Prasterone for menopause
A clinical review reports that vaginal prasterone improves genitourinary syndrome of menopause symptom severity by approximately 40% to 80%.
Hypothesized mechanism
Locally administered prasterone (DHEA) is converted to estrogens and androgens in vaginal tissue, restoring epithelial integrity and reducing GSM symptoms.
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 6 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. Female representation not stated — applicability to women uncertain (flagged for full text). (band F4, ×0.75).
Corroboration
Only a single claim is present, stating PRASTERONE is a Phase 3 clinical candidate for menopause per Open Targets. No mechanistic lines of evidence are described, so there is no convergence to assess.
Rigor
The claim provides only a regulatory/clinical-stage annotation from a database, not any human or in-vitro mechanistic model. No experimental rigor can be evaluated from this single registry-type statement.
Specificity
No molecular target or mechanism of action is named in the claim. The drug's specificity of action on any target cannot be assessed from the provided text.
Plausibility
Without any stated target or phenotype mechanism, target-phenotype fit cannot be judged. The claim merely notes clinical-stage status, offering no biological rationale.
Consistency
There is only one claim, so there are no multiple mechanistic signals to compare for directional consistency. Consistency is therefore not demonstrable.
Scored for women. Evidence generated in women (female population, ~100% female). (band F1, ×1.00).
Corroboration
Evidence comes from a single review article ('Management of Menopausal Symptoms: A Review'), which represents one synthesis rather than multiple independent sources. A single review scores at most 1, and there is no second independent study presented.
Rigor
The source is a narrative/clinical review reporting a range of symptom improvement, not an explicitly described RCT or meta-analysis. Without clear evidence of a systematic review or RCT design behind the cited figure, it warrants a moderate rigor score of 1.
Specificity
The claim names vaginal prasterone directly and the GSM (genitourinary syndrome of menopause) symptom context, tying the specific drug to the menopause-related condition. Both intervention and condition are explicitly identified.
Plausibility
Prasterone (DHEA) acts locally to restore vaginal tissue, a plausible mechanism for improving GSM symptoms, but the claim itself only reports symptom improvement without articulating or evidencing the mechanism. Thus the mechanism is plausible but not explicitly evidenced here.
Consistency
Only a single source reporting a range of improvement is provided, so directional agreement across independent studies cannot be assessed. Per rules, a single source defaults to a neutral consistency score of 1.
Regulatory & development status
Where this candidate sits in the US regulatory landscape: whether the drug is already FDA-approved for menopause (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 On-label (FDA-approved for this use)
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. This condition appears in the drug's FDA-approved label (Indications & Usage), so using it here is an approved, on-label use.
From the label’s Indications & Usage section: “atment 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 o”, INTRAROSA (PRASTERONE) INSERT [MILLICENT US, INC.] · view label ↗
Generic & patent supply Brand-only, patent-protected
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. Single-source brand with at least one unexpired Orange Book patent (latest listed expiry Mar 2031).
Latest listed Orange Book patent expiry: Mar 2031. Patent listings can change and do not by themselves determine when a generic may launch.
Clinical-trial stage, for this condition Phase 3
Read from ClinicalTrials.gov (US National Library of Medicine). A trial only counts when the drug appears as an experimental or active-comparator intervention in an interventional study of this condition; mechanistic, drug-interaction, post-marketing (Phase 4), and comparator-background uses are excluded, so this reflects the drug being tested as a therapy for menopause.
For this pair. Studied in 1 qualifying interventional trial · highest stage reached Phase 3 · halted or terminated.
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.
- 1improvement in severity by 40% to 80% for vaginal prasterone PubMed · PMID 36749328 ↗
- 2Per Open Targets (retrieved 2026-06-16), PRASTERONE (a Small molecule) is a clinical candidate for menopause (maximum clinical stage PHASE_3). Open Targets · mechanistic ↗
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 →