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Endometriosis and Microvascular Dysfunction; Simvastatin and Duavee

Study acronym: Endo2/SA3
StatusEnrolling by Invitation
PhasePhase 4
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 12 months later Dec 31, 2025 → Dec 31, 2026
See other at-risk trials from Penn State University

Record History

  1. Primary completion pushed from Dec 31, 2025 to Dec 31, 2026 Trial status changed: Recruiting → Enrolling by Invitation · Site details revisedv14 Show 2 more changesShow less
    • Trial status changed: Recruiting → Enrolling by Invitation
    • Site details revised
  2. 4 versions Re-verified since Nov 7, 2023, no change to tracked fieldsv10-v13
  3. Interventions: Bazedoxifene 20/Estrogens,Con 0.45Mg Tb (Drug), Placebo (Drug), simvastatin 10mg (Drug) to Bazedoxifene 20/Estrogens,Con 0.45Mg Tb (Drug), simvastatin 10mg (Drug) Study arms: 3 to 2 · Eligibility criteria expanded, about 4 words · Study description expanded, about 1 wordv9 Show 3 more changesShow less
    • Study arms: 3 to 2
    • Eligibility criteria expanded, about 4 words
    • Study description expanded, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  4. Start date: Sep 30, 2023 to Dec 1, 2023v8
  5. Primary completion date: Jun 1, 2025 to Dec 31, 2025v7
Show 5 earlier versionsHide 5 earlier versions
  1. Start date: Apr 30, 2023 to Sep 30, 2023 Primary completion date: Dec 2025 to Jun 1, 2025 · Completion date: Dec 2026 to Dec 31, 2026v6 Show 2 more changesShow less
    • Primary completion date: Dec 2025 to Jun 1, 2025
    • Completion date: Dec 2026 to Dec 31, 2026
  2. Start date: Jan 31, 2023 to Apr 30, 2023v5
  3. Start date: Jan 1, 2022 to Jan 31, 2023v4
  4. Enrollment target: 55 to 28v3
  5. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Jan 2022 to Jan 1, 2022 · Site details revisedv2 Show 2 more changesShow less
    • Start date changed from estimate of Jan 2022 to Jan 1, 2022
    • Site details revised
  1. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Purpose: To determine the effects of SERM and simvastatin interventions on endothelial dysfunction in women with endometriosis. Hypothesis: Treatment with the SERM (bazedoxifene + conjugated estrogen) or with simvastatin will decrease systemic inflammation and improve specific measures of cardiovascular function including endothelium-dependent vasodilation.
Trial Details
NCT Number NCT05059626
Lead Sponsor Penn State University
Collaborators: The John B. Pierce Laboratory
Conditions Endometriosis
Enrollment 28 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov