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

  • 2014–2027

  • Women with a newly inserted Intrauterine Device

  • N= ~ 97.000

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INAS-NEES

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

  • 2019–2029

  • Women with a newly prescribed COC (E4/DRSP; EE/LNG)

  • Venous thromboembolism

  • N=101,000 planned

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LIDEAR

Long-Term International Dual Source Endometriosis and Adenomyosis Registry (LIDEA Registry)

  • 2025-2030

  • Dynamic Multi-Country Execution

  • Women with diagnosed or presumed endometriosis or adenomyosis

  • 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

https://lidearegistry.com

GRACE

Fezolinetant Experience for the Treatment of Vasomotor Symptoms Associated with Menopause

  • 2024-2026

  • Women who initiate fezolinetant for the treatment of VMS associated with menopause per routine clinical practice in Germany.

  • N=~ 100

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Secondary Data

100+ Observational, Retrospective Studies 

  • Since 2017

  • Patient Data from Representative Claims Databases

  • Bone • Cardiovascular, Renal and Metabolism • Dermatology • Gastroenterology • General Health • Immunology • Infectious Diseases • Neurology • Oncology/Hematology • Ophthalmology • Rare Disease • Respiratory • Urology

  • 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)

  • 2010–2019

  • Women with a new hormonal therapy for endometriosis

  • Anemia associated with endometriosis-related bleeding, first time occurrence or worsening of existing clinically relevant depression, discontinuation patterns due to treatment failure

  • 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)

  • 2012–2021

  • Women with a new prescription for combined oral contraceptives

  • venous thromboembolism, arterial thromboembolism, depressive disorders, cholelithiasis, inflammatory bowel disease, effects on short- and long-term fertility and pregnancy outcomes.

  • N=101,498

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EURAS-IUD

European Active Surveillance Study for Intrauterine Devices (EURAS-IUD)

  • 2006-2016

  • Women with a newly inserted intrauterine device

  • Perforations

  • N=63,194

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EURAS-OC

European Active Surveillance Study of Oral Contraceptives (OC)

  • 2006–2009

  • Women with a new prescription for oral contraceptives

  • Drug utilization pattern

  • N=58,674

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EURAS-OC

European Active Surveillance Study of Women Taking Hormone Replacement Therapy (HRT)

  • 2004-2014

  • Women beginning oral continuous combined hormone therapy

  • Venous and arterial thromboembolism

  • N=30,597

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INAS-SCORE

International Active Surveillance study “Safety of Contraceptives: Role of Estrogens

  • 2009–2016

  • Women with a new prescription for a combined oral contraceptive

  • Venous and arterial thromboembolism

  • N=50,203

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NORA

Nexplanon Observational Risk Assessment

  • 2011–2017

  • Women with a newly inserted Nexplanon implant

  • Unintended pregnacy

  • 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