VAG-4602: Vaginal estradiol tablets (Vagifem®) and endometrial cancer risk in the treatment of postmenopausal vaginal atrophy: A register-based cohort study in postmenopausal women

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/50379
• EU PAS number:
  EUPAS44951
• Study ID:
  50379
• Official title and acronym:
  VAG-4602: Vaginal estradiol tablets (Vagifem®) and endometrial cancer risk in the treatment of postmenopausal vaginal atrophy: A register-based cohort study in postmenopausal women
• DARWIN EU® study:
  No
• Study countries:
  Denmark

  United States
• Study 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.
• Study status:
  Ongoing

Research institution and networks

Institutions

Novo Nordisk

North Zealand hospital Denmark, Truven Health MarketScan United States

Study timelines

Date when funding contract was signed

Planned: 10/12/2021

Actual: 10/12/2021

Study start date

Planned: 31/05/2022

Actual: 15/01/2022

Date of final study report

Planned: 31/12/2023

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Novo Nordisk A/S

Study protocol

Initial protocol

VAG-4602 16-1-01 protocol eu-pas-reg redacted

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable

Other study registration identification numbers and links

UTN: U1111-1270-0966