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

Novo Nordisk

Status: Completed

Conditions: Postmenopausal Vaginal Atrophy

Treatments: Drug: Non-Vagifem® LDVE, Estradiol; Drug: Vagifem®

Study type: Observational

Funder types: Industry

Identifiers

NCT05243823

U1111-1270-0966 (Other Identifier)

VAG-4602

Details and patient eligibility

About

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.

Enrollment: 500,000 patients

Sex: Female

Ages: 50 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

500,000 participants in 2 patient groups

Danish cohort

Description:

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.

Treatment:

Drug: Vagifem®

Drug: Non-Vagifem® LDVE, Estradiol

US cohort

Description:

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.

Treatment:

Drug: Vagifem®

Drug: Non-Vagifem® LDVE, Estradiol