This page shows what was measured, who it was measured in, and what that does not settle.
What Prasterone does in the body
Moderate to severe dyspareunia, a symptom of vulvar and vaginal atrophy, due to menopause
From the FDA-approved label: Mechanism of Action Prasterone is an inactive endogenous steroid and is converted into active androgens and/or estrogens. The mechanism of action of INTRAROSA in postmenopausal women with vulvar and vaginal atrophy is not fully established. 2 ng·h/mL, respectively, which were significantly higher than those in the group treated with placebo ( Table 1 ).
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 · 459AG36T1B · read 2026-08-29
Its recorded molecular formula is C19H28O2, weighing 288.424 g/mol.
US prescribing information · ada639d4-bac0-2ad0-e053-2a95a90afce7 · read 2026-08-30
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 86 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.
Enzyme
An enzyme is a protein that speeds up one chemical change.
A picture of it, and where the picture fails
An enzyme is like a machine on a production line doing one cut.
Where that stops being true. A machine is switched on and off by a person. Enzymes are controlled by the cell.
What people get wrong. Enzymes are thought to be used up. They are not; they work again and again.
A catalytic protein that lowers the activation energy of a specific reaction.
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 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 26 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
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.
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 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.
Energy
∅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 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.
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.
Which registered measures put each goal on this table
Body weight
body composition
Blood sugar
glucose and insulin metabolism
Energy
fatigue
Fertility and sexual health
sperm concentration
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.
Biological age as assessed by DNA methylation levels, to calculate the Epigenetic age.
✗ The study did not show it
Who was studied
NCT03353597
How many people
2120
Study design
Phase 1/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. Vaginal
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 in sexual health
✗ The study did not show it
Who was studied
NCT06590337
How many people
1202
Study design
Not applicable
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. Vaginal
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
Live birth rate
✗ The study did not show it
Who was studied
NCT01573858
How many people
1000
Study design
Not applicable
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. Vaginal
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
Live-birth rate
✗ The study did not show it
Who was studied
NCT01116167
How many people
660
Study design
Not applicable
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. Vaginal
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
Sexual desire
✗ The study did not show it
Who was studied
NCT03287232
How many people
653
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. Vaginal
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 in sexual health
✗ The study did not show it
Who was studied
NCT06891547
How many people
600
Study design
Not applicable
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. Vaginal
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 eventNo evidence recorded. Death, a heart attack, a stroke, a hospital stay.No registered study measures this.
□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.5 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.
■AnimalsEvidence recorded. Mice, rats, dogs. Useful for ideas, not proof about people.Stored records in Mouse, Rat, Dog, Non-human primate. A result in animals says what to test next. It does not say what happens in people.
■Cells in a dishEvidence recorded. Cells or chemistry on a bench, far from a whole body.Stored mechanism abstracts describe steps measured in cells or tissue.
□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.
quality of life
fatigue
Measured
Things only a test, a scale or a device shows.
bone mineral density
body composition
glucose and insulin metabolism
level of catecholamines in blood from baseline
sperm concentration
Meaningful
Things that change how a life goes, not only a number.
No registered study measured anything of this kind.
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 (19)
satisfaction
areal bone density by dxa
muscle protein synthesis
dose limiting toxicity
oocytes retrieved
live birth
tumor proliferation
clinical and ongoing pregnancy
clinical benefit rate
clinical pregnancy
ongoing pregnancy rates
live birth rate
oocytes
ongoing pregnancy rate
progression free rate
ongoing pregnancy
implantation rate
estradiol
number and maturity of oocytes retrieved
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.
INTRAROSA ® is a steroid indicated for the treatment of moderate to severe dyspareunia, a symptom of vulvar and vaginal atrophy, due to menopause. INTRAROSA ® is a steroid indicated for the treatment of moderate to severe dyspareunia, a symptom of vulvar and vaginal atrophy, due to menopause. ( 1 )
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 have not been established in pediatric patients.”
US prescribing information · ada639d4-bac0-2ad0-e053-2a95a90afce7 · read 2026-08-30
On older people, the label states: “Of the 1522 prasterone-treated postmenopausal women enrolled in the four placebo-controlled 12-week and one open-label 52-week clinical trial, 19 and 11 percent, respectively, were 65 years of age or older.”
US prescribing information · ada639d4-bac0-2ad0-e053-2a95a90afce7 · read 2026-08-30
On people who are pregnant, the label states: “Risk Summary INTRAROSA is indicated only in postmenopausal women.”
