Menopause Clinical Trial Demographics: Who Was Actually Studied

Menopause clinical trial demographics do not describe one shared population. The WHI hormone trials averaged 63.4 years; pivotal fezolinetant and elinzanetant programs averaged 54.3 and 54.6, enrolled no one older than 65, and included only 10 and 4 Asian participants. SWAN, by contrast, began before menopause.

What changes that answer: which study you mean, which demographic you are asking about, whether the study tested symptoms or long-term disease prevention, and whether the product was FDA-approved or individually compounded.

That is the short version. Here is the part almost nobody knows: the two WHI hormone trials ran inside the same program, through the same 40 US clinical centers, yet one enrolled more than twice the share of Black women as the other. Not by accident. By anatomy. The uterus requirement changed who could enter before a recruiter made a call.

We read the tables ourselves. Every number below traces to a regulator-published document or a named primary study, and every calculation made by The HRT Index is labeled.

Best for / not for you if

Best for: women who want the actual enrollment numbers, trial by trial; anyone asking whether people with their age, menopause stage, race, ethnicity, uterus status, or surgical history were studied; and writers who need a sourceable comparison.

Not for you if: your real question is whether hormone therapy is right for you personally. Start with The HRT Index's Find My HRT Path tool instead. If you want current treatment-use numbers rather than research participation, read how many women use HRT. New or changed bleeding after menopause needs clinical evaluation before it becomes a research question; do not put that off.

The HRT Index is the independent decision resource for online menopause and HRT care — comparing telehealth providers on clinical legitimacy, care quality, medication fit, price transparency, and access, with every claim verified and dated, so women can choose the path that fits their situation before their first consult

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What is the 60-second answer on menopause clinical trial demographics?

The fastest way to read this evidence is to separate age, purpose, menopause stage, and denominator. HERS and WHI were not hot-flash efficacy trials; SKYLIGHT and OASIS were. REPLENISH tested one FDA-approved oral estradiol/progesterone product. SWAN observed the menopause transition rather than testing a medication.

Question	Verified answer
How old were participants?	Mean 63.4 across the two WHI hormone trials, 66.7 in HERS, 54.3 in pooled SKYLIGHT 1/2, and 54.6 in pooled OASIS 1/2.
How White were the trial populations?	A weighted 80.5% across the two WHI hormone trials; 81.0% in SKYLIGHT 1/2; 80.4% in OASIS 1/2; and 65.4% in the REPLENISH safety population.
Were Black women included?	Yes: 6.8% in WHI estrogen plus progestin, 15.1% in WHI estrogen alone, 32.1% in REPLENISH, and about 17% in each new nonhormonal efficacy program.
Were Asian women included in the VEOZAH and LYNKUET programs?	Barely: 10 women in pooled SKYLIGHT 1/2 and 4 women in pooled OASIS 1/2.
Were women older than 65 included in those new programs?	No. Both efficacy populations had a recorded age range of 40 to 65.
Were perimenopausal women included?	Not in SKYLIGHT 1/2 or OASIS 1/2. They were included in other menopause studies, including a 339-participant MsFLASH treatment trial.
Do individually compounded hormones have equivalent FDA trial-demographic tables?	No. An individually compounded prescription has no FDA-approved product-level pivotal program, FDA label, or Drug Trials Snapshot.

The pooled WHI White percentage is a The HRT Index calculation weighted by each trial's randomized population. Race and ethnicity were recorded differently across eras, so a single cross-trial “diversity score” would be false precision.

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Before you go further

The right online HRT provider is not the same for every woman — it depends on your symptoms, where you are in the menopause transition, whether you have a uterus, medication preferences, risk history, insurance or cash-pay situation, and state. Some situations belong with an in-person clinician first.

That means the honest answer is it depends on your situation → use the tool. Find My HRT Path is an education-and-routing tool that takes about 90 seconds, requires no email, and shows a best-fit online care route plus two backups. It also keeps the when online care isn't the right starting point safety flag intact. A licensed clinician makes every treatment decision.

→ Find your best-fit HRT care path

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What do menopause clinical trial demographics actually show?

The eight trial rows below answer different questions with different populations. Prevention trials enrolled older postmenopausal women; timing trials selected healthier women closer to menopause; symptom trials required frequent hot flashes. Reading the age or race column without the purpose column can make a precise number tell the wrong story.

