An observational study in Menopause, Perimenopausal Disorder and Postmenopausal Symptoms, sponsored by Bespoke Clinical Research. Recruiting at 1 site in Australia. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-07-05.
Sponsored by Bespoke Clinical Research · Observational
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:
In the Virtual Peri-Menopause Registry of Australia -VITAL- the investigators will:
1,573 studies on the registry are indexed under Behavior; 313 are open to participants now.
This study's planned enrollment of 10,000 is above the median of 235 across 341 observational studies indexed under Behavior.
Browse Behavior studies →This is the only study on the registry with Bespoke Clinical Research as lead sponsor.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Menopause/Post-menopause, born with ovaries
Other: N/A Observational Registry
Peri-menopause, born with ovaries
Other: N/A Observational Registry
Pre-menopause, born with ovaries
Other: N/A Observational Registry
Not born with ovaries
Other: 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.
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.
Time frame: Through input completion per participant, an average of 4 years
Registry feasibility as measured by numbers of registry entries.
Registry feasibility shown by increasing Australian participation
Time frame: Through study completion, ongoing at least quarterly for a minimum of 10 years post-registry commencement.
Plan to share: 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.
Time frame: Start dates: As appropriate to minimum data level reached for the question of interest. End dates: At end of registry unless particular parameters are removed via amendment during annual conduct, whereupon 15 years after final collection.
Access criteria: Detailed requests must be submitted with ethics approval to the VITAL Steering Committee for review consideration. Sharing will be on hold by default until otherwise specified in VITAL information including public-facing webpage. Only IPD with individual-level consent will be shared. Otherwise any sharing and/or publication of VITAL data will be deidentified and/or aggregated as appropriate. Upon reaching internally-defined minimum data levels, more information on the IPD sharing request processes will be made available on the VITAL website.
Data sharing details ↗ · bespokeclinicalresearch.com.au
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