Postmarketing Noninterventional Study Evaluating the Risk of Endometrial Cancer in Women Who Have Been Prescribed Imvexxy®

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

  Drug utilisation

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Medicinal product name, other:
  Imvexxy
• Medical condition to be studied:
  Endometrial cancer

Population studied

• Age groups:
  • Adults (46 to < 65 years)
  • Adults (65 to < 75 years)
  • Adults (75 to < 85 years)
  • Adults (85 years and over)
• Estimated number of subjects:
  35000

Study design details

• Main study objective:
  1. Evaluate the risk of endometrial cancer in women who have been prescribed Imvexxy 4 μg or 10 μg. 2. Determine the duration and patterns of use of Imvexxy and other vaginal estrogen products. 3. To evaluate the risk of endometrial cancer in women who have been prescribed any very low-dose vaginal estrogen product, including Imvexxy.
• Outcomes:
  The study outcome is endometrial cancer, defined clinically as the first endometrial cancer after cohort entry. A validated electronic algorithm, to be developed as part of the study, will identify provisional cases of endometrial cancer in the administrative data of study cohort members.
• Data analysis plan:
  The drug utilization study will ascertain patterns of use of vaginal estrogen products. Characteristics of women at the beginning of their first therapy episode will be described. The safety study will evaluate the risk of endometrial cancer in women exposed to these products, incidence rates for endometrial cancer will be estimated separately for the exposed and unexposed groups as the number of events per 10,000 person-years. Analyses for Objective 1 will compare the propensity-score matched exposed (Imvexxy) and unexposed groups for their risk for endometrial cancer using Cox regression models with time-varying exposure. Analyses addressing Objective 3 will compare the propensity-score matched exposed (all very-low-dose vaginal estrogen products combined, including Imvexxy) and unexposed groups for their risk for endometrial cancer using Cox regression models with time-varying exposure. Outcomes will be identified using a previously validated algorithm.