Stephens-Shields AJ, Cauley JA, Gill TM, Barrett-Connor E, Swerdloff RS, Wang C, Ensrud KE, Lewis CE, Farrar JT, Cella D, Rosen RC, Pahor M, Crandall JP, Molitch ME, Cifelli D, Dougar D, Fluharty L, Resnick SM, Storer TW, Anton S, Basaria S, Diem SJ, Hou X, Mohler ER 3rd, Parsons JK, Wenger NK, Zeldow B, Landis JR, Ellenberg SS; Testosterone Trials Investigators. (2016). Effects of Testosterone Treatment in Older Men. The New England Journal of Medicine, 374(7):611–624.(PMID 26886521 · NCT00799617)
- Lincoff AM, Bhasin S, Flevaris P, Mitchell LM, Basaria S, Boden WE, Cunningham GR, Granger CB, Khera M, Thompson IM Jr, Wang Q, Wolski K, Davey D, Kalahasti V, Khan N, Miller MG, Snabes MC, Chan A, Dubcenco E, Li X, Yi T, Huang B, Pencina KM, Travison TG, Nissen SE; TRAVERSE Study Investigators. (2023). Cardiovascular Safety of Testosterone-Replacement Therapy. The New England Journal of Medicine, 389(2):107–117.(PMID 37326322)
- Choi EJ, Xu P, Barham D, El-Khatib FM, Yafi FA, Kavoussi PK. (2022). Comparison of Outcomes for Hypogonadal Men Treated With Intramuscular Testosterone Cypionate Versus Subcutaneous Testosterone Enanthate. The Journal of Urology, 207(3):677–683.(PMID 34694927)
- Pfizer / Pharmacia & Upjohn Company. Depo-Testosterone (testosterone cypionate) Injection prescribing information. US Food and Drug Administration. ANDA 085635 (originally approved 1953; label revised 2025 to reflect the FDA class-wide testosterone labeling changes — see [9]).
- Antares Pharma / Halozyme Therapeutics. Xyosted (testosterone enanthate) injection prescribing information. US Food and Drug Administration. NDA 209863, approved September 2018; current label SUPPL-020 (2025).
- World Anti-Doping Agency. The 2026 Prohibited List, International Standard (effective 1 January 2026). PDF: wada-ama.org/sites/default/files/2025-09/2026list_en_final_clean_september_2025.pdf. Testosterone is named explicitly under Section S1.1 (Anabolic Androgenic Steroids) — not S2 like the peptides covered elsewhere in this library. Verbatim from the 2026 List, page 5, alphabetic listing under S1.1 anabolic androgenic steroids (AAS): "Testosterone" — listed alongside other named anabolic-androgenic steroids (Bolasterone, Boldenone, Stanozolol, Trenbolone, etc.). The S1.1 catch-all clause reads: "and other substances with a similar chemical structure or similar biological effect(s)" — the strongest WADA prohibition tier. Prohibited at all times, in-competition and out-of-competition.
- US Drug Enforcement Administration. Anabolic Steroids — Schedule III Controlled Substances under the Anabolic Steroid Control Act of 1990 (Pub. L. No. 101-647), the Anabolic Steroid Control Act of 2004 (Pub. L. No. 108-358), and the Designer Anabolic Steroid Control Act of 2014 (Pub. L. No. 113-260; "DASCA"). DEA Diversion Control Division reference: deadiversion.usdoj.gov/drug_chem_info/anabolic.pdf. Federal Register implementation notice for the 2004 Act: federalregister.gov/documents/2005/12/16/05-23907/implementation-of-the-anabolic-steroid-control-act-of-2004. The regulatory chain that places testosterone under DEA Schedule III in the US: the 1990 Act placed anabolic steroids (defined to include testosterone and "any drug or hormonal substance, chemically and pharmacologically related to testosterone... that promotes muscle growth") into Schedule III; the 2004 Act expanded the definition (eliminated the "muscle growth" requirement, added 59 specifically named substances); the 2014 DASCA closed the chemical-modification loophole for designer derivatives.
- US Food and Drug Administration. FDA issues class-wide labeling changes for testosterone products. Drug Alerts and Statements, February 28, 2025.
- Tienforti D, Terrana G, Di Geronimo R, Perfetto E, Spagnolo L, Baroni MG, Barbonetti A. (2026). Testosterone replacement therapy and cardiovascular safety in older men: lessons from TRAVERSE and beyond. Journal of Endocrinological Investigation (published online 27 June 2026).(PMID 42364061)
- US Department of Health and Human Services. HHS Announces Requested Updates to Testosterone Therapy Product Labels. Press release, June 18, 2026.
- World Anti-Doping Agency. World Anti-Doping Code International Standard Prohibited List 2027 (effective 1 January 2027). PDF: wada-ama.org/sites/default/files/2026-09/2027list_en_final_clean_26_august_2026_2.pdf. Testosterone is named under S1.1 (Anabolic Androgenic Steroids), prohibited at all times.
- Endo USA. Aveed (testosterone undecanoate) injection prescribing information. US Food and Drug Administration. NDA 022219; label revised 07/2025.
- ASCEND Therapeutics US / Besins Healthcare. AndroGel (testosterone gel) 1.62% prescribing information. US Food and Drug Administration. NDA 022309; label revised 07/2025.
Related entries
- CJC-1295 / Ipamorelin Blend — discussed together in this entry's stacks section
- BPC-157 / TB-500 Blend — discussed together in this entry's stacks section
- AOD-9604 — discussed together in this entry's stacks section
Entry last updated 2026-09-29. Sourced from published literature and regulatory labelling; see Sources above.