Safety study comparing two types of hormonal contraceptives
International Active Surveillance Study: Native Estrogen Estetrol (E4) Safety Study
This study is testing whether a new hormonal birth control pill is safer than traditional options for women starting these contraceptives.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 101000 (estimated) |
| Sex | Female |
| Sponsor | Center for Epidemiology and Health Research, Germany Academic / other |
| Locations | 1 site (Berlin, State of Berlin) |
| Trial ID | NCT06028555 on ClinicalTrials.gov |
What this trial studies
This multinational, observational study aims to compare the safety profiles of a new oral contraceptive containing estetrol (E4) and drospirenone (DRSP) against traditional combined oral contraceptives containing ethinyl estradiol (EE) and levonorgestrel (LNG). It will follow two cohorts of new users of these contraceptives over one to two years, focusing on the incidence of venous thromboembolism (VTE) and other related outcomes. The study will utilize a non-interventional approach, gathering data through healthcare professionals and direct participant contact to ensure comprehensive and accurate reporting of outcomes.
Who should consider this trial
Good fit: Ideal candidates for this study are new users of hormonal contraceptives, specifically those prescribed E4/DRSP or EE/LNG.
Not a fit: Patients who are not new users of these contraceptives or those using them outside of on-label indications may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the safety of a new contraceptive option, potentially reducing the risk of serious side effects for users.
How similar studies have performed: Other studies have explored the safety of hormonal contraceptives, but this specific comparison of E4/DRSP with EE/LNG is novel.
Eligibility criteria
Show full inclusion / exclusion 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: \-
Where this trial is running
Berlin, State of Berlin
- Berlin Center for Epidemiology and Health Research — Berlin, State of Berlin, Germany (Recruiting)
Study contacts
- Principal investigator: Klaas Heinemann, Dr. — ZEG Berlin GmbH
- Study coordinator: Armin Papkalla, Dr.
- Email: a.papkalla@zeg-berlin.de
- Phone: +49 30 945 101 20
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.