Trial or program	What it tested	Denominator used here	Age	Menopause or anatomy requirement	Primary applicability limit
HERS	Oral conjugated equine estrogens plus medroxyprogesterone acetate for secondary coronary prevention	2,763 randomized	44–79; mean 66.7	Postmenopausal, uterus present, established coronary heart disease	Not a trial of healthy women starting symptom treatment
WHI estrogen + progestin	Oral conjugated equine estrogens plus medroxyprogesterone acetate for chronic-disease prevention	16,608 randomized	50–79; mean 63.3	Postmenopausal, uterus present	Did not test modern individualized symptom treatment or other routes and regimens
WHI estrogen alone	Oral conjugated equine estrogens for chronic-disease prevention	10,739 randomized	50–79; mean 63.6	Postmenopausal, prior hysterectomy	Cannot be merged with the uterus-intact trial or generalized to every estrogen regimen
KEEPS	Early oral or transdermal estrogen regimens and vascular surrogate outcomes	727 randomized	42–58; mean about 52.7	Natural menopause, 6 months to 3 years past final menstrual period	Selected healthy cohort; not powered for major clinical events
ELITE	Oral estradiol begun early versus late after menopause and carotid artery-wall progression	643 randomized	Early stratum mean 55.4; late stratum mean 65.4	Less than 6 years versus at least 10 years since menopause	Single-center, selected healthy cohort; surrogate endpoint
REPLENISH	Oral estradiol/progesterone for vasomotor symptoms and endometrial safety	1,845 randomized; 1,835 treated	40–65; mean 54.6	Postmenopausal, uterus present	Product-specific oral trial; does not answer transdermal or uterus-absent questions
SKYLIGHT 1/2	Fezolinetant for moderate-to-severe vasomotor symptoms	1,028 randomized; 1,022 treated	40–65; mean 54.3	Postmenopausal; at least 7 moderate-to-severe episodes per day	No participant older than 65; very small Asian and other race groups
OASIS 1/2	Elinzanetant for moderate-to-severe vasomotor symptoms	796 randomized; 793 treated	40–65; mean 54.6	Postmenopausal; at least 50 moderate-to-severe hot flashes per week	No participant older than 65; very small Asian and other race groups

SWAN sits beside this ledger, not inside it. It was an observational cohort of 3,302 women recruited at seven US sites while they were still menstruating. It tells us how menopause and symptoms unfolded; it did not test a medication.

The race table is less complete than the age table because older publications used different category systems and did not always publish mutually exclusive race and ethnicity fields. “NR” means the field was not reported in a form we could normalize from the named source — not that no one from that group participated.

Trial or program	White	Black or African American	Asian	Hispanic or Latina/Latino	Reporting note
HERS	89%	NR	NR	NR	Baseline report published White versus non-White in the abstract used here
WHI estrogen + progestin	83.9%	6.8%	NR	5.4%	Older label architecture reports Hispanic as a mutually exclusive category
WHI estrogen alone	75.3%	15.1%	NR	6.1%	Older label architecture reports Hispanic as a mutually exclusive category
KEEPS	80% non-Hispanic White	NR	NR	NR	Source reports a predominantly non-Hispanic White cohort; full categories are not collapsed here
ELITE	Published by stratum	Published by stratum	Published by stratum	Published by stratum	We do not force stratum counts into a single unlabeled total
REPLENISH safety population	65.4%	32.1%	NR	NR	Source used here reports White, African American, and 2.4% Other without expanding that category
SKYLIGHT 1/2 efficacy population	81.0% (828)	17.0% (174)	1.0% (10)	23.8% (243)	Hispanic ethnicity is reported separately from race
OASIS 1/2 efficacy population	80.4% (640)	17.1% (136)	0.5% (4)	8.5% (68)	Hispanic ethnicity is reported separately from race

Source: Sources for both ledgers:* HERS baseline report; current US prescribing information summarizing the WHI substudies; KEEPS and ELITE primary publications; REPLENISH publications; and FDA Drug Trials Snapshots plus current prescribing information for VEOZAH and LYNKUET. Full links are in the source list.

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Why does a trial's purpose matter as much as its demographics?

A demographic match cannot repair a question mismatch. HERS asked whether one oral estrogen/progestin regimen prevented repeat coronary events in women who already had heart disease. WHI asked chronic-disease prevention questions. KEEPS and ELITE tested timing and vascular surrogate outcomes. REPLENISH, SKYLIGHT, and OASIS tested symptom treatments.

That is why “the hormone trials averaged 63” is true and still incomplete.

• HERS enrolled women with established coronary disease. Its average participant was 66.7, and 59% had hypertension.
• WHI included women aged 50 to 79, but its hormone trials were designed around chronic-disease outcomes, not around a modern first consultation for new hot flashes.
• KEEPS moved closer to the population seeking symptom treatment: ages 42 to 58, within three years of natural menopause, and screened to exclude substantial cardiovascular risk. The result was a highly selected cohort: 80% non-Hispanic White and 74% college graduates.
• ELITE deliberately separated women less than six years from menopause from those at least ten years past it. Its primary vascular outcome was carotid intima-media thickness, not heart attacks, strokes, or symptom relief.
• REPLENISH, SKYLIGHT, and OASIS required postmenopausal women with defined symptom burdens and measured symptom efficacy at weeks 4 and 12.

They are not the same evidence. They were not built on the same women.

The WHI investigators' 2024 review draws the boundary clearly: WHI does not support menopausal hormone therapy to prevent cardiovascular disease or other chronic diseases, while current evidence supports hormone therapy for bothersome symptoms in appropriately selected women in early menopause who do not have contraindications. That is a much narrower clinical question than the one that dominated headlines after 2002.

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Why did the two WHI hormone trials enroll different women?

The two WHI hormone trials shared one program and 40 US clinical centers, but anatomy sent women down different paths. Women with a uterus entered the estrogen-plus-progestin trial. Women with a prior hysterectomy entered the estrogen-alone trial. That split changed race, age, education, blood pressure, and time-since-menopause distributions.

