Human medicines European public assessment report (EPAR): Drovelis, estetrol,drospirenone, Date of authorisation: 19/05/2021, Revision: 5, Status: Authorised
Drovelis was found to be effective at preventing unwanted pregnancies in 2 main studies involving a total of around 3,400 women.
The main measure of effectiveness was the number of unwanted pregnancies in 100 women-years (corresponding to 100 women taking contraception for one year). This measure is known as the Pearl Index, and a lower Pearl Index represents a lower chance of getting pregnant.
In a first study conducted in 1,553 women between the ages of 18 and 50, the Pearl Index was 0.44 in the group aged 18 to 35 and 0.38 in the whole group. This was considered a sufficiently low value for an oral contraceptive.
In a second study, conducted in 1,864 women aged 16 to 50 years old, where more pregnancies were reported, the Pearl Index was 2.42 in women aged 16 to 35 and 2.30 in the group aged 16 to 50.
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