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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06487130




Registration number
NCT06487130
Ethics application status
Date submitted
14/08/2023
Date registered
5/07/2024
Date last updated
5/07/2024

Titles & IDs
Public title
Virtual perI-/Menopause Registry of AusTrALia
Scientific title
Virtual perI-/Menopause Registry of AusTrALia
Secondary ID [1] 0 0
VITAL-Oz
Universal Trial Number (UTN)
Trial acronym
VITAL
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Menopause 0 0
Perimenopausal Disorder 0 0
Postmenopausal Symptoms 0 0
Health Knowledge, Attitudes, Practice 0 0
Healthy Aging 0 0
Health Care Utilization 0 0
Health Care Seeking Behavior 0 0
Mental Health Impairment 0 0
Mental Deterioration 0 0
Mental Health Issue 0 0
Osteoporosis, Postmenopausal 0 0
Diabetes Mellitus Risk 0 0
Diabetes Mellitus, Type 2 0 0
Dementia 0 0
Cardiovascular Diseases 0 0
Menopause Related Conditions 0 0
Hot Flashes 0 0
Hot Flushes Aggravated 0 0
Economic Burden 0 0
Social Stigma 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Osteoporosis
Reproductive Health and Childbirth 0 0 0 0
Menstruation and menopause
Metabolic and Endocrine 0 0 0 0
Diabetes
Mental Health 0 0 0 0
Other mental health disorders

Intervention/exposure
Study type
Observational [Patient Registry]
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Other interventions - N/A Observational Registry

Menopause/Post-menopause - Menopause/Post-menopause, born with ovaries

Peri-menopause - Peri-menopause, born with ovaries

Pre-menopause - Pre-menopause, born with ovaries

Other - Not born with ovaries


Other interventions: N/A Observational Registry
Registry participants may select to be contacted for future research and/or embedded clinical trials. Such interventions will require associated ethics review \& approval.
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Australian peri-/menopause experience as measured by qualitative self-report generated via participation & feedback of a critical mass of at least 10,000 registry participants, broadly representative of the Australian population.
Timepoint [1] 0 0
Through input completion per participant, an average of 4 years
Secondary outcome [1] 0 0
Registry feasibility as measured by numbers of registry entries.
Timepoint [1] 0 0
Through study completion, ongoing at least quarterly for a minimum of 10 years post-registry commencement.

Eligibility
Key inclusion criteria
* Any Australian over 18 years of age.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* None.

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
3/08/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/08/2073
Actual
Sample size
Target
10000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Bespoke Clinical Research. Community-driven from every Australian across the country. Registry led from Adelaide - Adelaide
Recruitment postcode(s) [1] 0 0
- Adelaide

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Bespoke Clinical Research
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
13 million (50.7%) Australians are born with ovaries, 14% (\~3 million) are currently aged 40-59 yrs, \& all such who live to midlife will experience menopause, defined as \>12 months without a period. Peri-menopause (peri), typically occurs 5 yrs before menopause as hormone levels decrease. As with oestrogen, peri symptoms can affect every bodily system; e.g. depression/anxiety, diminished mental function, irregular periods, hot flushes, sleep problems, vaginal atrophy \& urinary urgency. These symptoms are linked with lower quality of life \& significantly higher work impairment; a third experiencing symptoms so severe as to impede daily life \& increase risk of suicide. Lifetime increased risks of diabetes, heart disease, osteoporosis \& dementia are also associated with menopause, yet it remains disconcertingly poorly studied.

The investigators propose to create a world-first, cutting-edge, consumer-driven, Virtual peri-/menopause registry of AusTrALia (VITAL). The unique design will enable consumers to determine VITAL's questions, encourage secure revelation of private data e.g. vaginal \& mental health symptoms, \& to direct priorities for research, education, \& health service improvements. VITAL will thus deliver optimal assessments of incidence, prevalence \& impact.

The participating consumers, researchers, clinical specialists, policy makers, \& modern virtual data infrastructure enable this unique \& innovative registry design, future translation to improved community health, \& promote awareness \& collaborative synergies. Leveraging the investigators' critical range of expertise \& ongoing feedback opportunities for both participants \& stakeholder partnerships, the investigators will create a ground-breaking platform that:

* empowers the consumer voice and priorities,
* enables peri-/menopause research to extend beyond existing niche focuses,
* evidences the true impact of peri-/menopause across the nation,
* evolves healthcare services and outcomes, \&
* educates community, clinicians, \& policy-makers. After Australian registry establishment, the investigators will expand VITAL to mirror it in other nations while still protecting individual's data the right way, but so all can learn \& apply the best aspects of care from across the world.
Trial website
https://clinicaltrials.gov/study/NCT06487130
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Erin B Morton, PhD,Medicine
Address 0 0
Bespoke Clinical Research
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Erin B Morton, PhD,Medicine
Address 0 0
Country 0 0
Phone 0 0
+61403157844
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT06487130