This page shows what was measured, who it was measured in, and what that does not settle.
What Dienogest does in the body
• Natazia is a combination of dienogest , a progestin, and estradiol valerate, an estrogen, indicated for use by females of reproductive potential to prevent pregnancy.
COCs lower the risk of becoming pregnant primarily by suppressing ovulation.
Why people take it. • Natazia is a combination of dienogest , a progestin, and estradiol valerate, an estrogen, indicated for use by females of reproductive potential to prevent pregnancy.
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
RNAWiki has not recorded a supervision or regulatory status for this substance.
What the registries record it as
The substance registry classes this as chemical.
FDA substance registry · 46M3EV8HHE · 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 70 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.
Placebo
A placebo is a dummy treatment given so the real one can be compared with it.
A picture of it, and where the picture fails
A placebo is like a blank control in an experiment.
Where that stops being true. A blank does nothing. People given a placebo often do get better.
What people get wrong. A placebo effect is read as imaginary. The improvement is measured and real.
An inactive intervention matched in appearance to the test intervention, used to control for non-specific effects.
Comparator
A comparator is whatever the treatment was measured against.
A picture of it, and where the picture fails
It is like the other runner in a race.
Where that stops being true. A race has one winner. A study can show both arms improved.
What people get wrong. Results are read without asking what the other group got. Beating nothing is not beating a treatment.
The control condition against which the experimental intervention is assessed.
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 16 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
Pain
∅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.
Which registered measures put each goal on this table
Pain
pain before and after surgery; pain symptoms reduction
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.
… Waiting for a reviewer
2 registered symptom measure.
— Not recorded
Harms were not a registered measure for this goal.
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.
Change in lesions
✗ The study did not show it
Who was studied
NCT00280657
How many people
1326
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.
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
PubChem PUG-REST · a recorded source, not a stored snapshot
openFDA NDC Directory · a recorded source, not a stored snapshot
Europe PMC · a recorded source, not a stored snapshot
Bleeding pattern
✗ The study did not show it
Who was studied
NCT00302666
How many people
1315
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.
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
PubChem PUG-REST · a recorded source, not a stored snapshot
openFDA NDC Directory · a recorded source, not a stored snapshot
Europe PMC · a recorded source, not a stored snapshot
Number of pregnancies (evaluable cycles)
✗ The study did not show it
Who was studied
NCT03945513
How many people
1034
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.
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
PubChem PUG-REST · a recorded source, not a stored snapshot
openFDA NDC Directory · a recorded source, not a stored snapshot
Europe PMC · a recorded source, not a stored snapshot
Number of unintended pregnancies
✗ The study did not show it
Who was studied
NCT01638910
How many people
955
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.
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
PubChem PUG-REST · a recorded source, not a stored snapshot
openFDA NDC Directory · a recorded source, not a stored snapshot
Europe PMC · a recorded source, not a stored snapshot
Ovarian reserve
✗ The study did not show it
Who was studied
NCT03789123
How many people
710
Study design
Phase 4
Compared against
Not recorded for this study
Kind of result
A number that stands in for health
What was found
Result not recorded on this page
Repeated elsewhere
Unreplicated
What this does not prove. A study that did not show an effect does not show that no effect exists anywhere.
The limits of this study, and where it came from
Main limit. No limitation is recorded for this study.
How far it carries. This study is recorded from the curated record, not from the registry match.
Form and route.
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
PubChem PUG-REST · a recorded source, not a stored snapshot
openFDA NDC Directory · a recorded source, not a stored snapshot
Europe PMC · a recorded source, not a stored snapshot
Change Between Baseline Evaluation Period and Treatment Evaluation Period in the Number of Days With Dysmenorrheic Pain
✗ The study did not show it
Who was studied
NCT00909857
How many people
507
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.
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
PubChem PUG-REST · a recorded source, not a stored snapshot
openFDA NDC Directory · a recorded source, not a stored snapshot
Europe PMC · 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.3 registered measures of this kind.
□A number that stands in for healthNo evidence recorded. Cholesterol, blood sugar, bone density. A stand-in, not the thing itself.No registered study measures this.
■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 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.
pain before and after surgery
pain symptoms reduction
changes in quality of life
Measured
Things only a test, a scale or a device shows.
No registered study measured anything of this kind.
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 (13)
leiomyoma volume
endometrial thickness
clinical pregnancy rate
ongoing pregnancy rate
mollecular docking
lession size
normality of estrus cycle after the treatment
aes reported visanne treatment
adrs reported visanne treatment
retrieved oocytes
severity in dysmenorrhea
beta estradiol level
tnf alpha level
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
No description of who was studied is recorded.
