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

Postmenopausal Vaginal Atrophy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05243823
• Other study ID #: VAG-4602
• Secondary ID: U1111-1270-0966
• Status: Completed
• Start date: January 15, 2022
• Est. completion date: July 31, 2022

Study information

• Verified date: December 2022
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500000
• Est. completion date: July 31, 2022
• Est. primary completion date: July 31, 2022
• Gender: Female
• Age group: 50 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Atrophy
• Endometrial Neoplasms
• Postmenopausal Vaginal Atrophy

Intervention

Drug:
• Vagifem®
According to local clinical practice - independent of inclusion in this study
• Non-Vagifem® LDVE, Estradiol
According to local clinical practice - independent of inclusion in this study

Locations

Country	Name	City	State
Denmark	Novo Nordisk Investigational Site	Soeborg

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	From entry (day 0) to exit (upto 19 years)