levonorgestrel-releasing intrauterine system for adenomyosis
A systematic review and meta-analysis found that LNG-IUS was associated with significantly higher haemoglobin levels than dienogest in women with adenomyosis.
Hypothesized mechanism
LNG-IUS may reduce menstrual blood loss via local progestin-induced endometrial suppression, improving haemoglobin levels.
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 7 of 10 overall, a moderate reading, from a direct rated moderate 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.
Scored for women. Evidence generated in women (female population, ~100% female). (band F1, ×1.00).
Corroboration
Evidence comes from a single systematic review and meta-analysis comparing LNG-IUS and dienogest. Per scoring rules, a single synthesis scores 1 and does not count the pooled trials as independent sources.
Rigor
The source is a systematic review and meta-analysis, which qualifies as the highest design tier (score 2).
Specificity
Both the intervention (LNG-IUS) and the condition (adenomyosis) are named directly in the source title and claim.
Plausibility
Higher haemoglobin plausibly reflects reduced menstrual blood loss from progestin-induced endometrial suppression, but no explicit mechanism is described in the claim. This is a plausible, not evidenced, mechanism.
Consistency
Only a single comparative outcome (haemoglobin) is reported, so directional consistency across multiple findings cannot be assessed; per rules a single result scores 1.
Regulatory & development status
Where this candidate sits in the US regulatory landscape: whether the drug is already FDA-approved for adenomyosis (on-label) or approved for something else (off-label), whether the molecule is available as a generic or a single-source brand still under patent, and how far it has been studied as a therapy for this condition. Each fact is drawn from a public US source and reported beside the score; none of it is folded into the score.
This is descriptive context, not regulatory advice. It maps the landscape a 505(b)(2)route would build on (an already-approved active ingredient proposed for a new indication), but it is not a 505(b)(2) viability assessment, and says nothing about whether any particular development path is advisable. “Approved” means FDA-approved (US); approvals elsewhere are out of scope.
Approval relationship No FDA-approved label
Read from the drug’s FDA label via DailyMed, the US National Library of Medicine’s label repository. A label is only counted when it carries an FDA-approved marketing category (an NDA, ANDA, or biologic BLA); dietary supplements, homeopathics, and OTC-monograph products are not FDA-approved drugs and are excluded.
For this pair. No FDA-approved drug label was found for this molecule (it may be a supplement, a biologic, investigational, or approved only outside the US), so any use here is investigational.
Generic & patent supply Generic available
Read from the FDA Orange Book (Approved Drug Products with Therapeutic Equivalence Evaluations), using single-ingredient products only so that patents on novel branded combination formulations are never attributed to the base molecule.
For this molecule. A live ANDA lists this active ingredient, so the basic molecule is available as a generic (off-patent in its basic form).
Layers not covered for this pair
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 →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.
- 1subjects in the LNG-IUS group had significantly higher levels of haemoglobin than those in the dienogest group PubMed · PMID 39032312 ↗
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 →