International Active Surveillance Study of Women Taking Oral Contraceptives (INAS-OC)
Information source: Center for Epidemiology and Health Research, Germany
Information obtained from ClinicalTrials.gov on December 31, 2007
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Contraception
Intervention: drospirenone/ethinylestradiol (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Center for Epidemiology and Health Research, Germany Official(s) and/or principal investigator(s):
Juergen C Dinger, MD, PhD, Principal Investigator, Affiliation: Center for Epidemiology and Health Research
Overall contact:
Juergen C Dinger, MD, PhD, Phone: +49 171 974 5433, Email: dinger@zeg-berlin.de
Summary
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.
Clinical Details
Official title: International Active Surveillance Study of Women Taking Oral Contraceptives (INAS OC)
Study design: Cohort, Prospective
Primary outcome: Thromboembolic events
Detailed description:
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 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 and will be extended to several European countries based on registration and 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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Female.
Criteria:
Inclusion Criteria:
Women starting OC use or women switching OCs
Women willing to participate in the active surveillance for several years
Woman 18 years of age or older
Exclusion Criteria:
-
Locations and Contacts
Juergen C Dinger, MD, PhD, Phone: +49 171 974 5433, Email: dinger@zeg-berlin.de
Center for Epidemiology and Health Research, Berlin 10115, Germany; Recruiting
Juergen C Dinger, MD, PhD, Phone: +49 171 974 5433, Email: dinger@zeg-berlin.de
Juergen C Dinger, MD, PhD, Principal Investigator
Additional Information
Starting date: August 2005
Ending date: May 2011
Last updated: October 23, 2007
|
