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

Recruiting Observational Study
Contraception Birth Control
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Healthy Volunteers Welcome You do not need to have the condition being studied to take part. No Study Drug Researchers observe your health over time — no experimental treatment is given.
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At a Glance
Sex
Female
Study type
Observational
Participants needed
101,000 (estimated)
Sponsor
Center for Epidemiology and Health Research, Germany · Other
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About This Trial
Multinational, comparative, prospective, active surveillance study that follows two cohorts. 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…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: New users of E4/DRSP New users of EE/LNG Germany: only recruitment of study participants who are prescribed the COC within on-label use Exclusion Criteria: \-
Contacts

Armin Papkalla, Dr.

+49 30 945 101 20

a.papkalla@zeg-berlin.de

CONTACT

Silke Zimmermann, Dr.

+49 30 945 101 20

s.zimmermann@zeg-berlin.de

CONTACT