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

Completed

• Conditions: Postmenopausal Vaginal Atrophy
• Interventions: Drug: Vagifem®; Drug: Non-Vagifem® LDVE, Estradiol

• Registration Number: NCT05243823
• Lead Sponsor: Novo Nordisk A/S

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-01-14
• Study Start: 2022-01-15
• Study First Submitted QC: 2022-02-07
• Study First Posted: 2022-02-17
• Primary Completion: 2022-07-31
• Study Completion: 2022-07-31
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-22
• Last Update Posted: 2022-12-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 500000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Danish cohort	Vagifem®	Danish cohort starts on 1 January 2000 and ends on 31 December 2019. It consists of new users of low dose vaginal estrogens (LDVE) (split into Vagifem® and other LDVE products) in the study period, and a comparator group consisting of women using no hormone replacement therapy.
Danish cohort	Non-Vagifem® LDVE, Estradiol	Danish cohort starts on 1 January 2000 and ends on 31 December 2019. It consists of new users of low dose vaginal estrogens (LDVE) (split into Vagifem® and other LDVE products) in the study period, and a comparator group consisting of women using no hormone replacement therapy.
US cohort	Vagifem®	US cohort starts on 1 January 2007 and ends on 31 December 2019. It consists of new users of low dose vaginal estrogens (LDVE) (split into Vagifem® and other LDVE products) in the study period, and a comparator group consisting of women using no hormone replacement therapy.
US cohort	Non-Vagifem® LDVE, Estradiol	US cohort starts on 1 January 2007 and ends on 31 December 2019. It consists of new users of low dose vaginal estrogens (LDVE) (split into Vagifem® and other LDVE products) in the study period, and a comparator group consisting of women using no hormone replacement therapy.

Primary Outcome Measures

Name	Time	Method
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)	Yes/no

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇩🇰 Soeborg, Denmark