Header
- Model name
- Hormonal Imbalance (Male)
- Developer
- Zenlo LLC
- Release stage
- Research Tool (not FDA-cleared)
- Version
- 1.0
- Availability
- United States
- Regulatory status
- Not applicable — academic and transparency positioning
- Pattern slug
- hormonal_male
- Biomarkers
- TESTO, FREE_T, CORTISOL, CORT, DHEAS
This document follows the CHAI Applied Model Card format (v0.1).
Summary
The Hormonal Imbalance (Male) pattern evaluates testosterone (total and free), cortisol, and DHEA-sulfate in adult male laboratory panels, flagging androgen deficiency, adrenal axis signals, or anabolic–catabolic imbalance for physician review. Deterministic rules apply sex-specific reference comparisons and pattern-specific abnormality thresholds. Claude Haiku 4.5 synthesizes narrative context on which hormonal markers contributed. For licensed functional-medicine physicians, this is supportive clinical decision support — it does not diagnose hypogonadism, adrenal insufficiency, or PCOS-equivalent conditions, and it does not guide hormone replacement dosing. Outputs highlight endocrine laboratory signals requiring correlation with symptoms, timing of collection, and repeat testing.
Uses & Directions
Intended use
Clinical decision support for licensed physicians reviewing male sex-hormone and adrenal marker patterns in adult panels.
Primary users
Licensed functional medicine physicians and similarly qualified clinicians.
How to use
Review flagged hormones with diurnal collection timing, symptoms, medications, and repeat morning testosterone if indicated.
Target population
Adults aged 18 and older in the United States.
Out of scope
- Direct patient use without physician oversight
- Female or pediatric endocrine evaluation
- Standalone diagnosis or hormone replacement prescribing
- Dynamic stimulation or suppression testing interpretation
Warnings
Clinical risk level
Low — supportive tool; the treating physician retains full clinical judgment and responsibility.
Known limitations
- Testosterone varies diurnally; single random samples may misclassify status.
- Does not incorporate LH, FSH, SHBG, or prolactin in this pattern.
- Cortisol interpretation depends heavily on collection time and stress context.
Validation note
Validation pending — a Tier A NHANES validation run has not yet been completed for this pattern. Distribution, agreement, and fairness results will be published here when available.
Trust Ingredients
AI system facts
- Deterministic pattern detector (hormonal_male) plus Claude Haiku 4.5 for narrative synthesis
- Primary inputs: Total testosterone, free testosterone, cortisol, and DHEA-sulfate from structured extraction.
- Output: Pattern flag plus narrative on male hormonal marker abnormalities.
Security & compliance
- Anthropic Business Associate Agreement with zero-data-retention configuration
- HIPAA-aligned design; no patient data used for model training
Ongoing maintenance
Versioned, transparent, and reproducible via a public independent audit harness (see Resources).
Transparency
Self-funded development; no third-party sponsor for this pattern card.
Key Metrics
Usefulness / Efficacy
Zenlo's detection approach was benchmarked across five models in a separate study; see the medRxiv preprint in Resources. No per-pattern efficacy metric is published for this pattern.
Source: 5-model benchmark, medRxiv MEDRXIV/2026/346284
Fairness / Equity
Validation pending — a Tier A NHANES validation run has not yet been completed for this pattern. Distribution, agreement, and fairness results will be published here when available.
Safety / Reliability
- Supportive-only; not intended as a standalone diagnostic
- Physician authorization required before clinical use
- Deterministic detector is reproducible for inputs: TESTO, FREE_T, CORTISOL, CORT, DHEAS
Resources
- medRxiv preprint MEDRXIV/2026/346284 — 5-model benchmark (system-level detector evaluation)
- JAMIA Open submission JAMIO-2026-0120 (under review)
- Independent audit harness: github.com/dimashibakov/zenlo-audit — reproducibility manifest, NHANES 2015–2016 cycle, harness commit c10afe8
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