WHI baseline measure	Estrogen + progestin	Estrogen alone	Difference that matters
Randomized population	16,608	10,739	Different denominators
Mean age	63.3	63.6	Similar averages
White	83.9%	75.3%	8.6 percentage-point gap
Black	6.8%	15.1%	2.2 times the share
Hispanic	5.4%	6.1%	Smaller difference
Uterus status	Uterus present	Prior hysterectomy	Determines regimen and eligibility
Oral study regimen	CEE 0.625 mg + MPA 2.5 mg daily	CEE 0.625 mg daily	These exact regimens, not every form of HRT
Primary purpose	Chronic-disease prevention	Chronic-disease prevention	Neither substudy was designed to evaluate menopausal symptom relief

The pooled mean age across both hormone trials was 63.4. The pooled White share was 80.5%. Those are useful summary numbers, but they erase the anatomy split that created the most consequential demographic difference in the program.

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Why did one WHI trial have more than twice the share of Black women?

Black women were 6.8% of the WHI uterus-intact trial and 15.1% of the prior-hysterectomy trial. The eligibility split opened different doors. Because hysterectomy has been more common among Black women in the United States, a larger share could qualify for the estrogen-alone arm. Recruitment may also have mattered; anatomy changed the pool first.

Sit with that for a second, because the same fact did something completely different in another landmark study.

SWAN required participants to be aged 42 to 52, still menstruating, and to have an intact uterus and at least one ovary at enrollment. A 2023 re-analysis used SWAN screening records for 15,695 women screened and 3,302 enrolled. Black and Hispanic women had the lowest probability of eligibility, driven in part by a higher prevalence of surgical menopause.

Before the investigators corrected for selection, the Black-versus-White hazard ratio for menopause timing was 0.98. After correction, Black women reached natural menopause earlier (HR 1.13) and surgical menopause much earlier (HR 3.21). The adjusted model translated to an estimated 1.2-year earlier overall menopause timing that the uncorrected comparison had hidden.

The same fact — a higher rate of hysterectomy — pushed Black women into one landmark menopause trial and out of another. In WHI, it more than doubled their share. In SWAN, it reduced the chance that they could qualify.

This is what underrepresentation looks like up close. It is not always a recruiter deciding whom to call. An eligibility rule can be scientifically defensible and still sort women unevenly before recruitment begins. Nobody has to act in bad faith for the effect to be real.

If you have had a hysterectomy, your evidence base is different — not automatically smaller, different. For the exact oral WHI regimens and chronic-disease question, the estrogen-alone trial is the relevant WHI arm; the estrogen-plus-progestin result should not be substituted for it.

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Who was in the trials for VEOZAH and LYNKUET?

The pivotal efficacy populations for VEOZAH and LYNKUET look similar at first glance: mean age about 54½, roughly 80% White, roughly 17% Black, postmenopausal, and no one older than 65. The differences become visible in Hispanic enrollment, Asian enrollment, program geography, and FDA's conflicting LYNKUET fields.

Verified field	VEOZAH (fezolinetant)	LYNKUET (elinzanetant)
Original FDA approval	May 12, 2023	October 24, 2025
Pivotal efficacy trials	SKYLIGHT 1 and 2	OASIS 1 and 2
Randomized / treated in efficacy trials	1,028 / 1,022	796 / 793
Full approval program	3 trials; 368 sites; 9 countries	3 trials; 267 sites; 21 countries
Age range	40–65	40–65
Mean age	54.3	54.6
White	81.0% (828)	80.4% (640)
Black or African American	17.0% (174)	17.1% (136)
Asian	1.0% (10)	0.5% (4)
American Indian or Alaska Native	0.4% (4)	0.5% (4)
Hispanic or Latina/Latino	23.8% (243)	8.5% (68)
Symptom threshold	At least 7 moderate-to-severe VMS per day	At least 50 moderate-to-severe hot flashes per week
Placebo-controlled efficacy comparison	Weeks 4 and 12	Weeks 4 and 12
Separate long-term placebo-controlled safety study	52 weeks	52 weeks

The Hispanic swing

Two drugs. Same indication. Approved 29 months apart. Hispanic or Latina/Latino enrollment in the efficacy populations: 23.8% versus 8.5%. That is a 2.8-fold difference in two programs routinely grouped together as modern menopause trials.

We do not know why. The programs used different countries and sites, but the public demographic tables do not establish causation. “Modern trials are more diverse” is too blunt a sentence to survive contact with these two rows.

The Asian data void

Ten women. Then four.

That is the Asian enrollment in the pooled pivotal efficacy populations for VEOZAH and LYNKUET. FDA says the non-White, non-Black groups were too small to determine racial differences for LYNKUET. A percentage can look publishable while the underlying subgroup is four people.

Now put that next to SWAN. Median total duration of frequent vasomotor symptoms was 10.1 years for Black women, 8.9 for Hispanic women, 6.5 for White women, 5.4 for Chinese women, and 4.8 for Japanese women. Those observational differences do not prove that either drug works differently by race or ethnicity. They show why four and ten participants cannot close the question.

That does not mean the drugs fail Asian women. It means the subgroup evidence is almost empty, and there is no honest way to fill it with confidence.

Two conflicts inside FDA's LYNKUET documents

We read the snapshot and current prescribing information end to end. Two conflicts are worth reporting rather than smoothing over.

One. FDA's LYNKUET table labels its youngest age row “45 to 49,” yet the same table gives a minimum age of 40, the adjacent figure says “40 to 49,” and the adverse-event table also uses “40 to 49.” We treat the verified range as 40 to 65 and do not use the broken row label.

Two. The original Drug Trials Snapshot says OASIS 1/2 had 58% to 64% prior hysterectomy, 75% to 84% prior oophorectomy, and 68% to 69% prior hormone-therapy use. The current US prescribing information, revised August 2026, reports pooled values of 38.8% prior hysterectomy, 20.6% prior uni- or bilateral oophorectomy, and 31.4% prior menopausal hormone-therapy use.

Those documents do not agree. This page uses the current prescribing information for the pooled surgical-history values and preserves the discrepancy in the record.

We are telling you this partly because it is true and partly because it is the test. A page that copied the snapshot without opening the current label would miss it.

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Was the pivotal trial with the lowest White share the newest one?

No. In this selected ledger, REPLENISH had the lowest reported White share and the highest reported Black share among FDA-approval treatment programs: 65.4% White and 32.1% African American. It randomized 1,845 women; 1,835 received at least one dose and formed the safety population used for those demographics.

This one surprised us, and it inverts the story most coverage tells.

The standard narrative is a clean upward line: old trials were White, new trials are better. The data does not cooperate. REPLENISH finished enrollment before the pivotal fezolinetant and elinzanetant programs, yet its Black enrollment share was roughly double either one and nearly five times the share in WHI estrogen plus progestin.

Its participants were ages 40 to 65, averaged 54.6, were a mean 5.8 years past menopause, and all had a uterus because the program evaluated both vasomotor-symptom efficacy and endometrial safety for one FDA-approved oral estradiol/progesterone capsule.

What caused its enrollment pattern? The published sources used for this page do not establish that. REPLENISH ran at 117 US sites, but geography alone cannot be promoted from a plausible explanation to a fact.

One more thing this row tells you: diversity is not a hormonal-versus-nonhormonal story, a new-versus-old story, or a good-guys-versus-bad-guys story. The answer changes by study, site network, eligibility rules, recruitment, and which categories the investigators actually report.

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Were women older than 65 included in modern hot-flash drug trials?

No participant older than 65 appeared in the pooled SKYLIGHT 1/2 or OASIS 1/2 efficacy populations. FDA's participant tables record a maximum age of 65. That is different from WHI and HERS, where older women were central to the population and the mean ages were 63.4 and 66.7.

Study or stratum	Age floor	Age ceiling	Mean age
HERS	44	79	66.7
WHI estrogen + progestin	50	79	63.3
WHI estrogen alone	50	79	63.6
KEEPS	42	58	About 52.7
ELITE early stratum	Defined by <6 years since menopause	—	55.4
ELITE late stratum	Defined by ≥10 years since menopause	—	65.4
REPLENISH	40	65	54.6
SKYLIGHT 1/2	40	65	54.3
OASIS 1/2	40	65	54.6

Line up the rows and the strangest feature of the evidence base becomes visible:

The average woman in the trial that reshaped hormone-therapy decisions for a generation sat within roughly two years of the upper age boundary for the VEOZAH and LYNKUET efficacy programs.

That does not prove VEOZAH or LYNKUET is unsafe or ineffective after 65. It means the pivotal efficacy populations cannot answer the question directly. Asking a prescriber how age, other conditions, liver or kidney function, interacting medicines, and the current label affect the decision is not being difficult. It is using the evidence correctly.

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Were perimenopausal women included in menopause treatment trials?

Yes — but not in the pivotal VEOZAH or LYNKUET efficacy programs. SKYLIGHT 1/2 and OASIS 1/2 required postmenopausal status. Other research included perimenopausal women, including a 339-participant MsFLASH randomized trial of low-dose oral estradiol, venlafaxine, or placebo for bothersome vasomotor symptoms.

That correction matters because the draft version of this page made the gap sound universal. It is not.

SWAN followed women across the transition rather than testing a drug. Among 1,449 women with frequent vasomotor symptoms, the median total duration was 7.4 years, with 4.5 years after the final menstrual period. Timing changed the forecast dramatically: women whose frequent symptoms began while premenopausal or in early perimenopause had a median total duration exceeding 11.8 years and a median 9.4 years after the final menstrual period. Onset after menopause was associated with a median total duration of 3.4 years.

Which produces a more accurate version of the original finding:

The women with the longest observed symptom course were excluded from the VEOZAH and LYNKUET pivotal programs by their postmenopausal-status rules — but perimenopausal women have not been excluded from menopause treatment research as a whole.

If you are still having periods, do not apply a postmenopausal-only drug table to yourself without noticing the boundary. Start with the perimenopause symptoms checklist if you need help naming the stage, then take the question to a clinician.

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How long did the trials run compared with how long symptoms can last?

For both new nonhormonal drugs, the placebo-controlled efficacy comparison centered on weeks 4 and 12. Each approval program also included a separate 52-week placebo-controlled safety study. SWAN's observational estimate for frequent vasomotor symptoms was 7.4 years overall, with large differences by timing and race or ethnicity.

