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

NCT05243823 | Completed

• 2 other identifiers: VAG-4602U1111-1270-0966
• Study Type: observational
• Target: 500,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Postmenopausal Vaginal Atrophy

Outcome Measures

Primary Outcomes (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)

  Yes/no

  From entry (day 0) to exit (upto 19 years)

Study Arms (2)

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®; Drug: Non-Vagifem® LDVE, Estradiol

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®; Drug: Non-Vagifem® LDVE, Estradiol

Interventions

Vagifem® DRUG

According to local clinical practice - independent of inclusion in this study

Danish cohort; US cohort

Non-Vagifem® LDVE, Estradiol DRUG

According to local clinical practice - independent of inclusion in this study

Danish cohort; US cohort

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: female
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population includes postmenopausal women split into two separate cohort studies from two countries - Denmark and US. The study population for both the Danish and the US cohort consists of new users of LDVE (split into Vagifem® and other LDVE products) in the study period, and a comparator group consisting of women using no hormone replacement therapy.

You may qualify if:

• Female
• Age 50-75 years at entry

You may not qualify if:

• Endometrial cancer prior to entry
• Any use of vaginal estrogen products prior to entry
• Hysterectomy prior to entry

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (1)

Novo Nordisk Investigational Site

Soeborg, Denmark

Location

MeSH Terms

Interventions

Estradiol

Intervention Hierarchy (Ancestors)

Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Clinical Transparency dept. 2834

  Novo Nordisk A/S

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2022
• First Posted: February 17, 2022
• Study Start: January 15, 2022
• Primary Completion: July 31, 2022
• Study Completion: July 31, 2022
• Last Updated: December 23, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will share

Locations

DK (1)