Study identification

EU PAS number

EUPAS41957

Study ID

43435

Official title and acronym

Postmarketing Noninterventional Study Evaluating the Risk of Endometrial Cancer in Women Who Have Been Prescribed Imvexxy®

DARWIN EU® study

No

Study countries

United States

Study description

Vulvar and vaginal atrophy (VVA) is a common condition in postmenopausal women. Low dose vaginal estrogen therapy is recommended for symptomatic women with moderate to severe VVA. Imvexxy is a very low dose vaginal estrogen product approved for the treatment of VVA. This study is being conducted to meet a postmarketing requirement for Imvexxy from the US Food and Drug Administration. The objectives of this study are to: (1) estimate the risk of endometrial cancer in women who have been prescribed Imvexxy, (2) describe the duration and patterns of use of Imvexxy and other vaginal estrogen products, and (3) to estimate the risk of endometrial cancer in women who have been prescribed any very low dose vaginal estrogen product. This cohort study will be conducted using existing insurance claims data sources in the US, selected after a feasibility assessment. Yearly monitoring reports will provide counts of Imvexxy-exposed patients and person-time in the data sources, starting in 2021. A validation study with medical record review will be implemented to validate an electronic algorithm to identify endometrial cancer (using ICD-10-CM codes, report planned for 2022). The final report will include results of the drug utilization study (Objective 2) and safety study (Objectives 1 and 3), and is planned for 2026. The study outcome is defined clinically as the first endometrial cancer after cohort entry and will be ascertained using the previously validated algorithm. Exposure will be identified in electronic data based on dispensed prescriptions. Safety analyses will compare users of Imvexxy (Objective 1) or of any very low dose vaginal estrogen product (Objective 3) with comparable women who do not use vaginal estrogen products, using regression models. Confounding control will be implemented through propensity-score matching. Results from this study will provide additional information on long-term endometrial safety of low-dose vaginal estrogen products.

Study status

Planned
Research institutions and networks

Institutions

RTI Health Solutions (RTI-HS)
France
Spain
Sweden
United Kingdom
United Kingdom (Northern Ireland)
United States
First published:
13/03/2025
Institution Not-for-profit ENCePP partner
Optum
Germany
First published:
07/02/2014
Institution Outdated Other ENCePP partner
CVS Clinical Trial Strategy Minneapolis, Minnesota

Contact details

Andrea Margulis

Primary lead investigator

Study timelines

Date when funding contract was signed

Actual:

Study start date

Planned:

Date of interim report, if expected

Planned:

Date of final study report

Planned:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

TherapeuticsMD
Regulatory

Was the study required by a regulatory body?

Yes

Is the study required by a Risk Management Plan (RMP)?

Not applicable