EDC for menopause clinical trials
A menopause trial lives or dies on a daily symptom diary: hot flash frequency and severity, tracked for weeks, with a 52-week safety tail for endometrium and liver. Build the diary, the quality-of-life questionnaires and the safety monitoring in Capture, and test it free.
- Daily vasomotor diary
- Frequency and severity at set weeks
- Endometrial and liver safety
Free sandbox · No credit card · 21 CFR Part 11 compliant
| Assessment | Screen | Baseline | Wk 4 | Wk 12 | Wk 26 | Wk 52 |
|---|---|---|---|---|---|---|
| Daily hot flash e-diary | D | D | D | D | D | D |
| Menopause quality-of-life questionnaire | ||||||
| FSH, estradiol and menstrual history | ||||||
| Liver tests | ||||||
| Endometrial assessment | ||||||
| Bleeding and adverse events |
D = daily diary; x = completed at the visit
What a menopause trial needs from its EDC
- A daily diary as the primary data source: registered phase 3 trials in vasomotor symptoms use electronic diaries to produce frequency and severity of moderate to severe hot flashes.
- Co-primary endpoints at fixed weeks: published topline results for recent non-hormonal agents report frequency and severity co-primaries at weeks 4 and 12. A baseline week of qualifying hot flashes defines eligibility.
- Longer safety follow-up: trials often extend to 52 weeks with endometrial safety assessment and liver monitoring, depending on the product.
- Different instruments for different questions: symptom rating scales, menopause-specific quality of life, sleep and sexual function questionnaires, vaginal assessments for genitourinary studies.
- Menopausal status as a data field: staging, surgical menopause, last menstrual period and hormone levels all affect eligibility and need clean entry.
The endpoint model
Frequency, severity and the "clinically meaningful" question
Vasomotor symptom trials share a recognisable skeleton. Participants record moderate to severe hot flashes daily in an electronic diary for a baseline period, are randomised if they meet a minimum frequency, and continue to log through the treatment period. The change from baseline in frequency and in severity is analysed at fixed weeks. Topline results for fezolinetant's two pivotal trials were reported against four co-primary endpoints, frequency and severity at weeks 4 and 12, and esmirtazapine and estetrol studies likewise report 12-week frequency and severity from daily diaries. A published FDA statistical review of the fezolinetant application is also reported to have looked for a clinically meaningful reduction in frequency in addition to statistical significance. Treat that as context for how reviewers think, not a guarantee; check current regulatory guidance for your product.
The design implications for the EDC are specific. Severity is usually a mild, moderate, severe rating with a definition of each level supplied by the protocol, so the diary needs the exact anchors. Frequency is a count per day, and the analysis converts to a weekly or daily average over the window, so a gap of several days in the diary changes the estimate. Decide with your statistician how many missing days invalidate a week, and build the diary so that a "no hot flashes today" answer is as quick as any other. Capture supports daily scheduled questionnaires on the participant's phone, with reminders and completion tracking; see ePRO compliance and diary completion rates and patient diary software for clinical trials.
Beyond the diary, the Menopause Rating Scale and menopause-specific quality of life questionnaires such as MENQOL capture broader symptoms and are typical secondary or exploratory endpoints in many designs. Sleep, mood and sexual function measures are often added. Each has its own rights-holder terms, and the licence status of any of them should be checked before use; Capture does not supply instrument wording or verify licences, and licence controls exist only on participant questionnaires. For validated-instrument layouts in the library see the templates hub.
Daily hot flash diary (demo)
Participant 006-0014 · Day 17
Number of mild hot flashes today
HFMILDNumber of moderate hot flashes today
HFMODNumber of severe hot flashes today
HFSEVModerate to severe total
HFMSDerived from entries, read-only
5 CalculatedNight sweats woke me
NSWEATProtocol to build
Menopause protocol elements and where they live in Capture
| Protocol element | What the data looks like | Where it lives in Capture |
|---|---|---|
| Menopausal status | Last menstrual period, amenorrhoea duration, surgical menopause, FSH and estradiol | Screening form with date and lab fields; locked once approved |
| Vasomotor diary | Daily counts by severity, night sweats | Participant phone questionnaire with reminders; completion view for site staff |
| Symptom and quality-of-life scales | Item scores, subscale and total | Participant questionnaires at scheduled visits; totals as read-only calculated fields |
| Genitourinary measures | Most bothersome symptom, vaginal pH, cell maturation | Site form for clinic measures, participant form for symptoms |
| Endometrial safety | Ultrasound or biopsy result, pathology category, bleeding events | Site form; adverse event form for bleeding |
| Liver monitoring | ALT, AST, bilirubin at set visits, with reference ranges | Lab data and reference ranges; lab results form |
| Bone and cardiovascular measures | DXA, lipids, blood pressure, mammography result | Site forms; vital signs |
| Concomitant medicines | Hormone therapy, SSRIs, herbal products, supplements | Concomitant medications form, repeating rows |
Instrument wording is yours to supply. Licences stay with your study documents.
