Study identification

PURI

https://redirect.ema.europa.eu/resource/1000000443

EU PAS number

EUPAS1000000443

Study ID

1000000443

Official title and acronym

DARWIN EU® - Association of venous thromboembolism with non-steroidal anti-inflammatory drug use in women 15-49 years using hormonal contraceptives

DARWIN EU® study

Yes

Study countries

Denmark
Norway
Spain
United Kingdom

Study description

Venous thromboembolism (VTE) refers to the formation of a blood clot in a deep vein and is a rare but potentially preventable cause of death in women of reproductive age. Multiple studies have showed that oral combined hormonal contraception is associated with an increased risk of VTE, especially high-dose combined oral contraception (>=50 μg ethinyl estradiol and progestins).[1]
Additionally, the use of non-steroidal anti-inflammatory drugs (NSAIDs) has also been linked to increased VTE risk. Meta-analyses and observational studies have suggested an increased risk of VTE among NSAIDs users.[2,3]
Recently, a nationwide study from Denmark found that NSAIDs use is associated with increased VTE risk in women 15-49 years old, especially among those with concomitant use of high/medium risk hormonal contraception. [4] This study was fraught with limitations, particularly as the study design did not satisfactorily account for confounding.
More data on the association of venous thromboembolism with NSAIDs in women of reproductive age has been requested by medicines regulators to see if such associations are seen in other databases, including data on women using hormonal contraception.

Study status

Ongoing
Research institutions and networks

Institutions

Networks

Contact details

Xintong Li

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Date of final study report

Planned:
Sources of funding
EMA
Study protocol
Initial protocol

DARWIN EU_Protocol_P3-C3-008_NSAIDS_V4.pdf

English (958.48 KB - PDF)View document
Regulatory

Was the study required by a regulatory body?

Yes

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

Not applicable