NCT05243823

Vaginal Estradiol Tablets (Vagifem®) and Endometrial Cancer Risk in the Treatment of Postmenopausal Vaginal Atrophy

Vaginal Estradiol Tablets (Vagifem®) and Endometrial Cancer Risk in the Treatment of Postmenopausal Vaginal Atrophy: A Register-based Cohort Study in Postmenopausal Women

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 500,000 (actual)
• Sponsor: Novo Nordisk A/S · Industry
• Sex: Female
• Age: 50 Years – 75 Years
• Healthy volunteers: —

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.

Conditions

• Postmenopausal Vaginal Atrophy

Interventions

Type	Name	Description
DRUG	Vagifem®	According to local clinical practice - independent of inclusion in this study
DRUG	Non-Vagifem® LDVE, Estradiol	According to local clinical practice - independent of inclusion in this study

Timeline

• Start date: 2022-01-15
• Primary completion: 2022-07-31
• Completion: 2022-07-31
• First posted: 2022-02-17
• Last updated: 2022-12-23

Locations

1 site across 1 country: Denmark