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Testosterone Undecanoate

  • Hormone
  • Given by a clinician
  • Identity checked
  • Sources last checked 2026-09-04

This page shows what was measured, who it was measured in, and what that does not settle.

What Testosterone Undecanoate does in the body

Testosterone replacement therapy

From the FDA-approved label: Endogenous androgens, including testosterone and dihydrotestosterone (DHT), are responsible for the normal growth and development of the male sex organs and for maintenance of secondary sex characteristics. These effects include the growth and maturation of prostate, seminal vesicles, penis, and scrotum; the development of male hair distribution, such as facial, pubic, chest, and axillary hair; laryngeal enlargement; vocal cord thickening; alterations in body musculature; and fat distribution. Male hypogonadism, a clinical syndrome resulting from insufficient secretion of testosterone, has two main etiologies.

What happened in people

RNAWiki has not yet published a reviewed conclusion for this use.

A fixed RNAWiki sentence

Where this came from

Wording RNAWiki always uses, not a finding about this substance.

No reviewed claim names a result for any goal on this record.

No source is stored against this line.

The limit that matters most

Not recorded.

Where it acts
Not recorded.
Kind of result
No result is published, so no kind of result applies yet
Supervision
Professional supervision is normally required. A regulator classifies this substance in a way that restricts how it is supplied.

What the registries record it as

  • The substance registry classes this as chemical.

    FDA substance registry · H16A5VCT9C · read 2026-08-29

Where each sentence above came from

No recorded sentence describes the change this makes in a way that stands on its own. The page opens with what it is taken for instead, and the recorded explanation follows below.

Shown as the opening line on this page.

No statement of the main limit is recorded.

The four opening statements run to 102 words.

Words this page uses

Four words worth knowing first

Chosen from what this page shows, with each one explained before the word it depends on.

Stand-in result

A stand-in result is a number measured because the real result takes too long.

A picture of it, and where the picture fails

It is like judging a journey by the speedometer rather than by arriving.

Where that stops being true. Speed does predict arrival. Many stand-in results do not predict the real one.

What people get wrong. A stand-in result is often reported as the result itself.

A surrogate endpoint substituted for a clinical endpoint, valid only where the substitution has been shown to hold.

Formulation

A formulation is the exact made-up form a substance comes in.

A picture of it, and where the picture fails

It is like the difference between a whole bean and instant coffee.

Where that stops being true. Coffee tastes different. A formulation can change how much reaches the blood.

What people get wrong. Two products with the same name are assumed to behave the same. They often do not.

The specific composition and physical form of a product, including salt, excipients and release profile.

Receptor

A receptor is a part of a cell that a signal fits into.

A picture of it, and where the picture fails

A receptor is like a lock waiting for one key.

Where that stops being true. A lock either opens or does not. A receptor can be half-triggered, or worn out.

What people get wrong. Fitting a receptor is read as causing a benefit. It causes a step, and nothing more.

A protein that binds a specific ligand and converts that binding into a cellular response.

Pathway

A pathway is a chain of steps inside a cell, each one setting off the next.

A picture of it, and where the picture fails

A pathway is like a row of dominoes.

Where that stops being true. Dominoes fall one way. Pathways loop back and can switch themselves off.

What people get wrong. Changing one step is read as changing the outcome. Other steps often absorb it.

An ordered series of molecular interactions producing a defined cellular change.

What happened in peopleRead from sources, not yet reviewed

What was measured, goal by goal

One row for each goal a registered study measured something for. One column for each kind of thing that could be measured.

Registered studies list 40 outcome measures that RNAWiki could read. A registered study says what someone planned to measure. It does not say what they found. 0 of the matched studies tested this substance, and 0 posted a result.

There is no single score. A strong test result and a weak life result are different facts.

