MenopausePALLADIANCT04995276
PostmenopausAL heaLth And DIseAse (PALLADIA) Study
An observational study of Menopause, run by National and Kapodistrian University of Athens at 1 site in Greece.
Trial summary
This is a prospective study of the incidence and risk factors of chronic diseases that are associated with menopause. Read more about this study
- Who is it for?
- Ages 15 to 85 years, women only
- Conditions the study is for
- Menopause
- How many people
- 4,000 participants
- Where
- 1 siteGreece
- Study dates
- 1 Oct 2021to 31 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 15 to 85 years
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: The study will include 4.000 postmenopausal women
Who may be able to join
- Postmenopausal women
Who cannot join
- Men Women of reproductive age
Trial locations and contacts
1 site in 1 country.
Greece1 site, 1 recruiting
- Recruiting
Menopause Clinic, Aretaieio Hospital
Athens, Attica, 11528
Irene Lambrinoudaki, Prof, 6977005321 ext. +30, ilambrinoudaki@med.uoa.gr
About this study
Official title: PostmenopausAL heaLth And DIseAse (PALLADIA) Study: Prospective Study of the Incidence and Risk Factors of Chronic Diseases Associated With Menopause
This is a prospective study of the incidence and risk factors of chronic diseases that are associated with menopause.
- Conditions
- Menopause
- Keywords
- menopause
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiovascular death
Measured: up to 2025
Coronary heart disease
Measured: up to 2025
Stroke
Measured: up to 2025
Secondary outcomes (4)
Diabetes mellitus
Measured: up to 2025
Osteoporotic fractures
Measured: up to 2025
Breast cancer
Measured: up to 2025
Any cancer
Measured: up to 2025
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2021
- Study start1 Oct 2021
- Primary completion1 Oct 2025 (estimated)
- Study completion31 Dec 2025 (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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 4,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National and Kapodistrian University of Athens
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Irene Lambrinoudaki, National and Kapodistrian University of Athens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04995276
- Sponsor's protocol ID
- 8259
- Acronym
- PALLADIA
- Status last verified
- Apr 2022
- First submitted
- 23 Jul 2021
- Last updated
- 6 Apr 2022
- Results posted
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PostmenopausAL heaLth And DIseAse (PALLADIA) Study: Prospective Study of the Incidence and Risk Factors of Chronic Diseases Associated With Menopause
- ClinicalTrials.gov ID
- NCT04995276
- Acronym / sponsor ID
- PALLADIA / 8259
- Conditions
- Menopause
- Keywords
- menopause
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 4,000 participants (estimated)
- Lead sponsor
- National and Kapodistrian University of AthensUniversity, hospital or other
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 1 Oct 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 6 Aug 2021 (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.
This is a prospective study of the incidence and risk factors of chronic diseases that are associated with menopause.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 15 to 85 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study will include 4.000 postmenopausal women
Key inclusion criteria (1 listed)
- Postmenopausal women
Key exclusion criteria (1 listed)
- Men Women of reproductive age
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Cardiovascular death
Time frame: up to 2025
Coronary heart disease
Time frame: up to 2025
Stroke
Time frame: up to 2025
4 secondary outcomes
Diabetes mellitus
Time frame: up to 2025
Osteoporotic fractures
Time frame: up to 2025
Breast cancer
Time frame: up to 2025
Any cancer
Time frame: up to 2025
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2022.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
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, run by National and Kapodistrian University of Athens at 1 site in Greece.
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: status not confirmed, as of the sponsor's last update on 6 Apr 2022. 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 Greece. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Irene Lambrinoudaki, Prof. (6977005321 ext. +30, ilambrinoudaki@med.uoa.gr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiovascular death (time frame: up to 2025). The study lists 3 primary outcomes in all. 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 6 Apr 2022.