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

Novo Nordisk A/S500,000 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

500,000

Conditions

Postmenopausal Vaginal Atrophy

Interventions

Vagifem®DRUG

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

Non-Vagifem® LDVE, EstradiolDRUG

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

Eligibility

Sex: FEMALEMin age: 50 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

Novo Nordisk Investigational Site

Soeborg, Denmark

Outcomes

Primary Outcomes

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)

Yes/no

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

Data from ClinicalTrials.gov

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