This page shows what was measured, who it was measured in, and what that does not settle.
What Leuprorelin does in the body
FENSOLVI is indicated for the treatment of pediatric patients 2 years of age and older with central precocious puberty (CPP).
From the FDA-approved label: Leuprolide acetate, a gonadotropin releasing hormone (GnRH) agonist, acts as a potent inhibitor of gonadotropin secretion when given continuously in therapeutic doses. Animal and human studies indicate that after an initial stimulation, chronic administration of leuprolide acetate results in suppression of testicular and ovarian steroidogenesis. This effect is reversible upon discontinuation of drug therapy.
Why people take it. FENSOLVI is indicated for the treatment of pediatric patients 2 years of age and older with central precocious puberty (CPP).
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 · 8E3C3C493W · read 2026-08-29
Where each sentence above came from
The use the label states, quoted from it. No plain-language version of this sentence has been written.
The use the label states, quoted from it. It is written for a clinician, not for a reader without medical training.
No statement of the main limit is recorded.
The four opening statements run to 109 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.
Biomarker
A biomarker is a number from a test that stands in for something about health.
A picture of it, and where the picture fails
A biomarker is like a fuel gauge.
Where that stops being true. A gauge is wired to the tank. Many biomarkers are only loosely tied to health.
What people get wrong. A better number is read as a better life. Several medicines improved a number and helped nobody.
A measurable indicator used as a substitute for a clinical outcome of interest.
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.
What happened in people◇Read 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.
Goal
Life outcome
What a body can do
How a person feels
A test result
A step in the body
Harms
How long
Who was studied
Fertility and sexual health
∅Nothing 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.
Mood
∅Nothing 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 reviewer2 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.
Blood sugar
∅Nothing 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 moved2 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.
Healthy ageing
…Waiting for a reviewer1 registered study measure of this kind. No reviewed result yet.
∅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.
∅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.
Body weight
∅Nothing 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.
Sleep
∅Nothing 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.
∅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.
Which registered measures put each goal on this table
Fertility and sexual health
free testosterone; elevations in serum testosterone; testosterone 0 5ng/ from day 28 through day 364
Mood
beck depression inventory; edinburgh postnatal depression scale mean total
Blood sugar
insulin sensitivity; aim 2 acute insulin resistance to intravenous glucose
Healthy ageing
prostate cancer specific mortality
Body weight
markedly abnormal values in vital signs and body weight
Sleep
objective sleep efficiency
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
1 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 people◇Read 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.
Tamoxifen, Ovarian Ablation, and/or Chemotherapy in Treating Women With Stage I, Stage II, or Stage IIIA Breast Cancer
✗ The study did not show it
Who was studied
NCT00002582
How many people
6000
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. Subcutaneous
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
Disease-specific survival (i.e., death due to prostate cancer) (RADICALS-HD)
✗ The study did not show it
Who was studied
NCT00541047
How many people
4236
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
Living longer, or avoiding a major event
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. Subcutaneous
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
Invasive Disease-Free Survival (IDFS), Excluding Second Primary Non-Breast Cancers
✗ The study did not show it
Who was studied
NCT04961996
How many people
4170
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
Living longer, or avoiding a major event
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. Subcutaneous
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
Invasive breast cancer-free survival (IBCFS)
✗ The study did not show it
Who was studied
NCT05879926
How many people
3960
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
Living longer, or avoiding a major event
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. Subcutaneous
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
Number of Participants With Adverse Events (AEs) and Serious AEs (SAEs) During Treatment With Ribociclib + Letrozole in the Core Phase
✗ The study did not show it
Who was studied
NCT02941926
How many people
3246
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. Subcutaneous
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
Metastasis-free survival (MFS)
✗ The study did not show it
Who was studied
NCT04513717
How many people
2753
Study design
Phase 3
Compared against
Not recorded for this study
Kind of result
Living longer, or avoiding a major event
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. Subcutaneous
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 people◇Read 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.