Goals down the side, kinds of measurement across the top. Each cell says what kind of thing was registered, not what was found.
GoalLife outcomeWhat a body can doHow a person feelsA test resultA step in the bodyHarmsHow longWho was studied
Fertility and sexual healthNothing in the sources checkedNo registered study lists a life outcome for this goal.Nothing in the sources checkedNo registered study lists a performance measure for this goal.Nothing in the sources checkedNo registered study lists a symptom measure for this goal.Only a number moved4 registered test measure.Nothing in the sources checkedNo registered study lists a body-step measure for this goal.Not recordedHarms were not a registered measure for this goal.Not recordedNo finished study window is recorded.Waiting for a reviewerWho was studied is listed further down the page.
StrengthNothing in the sources checkedNo registered study lists a life outcome for this goal.Waiting for a reviewer2 registered performance measure of this kind.Nothing in the sources checkedNo registered study lists a symptom measure for this goal.Nothing in the sources checkedNo registered study lists a test result for this goal.Nothing in the sources checkedNo registered study lists a body-step measure for this goal.Not recordedHarms were not a registered measure for this goal.Not recordedNo finished study window is recorded.Waiting for a reviewerWho was studied is listed further down the page.
EnduranceNothing in the sources checkedNo registered study lists a life outcome for this goal.Waiting for a reviewer1 registered performance measure of this kind.Nothing in the sources checkedNo registered study lists a symptom measure for this goal.Nothing in the sources checkedNo registered study lists a test result for this goal.Nothing in the sources checkedNo registered study lists a body-step measure for this goal.Not recordedHarms were not a registered measure for this goal.Not recordedNo finished study window is recorded.Waiting for a reviewerWho was studied is listed further down the page.
Blood sugarNothing in the sources checkedNo registered study lists a life outcome for this goal.Nothing in the sources checkedNo registered study lists a performance measure for this goal.Nothing in the sources checkedNo registered study lists a symptom measure for this goal.Only a number moved1 registered test measure.Nothing in the sources checkedNo registered study lists a body-step measure for this goal.Not recordedHarms were not a registered measure for this goal.Not recordedNo finished study window is recorded.Waiting for a reviewerWho was studied is listed further down the page.
EnergyNothing in the sources checkedNo registered study lists a life outcome for this goal.Nothing in the sources checkedNo registered study lists a performance measure for this goal.Waiting for a reviewer1 registered symptom measure.Nothing in the sources checkedNo registered study lists a test result for this goal.Nothing in the sources checkedNo registered study lists a body-step measure for this goal.Not recordedHarms were not a registered measure for this goal.Not recordedNo finished study window is recorded.Waiting for a reviewerWho was studied is listed further down the page.
CholesterolNothing in the sources checkedNo registered study lists a life outcome for this goal.Nothing in the sources checkedNo registered study lists a performance measure for this goal.Nothing in the sources checkedNo registered study lists a symptom measure for this goal.Only a number moved1 registered test measure.Nothing in the sources checkedNo registered study lists a body-step measure for this goal.Not recordedHarms were not a registered measure for this goal.Not recordedNo finished study window is recorded.Waiting for a reviewerWho was studied is listed further down the page.
MuscleNothing in the sources checkedNo registered study lists a life outcome for this goal.Nothing in the sources checkedNo registered study lists a performance measure for this goal.Nothing in the sources checkedNo registered study lists a symptom measure for this goal.Only a number moved1 registered test measure.Nothing in the sources checkedNo registered study lists a body-step measure for this goal.Not recordedHarms were not a registered measure for this goal.Not recordedNo finished study window is recorded.Waiting for a reviewerWho was studied is listed further down the page.
Body weightNothing in the sources checkedNo registered study lists a life outcome for this goal.Nothing in the sources checkedNo registered study lists a performance measure for this goal.Nothing in the sources checkedNo registered study lists a symptom measure for this goal.Only a number moved1 registered test measure.Nothing in the sources checkedNo registered study lists a body-step measure for this goal.Not recordedHarms were not a registered measure for this goal.Not recordedNo finished study window is recorded.Waiting for a reviewerWho was studied is listed further down the page.
Which registered measures put each goal on this table
Fertility and sexual health
female sexual function index; serum testosterone cavg; testosterone; average serum testosterone after dosing on day 2; average serum testosterone after dosing on day 3; changes in serum concentration of testosterone
Strength
muscle strength; handgrip strength
Endurance
vo2 peak achieved during arm ergometry exercise alone; peak aerobic capacity
Blood sugar
insulin resistance
Energy
fatigue
Cholesterol
t cholesterol
Muscle
lean body mass
Body weight
body composition

Sorted by fixed word lists, version v1. A name the rules do not recognise stays unsorted rather than moving to the nearest column.

What each mark on this table means
Nothing in the sources checked
No registered study lists a life outcome for this goal.
Only a number moved
4 registered test measure.
Not recorded
Harms were not a registered measure for this goal.
Waiting for a reviewer
Who was studied is listed further down the page.

What happened in peopleRead from sources, not yet reviewed

What happened in people

Each card is one study: the exact question it asked, who was in it, and whether it showed what it set out to show.

Change From Baseline in 24-Hour Average Systolic Ambulatory Blood Pressure to End of Study (EOS)

The study did not show it

Who was studied
NCT04456296
How many people
673
Study design
Phase 4
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated

What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.

The limits of this study, and where it came from

Main limit. No limitation is recorded for this study.

How far it carries. This study is recorded from the curated record, not from the registry match.

Form and route. Intramuscular

Interval reported. Not recorded in this summary

Written into the record, not signed off as a reviewed claim.

  • openFDA Drugs@FDA · a recorded source, not a stored snapshot
  • openFDA NDC Directory · a recorded source, not a stored snapshot
  • openFDA SPL label · a recorded source, not a stored snapshot
  • PubChem PUG-REST · a recorded source, not a stored snapshot

Percentage of Participants Meeting Serum Total Testosterone Average Concentration Criteria for Responder During the 3rd Injection Interval in Part C

The study did not show it

Who was studied
NCT00467870
How many people
531
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated

What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.

The limits of this study, and where it came from

Main limit. No limitation is recorded for this study.

How far it carries. This study is recorded from the curated record, not from the registry match.

Form and route. Intramuscular

Interval reported. Not recorded in this summary

Written into the record, not signed off as a reviewed claim.

  • openFDA Drugs@FDA · a recorded source, not a stored snapshot
  • openFDA NDC Directory · a recorded source, not a stored snapshot
  • openFDA SPL label · a recorded source, not a stored snapshot
  • PubChem PUG-REST · a recorded source, not a stored snapshot

% of men who had a sperm concentration of 1 million/ml or less at week 16.

The study did not show it

Who was studied
NCT00403793
How many people
350
Study design
Phase 2
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated

What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.

The limits of this study, and where it came from

Main limit. No limitation is recorded for this study.

How far it carries. This study is recorded from the curated record, not from the registry match.

Form and route. Intramuscular

Interval reported. Not recorded in this summary

Written into the record, not signed off as a reviewed claim.

  • openFDA Drugs@FDA · a recorded source, not a stored snapshot
  • openFDA NDC Directory · a recorded source, not a stored snapshot
  • openFDA SPL label · a recorded source, not a stored snapshot
  • PubChem PUG-REST · a recorded source, not a stored snapshot

Percentage of Treated Patients With Average Serum Testosterone (T) Concentrations (Cavg) Between 300 and 1000 ng/dL

The study did not show it

Who was studied
NCT01403116
How many people
325
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated

What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.

The limits of this study, and where it came from

Main limit. No limitation is recorded for this study.

How far it carries. This study is recorded from the curated record, not from the registry match.

Form and route. Intramuscular

Interval reported. Not recorded in this summary

Written into the record, not signed off as a reviewed claim.

  • openFDA Drugs@FDA · a recorded source, not a stored snapshot
  • openFDA NDC Directory · a recorded source, not a stored snapshot
  • openFDA SPL label · a recorded source, not a stored snapshot
  • PubChem PUG-REST · a recorded source, not a stored snapshot

Change from baseline on the total score of the AMS rating scale

The study did not show it

Who was studied
NCT00434824
How many people
322
Study design
Phase 2
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated

What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.

The limits of this study, and where it came from

Main limit. No limitation is recorded for this study.

How far it carries. This study is recorded from the curated record, not from the registry match.

Form and route. Intramuscular

Interval reported. Not recorded in this summary

Written into the record, not signed off as a reviewed claim.

  • openFDA Drugs@FDA · a recorded source, not a stored snapshot
  • openFDA NDC Directory · a recorded source, not a stored snapshot
  • openFDA SPL label · a recorded source, not a stored snapshot
  • PubChem PUG-REST · a recorded source, not a stored snapshot

Proportion of LPCN 1021-treated subjects who achieve a total testosterone concentration [Cavg] between 300 - 1140 ng/dL.

The study did not show it

Who was studied
NCT02081300
How many people
315
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated

What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.

The limits of this study, and where it came from

Main limit. No limitation is recorded for this study.

How far it carries. This study is recorded from the curated record, not from the registry match.

Form and route. Intramuscular

Interval reported. Not recorded in this summary

Written into the record, not signed off as a reviewed claim.

  • openFDA Drugs@FDA · a recorded source, not a stored snapshot
  • openFDA NDC Directory · a recorded source, not a stored snapshot
  • openFDA SPL label · a recorded source, not a stored snapshot
  • PubChem PUG-REST · a recorded source, not a stored snapshot
What we know
RNAWiki holds 6 written-up human studies for this substance, each with the question it asked.
How we know it
Each card names the study, the number of people and what the study set out to measure.
What this does not prove
These summaries were written by a person and have not been signed off as reviewed claims.
Why it matters
A study that failed is as informative as one that worked, and both are here.
What we still do not know
No reviewed claim exists, so no exact population, effect size or interval is published yet.

What happened in peopleRead from sources, not yet reviewed

How close this is to real life

The top step is something a person would feel or care about. The bottom is a guess from software. Filled steps are where evidence exists for this substance.

  1. Living longer, or avoiding a major event Evidence recorded. Death, a heart attack, a stroke, a hospital stay.1 registered measure of this kind. No reviewed result.
  2. What a body can do day to day Evidence recorded. Walking, dressing, breathing, recovering.5 registered measures of this kind.
  3. Measured performance Evidence recorded. How much was lifted, how far was run, how fast.5 registered measures of this kind.
  4. Symptoms and quality of life Evidence recorded. Pain, tiredness, mood, sleep, as the person rated it.2 registered measures of this kind.
  5. A number that stands in for health Evidence recorded. Cholesterol, blood sugar, bone density. A stand-in, not the thing itself.15 registered measures of this kind.
  6. A step measured inside a person Evidence recorded. Something measured in human tissue or human cells.A human record sits on the stored organism ladder.
  7. Animals Evidence recorded. Mice, rats, dogs. Useful for ideas, not proof about people.Stored records in Mouse. A result in animals says what to test next. It does not say what happens in people.
  8. Cells in a dish No evidence recorded. Cells or chemistry on a bench, far from a whole body.No cell or bench record is stored.
  9. A guess from software No evidence recorded. Nobody measured it. RNAWiki never publishes one as a finding.RNAWiki stores no prediction for this record. Software can suggest a link. RNAWiki does not publish one as a finding.

Higher on these steps means closer to something a person would feel. It does not mean better done.

What it would be like to takeRead from sources, not yet reviewed

Felt, measured, or meaningful

Three different things that get called the same word. Registered studies measured all three, and mixing them is how a blood test becomes a health claim.

Felt

Things a person could notice without a test.

  • quality of life
  • fatigue

Measured

Things only a test, a scale or a device shows.

  • muscle strength
  • insulin resistance
  • serum t concentration at steady state
  • t cholesterol
  • lean body mass
  • serum testosterone cavg
  • vo2 peak achieved during arm ergometry exercise alone
  • vertical jump height
  • wingate peak power
  • psa concentration

and 10 more.

Meaningful

Things that change how a life goes, not only a number.