Time window	Verified duration
Pivotal placebo-controlled efficacy endpoints	Weeks 4 and 12
Separate long-term placebo-controlled safety study	52 weeks
Median total frequent-VMS duration in SWAN	7.4 years
Median persistence after final menstrual period	4.5 years
Black women in SWAN	10.1 years
Hispanic women in SWAN	8.9 years
White women in SWAN	6.5 years
Chinese women in SWAN	5.4 years
Japanese women in SWAN	4.8 years

Twelve weeks is roughly one thirty-second of 7.4 years.

We want to be fair here, because this is where a dramatic sentence could imply a scandal that does not exist. Short placebo-controlled efficacy windows give investigators a clean comparison, and the 52-week safety studies exist because twelve weeks is not enough to characterize longer exposure.

But the mismatch is still worth knowing. A trial can establish a symptom benefit over twelve weeks without answering how an individual should manage treatment across several years. That second question belongs in ongoing clinical follow-up, not in a headline built from the week-12 endpoint.

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Who was excluded before enrollment even started?

Demographics tell you who entered. Eligibility rules tell you who could. Across this evidence set, uterus status, surgical history, cardiovascular disease, years since menopause, symptom frequency, and age acted as gates before recruitment. The same rule that improves scientific clarity can make the result less transferable to a reader outside the gate.

Study or program	Key eligibility gate	What it means in practice
HERS	Established coronary heart disease and a uterus	Healthy women without heart disease were outside the trial question
WHI estrogen + progestin	Postmenopausal, age 50–79, uterus present	Prior hysterectomy routed women away from this trial
WHI estrogen alone	Postmenopausal, age 50–79, prior hysterectomy	Women with a uterus were outside this trial
KEEPS	Natural menopause 6 months to 3 years earlier; strict cardiovascular and metabolic screening	Surgical menopause, clinical cardiovascular disease, diabetes, BMI over 35, and several other risks were excluded
ELITE	Less than 6 or at least 10 years since menopause; no clinical cardiovascular disease	The middle timing window and women with clinical cardiovascular disease were outside the intended comparison
REPLENISH	Postmenopausal, ages 40–65, uterus present, moderate-to-severe VMS	Women without a uterus, outside the age range, or without the symptom threshold were not represented
SKYLIGHT 1/2	Postmenopausal, ages 40–65, at least 7 moderate-to-severe VMS per day	Perimenopause, age over 65, and lower symptom frequency were outside the pivotal population
OASIS 1/2	Postmenopausal, ages 40–65, at least 50 moderate-to-severe hot flashes per week	Perimenopause, age over 65, and lower symptom frequency were outside the pivotal population
SWAN	Ages 42–52, recent menstruation, intact uterus, at least one ovary	Prior hysterectomy or bilateral oophorectomy could prevent enrollment before follow-up began

That does not make the studies bad. It tells you where the border is.

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Does a demographic evidence gap mean a treatment will not work for you?

No. Absence from a trial is not proof of no benefit, and presence is not proof of an individual outcome. The honest question is how much direct evidence exists for your subgroup, whether the subgroup was large enough to analyze, and whether your clinical situation matches the study's purpose, product, and exclusions.

There are three different evidence states that are often collapsed into one:

1. Not represented: no one, or almost no one, from the subgroup was enrolled.
2. Represented but underpowered: people from the subgroup were enrolled, but too few to estimate a separate effect reliably.
3. Analyzed with useful precision: enough participants and events existed for a meaningful subgroup analysis.

VEOZAH and LYNKUET illustrate the middle problem. Both pivotal efficacy programs enrolled substantial numbers of White and Black women, and FDA published subgroup analyses for those groups. Asian enrollment was 10 and 4. That is representation on a pie chart, not a reliable subgroup answer.

The useful questions for a clinician are direct:

• Was anyone with my age and menopause stage in the pivotal population?
• Was my uterus or surgical history included?
• Was the subgroup large enough for FDA to analyze separately?
• Does my health history match the major exclusions?
• Am I looking at the exact FDA-approved product and route that was studied?

You are allowed to ask those questions. They are not a demand for certainty medicine cannot provide. They are how you find the boundary between what was measured and what must be decided clinically.

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Which demographic fields were missing or not comparable?

The missing cells are part of the result. Older studies often did not publish race and ethnicity using today's categories; some papers reported only grouped “Other” values; some split fields by treatment stratum. We preserved “not reported” rather than turning unknown into zero or manufacturing a clean-looking total.

Evidence source	Field that could not be normalized cleanly	How this page handles it
HERS baseline abstract	Detailed non-White race and ethnicity breakdown	Reports 89% White and leaves the rest unexpanded
WHI label summaries	Asian categories separated from “Other”	Uses the label's published White, Black, Hispanic, and Other architecture
KEEPS publications	One mutually exclusive race/ethnicity table comparable to FDA snapshots	Reports 80% non-Hispanic White and does not force the remainder into invented bins
ELITE baseline paper	One pooled demographic row instead of early/late stratum data	Keeps the age strata and does not publish an unlabeled pooled race estimate
REPLENISH analysis	Detailed Hispanic and Asian counts in the source used for the safety denominator	Reports White, African American, and Other only
LYNKUET FDA documents	Consistent surgical-history percentages	Uses the August 2026 prescribing information and records the snapshot conflict
Individually compounded prescriptions	FDA product-level pivotal demographics	States that no FDA-approved product-level table exists

A missing field is not a blank to decorate. It is a finding about the evidence record.

