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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1270-0966 | Other Identifier | World Health Organization (WHO) |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vagifem® | Drug | According to local clinical practice - independent of inclusion in this study |
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| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Transparency dept. 2834 | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novo Nordisk Investigational Site | Soeborg | Denmark |
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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| ID | Term |
|---|---|
| D004958 | Estradiol |
| ID | Term |
|---|---|
| D004963 | Estrenes |
| D004962 | Estranes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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| Non-Vagifem® LDVE, Estradiol | Drug | According to local clinical practice - independent of inclusion in this study |
|
| D011083 |
| Polycyclic Compounds |
| D045166 | Estradiol Congeners |
| D012739 | Gonadal Steroid Hormones |
| D042341 | Gonadal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |