Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
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
Query!
Scientific title
Virtual perI-/Menopause Registry of AusTrALia
Query!
Secondary ID [1]
0
0
VITAL-Oz
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
VITAL
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Menopause
0
0
Query!
Perimenopausal Disorder
0
0
Query!
Postmenopausal Symptoms
0
0
Query!
Health Knowledge, Attitudes, Practice
0
0
Query!
Healthy Aging
0
0
Query!
Health Care Utilization
0
0
Query!
Health Care Seeking Behavior
0
0
Query!
Mental Health Impairment
0
0
Query!
Mental Deterioration
0
0
Query!
Mental Health Issue
0
0
Query!
Osteoporosis, Postmenopausal
0
0
Query!
Diabetes Mellitus Risk
0
0
Query!
Diabetes Mellitus, Type 2
0
0
Query!
Dementia
0
0
Query!
Cardiovascular Diseases
0
0
Query!
Menopause Related Conditions
0
0
Query!
Hot Flashes
0
0
Query!
Hot Flushes Aggravated
0
0
Query!
Economic Burden
0
0
Query!
Social Stigma
0
0
Query!
Condition category
Condition code
Musculoskeletal
0
0
0
0
Query!
Osteoporosis
Query!
Reproductive Health and Childbirth
0
0
0
0
Query!
Menstruation and menopause
Query!
Metabolic and Endocrine
0
0
0
0
Query!
Diabetes
Query!
Mental Health
0
0
0
0
Query!
Other mental health disorders
Query!
Intervention/exposure
Study type
Observational [Patient Registry]
Query!
Patient registry
Query!
Target follow-up duration
Query!
Target follow-up type
Query!
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.
Query!
Intervention code [1]
0
0
Other interventions
Query!
Comparator / control treatment
Query!
Control group
Query!
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.
Query!
Assessment method [1]
0
0
Determination of the Australian peri-/menopause experience.
Query!
Timepoint [1]
0
0
Through input completion per participant, an average of 4 years
Query!
Secondary outcome [1]
0
0
Registry feasibility as measured by numbers of registry entries.
Query!
Assessment method [1]
0
0
Registry feasibility shown by increasing Australian participation
Query!
Timepoint [1]
0
0
Through study completion, ongoing at least quarterly for a minimum of 10 years post-registry commencement.
Query!
Eligibility
Key inclusion criteria
* Any Australian over 18 years of age.
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
Yes
Query!
Key exclusion criteria
* None.
Query!
Study design
Purpose
Query!
Duration
Query!
Selection
Query!
Timing
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Recruiting
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
3/08/2023
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
1/08/2073
Query!
Actual
Query!
Sample size
Target
10000
Query!
Accrual to date
Query!
Final
Query!
Recruitment in Australia
Recruitment state(s)
Query!
Recruitment hospital [1]
0
0
Bespoke Clinical Research. Community-driven from every Australian across the country. Registry led from Adelaide - Adelaide
Query!
Recruitment postcode(s) [1]
0
0
- Adelaide
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Query!
Name
Bespoke Clinical Research
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
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.
Query!
Trial website
https://clinicaltrials.gov/study/NCT06487130
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Erin B Morton, PhD,Medicine
Query!
Address
0
0
Bespoke Clinical Research
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Erin B Morton, PhD,Medicine
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
+61403157844
Query!
Fax
0
0
Query!
Email
0
0
[email protected]
Query!
Contact person for scientific queries
Data sharing statement
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT06487130
Download to PDF