US prescribing information · ada639d4-bac0-2ad0-e053-2a95a90afce7 · read 2026-08-30
On people with reduced liver function, the label states: “The effect of hepatic impairment on the pharmacokinetics of prasterone has not been studied.”
US prescribing information · ada639d4-bac0-2ad0-e053-2a95a90afce7 · read 2026-08-30
On people with reduced kidney function, the label states: “The effect of renal impairment on the pharmacokinetics of prasterone has not been studied.”
US prescribing information · ada639d4-bac0-2ad0-e053-2a95a90afce7 · 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
Withdrawn
❝ 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
Vaginal
✎ 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: S8.
No source is stored against this line.
What is in the pack
Sold as insert, liquid, cream, tablet, given by the vaginal, oral, transdermal 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.
Prasterone appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 228 reaction mentions were counted. One report can name several reactions.
The recorded terms (10)
headache — 30 reaction mentions
rash — 26 reaction mentions
feeling hot — 24 reaction mentions
swelling face — 24 reaction mentions
butterfly rash — 21 reaction mentions
cellulitis — 21 reaction mentions
periorbital oedema — 21 reaction mentions
photosensitivity reaction — 21 reaction mentions
tinnitus — 21 reaction mentions
head discomfort — 19 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 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
Vaginal
✎ 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
44 products list this as an active ingredient in the United States drug directory. 19 of them contain it and nothing else.
FDA National Drug Code directory · 64025-0015 · read 2026-08-29
They are sold as cream, crystal, gel, insert, liquid and powder, taken oral, sublingual, topical and transdermal.
FDA National Drug Code directory · 64025-0015 · read 2026-08-29
27 published labels name it as an active ingredient. 2 of them describe this substance alone, which is where its own label text on this page comes from.
US prescribing information · b5ba575a-e8ea-406b-b379-1c4439da01f1 · read 2026-08-29
Those labels are classed as human otc drug and human prescription drug.
US prescribing information · b5ba575a-e8ea-406b-b379-1c4439da01f1 · read 2026-08-29
Intrarosa is vaginal at 3 DOSAGE FORMS AND STRENGTHS Vaginal insert: 6.5 mg of prasterone, smooth, white to off-white solid fat bullet-shaped, measuring 28 mm in length, 9 mm in width at its wider end, and weighing 1.2 gram., recorded as fda label in effect 2026-07-17 in the United States.
US prescribing information · ada639d4-bac0-2ad0-e053-2a95a90afce7 · 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.
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, withdrawn medicine. The questions below are for a clinician or pharmacist.
Questions worth asking
Which of the trials of Prasterone 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.
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 Prasterone 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.
Where else this substance is registered
FDA substance identifier (UNII)
459AG36T1B
RxNorm concept
1927688
Checks this page had to pass
✓ Passed
Identity resolved
no open identity hold
✓ Passed
No unresolved merge across substance families
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.
✓ Passed
No internal keys in reader text
enforced by the copy-contract test over the rendered page
✓ Passed
Safety mode resolved
Suppression classes recorded: S8.
✓ Passed
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
1 approved application covers products containing this substance. The earliest was NDA208470, approved 20161116 to MILLICENT.
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 (13)
Q2
What did Prasterone's largest trial (558 people) and its longest (10 years) measure?
558 people in Prasterone's largest registered study, 10 years in its longest registered window, measuring The pharmacokinetics of vaginal suppositories at four different DHEA concentrations. ClinicalTrials.gov · 2026-09-01
25 phase3, 16 phase2, 13 na, 7 phase4, 6 phase1, 3 early phase1, 1 na or unstated; NCT01662466; 2022-12-31. Last human test completed 2026, NCT07771153.
Interpretation These counts include studies where Prasterone 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
phase3
25
phase2
16
na
13
phase4
7
phase1
6
early phase1
3
2 more recorded rows
na or unstated
1
Last recorded human testNCT07771153
2026-06-30
recorded 2026-09-01 · last checked 2026-09-04
Q3
From mouse to human: where has Prasterone shown lifespan?
4 recorded entries; human; also "DHEA (0.25%)", "DHEA (0.5%)", "DHEA (1.0%)"
Show the evidence
human
NCT01846442
DHEA (0.25%)
NCT01846442
DHEA (0.5%)
NCT01846442
DHEA (1.0%)
NCT04898556
Prasterone 6.5 MG
recorded 2026-09-01 · last checked 2026-09-04
Q6
Did Prasterone move Horvath, and by how much?
