english.prescrire.org > Spotlight > Archives : 2022 > Oral contraception: estetrol + drospirenone (Drovelis°), a combination to avoid

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Oral contraception: estetrol + drospirenone (Drovelis°), a combination to avoid

Yet another combined oral contraceptive has been marketed in Europe: a combination of estetrol and drospirenone (Drovelis°). But it is probably better to avoid the combination of an insufficiently evaluated oestrogen and a progestogen with worrying adverse effects.

A new oestrogen-progestogen combination, estetrol + drospirenone (Drovelis°), has been authorised in the European Union for use as an oral contraceptive. It is the first authorised medicinal product to contain this oestrogen.

Little is known about the harms of this new oestrogen, and the clinical trials conducted to evaluate its use in combination with drospirenone were not designed to show whether it is more effective or less harmful than other options. Data from non-comparative clinical trials suggest that estetrol + drospirenone has similar contraceptive efficacy to that reported with other oral hormonal contraceptives.

Drospirenone has an unfavourable harm-benefit balance as the progestogenic component of a combined oral contraceptive, because it can cause cardiac arrhythmias and exposes women to a higher risk of thrombosis than other progestogens, yet it has no proven advantages that might offset these risks. In addition to the adverse effects specific to drospirenone, estetrol + drospirenone has the same adverse effects as other oestrogen-progestogen combinations, in particular: weight fluctuation, gynaecological disorders, breast tenderness, depression, thromboembolic events, hypertension, hyperglycaemia and hyperlipaemia.

The combined oral contraceptive of first choice is a well-established combination of ethinylestradiol and levonorgestrel.

©Prescrire 1 October 2022

Source: "Estetrol + drospirenone (Drovelis°) for oral contraception. An insufficiently evaluated oestrogen combined with an unnecessarily dangerous progestogen" Prescrire International 2022; 31 (241): 229-231. Subscribers only.

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See also:

"Queries and Comments.
Progestogen-only
oral contraception:
is levonorgestrel still
the first choice in 2021?"
Prescrire Int 2021;
30 (232): 302-304.
Pdf, subscribers only


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