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Investigation of the Distinct Mechanisms Involved in Inflammatory Resolution Between Healthy Men and Women

Study acronym: RESOLVE-SEX
StatusActive, Not Recruiting
PhaseEarly Phase 1
Started
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Record History

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  1. Trial status changed: Recruiting → Active, Not Recruiting
    • Site details revised
    v7
  2. Primary and study completion dates: Oct 16, 2025 to Dec 12, 2027v6
  3. Trial status: Active, Not Recruiting to Recruiting
    • Site details revised
    v5
  4. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised
    v4
  5. Primary endpoints revised (3)
    • Start date changed from estimate of Dec 1, 2022 to Dec 12, 2022
    • Secondary endpoints: details revised at 4 of 4 entries
    • Study description expanded, about 3 words
    v3
  6. Start date: Oct 17, 2022 to Dec 1, 2022
    • Study description shortened, about 222 words
    v2
  7. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Important differences exist between sexes in incidence, disease patterns and outcomes in coronary artery disease that is not well understood. It is likely that key differences in the underlying biological mechanism, in particular in inflammatory responses, play a part in underpinning these differences. Previous evidence demonstrates that healthy females appear to be more adept at resolving inflammation compared to healthy males. Since inflammation is thought to be a key initiating phenomenon in coronary artery disease the investigators will examine the differences in inflammatory resolution between the sexes in healthy volunteers.
Trial Details
NCT Number NCT05597098
Lead Sponsor Queen Mary University of London
Conditions
(from sponsor)		 Inflammation
Related terms Inflammation
Enrollment 34 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov