MenopauseVITALNCT06487130
Virtual perI-/Menopause Registry of AusTrALia
An observational study of Menopause and Perimenopausal Disorder, run by Bespoke Clinical Research at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Menopause, Perimenopausal Disorder, Postmenopausal Symptoms
- What is being tested?
- N/A Observational Registry
- How many people
- 10,000 participants
- Where
- 1 siteAustralia
- Study dates
- 3 Aug 2023to Aug 2073
- How long will I take part?
- 50 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Although most questions are targeted towards those in peri-/menopause, other members from the community, clinical, research, employment or other areas can also provide valuable input through participative responses to a smaller number of questions. Note "Australian" includes Australian residents utilising the Australian healthcare system.
Who may be able to join
- Any Australian over 18 years of age.
Who cannot join
- None.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Australia1 site, 1 recruiting
- Recruiting
Bespoke Clinical Research. Community-driven from every Australian across the country. Registry led from Adelaide
Adelaide
Erin Morton, PhD, 0403157844, vital@bespokeclinicalresearch.com.au
Erin B Morton, PhD
About this study
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.
Read more
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.
Read the detailed description
In the Virtual Peri-Menopause Registry of Australia -VITAL- the investigators will:
- Co-create an innovative, multidisciplinary, ongoing digital epidemiological platform \& repository of Australian peri-/menopausal health, centred on relevance to the community;
- Establish incidence, prevalence \& impact of Australian peri-/menopause symptomology, associated disease risk factors, \& healthcare system pathways, via secure participant input, encouraging safe revelation of personal data, e.g. symptoms, impairment, substandard care;
- Determine \& define community consensus priorities in related healthcare \& associated policy.
- Disseminate not only results, but ensure accessibility of the data from the national registry to authorised, relevant \& ethical investigations to streamline research \& in turn, translate to community healthcare outcomes, e.g. community education, clinical advice, policies, data linkage with significant datasets and/or registries e.g. cardiac, cancer, ageing, Medicare etc.
- Conditions
- Menopause, Perimenopausal Disorder, Postmenopausal Symptoms, Health Knowledge, Attitudes, Practice, Healthy Aging, Health Care Utilization
- Being tested
- N/A Observational Registry
- Medical subject headings
- Behavior, Patient Acceptance of Health Care, Cognitive Dysfunction, Osteoporosis, Postmenopausal, Diabetes Mellitus, Type 2, Dementia, Cardiovascular Diseases, Hot Flashes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
N/A Observational RegistryOther
Registry participants may select to be contacted for future research and/or embedded clinical trials. Such interventions will require associated ethics review \& approval.
| Study group | Role | What they receive |
|---|---|---|
| Menopause/Post-menopause | Menopause/Post-menopause, born with ovaries Receives: Other: N/A Observational Registry | |
| Peri-menopause | Peri-menopause, born with ovaries Receives: Other: N/A Observational Registry | |
| Pre-menopause | Pre-menopause, born with ovaries Receives: Other: N/A Observational Registry | |
| Other | Not born with ovaries Receives: Other: N/A Observational Registry |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Determination of the Australian peri-/menopause experience.
Measured: Through input completion per participant, an average of 4 years
Secondary outcomes (1)
Registry feasibility as measured by numbers of registry entries.
Registry feasibility shown by increasing Australian participation
Measured: Through study completion, ongoing at least quarterly for a minimum of 10 years post-registry commencement.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2024
- Study start3 Aug 2023
- Primary completionAug 2073 (estimated)
- Study completionAug 2073 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MenopauseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 10,000 participants (estimated)
- Target duration
- 50 Years
Sponsor and investigators
- Lead sponsor
- Bespoke Clinical Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Erin Morton, Bespoke Clinical Research
- Investigators
- Erin B Morton, PhD,Medicine, Study director, Bespoke Clinical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06487130
- Sponsor's protocol ID
- VITAL-Oz
- Acronym
- VITAL
- Status last verified
- Jul 2024
- First submitted
- 14 Aug 2023
- Last updated
- 5 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual Participant Data collected during the trial may be shared but only if that individual participant specifically consented to it, \& only after approval decisions from both Ethics Committee \& VITAL Steering Committee review. Otherwise any sharing and/or publication of this data will be deidentified and/or aggregated as appropriate.