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 efficacy of Natazia have been established in women of reproductive age.”
US prescribing information · 02c91fba-9c47-43ef-ac78-e82369798834 · read 2026-08-30
On older people, the label states: “Natazia has not been studied in postmenopausal women and is not indicated in this population.”
US prescribing information · 02c91fba-9c47-43ef-ac78-e82369798834 · read 2026-08-30
On people who are pregnant, the label states: “Risk Summary There is no reason to use COCs in pregnancy Discontinue Natazia if pregnancy occurs.”
US prescribing information · 02c91fba-9c47-43ef-ac78-e82369798834 · read 2026-08-30
On people who are breastfeeding, the label states: “Risk Summary Contraceptive hormones and/or metabolites are present in human milk.”
US prescribing information · 02c91fba-9c47-43ef-ac78-e82369798834 · 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
Prescription only
❝ 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
Not recorded.
∅ Nothing recorded
Where this came from
RNAWiki holds nothing here and says so rather than guessing.
No form or route is recorded.
No source is stored against this line.
Who oversees it
RNAWiki has not recorded a supervision or regulatory status for this substance.
❝ Quoted from a source
Where this came from
Copied from a source RNAWiki stored, with the source named.
No register row and no identity class settled the question.
No source is stored against this line.
What is in the pack
Not recorded.
∅ Nothing recorded
Where this came from
RNAWiki holds nothing here and says so rather than guessing.
Nothing is recorded about product quality.
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.
Dienogest appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 122 reaction mentions were counted. One report can name several reactions.
The recorded terms (10)
pregnancy on oral contraceptive — 36 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
Not recorded.
∅ Nothing recorded
Where this came from
RNAWiki holds nothing here and says so rather than guessing.
The exact form studied is not recorded.
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
3 products list this as an active ingredient in the United States drug directory. 3 of them contain it and nothing else.
FDA National Drug Code directory · 24002-0034 · read 2026-08-29
They are sold as powder.
FDA National Drug Code directory · 24002-0034 · read 2026-08-29
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.
RNAWiki could not confidently classify this substance, so no self-experiment plan is offered.
Questions worth asking
Which of the trials of Dienogest 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 Dienogest 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)
46M3EV8HHE
CAS registry number
65928-58-7
PubChem compound
68861
ChEMBL
CHEMBL1201864
ChEBI
70708
WHO international nonproprietary name list entry
5286
RxNorm concept
22968
EMA substance identifier
100000092815
DrugBank
DB08866
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: Quoted from a stored source.
✗ 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
✗ Not passed
Safety mode resolved
No register row and no identity class settled the question.
✓ 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
3 approved applications cover products containing this substance. The earliest was NDA022252, approved 20100506 to BAYER HLTHCARE.
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 (12)
Q1
What did Dienogest's largest trial (5000 people) and its longest (14 years) measure?
5000 people in Dienogest's largest registered study, 14 years in its longest registered window, measuring No primary variables defined, all variables are considered exploratory since no confirmatory statistical analysis planned. ClinicalTrials.gov · 2026-09-01
11 na or unstated, 10 phase4, 9 phase3, 5 phase2, 3 na, 1 early phase1, 1 phase1; NCT03778359; 2018-10-18; no ageing endpoint recorded. Last human test completed 2024, NCT06145438.
Interpretation These counts include studies where Dienogest 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
na or unstated
11
phase4
10
phase3
9
phase2
5
na
3
early phase1
1
2 more recorded rows
phase1
1
Last recorded human testNCT06145438
2024-11-19
recorded 2026-09-01 · last checked 2026-09-04
Q2
Dienogest was tested only in human — what did it show?
Interpretation No primary variables defined, all variables are considered exploratory since no confirmatory statistical analysis planned — the recorded outcome words.
Show the evidence
humanNCT00754871
mechanism-only; No primary variables defined, all variables are considered exploratory since no confirmatory statistical analysis planned; 37
recorded 2026-09-01 · last checked 2026-09-04
Q3
3 of Dienogest's trials stopped: accrual/recruitment, other?
"PI went for a post-doc course and when he came back he moved for another job"; 3 of 37 registered studies
Show the evidence
Trial
NCT01738724
terminated; "PI went for a post-doc course and when he came back he moved for another job"
NCT02728245
withdrawn; "Placebo cannot be prepared"
NCT05637073
withdrawn; "After months of attempts, an insurmountable difficulty has arisen in recruiting patients at the main center, in addition to the retirement of the principal investigator."
recorded 2026-09-01 · last checked 2026-09-04
Q4
Human studies of Dienogest used Dienogest 2mg — over how long?