■Living longer, or avoiding a major eventEvidence recorded. Death, a heart attack, a stroke, a hospital stay.12 registered measures of this kind. 4 written-up studies measured this and did not show a benefit.
□What a body can do day to dayNo evidence recorded. Walking, dressing, breathing, recovering.No registered study measures this.
□Measured performanceNo evidence recorded. How much was lifted, how far was run, how fast.No registered study measures this.
■Symptoms and quality of lifeEvidence recorded. Pain, tiredness, mood, sleep, as the person rated it.2 registered measures of this kind.
■A number that stands in for healthEvidence recorded. Cholesterol, blood sugar, bone density. A stand-in, not the thing itself.4 registered measures of this kind.
■A step measured inside a personEvidence recorded. Something measured in human tissue or human cells.A human record sits on the stored organism ladder.
□AnimalsNo evidence recorded. Mice, rats, dogs. Useful for ideas, not proof about people.No animal record is stored.
□Cells in a dishNo evidence recorded. Cells or chemistry on a bench, far from a whole body.No cell or bench record is stored.
□A guess from softwareNo 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 take◇Read 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.
beck depression inventory
edinburgh postnatal depression scale mean total
Measured
Things only a test, a scale or a device shows.
insulin sensitivity
elevations in serum testosterone
aim 2 acute insulin resistance to intravenous glucose
markedly abnormal values in vital signs and body weight
Meaningful
Things that change how a life goes, not only a number.
overall survival rate
overall survival
disease free survival at 5 years
disease specific survival
progression free survival
prostate cancer specific mortality
effect of ias on overall survival
progression free survival in intent to treat population
progression free survival rate at month 36 in itt population
time to prostate specific antigen relapse
and 2 more.
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 (22)
efficacy
time to progression
free testosterone
progression free at 18 months
aim 1 apnea hypopnea index
experiencing dose limiting toxicities
testosterone 0 5ng/ from day 28 through day 364
pathological complete response
one or more drug related adverse events
adult height standard deviation
time to psa progression
prostate specific antigen failures
markedly abnormal values in safety laboratory variables
objective sleep efficiency
overall response rate as measured by recist
achieving pathological complete response
freedom from distant metastases
free from progression at 5 years
response
pathologic complete response at the time of surgery
These are harms, study-process measures, or names the rules did not recognise. They are shown rather than dropped.
What is missing or unclear◇Read 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.
LUPRON DEPOT 3.75 mg is a gonadotropin-releasing hormone (GnRH) agonist indicated for: Endometriosis Management of endometriosis, including pain relief and reduction of endometriotic lesions. ( 1.1 ) In combination with a norethindrone acetate for initial management of the painful symptoms of endometriosis and for management of recurrence of symptoms.
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: “The safety and effectiveness of FENSOLVI have not been established in pediatric patients less than 2 years old.”
US prescribing information · dfb6e01c-f138-471d-bf5b-2be38247e3f0 · read 2026-08-30
On people who are pregnant, the label states: “Risk Summary FENSOLVI is contraindicated in pregnancy [see Contraindications ( 4 )] .”
US prescribing information · dfb6e01c-f138-471d-bf5b-2be38247e3f0 · read 2026-08-30
On people who are breastfeeding, the label states: “Risk Summary There are no data on the presence of leuprolide acetate in either animal or human milk, the effects on the breastfed infants, or the effects on milk production.”
US prescribing information · dfb6e01c-f138-471d-bf5b-2be38247e3f0 · 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 take◇Read 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.
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 (10)
A different form was studied
The studied form is not the form on the shelf. Nothing in this record points to this reason.
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 take◇Read 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
Subcutaneous
✎ 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: S3.
No source is stored against this line.
What is in the pack
Sold as solution, for suspension, injectable, emulsion, given by the subcutaneous, intramuscular, injection 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 take∅Nothing 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.
Leuprorelin appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 9118 reaction mentions were counted. One report can name several reactions.
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 unclear◇Read 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
Subcutaneous
✎ 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
79 products list this as an active ingredient in the United States drug directory. 79 of them contain it and nothing else.
FDA National Drug Code directory · 11532-3338 · read 2026-08-29
They are sold as injection, injection, emulsion, injection, powder, lyophilized, for suspension, injection, suspension, extended release and powder, taken subcutaneous.
FDA National Drug Code directory · 11532-3338 · read 2026-08-29
The regulator's established pharmacologic class for it is gonadotropin releasing hormone receptor agonist [epc] and gonadotropin releasing hormone receptor agonists [moa].
FDA National Drug Code directory · 11532-3338 · read 2026-08-29
24 published labels name it as an active ingredient. 24 of them describe this substance alone, which is where its own label text on this page comes from.
US prescribing information · dfb6e01c-f138-471d-bf5b-2be38247e3f0 · read 2026-08-29
Those labels are classed as human prescription drug.
US prescribing information · dfb6e01c-f138-471d-bf5b-2be38247e3f0 · read 2026-08-29
Recorded price in US: 197.606 USD per one unit as the pricing file counts it — a tablet, capsule, patch or single item, across 8 priced products whose strengths and pack forms differ, as of 2026-08-26, paid by retail pharmacies buying the product, as surveyed by the Centers for Medicare & Medicaid Services. It is not a list price, an insurance price, or what anyone pays at a counter..
Recorded source · 2026-08-26 · read 2026-08-28
Evidence carries across two names for one substance. It does not carry across a salt, a mirror form or a mixture.
What it would be like to take◇Read 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 Leuprorelin 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 unclear◇Read from sources, not yet reviewed
What nobody knows yet
Open questions, each with why it is open and what would close it.
How fast does the body clear it?
The sources RNAWiki checked hold nothing for this field.
Why it matters. Without this, nothing on this page can say how long anything lasts.
What would answer it
A stored source that records 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 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 Leuprorelin 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 people◇Read 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.
How many documents were read
24 documents were read for this substance.
RNAWiki source record
11 of them state the same halfLife, and they agree.
RNAWiki source record
2 of them state the same tMax, and they agree.
RNAWiki source record
Where else this substance is registered
FDA substance identifier (UNII)
8E3C3C493W
RxNorm concept
2595044
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Trial roles classified for highlighted evidence
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Suppression classes recorded: S3.
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Canonical metadata present
slug and display name present
What is missing or unclear◇Read 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
27 approved applications cover products containing this substance. The earliest was NDA019010, approved 19850409 to ABBVIE ENDOCRINE INC.
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What is not here
6 questions this page could not answer
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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 (11)
Q2
What did Leuprorelin's largest trial (14417 people) and its longest (28 years) measure?
14417 people in Leuprorelin's largest registered study, 28 years in its longest registered window, measuring Prostate cancer-specific mortality. ClinicalTrials.gov · 2026-09-01
147 phase2, 75 phase3, 34 phase4, 28 phase1, 24 na, 19 na or unstated, 3 early phase1; NCT00001481; 2024-10-25; no ageing endpoint recorded. Last human test completed 2026, NCT05617885.
Interpretation These counts include studies where Leuprorelin 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
147
phase3
75
phase4
34
phase1
28
na
24
na or unstated
19
2 more recorded rows
early phase1
3
Last recorded human testNCT05617885
2026-06-01
recorded 2026-09-01 · last checked 2026-09-04
Q3
Leuprorelin was tested only in human — what did it show?
