Postmenopausal Vaginal AtrophyNCT05243823
Vaginal Estradiol Tablets (Vagifem®) and Endometrial Cancer Risk in the Treatment of Postmenopausal Vaginal Atrophy
An observational study of Postmenopausal Vaginal Atrophy, run by Novo Nordisk A/S at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 75 years, women only
- Conditions the study is for
- Postmenopausal Vaginal Atrophy
- What is being tested?
- Vagifem® and Non-Vagifem® LDVE, Estradiol
- How many people
- 500,000 participants
- Where
- 1 siteDenmark
- Study dates
- 15 Jan 2022to 31 Jul 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 75 years
- Women only
- Adult, Older adult
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.
Who may be able to join
- Female
- Age 50-75 years at entry
Who cannot join
- Endometrial cancer prior to entry
- Any use of vaginal estrogen products prior to entry
- Hysterectomy prior to entry
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Being tested
- Vagifem®, Non-Vagifem® LDVE, Estradiol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vagifem®Drug
According to local clinical practice - independent of inclusion in this study
Non-Vagifem® LDVE, EstradiolDrug
According to local clinical practice - independent of inclusion in this study
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Vagifem®; Drug: Non-Vagifem® LDVE, Estradiol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: From entry (day 0) to exit (upto 19 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2022
- Study start15 Jan 2022
- Primary completion31 Jul 2022
- Study completion31 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postmenopausal Vaginal AtrophyStudies of the same condition, open and under way.
- More trials run by Novo Nordisk A/SThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 500,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Transparency dept. 2834, Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05243823
- Sponsor's protocol ID
- VAG-4602
- Other IDs
- U1111-1270-0966
- Status last verified
- Dec 2022
- First submitted
- 14 Jan 2022
- Last updated
- 23 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05243823
- Acronym / sponsor ID
- VAG-4602
- Conditions
- Postmenopausal Vaginal Atrophy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500,000 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 15 Jan 2022 (actual)
- Primary completion
- 31 Jul 2022 (actual)
- Study completion
- 31 Jul 2022 (actual)
- First posted
- 17 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Danish cohort | – | Drug: Vagifem®, Drug: Non-Vagifem® LDVE, EstradiolDanish 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. |
| US cohort | – | Drug: Vagifem®, Drug: Non-Vagifem® LDVE, EstradiolUS 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. |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- Female only
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Female
- Age 50-75 years at entry
Key exclusion criteria (3 listed)
- Endometrial cancer prior to entry
- Any use of vaginal estrogen products prior to entry
- Hysterectomy prior to entry
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vagifem®According to local clinical practice - independent of inclusion in this study | Drug | Danish cohort, US cohort |
| Non-Vagifem® LDVE, EstradiolAccording to local clinical practice - independent of inclusion in this study | Drug | Danish cohort, US cohort |
Primary outcome
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)
Time frame: From entry (day 0) to exit (upto 19 years)
Yes/no
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2022.
- Individual participant dataSharing planned: Yes. According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Transparency dept. 2834 study director
Novo Nordisk A/S
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postmenopausal Vaginal Atrophy, run by Novo Nordisk A/S at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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) (time frame: From entry (day 0) to exit (upto 19 years)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2022.