STUDY INFORMATION
Studies and Research Initiatives
At ZEG Berlin, we are continuously advancing our understanding of drug safety and real-world outcomes. Our ongoing pharmacoepidemiology and late-phase research covers the full lifecycle of medicines, with a particular focus on women’s health and hormonal therapies. Our active research portfolio reflects both the breadth of our expertise and our ongoing commitment to advancing evidence-based healthcare for women at every life stage. Explore our current research initiatives below.
Current studies: Real-World Evidence in Action
EURAS-LCS12
European Active Surveillance Study of LCS12
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2014–2027
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Women with a newly inserted Intrauterine Device
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N= ~ 97.000
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INAS-NEES
International Active Surveillance Study: Native Estrogen Estetrol (E4) Safety Study (INAS-NEES)
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2019–2029
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Women with a newly prescribed COC (E4/DRSP; EE/LNG)
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Venous thromboembolism
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N=101,000 planned
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We are still recruiting – please use our physician contact form if you are interested in participating.
https://catalogues.ema.europa.eu/node/3455/administrative-details
LIDEAR
Long-Term International Dual Source Endometriosis and Adenomyosis Registry (LIDEA Registry)
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2025-2030
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Dynamic Multi-Country Execution
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Women with diagnosed or presumed endometriosis or adenomyosis
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N= ~ 14,000 planned
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We are still recruiting – please use our physician contact form if you are interested in participating.
https://catalogues.ema.europa.eu/node/3842/administrative-details
GRACE
Fezolinetant Experience for the Treatment of Vasomotor Symptoms Associated with Menopause
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2024-2026
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Women who initiate fezolinetant for the treatment of VMS associated with menopause per routine clinical practice in Germany.
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N=~ 100
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Secondary Data
100+ Observational, Retrospective Studies
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Since 2017
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Patient Data from Representative Claims Databases
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Bone • Cardiovascular, Renal and Metabolism • Dermatology • Gastroenterology • General Health • Immunology • Infectious Diseases • Neurology • Oncology/Hematology • Ophthalmology • Rare Disease • Respiratory • Urology
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80+ Publications & Conference Contributions
Past studies: A selection of key studies
VIPOS
International Active Surveillance Study of Medication Used for the Treatment of Endometriosis: Visanne Post-approval Observation Study (VIPOS)
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2010–2019
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Women with a new hormonal therapy for endometriosis
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Anemia associated with endometriosis-related bleeding, first time occurrence or worsening of existing clinically relevant depression, discontinuation patterns due to treatment failure
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N=27,840
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PRO-E2
Prospective controlled cohort study on the safety of a monophasic oral contraceptive containing nomegestrol acetate (2.5mg) and 17ß-estradiol (1.5mg) (PRO-E2)
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2012–2021
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Women with a new prescription for combined oral contraceptives
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venous thromboembolism, arterial thromboembolism, depressive disorders, cholelithiasis, inflammatory bowel disease, effects on short- and long-term fertility and pregnancy outcomes.
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N=101,498
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EURAS-IUD
European Active Surveillance Study for Intrauterine Devices (EURAS-IUD)
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2006-2016
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Women with a newly inserted intrauterine device
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Perforations
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N=63,194
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EURAS-OC
European Active Surveillance Study of Oral Contraceptives (OC)
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2006–2009
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Women with a new prescription for oral contraceptives
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Drug utilization pattern
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N=58,674
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EURAS-OC
European Active Surveillance Study of Women Taking Hormone Replacement Therapy (HRT)
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2004-2014
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Women beginning oral continuous combined hormone therapy
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Venous and arterial thromboembolism
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N=30,597
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INAS-SCORE
International Active Surveillance study “Safety of Contraceptives: Role of Estrogens
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2009–2016
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Women with a new prescription for a combined oral contraceptive
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Venous and arterial thromboembolism
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N=50,203
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NORA
Nexplanon Observational Risk Assessment
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2011–2017
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Women with a newly inserted Nexplanon implant
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Unintended pregnacy
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N=7,364
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Study Physician Contact Form
Our studies rely on the participation of recruiting physicians, who identify suitable participants for our observational studies. As a recruiting physician you can make a big contribution to research with minimal effort.
Please enter your contact details if you are interested in participating in one of our studies as a recruiting physician:
Frequently Asked Questions about ZEG Berlin
Who is ZEG and what are they doing?
ZEG Berlin is a contract research organization, which conducts observational studies to understand the risks and benefits of different medicines and medical devices. These studies require the collection of personal, health-related information from study participants. All data are pseudonymized, meaning that your personal data (name, contact details) are stored in a separate database from your health-related data (medical history, surgery, illnesses and pregnancies). Linking the two databases can only be done by a handful of data managers working at ZEG Berlin – maintaining your confidentiality and privacy is extremely important to us.
Are there any risks in study participation?
Our studies are usually observational studies, which means that we will only collect information about you and your health status. Your physician will continue to manage your care as if you were not part of our study. Therefore, participating in one of our studies does not affect or increase the risk of side effects of the drug or medical device (which are already approved and considered safe by authorities).
Why should I participate in studies?
We monitor aspects such as disease progression, drug use, or the occurrence of rare side effects – this is why it is necessary to obtain information from many participants. Your contribution will help to improve our understanding of real-world user populations and how often side effects occur, ultimately making drugs and medical devices safer.
What about data protection?
Our studies are conducted in accordance with Good Epidemiological Practice (GEP), Good Pharmacovigilance Practice (GVP) and Good Pharmacoepidemiology Practice (GPP) for non-interventional registry studies and the applicable (inter-)national regulations for the conduct of observational research.
For the course of the study, you will only be contacted by ZEG or one of our local partner organizations. Your information will only be used for the conduct and analysis of the study – and we are only allowed to do so after you have signed the informed consent form.
Further data protection information for study participants can be found here