20 recorded entries; human; also "ELIGARD 22.5 mg", "LUPRON depot 3.75 mg", "ELIGARD 22.5mg"
Show the evidence
human
NCT00378690
ELIGARD 22.5 mg
NCT01257802
LUPRON depot 3.75 mg
NCT01511874
ELIGARD 22.5mg
NCT01712230
Leuprolide Acetate 3.75mg
NCT01763541
Lupron Depot 3.75 mg and 7.5 mg
NCT02057939
leuprolide acetate (Lupron Depot, 22.5 mg)
14 more recorded rows
humanNCT02128334
Eligard 45 mg Exposure
humanNCT02134977
Leuplin SR 11.25 mg Injection Kit
humanNCT02452931
Leuprolide Acetate 45 mg
humanNCT02807363
Lupron Depot® 3.75 mg
humanNCT03963752
Leuprorelin Acetate 3.75mg Injection
humanNCT04783636
leuprorelin acetate 3.75mg
humanNCT04840745
CKD-841 A-1 3.75mg
humanNCT04840745
CKD-841 A-1 1.88mg
humanNCT04840745
CKD-841 D 2.92mg
humanNCT05304169
Leuprorelin Acetate (Eligard® 45 mg).
humanNCT06282588
Depo-Eligard 45 mg
humanNCT06282588
Leuprorelin acetate 45 mg
humanNCT06282588
Depo-Eligard 22.5 mg
humanNCT06282588
Leuprorelin acetate 22.5 mg
recorded 2026-09-01 · last checked 2026-09-04
Q6
Which of achieving pathological complete response, adult height standard deviation and aim 1 apnea hypopnea index did Leuprorelin's trials measure?
achieving pathological complete response, adult height standard deviation and aim 1 apnea hypopnea index lead 40 outcome terms across Leuprorelin's trials. ClinicalTrials.gov · 2026-09-01
overall survival, efficacy, disease free survival at 5 years, time to progression, disease specific survival and progression free survival follow.
Show the evidence
beck depression inventory
1
edinburgh postnatal depression scale mean total
1
overall survival rate
1
overall survival
1
efficacy
1
disease free survival at 5 years
1
14 more recorded rows
time to progression
1
disease specific survival
1
progression free survival
1
free testosterone
1
insulin sensitivity
1
elevations in serum testosterone
1
progression free at 18 months
1
prostate cancer specific mortality
1
aim 1 apnea hypopnea index
1
aim 2 acute insulin resistance to intravenous glucose
1
effect of ias on overall survival
1
experiencing dose limiting toxicities
1
testosterone 0 5ng/ from day 28 through day 364
1
pathological complete response
1
recorded 2026-09-01 · last checked 2026-09-04
Q7
Which of Leuprorelin's 66 ongoing trials reports first?
Number of Participants With Pathological Complete Response (pCR); Time to Prostate-specific Antigen (PSA) Relapse; latest 2041-08
Show the evidence
Trial
NCT00329043
"Sunitinib Malate With Hormonal Ablation for Patients Who Will Have Prostatectomy"; n 64; "Number of Participants With Pathological Complete Response (pCR)"; 2027-12-31
NCT00544830
"Hormone Therapy and Intensity-Modulated Radiation Therapy in Treating Patients With Metastatic Prostate Cancer"; n 29; "Time to Prostate-specific Antigen (PSA) Relapse"; 2027-02-15
NCT01442246
"Evaluation of Adjuvant Hormonal Treatment for 24 Months After Radical Prostatectomy in High Risk of Recurrence Patients."; n 700; "The principal criterion is the evaluation of effectiveness in terms of survival without metastases to 10 years, of adjuvant treatment with leuprorelin acetate (Eligard® 45 mg) for 24 months after radical prostatectomy."; 2027-09
NCT01674140
"S1207 Hormone Therapy With or Without Everolimus in Treating Patients With Breast Cancer"; n 1939; "Invasive Disease-Free Survival (IDFS)"; 2030-01
NCT01746849
