Postmenopausal Vaginal Atrophy
Conditions
Brief summary
The study will include data from a nationwide Danish cohort of postmenopausal women and the United States of America (US) cohort of postmenopausal women. The Danish nationwide cohort will be established through linkage of Danish national patient registries. The US cohort will be established based on data from US claims database, Truven. The aim of this study is to evaluate whether exposure to Vagifem® increases the rate of endometrial cancer in postmenopausal women.
Interventions
DRUGVagifem®
According to local clinical practice - independent of inclusion in this study
DRUGNon-Vagifem® LDVE, Estradiol
According to local clinical practice - independent of inclusion in this study
Sponsors
Novo Nordisk A/S
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
50 Years to 75 Years
Inclusion criteria
1. Female 2. Age 50-75 years at entry
Exclusion criteria
1. Endometrial cancer prior to entry 2. Any use of vaginal estrogen products prior to entry 3. Hysterectomy prior to entry
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| First time occurrence of endometrial cancer (yes/no) during time in cohort from entry (start of treatment) to exit (end of study period, occurrence of any other cancer (except non-melanoma skin cancer), date of emigration or date of death) | From entry (day 0) to exit (upto 19 years) | Yes/no |
Countries
Denmark
Outcome results
None listed