Clinical trial · Observational
Vaginal Estradiol Tablets (Vagifem®) and Endometrial Cancer Risk in the Treatment of Postmenopausal Vaginal Atrophy
Vaginal Estradiol Tablets (Vagifem®) and Endometrial Cancer Risk in the Treatment of Postmenopausal Vaginal Atrophy: A Register-based Cohort Study in Postmenopausal Women
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Postmenopausal Vaginal Atrophy | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Non-Vagifem® LDVE, Estradiol | Drug | — | UNRESOLVED |
| Vagifem® | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- 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.
- interventionNames
- Drug: Vagifem®
- Drug: Non-Vagifem® LDVE, Estradiol
- label
- 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.
- interventionNames
- Drug: Vagifem®
- Drug: Non-Vagifem® LDVE, Estradiol
Primary outcomes (1)
- measure
- 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)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 50 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available