MedTrace Logo

International Active Surveillance Study - Safety of Contraceptives: Role of Estrogens

NCT01009684 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 50203

Last updated 2019-06-17

No results posted yet for this study

Summary

The primary objective of the study is to assess the risks of short and long-term use of estradiol valerate/dienogest (EV/DNG) and of established oral contraceptives (OCs) in a study population that is representative for the actual users of the individual preparations. This includes an estimate of the absolute risk of rare serious adverse outcomes.

Conditions

  • Contraception

Sponsors & Collaborators

  • Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma

    collaborator INDUSTRY

  • Center for Epidemiology and Health Research, Germany

    lead OTHER

Principal Investigators

  • Klaas Heinemann, PhD, MD, MSc · Berlin Center for Epidemiology and Health Research

Eligibility

Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-08-31
Primary Completion
2017-02-28
Completion
2017-06-30

Countries

  • Germany

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01009684 on ClinicalTrials.gov