  • death

A registered study says what someone planned to measure. It does not say what they found. A number moving is not the same as a life going better. The two are shown apart here.

Felt, but not shown to help. A person notices a change. No study showed it leads anywhere good.

Measured, but not felt. A number moves. The person notices nothing. Both can be true.

Measured, but not shown to matter. A number moves in the good direction. Nobody showed that lives went better.

Matters, but takes years. The result that counts may take longer than anyone would keep watching.

Names that fit none of the three (17)
  • myocardial perfusion
  • waist to hip
  • prostate volume
  • female sexual function index
  • area under the curve
  • penile curvature
  • liver fat
  • load carriage time
  • total mass lifted
  • peak aerobic capacity
  • fat free mass
  • testosterone
  • fiber cross sectional area
  • myonuclei
  • skeletal muscle proteome
  • elimination phase half life
  • semen volume from baseline and between the treatment arms

These are harms, study-process measures, or names the rules did not recognise. They are shown rather than dropped.

What is missing or unclearRead from sources, not yet reviewed

Were people like you studied?

RNAWiki cannot tell whether a study fits you. It can show who was in it, and where the result stops carrying.

Who was studied

People similar to this profile were included.

  • TLANDO is indicated for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone: Primary hypogonadism (congenital or acquired): testicular failure due to conditions such as cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, orchiectomy, Klinefelter's syndrome, chemotherapy, or toxic damage from alcohol or heavy metals.

Who is missing from the studies

  • Which groups were under-represented in the studies has not been recorded for this substance. Pregnancy, breastfeeding, children, older adults, and people with liver or kidney conditions are commonly excluded from trials; nothing here says whether they were.

What the label states about particular groups

  • On pediatric, the label states: “Safety and effectiveness of AVEED in pediatric patients less than 18 years old have not been established.”

    US prescribing information · f80f025b-17d8-40af-8739-20ce07902045 · read 2026-08-30

  • On older people, the label states: “There have not been sufficient numbers of geriatric patients in controlled clinical studies with AVEED to determine whether efficacy or safety in those over 65 years of age differs from younger subjects.”

    US prescribing information · f80f025b-17d8-40af-8739-20ce07902045 · read 2026-08-30

  • On people who are pregnant, the label states: “Risk Summary AVEED is contraindicated in pregnant women.”

    US prescribing information · f80f025b-17d8-40af-8739-20ce07902045 · read 2026-08-30

  • On people who are breastfeeding, the label states: “8.3 Females and Males of Reproductive Potential Infertility During treatment with large doses of exogenous androgens, including AVEED, spermatogenesis may be suppressed through feedback inhibition of the hypothalamic-pituitary-testicular axis [see Warnings and Precautions ( 5.9 )] , possibly leading to adverse effects on semen parameters including sperm count.”

    US prescribing information · f80f025b-17d8-40af-8739-20ce07902045 · read 2026-08-30

  • On people with reduced liver function, the label states: “No studies were conducted in patients with hepatic impairment.”

    US prescribing information · f80f025b-17d8-40af-8739-20ce07902045 · read 2026-08-30

  • On people with reduced kidney function, the label states: “No studies were conducted in patients with renal impairment.”

    US prescribing information · f80f025b-17d8-40af-8739-20ce07902045 · read 2026-08-30

Where the result stopped carrying

  • This is a scope explorer, not a diagnosis engine.
  • It shows who was studied so you can see whether people similar to you were included.

RNAWiki cannot tell whether a study fits you. It can show who was in it.

What it would be like to takeRead from sources, not yet reviewed

Why it might seem to do nothing

A real effect and a noticed effect are different things. These are the recorded reasons the two come apart.

It was studied for a different goal

The studies measured something else entirely.

On this record: Some registered studies measured things that match no goal on this page.

It was studied in different people

The people in the studies were not much like the reader.

On this record: Which groups were under-represented in the studies has not been recorded for this substance. Pregnancy, breastfeeding, children, older adults, and people with liver or kidney conditions are commonly excluded from trials; nothing here says whether they were.

A different form was studied

The studied form is not the form on the shelf.

On this record: This record is linked to 1 related forms. Evidence does not carry across all of them.

The evidence may simply be wrong

Small early studies often do not hold up.

On this record: RNAWiki has not yet published a reviewed conclusion for this use.

Other reasons RNAWiki checked and found nothing for (9)
There was nothing to correct
Where a level is already normal, topping it up may change nothing. Nothing in this record points to this reason.
Something else had to happen too
In the studies it was paired with training, a diet or another treatment. Nothing in this record points to this reason.
The change is too small to feel
A real change can still sit below what a person notices. Nothing in this record points to this reason.
Day-to-day swing hides it
Sleep, food, stress and time of day move most numbers more than this would. Nothing in this record points to this reason.
Not enough time yet
The studies ran longer than the person has waited. Nothing in this record points to this reason.
It was not taken as studied
Missed days change the result, and studies count them. Nothing in this record points to this reason.
Something else changed at the same time
Two changes at once cannot be told apart afterwards. Nothing in this record points to this reason.
The product may not be what it says
Contents of a sold product are not always what the label states. Nothing in this record points to this reason.
No recorded reason
RNAWiki has nothing stored that would explain it. Nothing in this record points to this reason.

None of these is a reason to take more. Taking more is not a step this page ever suggests.