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual perI-/Menopause Registry of AusTrALia
- ClinicalTrials.gov ID
- NCT06487130
- Acronym / sponsor ID
- VITAL / VITAL-Oz
- Conditions
- Menopause, Perimenopausal Disorder, Postmenopausal Symptoms, Health Knowledge, Attitudes, Practice, Healthy Aging, Health Care Utilization
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- Bespoke Clinical ResearchIndustry (pharma, biotech, devices)
- Study start
- 3 Aug 2023 (actual)
- Primary completion
- Aug 2073 (estimated)
- Study completion
- Aug 2073 (estimated)
- First posted
- 5 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
In the Virtual Peri-Menopause Registry of Australia -VITAL- the investigators will:
- Co-create an innovative, multidisciplinary, ongoing digital epidemiological platform \& repository of Australian peri-/menopausal health, centred on relevance to the community;
- Establish incidence, prevalence \& impact of Australian peri-/menopause symptomology, associated disease risk factors, \& healthcare system pathways, via secure participant input, encouraging safe revelation of personal data, e.g. symptoms, impairment, substandard care;
- Determine \& define community consensus priorities in related healthcare \& associated policy.
- Disseminate not only results, but ensure accessibility of the data from the national registry to authorised, relevant \& ethical investigations to streamline research \& in turn, translate to community healthcare outcomes, e.g. community education, clinical advice, policies, data linkage with significant datasets and/or registries e.g. cardiac, cancer, ageing, Medicare etc.
Study design
- Observational model
- Other
- Time perspective
- Other
- Target follow-up
- 50 Years
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Menopause/Post-menopause | – | Other: N/A Observational RegistryMenopause/Post-menopause, born with ovaries |
| Peri-menopause | – | Other: N/A Observational RegistryPeri-menopause, born with ovaries |
| Pre-menopause | – | Other: N/A Observational RegistryPre-menopause, born with ovaries |
| Other | – | Other: N/A Observational RegistryNot born with ovaries |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Although most questions are targeted towards those in peri-/menopause, other members from the community, clinical, research, employment or other areas can also provide valuable input through participative responses to a smaller number of questions. Note "Australian" includes Australian residents utilising the Australian healthcare system.
Key inclusion criteria (1 listed)
- Any Australian over 18 years of age.
Key exclusion criteria (1 listed)
- None.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| N/A Observational RegistryRegistry participants may select to be contacted for future research and/or embedded clinical trials. Such interventions will require associated ethics review \& approval. | Other | Menopause/Post-menopause, Other, Peri-menopause, Pre-menopause |
Primary outcome
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.
Time frame: Through input completion per participant, an average of 4 years
Determination of the Australian peri-/menopause experience.
1 secondary outcome
Registry feasibility as measured by numbers of registry entries.
Time frame: Through study completion, ongoing at least quarterly for a minimum of 10 years post-registry commencement.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2024.
- VITAL Research: co-creating healthcare improvement.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Individual Participant Data collected during the trial may be shared but only if that individual participant specifically consented to it, \& only after approval decisions from both Ethics Committee \& VITAL Steering Committee review. Otherwise any sharing and/or publication of this data will be deidentified and/or aggregated as appropriate.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Erin B Morton, PhD,Medicine study director
Bespoke Clinical Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Menopause and Perimenopausal Disorder, run by Bespoke Clinical Research at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Erin B Morton, PhD,Medicine (+61403157844, vital@bespokeclinicalresearch.com.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: Through input completion per participant, an average of 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2024.