Horvath: "We analyzed the relationship between estradiol, dehydroepiandrosterone sulfate (DHEAS) and the Free Androgen Index with DNAmAA estimators from 6 epigenetic clocks (Horvath's, Hannum's, 7-CpG clock, PhenoAge, GrimAge, DunedinPACE) in 1 404 participants of the Berlin Aging Study II (BASE-II, mean age at baseline 68.7 ±…" Europe PMC · epigenetic clock search · 2025-06-01
4 recorded sentences; 2025, 2024, 2021; biomarker
Show the evidence
Horvath
PMID 40342106
2025; "We analyzed the relationship between estradiol, dehydroepiandrosterone sulfate (DHEAS) and the Free Androgen Index with DNAmAA estimators from 6 epigenetic clocks (Horvath's, Hannum's, 7-CpG clock, PhenoAge, GrimAge, DunedinPACE) in 1 404 participants of the Berlin Aging Study II (BASE-II, mean age at baseline 68.7 ± 3.7 years, 48% women)."
2024; "We analysed the relationship between estradiol, dehydroepiandrosterone sulfate (DHEAS) and the Free Androgen Index (FAI) with DNAmAA estimators from six epigenetic clocks (Horvath’s, Hannum’s, 7-CpG clock, PhenoAge, GrimAge, DunedinPACE) in 1,404 participants of the Berlin Aging Study II (BASE-II, mean age at baseline 68.7 ±3.7 years, 48% women)."
epigenetic clockPMID 38233512
2024; "To help address these gaps, we explored associations between social adversity and biomarkers of inflammation (interleukin-1β [IL-1β], IL-6, IL-8, tumor necrosis factor-alpha [TNF-α], and salivary cytokine hierarchical "clusters" based on the three interleukins), neuroendocrine function (cortisol, cortisone, dehydroepiandrosterone, testosterone, and progesterone), neuromodulation…"
epigenetic agePMID 33663025
2021; "Treatment of healthy men with a combination of GH, dehydroepiandrosterone, and metformin was reported to restore thymus function and reduce epigenetic age."
recorded 2025-06-01 · last checked 2026-09-04
Q7
More Prasterone was worse in human: at what point?
U-shaped in human: "While P5, DHEA, 17-OHP4 and AD concentrations exhibited inverted U-shaped dose responses, T2, T3 and T4 concentrations exhibited inverse linear dose responses, which are further confirmed by their relationships with hair hydroxylated PAHs (OH-PAHs) concentrations." Europe PMC · dose-response search · 2023-08-04
"While P5, DHEA, 17-OHP4 and AD concentrations exhibited inverted U-shaped dose responses, T2, T3 and T4 concentrations exhibited inverse linear dose responses, which are further confirmed by their relationships with hair hydroxylated PAHs (OH-PAHs) concentrations."
dose-responsePMID 36811237
"A restricted cubic spline was also used to model the association of serum dehydroepiandrosterone level with the risk of diabetic retinopathy and to describe the overall dose-response correlation."
Dose responsePMID 37543737
"Dose response was noted with vaginal DHEA and testosterone."
dose-responsePMID 32502234
"Pre- and post-ACTH stimulated DHEA levels also did not differ by frailty status, though the dose-response curves suggested divergence after stimulation, with a more rapid DHEA response with increasing frailty."
dose responsePMID 34880833
"<i>In utero</i> chlordecone exposure was associated with elevated levels of selected thyroid (TSH) and sex-steroid (DHEA, TT, and DHT) hormones at seven years in a non-monotonic dose response (inverted U) relationship."
recorded 2023-08-04 · last checked 2026-09-04
Q8
Which of areal bone density by dxa, body composition and bone mineral density did Prasterone's trials measure?
areal bone density by dxa, body composition and bone mineral density lead 26 outcome terms across Prasterone's trials. ClinicalTrials.gov · 2026-09-01
Interpretation areal bone density by dxa, quality of life, glucose and insulin metabolism, muscle protein synthesis, dose limiting toxicity and fatigue follow.
Show the evidence
bone mineral density
1
body composition
1
satisfaction
1
areal bone density by dxa
1
quality of life
1
glucose and insulin metabolism
1
14 more recorded rows
muscle protein synthesis
1
dose limiting toxicity
1
fatigue
1
oocytes retrieved
1
level of catecholamines in blood from baseline
1
live birth
1
tumor proliferation
1
clinical and ongoing pregnancy
1
clinical benefit rate
1
clinical pregnancy
1
ongoing pregnancy rates
1
live birth rate
1
oocytes
1
ongoing pregnancy rate
1
recorded 2026-09-01 · last checked 2026-09-04
Q9
Which of Prasterone's 4 ongoing trials reports first?