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Do compounded hormones have FDA clinical-trial demographics?

No — not in the product-level sense used for an FDA-approved drug. Individually compounded prescriptions can be prepared for a patient-specific clinical need, but compounded drugs are not FDA-approved. FDA does not verify their safety, effectiveness, or quality before they are marketed, and it does not publish a Drug Trials Snapshot for each compounded prescription.

That does not mean no research has ever studied any compounded preparation or ingredient. It means you cannot point to an FDA-approved pivotal package for an individually compounded product and retrieve the same standardized enrollment table available for VEOZAH, LYNKUET, or BIJUVA.

Keep the categories separate:

• FDA-approved product: a specific formulation, dose, manufacturing standard, label, and approval evidence package.
• Individually compounded prescription: prepared by a compounding pharmacy for a patient; not FDA-approved; no FDA product-level pivotal-demographics table.

Blurring those categories would turn a demographics page into a regulatory error.

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What does FDA currently require for trial diversity reporting?

FDA reporting has moved from demographic tabulation toward prospective enrollment planning, but the implementation status matters. The June 2024 Diversity Action Plan document remains draft guidance as of September 4, 2026. FDA labels it “not for implementation” and says its recommendations are nonbinding while the statutory timetable awaits final guidance.

Date	Regulatory step	Verified status on September 4, 2026
1998	FDA's Demographic Rule required new drug applications to present effectiveness and safety data by age, sex, and race	In force as a reporting requirement
January 2015	FDA began publishing Drug Trials Snapshots for newly approved novel drugs and biologics	Active public transparency program
December 2022	FDORA created Diversity Action Plan requirements for certain clinical studies	Statutory framework enacted
June 2024	FDA issued draft guidance on the form, content, timing, and waiver process for Diversity Action Plans	Still draft; not for implementation; nonbinding recommendations
Future trigger	Certain studies become subject to the requirement on the timetable tied to final guidance	Final guidance had not been issued on the verification date

The practical point is not that nothing has changed. Sponsors already report demographic data, FDA publishes snapshots for qualifying new approvals, and many programs plan enrollment prospectively. The point is narrower: do not describe the June 2024 document as final or claim its implementation clock has already run.

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How can you tell whether a clinical trial applies to you?

Start with the question, not the demographic resemblance. Then check the exact product, route, age, menopause stage, uterus or ovary status, baseline health, symptom threshold, and subgroup size. A study can look like you on one row and still answer a different medical question with a different regimen.

Use this six-question check:

1. What was the study trying to prove? Symptom relief, endometrial safety, cardiovascular prevention, or a surrogate outcome are not interchangeable.
2. What exact intervention was tested? Oral conjugated equine estrogens plus medroxyprogesterone acetate is not every form, route, or dose of menopausal hormone therapy.
3. How close were participants to menopause? Age alone does not tell you whether they were still cycling, recently postmenopausal, or decades past the final menstrual period.
4. Did anatomy determine eligibility or regimen? Uterus status, hysterectomy, and oophorectomy can move someone into a different evidence stream.
5. Which health conditions were excluded? A highly selected healthy cohort may not answer the same question for someone with cardiovascular disease, diabetes, or other conditions.
6. Was your subgroup large enough to analyze? Four participants and four hundred participants do not buy the same certainty.

Here is the permission-giving version: you do not have to prove that a study “matches” you before receiving care. You need enough context to ask what the evidence directly covers, what it does not, and how a clinician is handling the gap.

When the research question turns back into “which online care path fits my symptoms, preferences, safety history, budget, and state?”, that is a Decision Resolution Point. Use Find My HRT Path instead of forcing a trial-demographics table to make a provider decision it was never built to make.

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Can you join a menopause clinical trial now?

Sometimes. Recruiting status changes continuously, and “menopause” records include drug trials, devices, behavioral interventions, observational studies, and studies limited to specific diagnoses or treatments. The only responsible live answer is to check each record's current status, locations, dates, eligibility criteria, contacts, and update history.

Start with the ClinicalTrials.gov search for recruiting menopause studies, then open the individual record. “Recruiting” on a search page does not guarantee that a nearby site is open, that a cohort still has space, or that you qualify.

Before contacting a site, check:

• recruiting status and last update date;
• location and travel requirements;
• age, menopause stage, symptom threshold, and surgical-history rules;
• prohibited medicines and washout periods;
• placebo, crossover, or open-label design;
• visit, lab, diary, and follow-up burden;
• compensation, costs, and whom to contact.

A trial coordinator — not a search page — confirms eligibility.

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How did The HRT Index verify this page?

We used a source hierarchy, preserved denominator labels, recalculated only transparent comparisons, and refused to convert missing data into zero. FDA approval documents and current labels took priority for product-specific claims; primary peer-reviewed reports took priority for study design; ClinicalTrials.gov was used for live recruitment status, not historical outcomes.