5 recorded entries; human; orally; also "Dienogest 2 MG", "Dienogest 2 MG Oral Tablet", "Dienogest 2 MG (milligram)"
Show the evidence
human
NCT02575248
Dienogest 2mg
NCT03142035
Dienogest 2 MG
NCT04256200
Dienogest 2 MG Oral Tablet
NCT05937490
Dienogest 2 MG (milligram)
NCT07204093
orally; Dienogest 2 mg orally
recorded 2026-09-01 · last checked 2026-09-04
Q5
Could one person measure Dienogest's effect on leiomyoma volume?
Leiomyoma volume: measured in Dienogest's trials.
Interpretation leiomyoma volume is the recorded endpoint.
Show the evidence
biomarkers
leiomyoma volume; 2026-09-01
endometrial thickness; 2026-09-01
clinical pregnancy rate; 2026-09-01
ongoing pregnancy rate; 2026-09-01
pain before and after surgery; 2026-09-01
mollecular docking; 2026-09-01
10 more recorded rows
biomarkers
lession size; 2026-09-01
biomarkers
normality of estrus cycle after the treatment; 2026-09-01
biomarkers
aes reported visanne treatment; 2026-09-01
biomarkers
adrs reported visanne treatment; 2026-09-01
biomarkers
retrieved oocytes; 2026-09-01
biomarkers
pain symptoms reduction; 2026-09-01
biomarkers
severity in dysmenorrhea; 2026-09-01
biomarkers
beta estradiol level; 2026-09-01
biomarkers
tnf alpha level; 2026-09-01
biomarkers
changes in quality of life; 2026-09-01
human trials at or under30
3
Not recorded for this substance
a recorded half-life
smallest human trial
0; NCT02728245; PHASE2; the smallest recorded human enrolment at or below 30; the registry states no direction of its result; WITHDRAWN
Q6
Which of adrs reported visanne treatment, aes reported visanne treatment and beta estradiol level did Dienogest's trials measure?
adrs reported visanne treatment, aes reported visanne treatment and beta estradiol level lead 16 outcome terms across Dienogest's trials. ClinicalTrials.gov · 2026-09-01
Interpretation ongoing pregnancy rate, pain before and after surgery, mollecular docking, lession size, normality of estrus cycle after the treatment and aes reported visanne treatment follow.
Show the evidence
leiomyoma volume
1
endometrial thickness
1
clinical pregnancy rate
1
ongoing pregnancy rate
1
pain before and after surgery
1
mollecular docking
1
10 more recorded rows
lession size
1
normality of estrus cycle after the treatment
1
aes reported visanne treatment
1
adrs reported visanne treatment
1
retrieved oocytes
1
pain symptoms reduction
1
severity in dysmenorrhea
1
beta estradiol level
1
tnf alpha level
1
changes in quality of life
1
recorded 2026-09-01 · last checked 2026-09-04
Q7
Which of Dienogest's 3 ongoing trials reports first?
response to the progestin therapy; Average daily pelvic pain score, combined; latest 2026-11
Show the evidence
Trial
NCT06414720
"Salivary microRNA in Endometriosis: Correlation With Response to Progestin Therapy"; n 90; "response to the progestin therapy"; 2025-12-01
NCT07164183
"Clinical Study to Compare Efficacy and Safety of Indinol Forto® 200 mg Capsules and Visanne 2 mg Tablets in Treatment of Endometriosis"; n 290; "Average daily pelvic pain score, combined"; 2026-11
NCT07204093
"Ultra-Safe Hormonal Strategy: Transdermal Estradiol Added to Progestins for Endometriosis"; n 138; "Patients' statisfaction"; 2026-02
recorded 2026-09-01 · last checked 2026-09-04
Q8
Which 14 trials of Dienogest posted no result?
Posted no result
14 of 14 completed trials
Registrations
NCT00754871, NCT01283724, NCT01697111, NCT01822080, NCT01788722 and NCT03778359, and 8 more
Completion dates
oldest 2009-09; newest 2024-08-31
Show the evidence
Trial
NCT00754871
2009-09
NCT01283724
2014-06
NCT01697111
2014-12
NCT01822080
2015-11
NCT01788722
2017-08-11
NCT03778359
2018-10-18
8 further recorded trials
NCT02425462
2018-12-14
NCT04306276
2020-03-01
NCT04500743
2020-04-30
NCT04374006
2020-05-18
NCT05751876
2021-12-31
NCT05272930
2022-04-30
NCT04495855
2022-12-23
NCT06115408
2024-08-31
Q9
At the median, Dienogest's trials enrolled 120 people — anything larger?
