Skip to main content
OpenTrials
Completed

NCT Number: NCT05243823

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Postmenopausal Vaginal Atrophy

Age range

50 year–75 year

Sex eligibility

Female

Study type

Observational

Primary location

Novo Nordisk Investigational Site

Soeborg, Denmark

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Female
  • Age 50-75 years at entry

Exclusion criteria

  • Endometrial cancer prior to entry
  • Any use of vaginal estrogen products prior to entry
  • Hysterectomy prior to entry

Treatment and study plan

Vagifem®

Drug

According to local clinical practice - independent of inclusion in this study

Non-Vagifem® LDVE, Estradiol

Drug

According to local clinical practice - independent of inclusion in this study

Primary outcomes

  1. 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)

    Time frame: From entry (day 0) to exit (upto 19 years)

    Yes/no

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Feb 17, 2022
Registry last updated
Dec 23, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.