What it would be like to takeRead from sources, not yet reviewed

What taking it involves

The recorded facts about getting hold of it and using it. Nothing here is a suggestion about what you should do.

How it is supplied

Given by a clinician

Quoted from a source

Where this came from

Copied from a source RNAWiki stored, with the source named.

Read from the recorded approval status.

No source is stored against this line.

Form and route

Intramuscular

Source-linked record

Where this came from

A person wrote this into the record with the study named beside it. No reviewer has signed it off.

The form and route recorded on this substance.

No source is stored against this line.

Who oversees it

Professional supervision is normally required. A regulator classifies this substance in a way that restricts how it is supplied.

Quoted from a source

Where this came from

Copied from a source RNAWiki stored, with the source named.

Suppression classes recorded: S5.

No source is stored against this line.

What is in the pack

Sold as injectable, capsule, capsule, liquid filled, injection, given by the intramuscular, oral route.

Source-linked record

Where this came from

A person wrote this into the record with the study named beside it. No reviewer has signed it off.

Recorded notes on how this is sold and what that means for what is in the pack.

No source is stored against this line.

Where it is registered

Regulatory records are listed in the technical disclosure at the foot of this page.

Counted from records

Where this came from

A count of rows RNAWiki holds. It describes our records, not your body.

Register entries are stored per jurisdiction and shown with their dates.

No source is stored against this line.

Why people stop

Not recorded.

Nothing recorded

Where this came from

RNAWiki holds nothing here and says so rather than guessing.

No record of why people stopped taking it is stored for this substance.

No source is stored against this line.

What it would be like to takeNothing found in the sources checked

What can go wrong

Sorted by where each line came from. A regulator's label and a report somebody sent in are not the same kind of fact.

Nothing found in the sources checked

No harm is recorded against this substance in the sources RNAWiki checked. Finding nothing is not the same as showing there is nothing.

The sources listed were searched and held nothing. That is not the same as nothing existing.

Reports sent to a regulator

  • These are reports people sent to a regulator. They do not show the medicine caused the reaction.
  • Nobody counted how many people took the medicine and reported nothing.
  • The same event can be reported more than once, and many reports are incomplete.
  • News coverage, lawsuits and new warnings change how often people report.
  • A count is not a rate and not a risk.

Testosterone Undecanoate appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 1360 reaction mentions were counted. One report can name several reactions.

The recorded terms (10)
  • blood testosterone decreased — 339 reaction mentions
  • deep vein thrombosis — 180 reaction mentions
  • pulmonary embolism — 161 reaction mentions
  • drug abuse — 145 reaction mentions
  • blood testosterone increased — 141 reaction mentions
  • myocardial infarction — 105 reaction mentions
  • polycythaemia — 80 reaction mentions
  • osteonecrosis — 74 reaction mentions
  • prostate cancer — 68 reaction mentions
  • acute myocardial infarction — 67 reaction mentions
  • open-targets-adr · recorded 2026-06-24 · a recorded source, not a stored snapshot

Over a long time. No completed tested study window is recorded, so long-term effects are not established by the registry record.

Groups the studies covered thinly. Which groups were under-represented in the studies has not been recorded for this substance. Pregnancy, breastfeeding, children, older adults, and people with liver or kidney conditions are commonly excluded from trials; nothing here says whether they were.

What is missing or unclearRead from sources, not yet reviewed

Does the exact form matter?

Evidence belongs to the exact thing that was tested. A different salt, a different mixture or a different preparation is a different question.

The form that was studied

Intramuscular

Source-linked record

Where this came from

A person wrote this into the record with the study named beside it. No reviewer has signed it off.

The form used in the studies cited on this page.

No source is stored against this line.

What is sold

Not recorded.

Nothing recorded

Where this came from

RNAWiki holds nothing here and says so rather than guessing.

Nothing further is recorded about which forms are sold.

No source is stored against this line.

What is recorded as being sold

  • 23 products list this as an active ingredient in the United States drug directory. 23 of them contain it and nothing else.

    FDA National Drug Code directory · 10745-1444 · read 2026-08-29

  • They are sold as capsule, capsule, liquid filled, injection and powder, taken intramuscular and oral.

    FDA National Drug Code directory · 10745-1444 · read 2026-08-29

  • The regulator's established pharmacologic class for it is androgen receptor agonists [moa], androgen [epc] and androstanes [cs].

    FDA National Drug Code directory · 10745-1444 · read 2026-08-29

  • 4 published labels name it as an active ingredient. 4 of them describe this substance alone, which is where its own label text on this page comes from.

    US prescribing information · 4b0b92e9-6d3c-a0e5-e1c7-342999f72580 · read 2026-08-29

  • Those labels are classed as human prescription drug.

    US prescribing information · 4b0b92e9-6d3c-a0e5-e1c7-342999f72580 · read 2026-08-29

  • Aveed is intramuscular at 3 DOSAGE FORMS AND STRENGTHS 750 mg/3 mL (250 mg/mL) testosterone undecanoate sterile injectable solution is provided in an amber glass, single use vial with silver-colored crimp seal and gray plastic cap. 750 mg/3 mL (…, recorded as fda label in effect 2025-07-15 in the United States.

    US prescribing information · f80f025b-17d8-40af-8739-20ce07902045 · read 2026-08-30

Evidence carries across two names for one substance. It does not carry across a salt, a mirror form or a mixture.

