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

• Sponsor: Novo Nordisk A/S (Industry)
• Overall Status: Completed
• CT.gov ID: NCT05243823
• Collaborator: (none)
• Enrollment: 500,000
• Location: 1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Postmenopausal Vaginal Atrophy	Drug: Vagifem®; Drug: Non-Vagifem® LDVE, Estradiol

Study Design

• Study Type: Observational
• Actual Enrollment: 500000 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• 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
• Actual Study Start Date: May 31, 2022
• Actual Primary Completion Date: May 31, 2022
• Actual Study Completion Date: May 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Danish cohort 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.	Drug: Vagifem®; According to local clinical practice - independent of inclusion in this study; Drug: Non-Vagifem® LDVE, Estradiol; According to local clinical practice - independent of inclusion in this study
US cohort 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.	Drug: Vagifem®; According to local clinical practice - independent of inclusion in this study; Drug: Non-Vagifem® LDVE, Estradiol; According to local clinical practice - independent of inclusion in this study

Outcome Measures

Primary Outcome Measures

1. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years to 75 Years
• Sexes Eligible for Study: Female

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Novo Nordisk Investigational Site	Soeborg		Denmark

Sponsors and Collaborators

• Novo Nordisk A/S

Investigators

• Study Director: Clinical Transparency dept. 2834, Novo Nordisk A/S

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Novo Nordisk A/S
• ClinicalTrials.gov Identifier: NCT05243823
• Other Study ID Numbers: VAG-4602; U1111-1270-0966
• First Posted: Feb 17, 2022
• Last Update Posted: Jul 6, 2022
• Last Verified: Jul 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Endometrial Neoplasms; Atrophy; Estradiol

Study Results

No Results Posted as of Jul 6, 2022