Source labels used on this page

• Regulator-published: FDA Drug Trials Snapshot, current US prescribing information, statute, or FDA guidance page.
• Publication-reported: denominator or result printed in a named primary or peer-reviewed study.
• The HRT Index calculation: arithmetic derived from published denominators, such as the 63.4 pooled WHI mean age, 80.5% pooled White share, 2.2-fold WHI Black-enrollment difference, 2.8-fold Hispanic-enrollment difference, and one-thirty-second duration comparison.
• Not reported: unavailable in a comparable form from the source used. Never interpreted as zero.

What we verified directly

• participant denominators, age ranges, means, race and ethnicity fields, symptom thresholds, study purpose, and menopause-stage rules for the eight trial rows;
• SWAN cohort size, screening denominator, selection analysis, and vasomotor-symptom duration estimates;
• FDA approval dates and current VEOZAH and LYNKUET demographics;
• the August 2026 LYNKUET prescribing-information values that conflict with the original Drug Trials Snapshot;
• current FDA compounded-drug language;
• the September 2026 status of FDA's Diversity Action Plan guidance;
• the live claims made by Find My HRT Path: about 90 seconds, no email, education and routing only, one best-fit route plus two backups, and a licensed clinician making treatment decisions.

What we did not do

• invent a pooled race table where source categories were incompatible;
• treat SWAN as a clinical trial;
• convert enrollment into proof that a treatment works identically in every subgroup;
• fabricate a clinician review, testimonial, first-person treatment experience, author credential, provider score, or compounded-drug approval claim;
• use a telehealth review as evidence about clinical-trial enrollment.

We applied The HRT Index Verification Standard without creating a score. Its five pillars remain clinical legitimacy, care quality, medication fit, price transparency, access. On this research page, that means using legitimate primary sources, preserving what the evidence can and cannot answer, separating FDA-approved products from compounded prescriptions, disclosing the absence of pricing or affiliate claims, and keeping the route to care honest.

Found an error or a source that resolves a missing field? Use the corrections process. Corrections are dated. Our medical review policy explains what “editorial research” and “not medically reviewed by a clinician” mean on this site.

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Frequently asked questions

What was the average age in the WHI hormone trials?

The weighted mean was about 63.4 years across both trials: 63.3 in WHI estrogen plus progestin and 63.6 in WHI estrogen alone. Participants were ages 50 to 79, so the mean should not be misread as “no women in their fifties.”

Were women in their fifties included in WHI?

Yes. WHI enrolled women from age 50 through 79. Women in their fifties were part of both hormone trials, even though the overall mean was in the early sixties.

Were Black women included in menopause clinical trials?

Yes, but the share changed sharply by study. Black women were 6.8% of WHI estrogen plus progestin, 15.1% of WHI estrogen alone, 32.1% of REPLENISH, 17.0% of pooled SKYLIGHT 1/2, and 17.1% of pooled OASIS 1/2.

Were Hispanic women included?

Yes, with large program-to-program differences. Hispanic or Latina/Latino participants were 23.8% of the pooled VEOZAH efficacy population and 8.5% of the pooled LYNKUET efficacy population. Older studies did not always record ethnicity using the same separate field, so direct comparisons need care.

Were Asian women included in the new nonhormonal drug trials?

Yes, but in very small numbers: 10 in pooled SKYLIGHT 1/2 and 4 in pooled OASIS 1/2. FDA could not determine reliable treatment differences for several smaller racial groups from those data.

Were women older than 65 included in the VEOZAH or LYNKUET efficacy trials?

No participant was older than 65 in the pooled pivotal efficacy populations. FDA's tables record a 40-to-65 range for both programs.

Were perimenopausal women included in major menopause trials?

Some, yes. The pivotal VEOZAH and LYNKUET programs were postmenopausal-only. WHI, HERS, KEEPS, ELITE, and REPLENISH also enrolled postmenopausal populations under their own rules. A MsFLASH trial included both perimenopausal and postmenopausal women, while SWAN began before menopause and followed the transition observationally.

Did WHI include women who had a hysterectomy?

Yes, in a separate estrogen-alone trial of 10,739 women. The 16,608 women with a uterus entered the estrogen-plus-progestin trial. Those two regimens, populations, and results should not be collapsed into one arm.

Does diverse enrollment prove a drug works the same in every group?

No. Enrollment and subgroup certainty are different. A group can appear in the demographic table while remaining too small for a reliable treatment-effect estimate.

Are newer menopause trials always more diverse than WHI?

No. The answer depends on the field. Black enrollment was higher in the VEOZAH and LYNKUET programs than in pooled WHI, but Asian enrollment remained tiny. REPLENISH, completed earlier than those programs, had the lowest White share and highest Black share among the FDA-approval treatment programs in this ledger.

Does “not reported” mean no one from that group participated?

No. It means the field was not published in a form this page could normalize. Unknown is not zero.

Can trial demographics tell me whether a treatment is safe for me?

No. Demographic overlap is context, not a personal safety or effectiveness conclusion. Your health history, anatomy, other medicines, treatment route, current label, and clinician's assessment matter.

Is SWAN a menopause clinical trial?