Names and forms linked to this record

  • Ester of

    Testosterone

    Evidence on this page does not automatically apply to this one.

What it would be like to takeRead from sources, not yet reviewed

What you could measure

This one is decided with a clinician, so this section holds questions to ask rather than a plan to run.

Self-experiment planning is not offered for a prescription or clinician-supervised medicine. The questions below are for a clinician or pharmacist.

Questions worth asking

  • Which of the trials of Testosterone Undecanoate studied people like me?
  • What was measured, and for how long?
  • Was the result a laboratory value or a health outcome?
  • What would we watch for, and when would we stop?

Tracking can show whether something changed for you. It cannot show what caused it.

RNAWiki records evidence. It does not say whether this substance is right for you.

What is missing or unclearRead from sources, not yet reviewed

What nobody knows yet

Open questions, each with why it is open and what would close it.

Missing populations

Which groups were under-represented in the studies has not been recorded.

Why it matters. Recorded by the evidence model as a gap on this record.

What would answer it

A study that measures it, and a reviewer to sign it off.

Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.

Missing long-term data

No completed tested study window is recorded.

Why it matters. Recorded by the evidence model as a gap on this record.

What would answer it

A study that measures it, and a reviewer to sign it off.

Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.

No reviewed conclusion

RNAWiki has not yet published a reviewed conclusion for this use.

Why it matters. Recorded by the evidence model as a gap on this record.

What would answer it

A study that measures it, and a reviewer to sign it off.

Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.

Missing interaction studies

No interaction was found in the registers checked. Not finding one is not the same as showing there is none.

Why it matters. Recorded by the evidence model as a gap on this record.

What would answer it

A study that measures it, and a reviewer to sign it off.

Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.

Formulation uncertainty

Several salts, forms or products of Testosterone Undecanoate are recorded. Results from one form may not transfer to another.

Why it matters. Recorded by the evidence model as a gap on this record.

What would answer it

A study that measures it, and a reviewer to sign it off.

Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.

Mechanism not reviewed

No reviewed mechanism story exists for this substance.

Why it matters. Recorded by the evidence model as a gap on this record.

What would answer it

A study that measures it, and a reviewer to sign it off.

Last checked 2026-09-04. Searched: The sources listed in the receipts at the foot of this page.

What happened in peopleRead from sources, not yet reviewed

Check any of this yourself

Every line above traced back to the study it came from. This is the technical layer, and the vocabulary changes here.

Where else this substance is registered

FDA substance identifier (UNII)
H16A5VCT9C
RxNorm concept
2599054

Checks this page had to pass

  • Passed

    Identity resolved

    no open identity hold

  • Passed

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    no quarantine open

  • Passed

    Every public sentence names a source

    The opening statement carries the origin: Written into the record, not signed off.

  • Not passed

    Trial roles classified for highlighted evidence

    No registered study is classified as testing this substance.

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    enforced by the copy-contract test over the rendered page

  • Passed

    Safety mode resolved

    Suppression classes recorded: S5.

  • Passed

    Canonical metadata present

    slug and display name present

What is missing or unclearRead from sources, not yet reviewed

How this medicine reached us

Kept near the foot of the page. A historical event moves up only when it changes something about this substance today.

What the approval register records

  • 5 approved applications cover products containing this substance. The earliest was NDA022219, approved 20140305 to ENDO OPERATIONS.

    Drugs@FDA application register · NDA022219 · read 2026-08-29

  • Marketing status on the register: discontinued, none (tentative approval) and prescription.

    Drugs@FDA application register · NDA022219 · read 2026-08-29

  • The earliest marketing start date recorded for a listed product is 19991118.

    FDA National Drug Code directory · 10745-1444 · read 2026-08-29

What is missing or unclearRead from sources, not yet reviewed

What to learn next

Ordered by what would most change how you read this page, starting with what is easiest to misunderstand.

This order is fixed in code and does not count clicks or time on the page.

What is not here

6 questions this page could not answer

These sections were prepared and left out because there was nothing to put in them. They are listed rather than hidden, so the gaps in this record are visible.

  • The path through the body — found nothing in the sources checked.
  • How long anything takes — found nothing in the sources checked.
  • What it may clash with — found nothing in the sources checked.
  • Other ways to the same goal — found nothing in the sources checked.
  • Claims that go past the evidence — found nothing in the sources checked.
  • What changed on this page — found nothing in the sources checked.

The record as stored

The full record, for auditing

Everything above is built from what is below. This layer keeps the technical vocabulary, record identifiers and every stored row, so a reader who wants to check the page can.

Recorded evidence blocks (10)

What did Testosterone Undecanoate's largest trial (1493 people) and its longest (9 years) measure?

1493 people in Testosterone Undecanoate's largest registered study, 9 years in its longest registered window, measuring Percentage of Participants Meeting Serum Total Testosterone Average Concentration Criteria for Responder During the 3rd Injection Interval in Part C. ClinicalTrials.gov · 2026-09-01

22 phase2, 16 phase4, 14 phase3, 5 phase1, 4 na, 3 na or unstated, 1 early phase1; NCT01206270; 2018-06. Last human test completed 2026, NCT05964920.

Interpretation These counts include studies where Testosterone Undecanoate was a comparison treatment, a background treatment or an exposure in an observational study, and the longest window may be a planned end date. Trial roles have not yet been classified for this record.

