Study identification

EU PAS number

EUPAS1000000455

Study ID

1000000455

Official title and acronym

DARWIN EU® - Impact of risk minimisation measures related to the risk of meningioma in women using nomegestrol and chlormadinone

DARWIN EU® study

Yes

Study countries

Belgium
Croatia
Germany

Study description

Nomegestrol acetate (NOMAC) and chlormadinone acetate (CMA) are synthetic progestins indicated for the treatment of several gynaecological and menstrual disorders, as hormone replacement therapy and as hormonal contraception.
Recent epidemiological studies have found a dose-dependent association between NOMAC or CMA and meningioma.
As a result, risk minimisation measures (RMM) were implemented in 2022, especially for high-dose products, which should be used at the lowest effective dose and for the shortest duration possible and should not be used for first-line treatment.
For all products containing NOMAC or CMA, treatment was contraindicated in patients with meningioma or a history of meningioma.
All patients should be monitored for symptoms of meningioma and treatment should be permanently discontinued if diagnosed with meningioma during treatment. This contraindication was already in place for NOMAC, with previous regulatory actions implemented in 2018 and 2020.

Study status

Ongoing
Research institutions and networks

Institutions

Networks

Contact details

Berta Raventós

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
Regulatory

Was the study required by a regulatory body?

Yes

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

Not applicable