Median enrolment
120
Largest enrolment
5000
Registered trials counted
37
Q10
What do 122 spontaneous reports say about Dienogest — 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.
Dienogest appears in spontaneous reports to regulators. Across the 10 most-reported reaction terms, 122 reaction mentions were counted: pregnancy on oral contraceptive 36; metrorrhagia 13; pulmonary embolism 13; abdominal pain 12. open-targets-adr · CHEMBL1201864 · 2026-06-24
Show the evidence
pregnancy on oral contraceptive
36
metrorrhagia
13
pulmonary embolism
13
abdominal pain
12
amenorrhoea
9
haemorrhage in pregnancy
9
4 more recorded rows
abdominal pain lower
8
abortion spontaneous
8
endometriosis
8
abnormal withdrawal bleeding
6
recorded 2026-06-24 · last checked 2026-09-04
Q11
Dienogest and CYP3A4: shared by which compounds?
CYP3A4 appear in Dienogest's recorded interaction sentences, 6 in all. openfda-label+europepmc · 2026-08-30
Interpretation pharmacokinetics
Show the evidence
CYP3A4
pharmacokinetics
CYP3A4 was identified as a predominant enzyme catalyzing the metabolism of dienogest.
pharmacokinetics
Drugs or herbal products that induce certain enzymes, including CYP3A4, may decrease the effectiveness of COCs or increase breakthrough bleeding.
pharmacokinetics
The effect of the CYP3A4 inducer rifampin was studied in an open-label, non-randomized, single center study in 16 healthy postmenopausal women.
pharmacokinetics
Substances Increasing the Systemic Exposure of COCs (enzyme inhibitors): The effect of a strong CYP3A4 inhibitor, ketoconazole, on dienogest and estradiol exposure was studied in an open-label, one-sequence, one-way crossover study in healthy postmenopausal Caucasian women.
pharmacokinetics
The effect of a moderate CYP3A4 inhibitor, erythromycin, on dienogest and estradiol exposure was studied in an open-label, one-sequence, one-way crossover study in healthy postmenopausal Caucasian women.
pharmacokinetics
Effects of Other Drugs on Combined Oral Contraceptives Substances diminishing the efficacy of COCs: Dienogest is a substrate of CYP3A4.
recorded 2026-08-30 · last checked 2026-09-04
Q12
What is recorded about Dienogest and autophagy?
"In contrast, dienogest, a specific progesterone receptor agonist, reduced NLRP3 inflammasome-mediated IL-1β production through autophagy induction in ECSCs." — where Dienogest and autophagy appear together. Europe PMC · pathway abstract search · 2022-04-01
autophagy, mTOR; PMID 35333355, 26051103
Show the evidence
autophagyPMID 35333355
"In contrast, dienogest, a specific progesterone receptor agonist, reduced NLRP3 inflammasome-mediated IL-1β production through autophagy induction in ECSCs."
mTORPMID 26051103
"To elucidate the therapeutic mechanisms of progestin and the effects of progesterone and progestin (dienogest) on autophagy induction and regulation in endometriotic cells, specifically the effects of progesterone and dienogest on the phosphoinositide-3/protein kinase B (PI3K-AKT) and mitogen-activated protein kinase kinases 1 and 2 (MEK1/2)/extracellular-signal-regulated kinase 1/2 (ERK1/2)…"
autophagy
PMID 26051103
"To elucidate the therapeutic mechanisms of progestin and the effects of progesterone and progestin (dienogest) on autophagy induction and regulation in endometriotic cells, specifically the effects of progesterone and dienogest on the phosphoinositide-3/protein kinase B (PI3K-AKT) and mitogen-activated protein kinase kinases 1 and 2 (MEK1/2)/extracellular-signal-regulated kinase 1/2 (ERK1/2)…"
PMID 26051103
"In addition, cotreatment with dienogest and 3-methyladenine (autophagy inhibitor) decreased the levels of apoptosis of ECSCs compared with the single treatment with dienogest."
mTORPMID 26051103
"Our results suggest that dienogest treatment of endometriotic cells suppresses AKT and ERK1/2 activity, thereby in turn inhibiting mTOR, inducing autophagy, and promoting apoptosis."
recorded 2022-04-01 · 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: 4 required field(s) not terminal: 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: 9 source rows
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