Show the evidence
  • phase2
    22
  • phase4
    16
  • phase3
    14
  • phase1
    5
  • na
    4
  • na or unstated
    3
2 more recorded rows
  • early phase1
    1
  • Last recorded human test NCT05964920
    2026-02-06

recorded 2026-09-01 · last checked 2026-09-04

From mouse to human: where has Testosterone Undecanoate shown biomarker?

mouse: mechanism-only and human: biomarker (59): the rungs where Testosterone Undecanoate has a recorded finding. Europe PMC and ClinicalTrials.gov · organism ladder · 2026-09-01

Percentage of Participants Meeting Serum Total Testosterone Average Concentration Criteria for Responder During the 3rd Injection Interval in Part C — the recorded outcome words.

Yeast C. elegans Drosophila Mouse mechanism-onlyRat Dog Non-human primate Human biomarker
Show the evidence
  • mouse
    mechanism-only
  • human NCT00467870
    biomarker; Percentage of Participants Meeting Serum Total Testosterone Average Concentration Criteria for Responder During the 3rd Injection Interval in Part C; 59

recorded 2026-09-01 · last checked 2026-09-04

2 of Testosterone Undecanoate's trials stopped: accrual/recruitment, other?

accrual/recruitment (1) and other (1): Testosterone Undecanoate's stop wording, clustered. ClinicalTrials.gov · 2026-09-01

"Poor recruitment"; 2 of 59 registered studies

Show the evidence

Trial

  • NCT01516554
    terminated; "Poor recruitment"
  • NCT03335254
    terminated; "Incomplete effect"

recorded 2026-09-01 · last checked 2026-09-04

Human studies of Testosterone Undecanoate used Testosterone Undecanoate,1000mg — over how long?

studies of Testosterone Undecanoate used the recorded amount. ClinicalTrials.gov · 2026-09-01

11 recorded entries; human; also "Testosterone Undecanoate,1000mg", "Nebido 1000 mg", "Testosterone Undecanoate 750 mg"

Show the evidence

human

  • NCT00421460
    Testosterone Undecanoate,1000mg
  • NCT00421460
    Nebido 1000 mg
  • NCT00467870
    Testosterone Undecanoate 750 mg
  • NCT00467870
    Testosterone Undecanoate 1000 mg
  • NCT00695110
    Oral testosterone undecanoate (TU) (300 mg T equivalents/dose)
  • NCT00695110
    Oral testosterone undecanoate (TU) combined with testosterone enanthate (TE) (400 mg T equivalents/dose)
5 more recorded rows
  • human NCT00695110
    Oral testosterone undecanoate (TU) (200 mg T equivalents/dose with and without food)
  • human NCT00695110
    Oral testosterone undecanoate (TU) combined with testosterone enanthate (TE) (300 mg T equivalents/dose)
  • human NCT00924612
    Oral testosterone undecanoate (containing 300 mg T)
  • human NCT01758029
    Nebido 1000mg
  • human NCT06312761
    Testosterone Undecanoate 237 MG Oral Capsule

recorded 2026-09-01 · last checked 2026-09-04

Which of Testosterone Undecanoate's 6 ongoing trials reports first?

6 registered trials of Testosterone Undecanoate are open; earliest completion 2025-12. ClinicalTrials.gov · 2026-09-01

Change in Maximal isometric muscle strength (N) in shoulder muscles; Liver fat; latest 2030-09-30

Show the evidence

Trial

  • NCT03721497
    "Testosterone in Bariatric Patients"; n 64; "Change in Maximal isometric muscle strength (N) in shoulder muscles"; 2025-12
  • NCT03851627
    "Effects of Testosterone Undecanoate vs Placebo on Intrahepatic Fat Content in Overweight/Obese Men With T2DM or Prediabetes and Hypogonadism"; n 32; "Liver fat"; 2028-12
  • NCT06082817
    "An Open-Label Study of 50 Mg Oral Testosterone Undecanoate (Kyztrex) in Menopausal Women with Low Testosterone and HSDD"; n 30; "Testosterone"; 2025-12-31
  • NCT06188767
    "Testosterone-induced Muscle Memory and Underlying Mechanisms"; n 30; "Fiber cross-sectional area"; 2028-12-01
  • NCT06385509
    "A Phase 4 Study to Evaluate Adrenal Function in Hypogonadal Men Treated With JATENZO® for 12 Months"; n 110; "CST Test"; 2026-03
  • NCT07512323
    "Effect of Testosterone on Elderly Frail Men With Testosterone Deficiency"; n 96; "Chair-stand test"; 2030-09-30

recorded 2026-09-01 · last checked 2026-09-04

Which running trial of Testosterone Undecanoate could settle function?

NCT07512323 measures Chair-stand test, reading out 2030-09-30.

1 open trial; n 96; "Effect of Testosterone on Elderly Frail Men With Testosterone Deficiency"

Show the evidence
  • Trial NCT07512323
    "Effect of Testosterone on Elderly Frail Men With Testosterone Deficiency"; n 96; "Chair-stand test"; 2030-09-30

Which 22 trials of Testosterone Undecanoate posted no result?