Change in the level of catecholamines in plasma; Pain Numerical Rating Scale (0-10) Change; latest 2029-12-31
Show the evidence
Trial
NCT03228732
"The Effects of Fluoxetine and/or DHEA"; n 60; "Change in the level of catecholamines in plasma"; 2026-12-15
NCT05935761
"Investigating Novel Interventions for Low Back Pain in US Military Veterans: A Randomized Controlled Adaptive Phase II Trial"; n 108; "Pain Numerical Rating Scale (0-10) Change"; 2029-12-31
NCT06611514
"Effect of Intravaginal Prasterone on Symptoms of Genitourinary Syndrome of Menopause (GSM) in Women in Menopause With Previous Breast Cancer"; n 95; "Establish subjective improvement in genitourinary symptomatology at intervals marked by the study"; 2027-01-01
NCT07407647
"Vaginal DHEA to Improve Vaginal Health After Radiation for Women With Gynecologic, Anal or Rectal Cancer"; n 25; "Incidence of grade 2 or higher adverse events"; 2026-12-31
recorded 2026-09-01 · last checked 2026-09-04
Q10
Which 25 trials of Prasterone posted no result?
Posted no result
25 of 25 completed trials
Registrations
NCT00065104, NCT00099697, NCT00111930, NCT00082511, NCT00205686 and NCT00664053, and 19 more
Completion dates
oldest 2003-04; newest 2024-06-30
Show the evidence
Trial
NCT00065104
2003-04
NCT00099697
2004-02
NCT00111930
2005-03
NCT00082511
2005-08
NCT00205686
2005-09
NCT00664053
2006-10
14 further recorded trials
NCT00006219
2006-12
NCT00434915
2007-04
NCT00429806
2007-07
NCT00202163
2007-09
NCT00317148
2007-12
NCT00289926
2008-04
NCT02132559
2013-07
NCT01915186
2013-09
NCT02151006
2015-05
NCT02866253
2016-02
NCT02268032
2016-08-31
NCT00607646
2018-10-09
NCT03418363
2019-12-11
NCT03568604
2020-01-28
Q11
At the median, Prasterone's trials enrolled 62 people — anything larger?
Median enrolment
62
Largest enrolment
558
Registered trials counted
62
Q12
What do 228 spontaneous reports say about Prasterone — 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.
Prasterone appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 228 reaction mentions were counted: headache 30; rash 26; feeling hot 24; swelling face 24. open-targets-adr · CHEMBL90593 · 2026-06-24
Show the evidence
headache
30
rash
26
feeling hot
24
swelling face
24
butterfly rash
21
cellulitis
21
4 more recorded rows
periorbital oedema
21
photosensitivity reaction
21
tinnitus
21
head discomfort
19
recorded 2026-06-24 · last checked 2026-09-04
Q13
Was Prasterone studied with exercise?
exercise is named in Prasterone's label sentences: "For the overall effect of exercise vs. control, meta-analysis of 12 studies (<i>n</i> = 563 participants) showed no significant effect on Total Testosterone, DHEA-S (5 studies, <i>n</i> = 231 participants), or SHBG (10 studies, <i>n</i> = 422 participants)." openfda-label+europepmc · 2026-01-08
1 recorded statement; exercise
Show the evidence
exercise
For the overall effect of exercise vs. control, meta-analysis of 12 studies (<i>n</i> = 563 participants) showed no significant effect on Total Testosterone, DHEA-S (5 studies, <i>n</i> = 231 participants), or SHBG (10 studies, <i>n</i> = 422 participants).
recorded 2026-01-08 · last checked 2026-09-04
Q14
What is recorded about Prasterone and mTOR?
"PCOS was induced via subcutaneous injection of dehydroepiandrosterone (6 mg/100 g), and mTOR inhibition was achieved with KU-0063794 (1 mg/100 g)." — where Prasterone and mTOR appear together. Europe PMC · pathway abstract search · 2026-04-16
"PCOS was induced via subcutaneous injection of dehydroepiandrosterone (6 mg/100 g), and mTOR inhibition was achieved with KU-0063794 (1 mg/100 g)."
