NCT06487130 Virtual perI-/Menopause Registry of AusTrALia
| NCT ID | NCT06487130 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Bespoke Clinical Research |
| Condition | Menopause |
| Study Type | OBSERVATIONAL |
| Enrollment | 10,000 participants |
| Start Date | 2023-08-03 |
| Primary Completion | 2073-08 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 10,000 participants in total. It began in 2023-08-03 with a primary completion date of 2073-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: * Any Australian over 18 years of age. Exclusion Criteria: * None.
Contact & Investigator
Erin B Morton, PhD,Medicine
STUDY DIRECTOR
Bespoke Clinical Research
Frequently Asked Questions
Who can join the NCT06487130 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Menopause. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06487130 currently recruiting?
Yes, NCT06487130 is actively recruiting participants. Contact the research team at vital@bespokeclinicalresearch.com.au for enrollment information.
Where is the NCT06487130 trial being conducted?
This trial is being conducted at Adelaide, Australia.
Who is sponsoring the NCT06487130 clinical trial?
NCT06487130 is sponsored by Bespoke Clinical Research. The principal investigator is Erin B Morton, PhD,Medicine at Bespoke Clinical Research. The trial plans to enroll 10,000 participants.