"Palifermin With Leuprolide Acetate for the Promotion of Immune Recovery Following Total Body Irradiation Based T-Cell Depleted Allogeneic Hematopoietic Stem Cell Transplantation"; n 82; "a CD4+ T cell count of greater than 200"; 2026-12
NCT01786265
"Finite Androgen Ablation With or Without Abiraterone Acetate and Prednisone in Treating Patients With Recurrent Prostate Cancer"; n 310; "Prostate-specific antigen (PSA) free survival (PSA < 0.1 ng/ml)"; 2027-02-01
14 further recorded trials
NCT02023463
"Enzalutamide, Radiation Therapy and Hormone Therapy in Treating Patients With Intermediate or High-Risk Prostate Cancer"; n 25; "Acute toxicities, monitored using the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 criteria"; 2040-01-01
NCT02319837
"Safety and Efficacy Study of Enzalutamide Plus Leuprolide in Patients With Nonmetastatic Prostate Cancer (EMBARK)"; n 1068; "Metastasis-free Survival (MFS) Compared Between Enzalutamide Plus Leuprolide and Placebo Plus Leuprolide"; 2026-09-19
NCT02685397
"Management of Castration-Resistant Prostate Cancer with Oligometastases"; n 102; "Radiographic Progression-free Survival"; 2041-08
NCT02960022
"A Study for Subjects With Prostate Cancer Who Previously Participated in an Enzalutamide Clinical Study"; n 900; "Number of participants with adverse events"; 2029-07-31
NCT03361735
"Radium Ra 223 Dichloride, Hormone Therapy and Stereotactic Body Radiation Therapy in Treating Patients With Metastatic Prostate Cancer"; n 25; "Time to Treatment Failure"; 2027-01-06
NCT03541928
"Phase II High Risk Prostate Cancer Trial Using Gene & Androgen Deprivation Therapies, Radiotherapy, & Surgery"; n 60; "Biochemical control rate"; 2023-07
NCT03678025
"Standard Systemic Therapy With or Without Definitive Treatment in Treating Participants With Metastatic Prostate Cancer"; n 1273; "Overall survival (OS)"; 2031-10-01
NCT03703778
"Real-life Evaluation of the Effect of ADT in Prostate Cancer Patients in Asia (READT Asia Study)"; n 300; "The proportion of patients using surgical castration and medical castration in prostate cancer patients in Asia"; 2026-03-31
NCT03809000
"A Study of Salvage Radiotherapy With or Without Enzalutamide in Recurrent Prostate Cancer Following Surgery"; n 188; "Percentage of Participants Alive Without Progression (Progression-Free Survival)"; 2029-09-15
NCT03900637
"PersonaLized neoAdjuvant Strategy ER Positive and HER2 Negative Breast Cancer TO Increase BCS Rate"; n 122; "Conversion Rate"; 2028-12-31
NCT03902951
"Antiandrogen Therapy and SBRT in Treating Patients With Recurrent, Metastatic Prostate Cancer"; n 28; "Percent of patients achieving a serum prostate specific antigen (PSA) of < 0.05 ng/mL"; 2028-01-01
NCT03944434
"FACILE: FeAsibility of First-line RiboCIclib in OLdEr Patients with Advanced Breast Cancer"; n 116; "Treatment feasibility"; 2025-11-27
NCT03951831
"REGN2810 Followed by Chemoimmunotherapy for Newly Metastatic Hormone-sensitive Prostate Cancer"; n 26; "Percentage of Subjects Achieving Undetectable PSA at 6 months after Combination Treatment"; 2028-04
NCT04126070
"Nivolumab + Docetaxel + ADT in mHSPC Patients With DDRD or Inflamed Tumors"; n 47; "Percentage of Subjects With Prostate Specific Antigen (PSA) Less Than or Equal to 0.2 ng/mL at 7 Months From Start of Chemoimmunotherapy"; 2026-10-30
recorded 2026-09-01 · last checked 2026-09-04
Q8
Which running trial of Leuprorelin could settle lifespan?
NCT02319837 measures Metastasis-free Survival (MFS) Compared Between Enzalutamide Plus Leuprolide and Placebo Plus Leuprolide, reading out 2026-09-19.