Test your diary and its completion rules before launch
Build the daily vasomotor diary, set reminders, and enter a month of sample days including gaps. Free sandbox, no credit card.
Operations
Recruiting, safety follow-up and how this differs from fertility studies
Recruitment for menopause studies often comes from community and online outreach, since many participants are otherwise healthy and not in a hospital clinic. Capture offers QR-code enrolment, site-specific or study-specific, with no app install, which suits a flyer or clinic poster. Pre-screening still has to apply the protocol's criteria, and any health information you collect before consent must be covered by your ethics approval. See eConsent software for clinical trials for the consent step, and remote patient consent if participants will consent from home.
Safety follow-up is where menopause trials diverge by product class. Trials of oestrogen-containing treatments are expected to examine the endometrium over about a year, with bleeding patterns and, in many designs, biopsy or ultrasound results. Some recent non-hormonal agents have attracted liver-enzyme monitoring requirements, so your protocol may schedule frequent liver tests and stopping rules; confirm against the current product information. Edit checks can flag an ALT above a protocol threshold and raise an automatic query, and the lab form can hold reference ranges by sex and age. Make the stopping rule a human-reviewed procedure, not an automated action.
This page is about menopause and its symptoms, bone and genitourinary effects. It is deliberately different from reproductive-age fertility work. For IVF and ovulation-related studies see EDC for IVF and fertility clinical trials and EDC for endometriosis, PCOS and fertility trials; for cycle-based diaries in younger women, menstrual cycle tracking study software. For sleep outcomes alongside vasomotor symptoms, PSQI sleep quality template and EDC for sleep disorder trials are relevant starting points.
Before first participant
Menopause study readiness checklist
Diary definitions fixed
Severity anchors, qualifying hot flash definition and missing-day rule written with the statistician.
Instruments and licences filed
Rating and quality-of-life scales with rights-holder terms in study documents.
Menopausal status criteria tested
Screening logic for last menstrual period, FSH and surgical history.
Safety schedule built
Liver tests, endometrial assessment and bleeding events with edit checks.
Reminder plan set
Daily diary reminders and a site call rule for missed days.
Concomitant therapy list ready
Prohibited hormones, SSRIs and supplements flagged at entry.
Can participants record hot flashes daily on their phone?
Yes. The diary is a participant questionnaire opened from a secure link in the phone browser, with reminders and completion tracking. No app install is needed.
Can Capture calculate the weekly average of hot flashes?
It can show derived totals as read-only calculated fields, and exports give your statistician each daily record. The averaging and missing-day rules belong in your analysis plan.
Can I use the Menopause Rating Scale or MENQOL?
Capture does not supply instrument wording or verify licences. You provide your licensed or permitted version, and the licence stays with your study documents.
How do we monitor liver enzymes?
Enter liver tests on a lab form with reference ranges, and use an edit check to raise a query when a value exceeds a protocol threshold. The decision to pause treatment stays with the investigator.
Is this the same as your fertility pages?
No. Fertility pages cover reproductive-age studies such as IVF and PCOS. This page covers vasomotor, genitourinary and bone-related menopause trials.
Can it support a 52-week safety extension?
Yes. Epochs let a 12-week efficacy period and a longer safety period sit in one study with the same participant record.
What does it cost?
The sandbox is free with every feature, no credit card. Plans for live studies are on the pricing page.
Keep exploring
Related pages
EDC for IVF and fertility trials
Reproductive-age studies.
EDC for endometriosis, PCOS and fertility
Gynaecological indications.
Menstrual cycle tracking software
Cycle-based diaries.
Patient diary software
Daily diary design.
ePRO compliance and diary completion
Keeping diaries complete.
Pricing
Plans and go-live rates.
Start building your menopause study free
Free sandbox with every feature. No credit card.