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RIVET - Retrospective Cohort Study on the Risk of Venous Thromboembolism

NCT02828904 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 124000

Last updated 2024-03-05

No results posted yet for this study

Summary

The risk of venous thromboembolism (VTE) associated with the use of chlormadinone acetate (CMA) compared to the gold-standard progestin levonorgestrel (LNG) as component of combined oral contraceptives (COC) is currently unknown. The Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) recommended a pooled analysis of four prospective cohort studies carried out by the Berlin Center for Epidemiology and Health Research (ZEG Berlin) in order to clarify whether CMA-containing COCs carry a different VTE risk compared to LNG-containing COCs.

Conditions

  • Venous Thromboembolism

Sponsors & Collaborators

  • Center for Epidemiology and Health Research, Germany

    lead OTHER

Eligibility

Min Age
15 Years
Max Age
49 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-03-10
Primary Completion
2024-01-15
Completion
2024-01-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02828904 on ClinicalTrials.gov