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Sponsors and Collaborators: |
Center for Epidemiology and Health Research, Germany Bayer Schering Pharmaceutical |
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Information provided by: | Center for Epidemiology and Health Research, Germany |
ClinicalTrials.gov Identifier: | NCT00335257 |
The study compares the short- and long-term risks of a 24-day regimen of a drospirenone-containing oral contraceptive with the risks of established oral contraceptives in a study population that is representative for the actual users of the individual preparations.
Study Type: | Observational |
Study Design: | Cohort, Prospective |
Official Title: | International Active Surveillance Study of Women Taking Oral Contraceptives (INAS OC) |
Estimated Enrollment: | 80000 |
Study Start Date: | August 2005 |
Estimated Study Completion Date: | December 2012 |
Groups/Cohorts |
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1
Users of OCs containing DRSP
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2
Users of OCs containing other progestins
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Drospirenone is a novel progestogen with antiandrogenic and antimineralocorticoid properties. A large active post-marketing surveillance study has demonstrated that a 21-day regimen of 3mg drospirenone and 30mcg ethinylestradiol can be used safely for oral contraception. The study investigates the risks of short and long-term use of a 24-day regimen of drospirenone/ethinylestradiol in comparison to established OCs in a study population that is representative of the actual users of the individual preparations.
This is a prospective, controlled, non-interventional cohort study with two study arms: OCs containing drospirenone and OCs containing any other progestogen. The study was started in the USA in April 2005 and was extended to several European countries in May 2008 based on the launch status of the 24-day regimen. New users of an OC (starters or switchers) are accrued by a network of prescribing physicians. Baseline and follow-up information are collected via a self-administered questionnaire. Data analysis will be based on life-table methods comparing the cohorts. All analyses will make allowance for confounding, using methods that will include multivariate techniques such as Cox regression.
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
Women using oral contraceptives
Inclusion Criteria:
Exclusion Criteria:
Contact: Kristina Voigt, MSc | +49 30 945 101 62 | voigt@zeg-berlin.de |
Contact: Anita Assmann, MSc | +49 30 945 101 30 | assmann@zeg-berlin.de |
Germany | |
Center for Epidemiology and Health Research | Recruiting |
Berlin, Germany, 10115 | |
Contact: Kristina Voigt, MSc +49 30 945 101 62 voigt@zeg-berlin.de | |
Contact: Anita Assmann, MSc +49 30 945 101 30 assmann@zeg-berlin.de | |
Principal Investigator: Juergen C Dinger, MD, PhD |
Principal Investigator: | Juergen C Dinger, MD, PhD | Center for Epidemiology and Health Research, Berlin, Germany |
Responsible Party: | Center for Epidemiology and Health Research, Germany ( Juergen C Dinger, MD, PhD, Principal Investiator ) |
Study ID Numbers: | ZEG 2005-2 |
Study First Received: | June 8, 2006 |
Last Updated: | December 22, 2008 |
ClinicalTrials.gov Identifier: | NCT00335257 |
Health Authority: | United States: Food and Drug Administration |
Drospirenone Safety INAS |
Drospirenone |