Posted no result
22 of 22 completed trials
Registrations
NCT00434824, NCT00119483, NCT00131183, NCT00410306, NCT04545450 and NCT00421460, and 16 more
Completion dates
oldest 2004-07; newest 2023-06-30
Show the evidence

Trial

  • NCT00434824
    2004-07
  • NCT00119483
    2007-12
  • NCT00131183
    2008-05
  • NCT00410306
    2010-07
  • NCT04545450
    2010-10-15
  • NCT00421460
    2011-05
14 further recorded trials
  • NCT01724658
    2013-05
  • NCT01065220
    2014-01
  • NCT01813201
    2014-03
  • NCT00613782
    2014-04
  • NCT02514629
    2016-07-12
  • NCT01919294
    2017-01-30
  • NCT03126656
    2017-04
  • NCT03792321
    2018-03-05
  • NCT01206270
    2018-06
  • NCT03973840
    2018-07-31
  • NCT02966652
    2018-10-04
  • NCT02433730
    2019-09-01
  • NCT04134130
    2019-12-31
  • NCT05417035
    2020-08-01

At the median, Testosterone Undecanoate's trials enrolled 33 people — anything larger?

Median enrolment
33
Largest enrolment
1493
Registered trials counted
59

What do 1360 spontaneous reports say about Testosterone Undecanoate — and not say?

These are reports people sent to a regulator. They do not show the medicine caused the reaction. Nobody counted how many people took the medicine and reported nothing. The same event can be reported more than once, and many reports are incomplete. News coverage, lawsuits and new warnings change how often people report. A count is not a rate and not a risk.

Testosterone Undecanoate appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 1360 reaction mentions were counted: blood testosterone decreased 339; deep vein thrombosis 180; pulmonary embolism 161; drug abuse 145. open-targets-adr · CHEMBL2107067 · 2026-06-24

Show the evidence
  • blood testosterone decreased
    339
  • deep vein thrombosis
    180
  • pulmonary embolism
    161
  • drug abuse
    145
  • blood testosterone increased
    141
  • myocardial infarction
    105
4 more recorded rows
  • polycythaemia
    80
  • osteonecrosis
    74
  • prostate cancer
    68
  • acute myocardial infarction
    67

recorded 2026-06-24 · last checked 2026-09-04

Was Testosterone Undecanoate studied with exercise?

exercise is named in Testosterone Undecanoate's label sentences: "127 patients with cirrhosis and sarcopenia were randomized to receive either nutrition and structured exercise with intramuscular testosterone undecanoate 1000 mg administered at 0, 6, 12, 16, 20, and 24 weeks (NExT group, n = 64) or only structured exercise and nutrition (NEx group, n = 63)." openfda-label+europepmc · 2026-06-19

1 recorded statement; exercise

Show the evidence
  • exercise
    127 patients with cirrhosis and sarcopenia were randomized to receive either nutrition and structured exercise with intramuscular testosterone undecanoate 1000 mg administered at 0, 6, 12, 16, 20, and 24 weeks (NExT group, n = 64) or only structured exercise and nutrition (NEx group, n = 63).

recorded 2026-06-19 · last checked 2026-09-04

Where it is registered
Identifiers, relations and other names

The exact record

ChEMBL id
CHEMBL2107067
PubChem CID
65157
CAS number
5949-44-0
RxCUI
37864
InChIKey
UDSFVOAUHKGBEK-CNQKSJKFSA-N

Relations

Trade name
Andriol, Aveed, Jatenzo, Nebido, Restandol, Restandol testocap, Undestor, Jatenzo / Kyzatrex / Aveed / Tlando
Also called
Kyzatrex, Testosterone 17.beta.-undecylate, Testosterone undecylate, Tlando, bay86-5037, lpcn 1021, nebido-r, sov2012-f1, testosterone, testosterone undeconate, tu, (17.BETA.)-17-HYDROXYANDROST-4-EN-3-ONE UNDECANOATE
Development code
MK-3033, ORG 538, TSX-011
Salt form
oral testosterone undecanoate, oral tu
Sources (8)

Sources

  • ClinicalTrials.gov clinicaltrials.gov ·
  • ClinicalTrials.gov ClinicalTrials.gov API v2 snapshot 2026-09-01T09:00:05 ·
  • this record's own fields 2,3,5 ·
  • Europe PMC and ClinicalTrials.gov organism ladder ·
  • open-targets-adr CHEMBL2107067 ·
  • openfda-label 4b0b92e9-6d3c-a0e5-e1c7-342999f72580 ·
2 more sources
  • openfda-label+europepmc K1:H16A5VCT9C ·
  • national registers US, CA ·

ClinicalTrials.gov — US Government work · Europe PMC — metadata only, under the recorded legal gate · Open Targets 26.06 — CC0 · derived from this page's own recorded fields; no external licence · mixed register set; per-register licences in docs/specs/corpus-20k-sources.md · openFDA / DailyMed — US Government work

How these records are assembled · Which registers were checked

Index-quality checks
  • identity passed: no open identity hold
  • required summary fields resolved: 5 required field(s) not terminal: Why people use it, Best-supported result, Most important common problem, Biggest unanswered question, Human evidence
  • public claims reviewed: 0 reviewed claim(s); drafts are never rendered
  • source coverage passed: 8 source rows
  • no critical contamination: no quarantine open
  • canonical metadata passed: slug and display name present
  • no raw internal fields: enforced by the copy-contract test over the rendered page

This is a record of evidence. It is not medical advice, and it does not say this substance suits you. Nothing here says any substance on RNAWiki is appropriate for a child.