PMID 41989659
"In the PCOS + INH group, mTOR and p-mTOR immunoreactivity were significantly reduced compared with PCOS (p < 0.001), and DHEA-induced weight gain was attenuated; however, E<sub>2</sub> remained elevated (p < 0.001) and corpora lutea were not restored (p < 0.001). miR-21 expression was significantly upregulated in both PCOS (p < 0.05)-PCOS + INH (p < 0.001) groups, indicating persistent miR-21…"
AMPKPMID 38453773
"This study aims to investigate the effect and mechanism of dehydroepiandrosterone (DHEA) on diminished ovarian reserve (DOR) by modulating the AMPK-SIRT1 signaling and mitophagy in rats."
sirtuinPMID 38453773
"This study aims to investigate the effect and mechanism of dehydroepiandrosterone (DHEA) on diminished ovarian reserve (DOR) by modulating the AMPK-SIRT1 signaling and mitophagy in rats."
IGF-1
"Other therapeutic approaches used with success in women include hormonal and growth factor (GF) modulators, such as growth hormone (GH), insulin-like growth factor 1 (IGF-1), vascular endothelial growth factors (VEGF) and dehydroepiandrosterone (DHEA), and the development of patient-tailored combination-based therapies (IGF-1 + VEGF + DHEA) was suggested."
sirtuinPMID 41241089
"Our findings support a potential therapeutic value of DHEA in modulating age-dependent decline in cardiac functions through a possible NFκB/IL-10/Sirt1/Nrf2 pathway."
AMPKPMID 41320873
"C-PC also reduced DHEA-induced phosphorylation of AMPK, while co-treatment with an AMPK activator attenuated its effects on GPX4 and xCT, abolishing its anti-ferroptotic protection against granulosa cells."
autophagyPMID 40409529
"Our findings demonstrate that DHEA-induced autophagy is mediated by estrogen receptor alpha (ER-α) and androgen receptor (AR) activation and protects hepatic cells against palmitate-induced apoptosis, steatosis, and inflammasome activation."
7 more recorded rows
IGF-1PMID 41465398
"Other therapeutic approaches used with success in women include hormonal and growth factor (GF) modulators, such as growth hormone (GH), insulin-like growth factor 1 (IGF-1), vascular endothelial growth factors (VEGF), and dehydroepiandrosterone (DHEA), and the development of patient-tailored combination-based therapies (IGF-1 + VEGF + DHEA) has also been suggested."
sirtuinPMID 31947651
"By using a PCOS mouse model induced by administration of dehydroepiandrosterone (DHEA), we investigated whether MG-dependent glycative stress contributes to ovarian PCOS phenotype and explored changes in the Sirtuin 1 (SIRT1) functional network regulating mitochondrial functions and cell survival."
mTORPMID 39498504
"In this study, for the first time, mTORC1 and activation products are presented at protein and mRNA levels after rapamycin treatment in DHEA-induced PCOS mouse ovary."
AMPKPMID 36565630
"Furthermore, DHEA promoted the phosphorylation of AMP-activated protein kinase (AMPK) and inhibited the phosphorylation of mammalian target of rapamycin (mTOR)."
autophagyPMID 34161185
"This review's main objective is to provide a background of autophagy in the ovary, its possible connection with PCOS and suggested a novel proposal for future studies to aid a better understanding of PCOS pathogenesis.<b>Abbreviations</b>: AE: androgen excess; AF: antral follicle; AKT/PKB: AKT serine/threonine kinase; AMH: anti-Mullerian hormone; AMPK: AMP-activated protein kinase; ATG:…"
IGF-1PMID 34161185
"This review's main objective is to provide a background of autophagy in the ovary, its possible connection with PCOS and suggested a novel proposal for future studies to aid a better understanding of PCOS pathogenesis.<b>Abbreviations</b>: AE: androgen excess; AF: antral follicle; AKT/PKB: AKT serine/threonine kinase; AMH: anti-Mullerian hormone; AMPK: AMP-activated protein kinase; ATG:…"
autophagyPMID 39431156
"Further study reveals that DHEA induces endoplasmic reticulum (ER) stress and triggers PERK/eIF2/ATF4/CHOP UPR signaling pathway to activate autophagy followed by apoptosis, which was confirmed by suppression of 4-phenylbutyric acid (an ER stress inhibitor) or knockdown either ATF4 or CHOP."
recorded 2026-04-16 · last checked 2026-09-04
Where it is registeredIdentifiers, relations and other names
ChEMBL ATC CC BY-SA · 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: 12 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.