WhelWomen's Health Evidence Lab
WHEL-C-012 · Emerging evidence · 5/10

DIENOGEST for endometriosis

In a randomized trial of women with endometriosis, dienogest (2 mg/day) significantly improved endometriosis-associated pelvic pain (VAS mean difference 6.0, 95% CI 4.9-7.1) and HRQoL, comparable to a combined oral contraceptive.

Origin · ApprovedPathway · 505(b)(2) · existing active ingredient, new indicationEvidence arm · Direct researchEvidence supports
How to read thisThe summary above and the proposed mechanism are generated by the model from the sources it ingested, and are written as the model’s reasoning rather than established fact. Any figure quoted from MATRIX is a model-derived association score, not a clinical measurement. How far the published record backs this pair is carried by the score’s own rigor dimension and traced to verbatim sources at the foot of the page.

Hypothesized mechanism

Mechanism not yet characterized in the substrate.

This is the model’s proposed mechanism from the sources on file, not a demonstrated causal pathway. How well the published record supports it is reflected in the rigor and plausibility dimensions of the score, and traced to the verbatim sources at the foot of the page.

How the score was reached, for this pair

The composite score is the sum of five dimensions, each scored 0 to 2 by the model from the evidence on file. Below is the sub-score this specific pair received on each, with what that dimension measures. It scored 5 of 10 overall, a emerging reading, from a direct rated emerging in strength.

The model’s overall reasoning for this pair is the summary at the top of the page, and the mechanism it proposed is in the section above.

Pathway arm0.8 / 10 · Exploratory

Scored for women. Female representation not stated — applicability to women uncertain (flagged for full text). (band F4, ×0.75).

Corroboration

Only a single claim is provided, an Open Targets database entry stating DIENOGEST is an approved clinical candidate for endometriosis. No independent mechanistic lines are described, so there is no convergence to assess.

0 / 2

Rigor

The sole claim is a regulatory/database status entry from Open Targets, not a mechanistic model (human, animal, or in-vitro). No experimental data of any kind is cited.

0 / 2

Specificity

The claim identifies DIENOGEST as a small-molecule clinical candidate but provides no information about its molecular target or mode of action on endometriosis. No specificity of drug-target action can be evaluated.

0 / 2

Plausibility

DIENOGEST is noted as having reached maximum clinical stage APPROVAL for endometriosis, which implies an established target-phenotype fit, though no mechanism is described in the claim. The approval status lends partial plausibility without explicit mechanistic support.

1 / 2

Consistency

With only one claim and no described mechanistic signals, there is nothing to compare for directional agreement. Consistency cannot be established from a single database entry.

0 / 2
Direct research arm · anchors the headline5.0 / 10 · Emerging

Scored for women. Evidence generated in women (female population, ~100% female). (band F1, ×1.00).

Corroboration

The substantive efficacy data come from a single RCT (claims 2-10). The 'Medical management of endometriosis' source (claims 11-12) merely references the same trial rather than providing independent corroboration. A single primary study scores 0.

0 / 2

Rigor

The evidence is a randomized clinical trial comparing dienogest to a combined oral contraceptive (claims 1-2), which qualifies as RCT-level design. Outcomes include VAS scores, EHP-30 HRQoL, and validated B&B severity profiles.

2 / 2

Specificity

Both the drug (dienogest, 2 mg/day) and the condition (endometriosis-associated pelvic pain) are named directly and repeatedly (claims 2, 4, 5).

2 / 2

Plausibility

No mechanism of action is described in any claim; the evidence is purely clinical-outcome based with no statement of how dienogest acts on endometriotic tissue or pain pathways.

0 / 2

Consistency

Results derive essentially from one trial, so cross-study consistency cannot be assessed; within the trial, dienogest consistently improved VAS and HRQoL and was comparable to COC across multiple measures (claims 2, 6, 7-10).

1 / 2
How the scoring rubric works, in general

Layers not covered for this pair

Sex-specific pharmacokineticsNone on file

Not covered for this pair. This layer holds documented sex-specific pharmacokinetics for a limited set of drugs, and this compound is not among them yet. A blank here means the drug is not covered by the layer, not that no sex difference exists.

More on the sex-specific pharmacokinetics layer and its sources
Cycle-phase dependenceNone on file

Not covered for this pair. The cycle-phase layer is seeded for the strongest-evidence cases so far (PMDD), and this pair is not among them yet. A blank here means the pair is not covered by the layer, not that the effect was found to be phase-independent.

More on the cycle-phase layer and its sources

Source evidence · what the pipeline ingested

These are the sources the pipeline ingested to detect and score this signal, the published literature the model actually read, each tagged by study type. Where the model combined findings the claim is marked as a synthesis (S), and where the literature disagrees the contradiction is shown (!).

Every source below belongs to this signal’s evidence arm, Direct research. Whel reads each drug-condition pair through four such arms, each held to its own inclusion bar; a signal is surfaced through one of them.

  • 1Efficacy of dienogest vs combined oral contraceptive on pain associated with endometriosis PubMed · PMID 34826668
  • 2mean difference 6.0 [95% confidence interval (CI) 4.9-7.1; p < 0.0001] in the dienogest group PubMed · PMID 34826668
  • 3the difference between them was not significant (p = 0.111) PubMed · PMID 34826668
  • 4Dienogest (2 mg/day) is comparable to the COC Yasmin for the relief of endometriosis-associated pelvic pain PubMed · PMID 34826668

These are the verbatim sources the pipeline surfaced and read; they may not be the full published record for a pair, and the score reflects the strength and agreement of the evidence rather than its volume. The strength of these source types is what the rigor dimension of the score reads off. MATRIX, sex-specific pharmacokinetics, and cycle phase are separate layers the pipeline does not ingest, external cross-references reported beside the score, and they link to their own sources in their sections above.

The primary sources and pipelines this evidence is drawn from