Study identification

EU PAS number

EUPAS49984

Study ID

49985

Official title and acronym

International Active Surveillance Study: Native Estrogen Estetrol (E4) Safety Study (INAS-NEES)

DARWIN EU® study

No

Study countries

Czechia
Germany
Hungary
Italy
Poland
Spain
Sweden
United Kingdom
United States

Study description

The primary objective of the study is to characterize and compare the risks of E4/Drospirenone (DRSP) with levonorgestrel-containing combined oral contraceptives (EE/LNG) in a study population that is representative of the actual users of these preparations.
The main clinical outcome of interest is: venous thromboembolism (VTE), specifically deep venous thrombosis (DVT) and pulmonary embolism (PE).
Secondary objectives include measuring the occurrence of unintended pregnancy, assessing the risk of arterial thromboembolism (ATE), describing the drug utilization pattern, describing the baseline risk profile for VTE and ATE, and investigating outcomes associated with fetal exposure to E4/DRSP.

Study status

Ongoing
Research institutions and networks

Institutions

Contact details

Klaas Heinemann

Primary lead investigator

Study timelines

Date when funding contract was signed

Actual:

Study start date

Planned:
Actual:

Data analysis start date

Actual:

Date of interim report, if expected

Planned:
Actual:

Date of final study report

Planned:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

Gedeon Richter Plc
Gyömrői út 19-21
1103 Budapest
Hungary
Regulatory

Was the study required by a regulatory body?

Yes

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

EU RMP category 3 (required)