Study identification

PURI

https://redirect.ema.europa.eu/resource/46024

EU PAS number

EUPAS12171

Study ID

46024

Official title and acronym

Retrospective Cohort Study on the Risk of Venous Thromboembolism with the use of combined oral contraceptives containing Chlormadinone Acetate/Ethinylestradiol and Levonorgestrel/Ethinylestradiol (RIVET-RCS)

DARWIN EU® study

No

Study countries

Germany

Study description

Rationale and background: The risk of venous thromboembolism (VTE) associated with the use of chlormadinoe acetate (CMA) is currently unknown as the available data have significant limitations and lack data on direct comparison between levonorgestrel- (LNG) and CMA-containing combined oral contraceptives (COCs).
Study design: this is a retrospective cohort study and will be conducted as substitute for the RIVET-Case Control study, which was discontinued due to slow recruitment of both cases and controls. Following several attempts to enhance the recruitment in RIVET-CC, the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency recommended a pooled analysis of 4 prospective cohort studies in order to clarify whether CMA/EE-containing COCs carry a different VTE risk compared to LNG/EE-containing COCs. Participants will be identified retrospectively from a pooled dataset which comprises four large, controlled, prospective, non-interventional active surveillance studies that focused on the risk of VTE associated with the use of combined oral contraceptives (LASS/EURAS-OC, INAS-OC, INAS-SCORE, INAS-FOCUS). All data were prospectively collected by ZEG Berlin and follow the EURAS/INAS study design. Inclusion and exclusion criteria, the method of patient recruitment and follow-up as well as research methods were similar across studies.
Gedeon Richter and its Collaborators requested this Study in agreement with the competent European regulatory authority and supports it by an unconditional grant to ZEG. Gedeon Richter and its Collaborators are not actively involved in the conduct of the Study.

Study status

Finalised
Research institution and networks

Institutions

Contact details

Klaas Heinemann

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
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Data analysis start date

Planned:
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Date of final study report

Planned:
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Sources of funding
Pharmaceutical company and other private sector 

More details on funding

Aristo Pharma, Dr.Kade, Gynial, Hormosan Pharma, Jenapharm, Kwizda Pharma, Meda Pharma, Mibe, Acis, Dermapharm, Sun-Farm, Mithra, Mylan, Gedeon Richter, Pfizer Austria, STADA,WH-Pharma, Zentiva Ph, Actavis, ITF Farmahealth, Sandoz, 1APharma, Hexal, Heaton
Regulatory

Was the study required by a regulatory body?

Yes

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

EU RMP category 1 (imposed as condition of marketing authorisation)