20 open trials; n 1068; "Safety and Efficacy Study of Enzalutamide Plus Leuprolide in Patients With Nonmetastatic Prostate Cancer (EMBARK)"
Show the evidence
Trial
NCT02319837
"Safety and Efficacy Study of Enzalutamide Plus Leuprolide in Patients With Nonmetastatic Prostate Cancer (EMBARK)"; n 1068; "Metastasis-free Survival (MFS) Compared Between Enzalutamide Plus Leuprolide and Placebo Plus Leuprolide"; 2026-09-19
NCT01786265
"Finite Androgen Ablation With or Without Abiraterone Acetate and Prednisone in Treating Patients With Recurrent Prostate Cancer"; n 310; "Prostate-specific antigen (PSA) free survival (PSA < 0.1 ng/ml)"; 2027-02-01
NCT01442246
"Evaluation of Adjuvant Hormonal Treatment for 24 Months After Radical Prostatectomy in High Risk of Recurrence Patients."; n 700; "The principal criterion is the evaluation of effectiveness in terms of survival without metastases to 10 years, of adjuvant treatment with leuprorelin acetate (Eligard® 45 mg) for 24 months after radical prostatectomy."; 2027-09
NCT04455750
"A Clinical Study Evaluating The Benefit of Adding Rucaparib to Enzalutamide for Men With Metastatic Prostate Cancer That Has Become Resistant To Testosterone-Deprivation Therapy"; n 61; "Radiographic progression-free survival (rPFS)"; 2027-09
NCT04302454
"Androgen Deprivation Therapy for Oligo-recurrent Prostate Cancer in Addition to radioTherapy"; n 280; "Metastases progression-free survival (MPFS)"; 2027-12-01
NCT04484818
"Testing the Addition of Darolutamide to Hormonal Therapy (Androgen Deprivation Therapy [ADT]) After Surgery for Men With High-Risk Prostate Cancer, The ERADICATE Study"; n 27; "Metastasis-free survival (MFS)"; 2028-05-31
14 further recorded trials
NCT05189457
"First Strike, Second Strike Therapies for High Risk Metastatic Castration Sensitive Prostate Cancer"; n 32; "Overall Survival"; 2028-07
NCT03809000
"A Study of Salvage Radiotherapy With or Without Enzalutamide in Recurrent Prostate Cancer Following Surgery"; n 188; "Percentage of Participants Alive Without Progression (Progression-Free Survival)"; 2029-09-15
NCT01674140
"S1207 Hormone Therapy With or Without Everolimus in Treating Patients With Breast Cancer"; n 1939; "Invasive Disease-Free Survival (IDFS)"; 2030-01
NCT05827081
"Phase IIIb Study of Ribociclib + ET in Early Breast Cancer"; n 1400; "Invasive Breast Cancer Free Survival (iBCFS) rate at 3 years"; 2030-09-20
NCT07650240
"Study of PSMA-targeted Therapy and Androgen Receptor Suppression in Low-volume Metastatic ProstatE Cancer: SPARKLE Trial"; n 202; "Radiographic progression free survival (rPFS)"; 2030-12-30
NCT06282588
"Treatment of High-Risk Prostate Cancer Guided by Novel Diagnostic Radio- and Molecular Tracers"; n 493; "Phase 3: PSMA PET metastasis free survival (ppMFS)"; 2030-12-31
NCT06378866
"Stereotactic Body Radiation Therapy Plus Immediate or Delayed Androgen Receptor Pathway Inhibitor and Androgen Deprivation Therapy or Salvage Radiation Therapy for the Treatment of Prostate Cancer, DIVINE Trial"; n 532; "Modified radiographic progression-free survival (mrPFS) (Groups A & B)"; 2031-02-28
NCT06348264
"Adjuvant Rezvilutamide in Combination With Androgen Deprivation Therapy in Androgen Receptor-positive, High-risk Salivary Duct Carcinoma"; n 37; "3-year disease-free survival (DFS)"; 2031-03-30
NCT06654336
"Study of Recurrence-directed Therapy (RDT) With or Without Androgen-Deprivation Therapy (ADT) In Patients With Radio-recurrent Oligo-metastatic Hormone/Castrate Sensitive Prostate Cancer (romCSPC)"; n 162; "Composite progression free survival"; 2031-06
NCT06922318
