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

NCT05243823 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 500000

Last updated 2022-12-23

No results posted yet for this study

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

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

Sponsors & Collaborators

Principal Investigators

  • Clinical Transparency dept. 2834 · Novo Nordisk A/S

Eligibility

Min Age
50 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-15
Primary Completion
2022-07-31
Completion
2022-07-31

Countries

  • Denmark

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05243823 on ClinicalTrials.gov