Clinical trial

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

Name

VAG-4602

Description

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.

Trial arms

Trial start

2022-01-15

Estimated PCD

2022-07-31

Trial end

2022-07-31

Status

Completed

Treatment

Vagifem®

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

Arms:

Danish cohort, US cohort

Non-Vagifem® LDVE, Estradiol

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

Arms:

Danish cohort, US cohort

Size

500000

Primary endpoint

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)

Eligibility criteria

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

Protocol

{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'RETROSPECTIVE'}, 'enrollmentInfo': {'count': 500000, 'type': 'ACTUAL'}}

Updated at

2022-12-23

1 organization

2 products

1 indication

Organization

Novo Nordisk

Product

Vagifem®

Indication

Genitourinary Syndrome of Menopause

Product

Non-Vagifem