"The COSMYC Trial (COmbined Suppression of MYC)"; n 50; "Clinical/radiographic progression free survival (PFS) with BATZEN"; 2031-08-30
NCT03678025
"Standard Systemic Therapy With or Without Definitive Treatment in Treating Participants With Metastatic Prostate Cancer"; n 1273; "Overall survival (OS)"; 2031-10-01
NCT04423211
"Treating Prostate Cancer That Has Come Back After Surgery With Apalutamide and Targeted Radiation Based on PET Imaging"; n 804; "Progression-free survival (PFS)"; 2032-12-31
NCT04513717
"Two Studies for Patients With High Risk Prostate Cancer Testing Less Intense Treatment for Patients With a Low Gene Risk Score and Testing a More Intense Treatment for Patients With a High Gene Risk Score, The PREDICT-RT Trial"; n 2753; "Metastasis-free survival (MFS)"; 2038-12-31
NCT02685397
"Management of Castration-Resistant Prostate Cancer with Oligometastases"; n 102; "Radiographic Progression-free Survival"; 2041-08
Q9
Which 60 trials of Leuprorelin posted no result?
Posted no result
60 of 60 completed trials
Registrations
NCT00004311, NCT00004426, NCT00004436, NCT00004438, NCT00003394 and NCT00026377, and 54 more
Completion dates
oldest 1996-01; newest 2024-08-21
Show the evidence
Trial
NCT00004311
1996-01
NCT00004426
1998-09
NCT00004436
2000-06
NCT00004438
2002-09
NCT00003394
2003-04
NCT00026377
2003-04
14 further recorded trials
NCT00056654
2004-07
NCT00220194
2005-06
NCT00684905
2005-10
NCT00063310
2006-02
NCT00349258
2006-05
NCT00161421
2006-07
NCT00003124
2007-01
NCT00076440
2007-03
NCT00002582
2007-04
NCT00776074
2007-07
NCT00128531
2007-11
NCT00653757
2007-12
NCT01011751
2007-12
NCT00817739
2008-12
Q10
At the median, Leuprorelin's trials enrolled 66 people — anything larger?
Median enrolment
66
Largest enrolment
14417
Registered trials counted
313
Q11
What do 9118 spontaneous reports say about Leuprorelin — 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.
Leuprorelin appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 9118 reaction mentions were counted: syringe issue 2363; intercepted product preparation error 1982; wrong technique in product usage process 1565; hot flush 1124. open-targets-adr · CHEMBL1200775 · 2026-06-24
Show the evidence
syringe issue
2363
intercepted product preparation error
1982
wrong technique in product usage process
1565
hot flush
1124
prostatic specific antigen increased
513
malignant neoplasm progression
481
4 more recorded rows
metastases to bone
289
needle issue
286
product leakage
270
prostate cancer
245
recorded 2026-06-24 · last checked 2026-09-04
Q12
Was Leuprorelin studied with fasting?
fasting is named in Leuprorelin's label sentences: "To determine whether this platform can deliver therapeutic doses of the GnRH agonist leuprolide, we conducted a randomized, four-period, four-treatment, crossover pharmacokinetic and food effect study in 14 healthy female volunteers, which compared PK profiles following single administrations of 1…" openfda-label+europepmc · 2022-11-01
1 recorded statement; fasting
Show the evidence
fasting
To determine whether this platform can deliver therapeutic doses of the GnRH agonist leuprolide, we conducted a randomized, four-period, four-treatment, crossover pharmacokinetic and food effect study in 14 healthy female volunteers, which compared PK profiles following single administrations of 1 and 4 mg of leuprolide --- the latter under both fasting and fed conditions --- to that of a single…
recorded 2022-11-01 · last checked 2026-09-04
Where it is registeredIdentifiers, relations and other names
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
✗ 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.