N/A
Completed N=30,597
European Active Surveillance Study of Women Taking Hormone Replacement Therapy (HRT)
Menopausal Symptoms
Source: ClinicalTrials.gov NCT00214903 ↗
Enrolled (actual)
30,597
Serious AEs
12.4%
Results posted
Nov 2014
Primary outcomePrimary: Venous Thromboembolism (e.g., Deep Venous Thrombosis and Pulmonary Embolism) — 24; 74; 21; 12 participants
Summary
The objective of the active surveillance study is to compare incidence rates of serious adverse events in users of all types of newly prescribed oral continuous combined HRT products. The primary focus is the assessment of pertinent cardiovascular outcomes (such as venous and arterial thromboembolism) in new HRT users for up to 8.5 years.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Venous Thromboembolism (e.g., Deep Venous Thrombosis and Pulmonary Embolism) |
24; 74; 21; 12 | — |
| PRIMARY Arterial Thromboembolism (e.g., Acute Myocardial Infarction and Stroke) |
15; 95; 33; 23 | — |
Eligibility Criteria
Inclusion Criteria
- All women aged 40 or more years who started use of a new oral HRT at the time of inclusion in the study
Exclusion Criteria
- Women who do not consent to participate in the study
Data sourced from ClinicalTrials.gov (NCT00214903). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.