No. SWAN is an observational cohort. It enrolled 3,302 women at seven US sites and tracked the menopause transition; it did not assign a medication.

Why does study purpose matter so much?

Because a cardiovascular secondary-prevention trial, a chronic-disease prevention trial, a carotid-thickness timing trial, and a 12-week hot-flash efficacy trial answer different questions even when some participant demographics overlap.

How long did the new hot-flash programs study efficacy and safety?

The pivotal placebo-controlled efficacy comparisons used weeks 4 and 12. Both approval programs also included a separate 52-week placebo-controlled safety study. Those durations should not be confused with SWAN's 7.4-year median estimate for frequent vasomotor symptoms.

Where can I find demographics for a specific FDA-approved menopause drug?

Search FDA's Drug Trials Snapshots and open the current US prescribing information. The snapshot describes the original approval population; the current label may contain later corrections or updates, as the LYNKUET discrepancy on this page demonstrates.

Where are the equivalent demographics for compounded hormones?

There is no equivalent FDA product-level snapshot for an individually compounded prescription because compounded drugs are not FDA-approved. Do not substitute ingredient-level research or an FDA-approved product's trial for a compounded prescription's own nonexistent approval package.

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The bottom line

Menopause clinical trial demographics are not one story. They are at least four:

• Age is the sharpest modern cutoff in this dataset. The VEOZAH and LYNKUET pivotal programs enrolled no one older than 65. WHI averaged 63.4; HERS averaged 66.7.
• Race representation changed unevenly. Black enrollment reached about 17% in both new programs and 32.1% in REPLENISH. Asian enrollment was 1.0% and 0.5% in the two new efficacy populations.
• Eligibility rules can sort women before recruiters do. The WHI uterus split more than doubled Black representation in one arm; SWAN's intact-uterus and ovary rules reduced eligibility for groups with more surgical menopause.
• None of this tells you a treatment will or will not work for you. It tells you what was measured, what was not, and which questions you are entitled to ask.

You now know more about the evidence base than most people who will discuss it with you. Use it to ask better questions, not to talk yourself out of care you need.

Still not sure which HRT program is right for you? Take the free 90-second matching quiz.

→ Use The HRT Index's Find My HRT Path tool

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Primary sources

1. Grady D, et al. Heart and Estrogen/progestin Replacement Study (HERS): design, methods, and baseline characteristics. Controlled Clinical Trials. 1998;19(4):314–335.
2. FDA / DailyMed. Current PREMPRO/PREMPHASE prescribing information, including WHI estrogen-plus-progestin and estrogen-alone population summaries.
3. Manson JE, et al. The Women's Health Initiative Randomized Trials and Clinical Practice: A Review. JAMA. 2024;331(20):1748–1760. doi:10.1001/jama.2024.6542.
4. Miller VM, et al. Using Basic Science to Design a Clinical Trial: Baseline Characteristics of Women Enrolled in KEEPS. Journal of Cardiovascular Translational Research. 2009;2(3):228–239.
5. Harman SM, et al. Arterial Imaging Outcomes and Cardiovascular Risk Factors in Recently Menopausal Women. Annals of Internal Medicine. 2014;161(4):249–260.
6. Hodis HN, et al. Methods and baseline cardiovascular data from ELITE. Menopause. 2015;22(4):391–401.
7. Hodis HN, et al. Vascular Effects of Early versus Late Postmenopausal Treatment with Estradiol. New England Journal of Medicine. 2016;374:1221–1231.
8. Lobo RA, et al. A 17β-Estradiol–Progesterone Oral Capsule for Vasomotor Symptoms in Postmenopausal Women. Obstetrics & Gynecology. 2018;132(1):161–170.
9. Liu JH, et al. Breast Effects of Oral, Combined 17β-Estradiol and Progesterone Capsules in Menopausal Women. Menopause. 2020;27(12):1388–1395.
10. FDA. Drug Trials Snapshot: VEOZAH. Original approval May 12, 2023.
11. FDA. Drug Trials Snapshot: LYNKUET. Original approval October 24, 2025.
12. FDA / DailyMed. Current LYNKUET prescribing information. Revised August 2026.
13. Avis NE, et al. Duration of Menopausal Vasomotor Symptoms Over the Menopause Transition. JAMA Internal Medicine. 2015;175(4):531–539.
14. Reeves A, et al. Systematic exclusion at study commencement masks earlier menopause for Black women in SWAN. International Journal of Epidemiology. 2023;52(5):1612–1623. doi:10.1093/ije/dyad085.
15. Joffe H, et al. Low-dose estradiol and venlafaxine for vasomotor symptoms. JAMA Internal Medicine. 2014;174(7):1058–1066.
16. FDA. Compounding and FDA: Questions and Answers.
17. FDA. Drug Trials Snapshots.
18. FDA. Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies. Draft guidance, June 2024; status checked September 4, 2026.
19. ACOG. Updated guidance on evaluation of postmenopausal bleeding. April 16, 2026.
20. US Food and Drug Administration. Investigational New Drug Applications and New Drug Applications: Demographic Subgroup Data. Final rule, 63 FR 6854, February 11, 1998.
21. ClinicalTrials.gov. Recruiting studies indexed under menopause. Live status; check individual records.