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Methodology

Every number, approval date, and trial reference on this site is traced to a cited primary source. This page explains how we choose sources, handle conflicting evidence, and keep the data current.

Our core principle: no unsourced data

If a claim cannot be verified against an authoritative source, it does not appear on NonHormonal.com. We would rather show a missing field than an unverified number. When a data point is unknown or contested, we say so explicitly in the relevant details field rather than filling the gap with a guess.

This applies to every data type we publish: efficacy percentages, FDA approval dates, clinical trial IDs, manufacturer names, and cost ranges.

Where the data comes from

We use a fixed source hierarchy so the same kind of claim is always traced to the same kind of authority. When a newer authoritative source supersedes the one listed here, we update the hierarchy first, then update the affected pages.

  • Class-level contraceptive failure rates (condoms, diaphragm, spermicide, withdrawal, IUD, sterilization) come from the Guttmacher Institute contraceptive effectiveness table, which is built on the Trussell / Contraceptive Technology underlying data.
  • Product-specific contraceptive efficacy (Paragard, Phexxi, Caya, Natural Cycles, and others) comes from the pivotal Phase 3 trial for that product, or the FDA label, cited via PubMed or DailyMed. We do not substitute a class-level number when a product-specific trial exists.
  • Menopause vasomotor symptom (VMS) efficacy (fezolinetant, elinzanetant, paroxetine, oxybutynin, gabapentin, CBT, hypnosis, stellate ganglion block, pollen extract, phyto-SERM) comes from the pivotal randomized controlled trial for that treatment, cited via PubMed. When only an observational study exists, we say so.
  • Menopause clinical guidelines come from The Menopause Society (NAMS) 2023 Nonhormone Therapy Position Statement, with NICE NG23 used as a complementary international source.
  • Genitourinary syndrome of menopause (GSM) guidance comes from the NAMS 2020 GSM Position Statement.
  • Contraception clinical guidelines come from the CDC U.S. Medical Eligibility Criteria (2024) for category ratings and the CDC U.S. Selected Practice Recommendations (2024) for LARC insertion and management guidance.
  • STI protection claims come from WHO fact sheets, with CDC U.S. MEC used for spermicide HIV risk category.
  • FDA approval status and dates come from DailyMed or the Drugs.com approval history. DailyMed is the source of truth for current labeling and boxed warnings.
  • FDA device clearances (non-hormonal apps, femtech, and physical devices that may not have a standard drug label on DailyMed) come from the FDA Medical Device Databases — PMA, De Novo, and 510(k) clearance records — as co-equal primary sources alongside DailyMed for validating clearance and pivotal data.
  • Boxed warnings are quoted from the current FDA label on DailyMed, with the URL and the date the warning was added recorded alongside the text.
  • Manufacturer identity is verified against DailyMed's Packager field for drugs and the FDA PMA database for devices, since drugs and devices change hands (for example, Brisdelle moved from Noven to Sebela to Legacy Pharma).
  • Clinical trial registry numbers come from ClinicalTrials.gov for US and international trials, CTRI for India, and ANZCTR for Australia. Every registry ID is checked to confirm it resolves before it is added.

Source accessibility

Every cited source URL must be freely accessible, with no paywall or login wall, so readers can verify anything we cite. We prefer PubMed over journal pages because PubMed is always free and contains the abstract with the headline numbers, and we avoid rate-limited or paywalled sources in favor of freely accessible equivalents.

How we report efficacy numbers

Primary sources often report annual failure rates (for example, 13% typical failure for external condoms). We mathematically invert these to a consistent "effectiveness rate" format for consumer scannability (87% effective), while preserving the original measurement context in the details field so the inversion is traceable.

  • Only numbers a source directly reports. No derived percentages and no extrapolation across time periods. If a trial reports 6-month data, we publish 6-month data. If it reports an absolute reduction (for example, "6.4 fewer episodes per day") but not a percentage, we record the absolute reduction and leave the percentage field empty.
  • The cited source must support the headline number. The efficacy source URL points to a page that contains or directly references the number shown. We do not cite a 2024 paper while using a number from a 1996 paper.
  • Most authoritative, not just newest. A higher-quality older study (a prospective cohort of more than 10,000 participants) beats a lower-quality newer one (a retrospective survey). Guidelines are always the latest published edition.
  • Empty rather than misleading. When effectiveness varies by subgroup (parity for sponges and caps, body mass for lactational amenorrhea), we leave the percentage empty and explain the range in the details field. For investigational products with only animal data, we leave the percentage empty and label the findings as preclinical.

How we assign efficacy tiers

Every efficacy entry has either a numeric value, an efficacy tier (which we call a bucket), or both. The bucket gives readers an immediate "does this work?" signal without requiring a single percentage that may not exist.

Contraception tiers follow the CDC classification. The CDC groups contraceptive methods into three tiers by typical-use failure rate: Tier 1 (at least 99% effective, labeled "Most effective"), Tier 2 (90 to 99% effective, labeled "Moderately effective"), and Tier 3 (under 90% effective, labeled "Least effective"). These boundaries are authoritative and we do not adjust them. When a product has its own typical-use number, the tier is derived automatically. When it does not, the product inherits the tier of its method class, with the Guttmacher URL cited as the source.

Menopause tiers follow NAMS recommendation status. The Menopause Society 2023 Nonhormone Therapy Position Statement assigns each treatment a recommendation level: Level I ("Recommended"), Levels I-II or II-III ("Recommended, limited evidence"), or Not Recommended. For genitourinary syndrome treatments, the NAMS 2020 GSM Position Statement is used instead. The bucket is independent of the numeric efficacy value: a treatment can be "Recommended" with a modest percentage, or "Recommended" with no percentage at all.

"Limited evidence" is honest, not a judgment of failure. It means we cannot verify efficacy for a specific product. It does not mean the product does not work. "In trials" is used for investigational treatments that are still in preclinical or early clinical stages with no published human efficacy data.

Regulatory and approval claims

  • Every FDA approval date is verified against DailyMed or the Drugs.com approval history, and matches the FDA's recorded approval date rather than a press release date.
  • The current manufacturer is verified, not the original developer, since drugs and devices change hands.
  • Boxed warnings, REMS programs, and lab monitoring requirements match the current FDA label, with the monitoring schedule (baseline, frequency, duration) described in the product details.

Clinical trials

Every clinical trial listed on a product or method page includes the trial name, phase, recruitment status, registry ID, and a direct URL to the registry record. Registry IDs are checked to confirm they resolve before they are added. Trial status is checked against ClinicalTrials.gov and updated when it changes. Trial URLs always link directly to the specific study record, not the registry homepage.

Side effects and contraindications

For approved products, side effects and contraindications are verified against the Contraindications and Adverse Reactions sections of the FDA label on DailyMed. For class-level methods, they are verified against CDC U.S. MEC or NAMS guidelines. We do not list speculative or unsourced safety details.

Cost data

Cost figures are estimates, not guarantees. They go stale as prices change, so we review them quarterly and always include context about what each figure represents: list price, cash price, with-savings-card, insurance copay, App Store price, and so on.

Every cost entry has two labels that together tell you exactly what you are looking at. The first describes how often the product is consumed or repurchased: per act (condoms, spermicide), per month (a daily pill), per year (an app subscription), weekly (Saheli), or one time (a device or procedure). The second describes what the price number itself covers: a single unit (one condom), a retail package (a can of foam, a box of applicators), one billing period (a month's supply), or the total cost (a device, a procedure). A spermicide used per act but sold in a multi-dose can is labeled "per act / per package" so the price is not mistaken for a single dose.

How we handle conflicting sources

When two authoritative sources report different numbers for the same claim, we prefer the higher-quality evidence type (randomized controlled trial over cohort, cohort over survey, survey over expert opinion) and the source closer to the data (the FDA label over a secondary summary, the primary trial publication over a review). If quality is equal, the more recent source wins.

Editorial independence

Commercial relationships do not influence the data. Affiliate links, provider partnerships, and sponsorships never shape efficacy numbers, efficacy tiers, approval dates, side effect listings, or editorial prose. The commercial call-to-action link on a product page is added only after the clinical content is finalized, and it is the only commercial surface on that page. Payments from partners, including commissions and referral fees, have no influence on which methods or products we list, how we describe them, or the numbers we publish. The methodology described here is applied the same way regardless of whether a product has an affiliate link or not.

Keeping the data current

Each content file carries two dates that track its lifecycle. The "Last verified" date is when the data was last checked against its primary sources: efficacy numbers traced to the cited trial, FDA approval dates confirmed against DailyMed, trial statuses confirmed against ClinicalTrials.gov, and manufacturer names confirmed against the current label. The "Updated" date is when the content was last edited. "Last verified" is the primary trust signal and appears alongside the schema.org MedicalWebPage metadata that search engines use to assess content freshness.

The fixed source hierarchy itself is formally audited every 12 months. This ensures the foundational guidelines — the CDC U.S. MEC and SPR, The Menopause Society position statements, WHO fact sheets, and others — are systematically checked against the latest national or international consensus updates. When a newer edition supersedes a canonical source, we update the hierarchy first, then update every page that cites the superseded source.